Paulness
2週前
NEWS -- Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044
Intellectual property update confirms pelareorep's unique manufacturing process and scalability
Previously filed method-of-use patent application expected to provide protection into 2046
Additional patent filings planned in 2026 to further expand the pelareorep intellectual property estate
SAN DIEGO, June 16, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today announced that the United States Patent and Trademark Office ("USPTO") has issued a new patent broadly protecting the Company's proprietary manufacturing process for pelareorep.
The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide intellectual property protection into 2044. The patent is designed to protect the Company's ability to consistently produce pelareorep at commercial scale and represents a significant addition to Oncolytics' growing intellectual property portfolio.
The Company also announced that a previously filed method-of-use patent application directed at pelareorep's use as an immunotherapy remains under review and, if issued, is expected to provide protection into the year 2046. In addition, Oncolytics plans to file further patent applications this year that are designed to expand and strengthen the pelareorep intellectual property estate across additional therapeutic applications, treatment settings, and combination approaches.
"Building a strong intellectual property estate around pelareorep is an important part of our strategy as we advance the program toward potential registration and commercialization," said Jared Kelly, Chief Executive Officer of Oncolytics. "This newly issued patent strengthens our protection around the manufacturing of pelareorep and supports our ability to produce the product at commercial scale. Combined with our previously filed method-of-use patent application and additional planned filings, we continue to build a durable patent portfolio designed to support the long-term value of pelareorep. Checking this box represents another important milestone as we execute on our strategy and move pelareorep into its next phase of development."
The Company's intellectual property strategy is focused on protecting pelareorep through a combination of manufacturing, method-of-use, formulation, and combination therapy patents designed to support the continued development and commercialization of pelareorep across multiple oncology indications.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically "cold" tumors to "hot" through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company's goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; the Company's goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers; and plans for future disclosure of clinical trial results. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.com
Paulness
4週前
NEWS -- Oncolytics Biotech® Announces Appointment of Steve Glover to Board of Directors and Promotion of John McAdory to Chief Operating Officer
SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today announced the appointment of Steve Glover to its Board of Directors and the promotion of John McAdory to Chief Operating Officer (“COO”).
Mr. Glover brings significant public company leadership and transaction experience to Oncolytics, including serving as Chairman of Ambrx Biopharma during its acquisition by Johnson & Johnson in a transaction valued at approximately $2 billion.
Additionally, Mr. McAdory has been promoted to Chief Operating Officer. As COO, he will oversee the Company’s clinical operations and development activities, preclinical research and development efforts, and will play a key role in strategic partnerships and broader business development initiatives. Mr. McAdory joined Oncolytics earlier this year after serving as VP of Clinical Operations at CG Oncology.
“We are thrilled to welcome Steve to our Board at a transformational time for Oncolytics,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Steve has extensive experience helping build and position innovative biotechnology companies for strategic growth and value creation, including through the successful sale of Ambrx to Johnson & Johnson. His experience across corporate strategy, financing, and strategic transactions will be invaluable as we continue to advance pelareorep and expand our immunotherapy platform strategy.”
Mr. Kelly continued, “I am also very excited to announce John’s promotion to Chief Operating Officer. Since joining Oncolytics, John has already had a meaningful impact on our operational execution and clinical development strategy. His background helping advance innovative oncology programs at CG Oncology and his strong operational leadership make him ideally suited to help drive our next phase of growth as we advance our registration-enabling studies, expand our preclinical pipeline, and pursue strategic partnership opportunities.”
“I am excited to join the Board of Oncolytics during this important period of clinical and corporate momentum,” said Mr. Glover. “I believe pelareorep has the potential to become an important immunotherapy backbone across multiple solid tumor indications, and I look forward to working with the management team and Board to help maximize the platform’s value.”
“I appreciate the confidence the Board and leadership team have placed in me,” said John McAdory, Chief Operating Officer of Oncolytics. “I believe Oncolytics is uniquely positioned with compelling clinical and translational data, particularly in gastrointestinal cancers, and I look forward to helping accelerate and execute on the Company’s developmental, operational, and strategic objectives.”
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors to “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.com
ErnieBilco
1月前
Monday's Radar Pings (Nasdaq: ONCY) And 5 Key Potential Catalysts (Strong Analyst Targets)
June 1st
Greetings Readers,
Advances in oncology are accelerating as demand for more effective cancer treatments continues to rise.
The gastrointestinal cancer market alone is expanding rapidly, growing from $27.05Bn in 2025 to $30.33Bn in 2026.
One innovative, clinical-stage biotech company is drawing attention for its novel approach to targeting difficult-to-treat tumors using immune-based therapies.
By focusing on mechanisms that selectively attack cancer cells while sparing healthy tissue, this group is positioning itself within a critical area of unmet medical need.
Their progress reflects a broader shift in how cancer care may be approached in the years ahead.
And with an average analyst target projecting triple-digit potential upside, this Nasdaq idea is topping our watchlist Monday:
Oncolytics Biotech Inc. (Nasdaq: ONCY)
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent.
Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer.
And based on 5 key potential catalysts on our radar, (Nasdaq: ONCY) has hit the top of our watchlist. Take a look:
#1. An Average Of 4 Analyst Targets Suggest Major Upside Potential (Triple-Digit).
#2. An Interesting Chart Position Could Put ONCY On High Alert This Week.
#3. The Company Presents Translational Data From Key Trials At ASCO 2026.
#4. Announced Durability Data Points To Demonstrate Meaningful And Sustained Clinical Benefit In Patients.
#5. A Zacks Small-Cap Research Analyst Chimes In With A $6 Target For ONCY.
But more on those in a second...
?Complete Company Breakdown - Oncolytics Biotech Inc. (Nasdaq: ONCY)
Oncolytics Biotech Inc. is driven to improve the lives of people with cancer by giving them what matters most: more quality time.
To achieve this, the company is developing pelareorep, a unique immunotherapy designed to awaken the immune system and unlock its antitumor potential.
Pelareorep is delivered intravenously and is systemically active, setting it apart from similar immunotherapies that require direct injection into the tumor.
It has the ability to turn immunologically “cold” tumors that are resistant to therapeutic intervention “hot” by replicating in cancer cells, expanding tumor-infiltrating lymphocyte (TIL) clones in the blood, and upregulating interferons, CXCL9/10/11, and PD-L1.
Pelareorep has the potential to benefit patients with cancer across a variety of indications and can be used as a single agent or combined with other standard-of-care therapies, including chemotherapy and checkpoint inhibitors, to enhance its tumor-fighting capabilities.
The Expansive Potential of Pelareorep
Pelareorep is a first-in-class, nonpathogenic, oncolytic virus that can be delivered intravenously and works by generating, recruiting, and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access.
In addition to its demonstrated single-agent activity, pelareorep can also work in synergy with chemotherapy, immune checkpoint inhibitors (ICIs), CAR T-cell therapy, proteasome inhibitors, bispecific antibodies, and CDK4/6 and PARP inhibitors to enhance its antitumor potential and meaningfully extend patient remissions.
Pelareorep specifically targets cancer cells and induces a cascade of inflammatory responses that activate the innate and adaptive immune system to destroy the tumor while sparing normal tissue.
Pelareorep’s unique ability to introduce double-stranded RNA, a powerful immune stimulant, directly into cancer cells results in PD-L1 upregulation and cytokine and chemokine production, inducing enhanced infiltration and T-cell activation. Because pelareorep replicates only in tumor cells, it is well-tolerated by patients.
Pelareorep Mechanism Of Action
Market Opportunities
Gastrointestinal cancer is the fastest growing cancer in the world in people under 50 years old.
2L Metastatic Colorectal Cancer (mCRC)
~ 1,900,000 patients globally
~ $20Bn total addressable market with 4.7% CAGR to 2033
RAS mutant patient population high unmet medical need
15% mCRC 5-year survival rate
≥2L unresectable Squamous Cell Anal Carcinoma (SCAC)
~ 54,000 patients globally
~ $2.3Bn total addressable market by 2035, growing at 7.7% CAGR 2025-2035
Evolving standard of care with very few treatment options
36% mSCAC 5-year survival rate
1L Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
~ 500,000 patients globally
~ $3Bn total addressable market with 15% CAGR to 2032
Chemotherapy standard of care with no approved immunotherapy
3% mPDAC 5-year survival rate
Pipeline
The cancer-fighting potential of pelareorep has generated partnerships with leading academic institutions and pharmaceutical industry collaborators.
Given the validity of the mechanism of action and the efficacy observed thus far, the Company anticipates that its benefits will extend across multiple indications, including breast, gastrointestinal (GI), and hematologic malignancies.
Grab Source And More Here: ONCY Website. ONCY Presentation.
And as we mentioned previously, (Nasdaq: ONCY) has several potential catalysts putting it on our radar. Take a look:
#1. ONCY Potential Catalyst - An Average Of 4 Analyst Targets Suggest Major Upside Potential (Triple-Digit).
Check out what MarketBeat is reporting:
As of Friday's close, ONCY had 4 analyst targets pointing to a significant amount of upside potential.
In fact, with an average target of $8.50, ONCY could have over 650% potential upside from its closing valuation on the 29th.
MarketBeat reports further that Patrick R. Trucchio of H.C. Wainwright has given ONCY a $10 target representing a potential upside over 800% from Friday's close.
Could (Nasdaq: ONCY) be undervalued from current chart levels?
#2. ONCY Potential Catalyst - An Interesting Chart Position Could Put ONCY On High Alert This Week.
With ONCY closing above those 4 levels Friday, could strong support be developing during a recent vertical chart burst that has seen this profile climb from the $.77 range over the past two weeks?
Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors
Translational data demonstrate induction of both innate and adaptive antiviral and anti-tumor specific immune responses capable of controlling tumor growth
SAN DIEGO, May 22, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced translational data from the GOBLET and AWARE-1 trials will be presented at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting at McCormick Place, Chicago, Illinois, from May 29-June 2, 2026. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.
“These findings demonstrate that pelareorep works by expanding preexisting tumor-reactive immune cells rather than introducing new antigens,” said Dr. Richard Vile, Ph.D., Professor of Immunology at the Mayo Clinic and Oncolytics Scientific Advisory Board Member. “This further underscores Oncolytics’ continued commitment to define the mechanisms by which pelareorep engages the immune system and illustrates the progress being made in developing a differentiated immunotherapy to improve treatment options for difficult-to-treat cancers.”
“KRAS-mutant tumors remain among the most challenging to treat with immunotherapy,” said Jared Kelly, Chief Executive Officer of Oncolytics. “These data reflect important progress in bridging translational and clinical data and help us better understand how immune responses are activated by pelareorep. When we can point to translational and mechanistic data as the reason for clinical efficacy, it gives us confidence that our development plans are more likely to succeed.”
#4. ONCY Potential Catalyst - Announced Durability Data Points To Demonstrate Meaningful And Sustained Clinical Benefit In Patients.
Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer
2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark
Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC
SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced new durability data in metastatic colorectal cancer (“mCRC”), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable (“MSS”) disease.
“We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “A 19.5-month median duration of response in second-line patients—representing a three- to four-fold improvement over historical expectations—highlights pelareorep’s potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study.”
#5. ONCY Potential Catalyst - A Zacks Small-Cap Research Analyst Chimes In With A $6 Target For ONCY.
Another analyst, David Bautz of Zacks Small-Cap Research, has shared a $6.00 target as of mid-May.
From its 4:00PM EST close on Friday, that targets suggests 450+% potential upside for ONCY.
We look forward to additional details on the upcoming pivotal trial for pelareorep in anal cancer, for which we continue to anticipate it initiating in the second half of 2026. The updated response data for pelareorep in mCRC is very encouraging, and we look forward to updates from the company regarding the potential for accelerated approval in that indication. With no changes to our model, our valuation remains at $6 per share.
We're initiating coverage on Oncolytics Biotech Inc. (Nasdaq: ONCY).
Be on the lookout for updates coming your way soon. Talk shortly.
Sincerely,
Kai Parker
StockWireNews
Paulness
1月前
NEWS -- Oncolytics Biotech® Announces Positive Initial Preclinical Findings Supporting Further Evaluation of Pelareorep in Combination with RAS-Targeted Approaches
Early results from solid tumor model support additional studies in pancreatic and colorectal cancer models; full dataset planned for presentation later in 2026
SAN DIEGO, June 01, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.
Based on these findings, the Company is planning additional studies in models of pancreatic ductal adenocarcinoma (“PDAC”) and colorectal cancer (“CRC”) designed to further evaluate the combinations’ effects on immune activation, tumor response durability, and time-to-resistance. The ongoing work includes evaluations of pelareorep in combination with KRAS G12C inhibitors, pan-RAS inhibitors, and additional next-generation RAS pathway-targeting agents in RAS-mutated tumor models.
“We believe these initial findings further support pelareorep’s potential to serve as an immune-priming backbone for next-generation targeted therapies,” said Jared Kelly, Chief Executive Officer of Oncolytics. “RAS-mutated tumors, particularly pancreatic and colorectal cancers, remain among the most difficult cancers to treat due to intrinsic immune resistance and the emergence of therapeutic resistance over time. These preclinical results support further study of the combinations’ anti-tumor and immune effects, including in models designed to assess durability and time-to-resistance.”
Mr. Kelly continued, “Importantly, we believe this strategy may ultimately represent a potentially important area for further investigation in pancreatic cancer, where nearly all tumors harbor RAS pathway alterations and where patients continue to face extremely limited treatment options. The potential synergy observed in previous PDAC clinical studies and preclinical RAS-targeted modalities reinforces our belief that pelareorep may play an important role in future combination strategies designed to improve the durability of targeted therapies.”
Full results from the initial preclinical studies are expected to be presented in the fall or winter of 2026.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors to “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers; and plans for future disclosure of clinical trial results. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
ErnieBilco
1月前
(Nasdaq: ONCY) Tops Monday's Biotech Watchlist (Aiming For Disruption Of Potential $30Bn Market)
NOTE: the graphs and charts don't show up - look it up on Stockwirenews.com
*Click Here To Get Our Alerts Faster Via SMS*
May 31st
Greetings Readers,
Advances in oncology are accelerating as demand for more effective cancer treatments continues to rise.
The gastrointestinal cancer market alone is expanding rapidly, growing from $27.05Bn in 2025 to $30.33Bn in 2026.
One innovative, clinical-stage biotech company is drawing attention for its novel approach to targeting difficult-to-treat tumors using immune-based therapies.
By focusing on mechanisms that selectively attack cancer cells while sparing healthy tissue, this group is positioning itself within a critical area of unmet medical need.
Their progress reflects a broader shift in how cancer care may be approached in the years ahead.
And with an average analyst target projecting triple-digit potential upside, this Nasdaq idea is topping our watchlist Monday:
Oncolytics Biotech Inc. (Nasdaq: ONCY)
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent.
Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer.
And based on 5 key potential catalysts on our radar, (Nasdaq: ONCY) has hit the top of our watchlist. Take a look:
#1. An Average Of 4 Analyst Targets Suggest Major Upside Potential (Triple-Digit).
#2. An Interesting Chart Position Could Put ONCY On High Alert This Week.
#3. The Company Presents Translational Data From Key Trials At ASCO 2026.
#4. Announced Durability Data Points To Demonstrate Meaningful And Sustained Clinical Benefit In Patients.
#5. A Zacks Small-Cap Research Analyst Chimes In With A $6 Target For ONCY.
But more on those in a second...
?Complete Company Breakdown - Oncolytics Biotech Inc. (Nasdaq: ONCY)
Oncolytics Biotech Inc. is driven to improve the lives of people with cancer by giving them what matters most: more quality time.
To achieve this, the company is developing pelareorep, a unique immunotherapy designed to awaken the immune system and unlock its antitumor potential.
Pelareorep is delivered intravenously and is systemically active, setting it apart from similar immunotherapies that require direct injection into the tumor.
It has the ability to turn immunologically “cold” tumors that are resistant to therapeutic intervention “hot” by replicating in cancer cells, expanding tumor-infiltrating lymphocyte (TIL) clones in the blood, and upregulating interferons, CXCL9/10/11, and PD-L1.
Pelareorep has the potential to benefit patients with cancer across a variety of indications and can be used as a single agent or combined with other standard-of-care therapies, including chemotherapy and checkpoint inhibitors, to enhance its tumor-fighting capabilities.
The Expansive Potential of Pelareorep
Pelareorep is a first-in-class, nonpathogenic, oncolytic virus that can be delivered intravenously and works by generating, recruiting, and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access.
In addition to its demonstrated single-agent activity, pelareorep can also work in synergy with chemotherapy, immune checkpoint inhibitors (ICIs), CAR T-cell therapy, proteasome inhibitors, bispecific antibodies, and CDK4/6 and PARP inhibitors to enhance its antitumor potential and meaningfully extend patient remissions.
Pelareorep specifically targets cancer cells and induces a cascade of inflammatory responses that activate the innate and adaptive immune system to destroy the tumor while sparing normal tissue.
Pelareorep’s unique ability to introduce double-stranded RNA, a powerful immune stimulant, directly into cancer cells results in PD-L1 upregulation and cytokine and chemokine production, inducing enhanced infiltration and T-cell activation. Because pelareorep replicates only in tumor cells, it is well-tolerated by patients.
Pelareorep Mechanism Of Action
Market Opportunities
Gastrointestinal cancer is the fastest growing cancer in the world in people under 50 years old.
2L Metastatic Colorectal Cancer (mCRC)
~ 1,900,000 patients globally
~ $20Bn total addressable market with 4.7% CAGR to 2033
RAS mutant patient population high unmet medical need
15% mCRC 5-year survival rate
≥2L unresectable Squamous Cell Anal Carcinoma (SCAC)
~ 54,000 patients globally
~ $2.3Bn total addressable market by 2035, growing at 7.7% CAGR 2025-2035
Evolving standard of care with very few treatment options
36% mSCAC 5-year survival rate
1L Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
~ 500,000 patients globally
~ $3Bn total addressable market with 15% CAGR to 2032
Chemotherapy standard of care with no approved immunotherapy
3% mPDAC 5-year survival rate
Pipeline
The cancer-fighting potential of pelareorep has generated partnerships with leading academic institutions and pharmaceutical industry collaborators.
Given the validity of the mechanism of action and the efficacy observed thus far, the Company anticipates that its benefits will extend across multiple indications, including breast, gastrointestinal (GI), and hematologic malignancies.
Grab Source And More Here: ONCY Website. ONCY Presentation.
-----
And as we mentioned previously, (Nasdaq: ONCY) has several potential catalysts putting it on our radar. Take a look:
#1. ONCY Potential Catalyst - An Average Of 4 Analyst Targets Suggest Major Upside Potential (Triple-Digit).
Check out what MarketBeat is reporting:
As of Friday's close, ONCY had 4 analyst targets pointing to a significant amount of upside potential.
In fact, with an average target of $8.50, ONCY could have over 650% potential upside from its closing valuation on the 29th.
MarketBeat reports further that Patrick R. Trucchio of H.C. Wainwright has given ONCY a $10 target representing a potential upside over 800% from Friday's close.
Could (Nasdaq: ONCY) be undervalued from current chart levels?
-----
#2. ONCY Potential Catalyst - An Interesting Chart Position Could Put ONCY On High Alert This Week.
Here was ONCY's 6-month chart at close on Friday.
As you can see above, ONCY closed above 4 key technical chart levels in its:
20-Day Simple Moving Average (SMA)
50-Day SMA
5-Day Exponential Moving Average (EMA)
13-Day EMA
With ONCY closing above those 4 levels Friday, could strong support be developing during a recent vertical chart burst that has seen this profile climb from the $.77 range over the past two weeks?
-----
#3. ONCY Potential Catalyst - The Company Presents Translational Data From Key Trials At ASCO 2026.
Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors
Translational data demonstrate induction of both innate and adaptive antiviral and anti-tumor specific immune responses capable of controlling tumor growth
SAN DIEGO, May 22, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced translational data from the GOBLET and AWARE-1 trials will be presented at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting at McCormick Place, Chicago, Illinois, from May 29-June 2, 2026. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.
“These findings demonstrate that pelareorep works by expanding preexisting tumor-reactive immune cells rather than introducing new antigens,” said Dr. Richard Vile, Ph.D., Professor of Immunology at the Mayo Clinic and Oncolytics Scientific Advisory Board Member. “This further underscores Oncolytics’ continued commitment to define the mechanisms by which pelareorep engages the immune system and illustrates the progress being made in developing a differentiated immunotherapy to improve treatment options for difficult-to-treat cancers.”
“KRAS-mutant tumors remain among the most challenging to treat with immunotherapy,” said Jared Kelly, Chief Executive Officer of Oncolytics. “These data reflect important progress in bridging translational and clinical data and help us better understand how immune responses are activated by pelareorep. When we can point to translational and mechanistic data as the reason for clinical efficacy, it gives us confidence that our development plans are more likely to succeed.”
...
Read the full article here.
-----
#4. ONCY Potential Catalyst - Announced Durability Data Points To Demonstrate Meaningful And Sustained Clinical Benefit In Patients.
Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer
2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark
Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC
SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced new durability data in metastatic colorectal cancer (“mCRC”), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable (“MSS”) disease.
...
“We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “A 19.5-month median duration of response in second-line patients—representing a three- to four-fold improvement over historical expectations—highlights pelareorep’s potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study.”
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Read the full article here.
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#5. ONCY Potential Catalyst - A Zacks Small-Cap Research Analyst Chimes In With A $6 Target For ONCY.
Another analyst, David Bautz of Zacks Small-Cap Research, has shared a $6.00 target as of mid-May.
From its 4:00PM EST close on Friday, that targets suggests 450+% potential upside for ONCY.
Report highlights:
We look forward to additional details on the upcoming pivotal trial for pelareorep in anal cancer, for which we continue to anticipate it initiating in the second half of 2026. The updated response data for pelareorep in mCRC is very encouraging, and we look forward to updates from the company regarding the potential for accelerated approval in that indication. With no changes to our model, our valuation remains at $6 per share.
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(Nasdaq: ONCY) Recap - 5 Potential Catalysts Hits Our Radar
#1. An Average Of 4 Analyst Targets Suggest Major Upside Potential (Triple-Digit).
#2. An Interesting Chart Position Could Put ONCY On High Alert This Week.
#3. The Company Presents Translational Data From Key Trials At ASCO 2026.
#4. Announced Durability Data Points To Demonstrate Meaningful And Sustained Clinical Benefit In Patients.
#5. A Zacks Small-Cap Research Analyst Chimes In With A $6 Target For ONCY.
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We're initiating coverage on Oncolytics Biotech Inc. (Nasdaq: ONCY).
Be on the lookout for updates coming your way soon. Talk shortly.
Sincerely,
Kai Parker
StockWireNews
Paulness
1月前
NEWS -- Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors
Translational data demonstrate induction of both innate and adaptive antiviral and anti-tumor specific immune responses capable of controlling tumor growth
SAN DIEGO, May 22, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced translational data from the GOBLET and AWARE-1 trials will be presented at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting at McCormick Place, Chicago, Illinois, from May 29-June 2, 2026. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.
“These findings demonstrate that pelareorep works by expanding preexisting tumor-reactive immune cells rather than introducing new antigens,” said Dr. Richard Vile, Ph.D., Professor of Immunology at the Mayo Clinic and Oncolytics Scientific Advisory Board Member. “This further underscores Oncolytics’ continued commitment to define the mechanisms by which pelareorep engages the immune system and illustrates the progress being made in developing a differentiated immunotherapy to improve treatment options for difficult-to-treat cancers.”
“KRAS-mutant tumors remain among the most challenging to treat with immunotherapy,” said Jared Kelly, Chief Executive Officer of Oncolytics. “These data reflect important progress in bridging translational and clinical data and help us better understand how immune responses are activated by pelareorep. When we can point to translational and mechanistic data as the reason for clinical efficacy, it gives us confidence that our development plans are more likely to succeed.”
Abstract: Influence of pelareorep on mutant KRAS-specific blood TIL clonal expansion.
Author: Richard Trauger, PhD
Date: May 30, 2026, 1:30-4:30 p.m. Central Time
Abstract Number: 2664
Poster Board Number: 454
Translational analyses from the Phase 1/2 GOBLET study in advanced pancreatic cancer and the AWARE-1 window-of-opportunity study in early-stage breast cancer illustrate a multi-step immune activation process following treatment with pelareorep. Results demonstrate that pelareorep induces an antiviral immune response within the tumor via double-stranded RNA signaling, leading to expansion of virus-specific T cells and subsequent activation of tumor-specific T cells associated with tumor regression.
In pancreatic cancer, serial blood analyses demonstrated expansion of anti-viral T cells by ELISPOT and clonal expansion of tumor-specific T cells after one cycle of therapy. Notably, the expansion of pre-existing tumor-infiltrating lymphocyte (“TIL”) clones in blood correlated with reductions in tumor volume in pancreatic cancer. T-cell receptor sequencing with antigen specificity assessment confirmed expansion of mutant KRAS-specific T-cell clones, supporting a model in which pelareorep engages both innate and adaptive immunity and may help drive tumor-directed immune responses in difficult-to-treat, KRAS-driven disease.
In serial breast tumor biopsies, gene expression profiling demonstrated significant increases in antiviral and immune gene expression, consistent with activation of toll-like receptor 3 (TLR3), alongside induction of CXCL13, a chemokine linked to the formation of tertiary lymphoid structures (TLS). TLS formation in the tumor microenvironment was further supported by imaging mass cytometry following treatment. Across studies, evidence of the expansion of TILs was observed in the tumor and the blood.
A copy of the ASCO presentation will be available on the Media page of the Oncolytics’ website following the conclusion of the meeting.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab (Tecentriq®), gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.About AIO
AIO-Studien-gGmbH (“AIO”) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers; and plans for future disclosure of clinical trial results. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Paulness
2月前
NEWS -- Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer
2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark
Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC
SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced new durability data in metastatic colorectal cancer (“mCRC”), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable (“MSS”) disease.
Pelareorep-based combination therapy demonstrated a 19.5-month median duration of response in second-line (“2L”) KRAS-mutant MSS mCRC patients in the REO 022 study, compared to historical benchmarks of approximately 4–6 months in this setting.1 Additional data from this study include an objective response rate of 33% for patients receiving pelareorep, bevacizumab, and FOLFIRI, tripling the 6-11% for the standard of care.2, 3
“We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “A 19.5-month median duration of response in second-line patients—representing a three- to four-fold improvement over historical expectations—highlights pelareorep’s potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study.”
Oncolytics is currently enrolling patients in its randomized Phase 2 study evaluating pelareorep in combination with FOLFIRI and bevacizumab in second-line RAS-mutant MSS mCRC (link to study on ClinicalTrials.gov). The Company is actively engaging with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated approval pathway based on response durability and time-to-event endpoints from this study.
Colorectal cancer remains one of the largest oncology markets globally, with significant unmet need in later-line settings. RAS-mutant MSS mCRC represents a particularly difficult-to-treat population, where patients typically experience rapid disease progression and limited durability of response on standard therapies. The magnitude and consistency of durability and patient response observed with pelareorep-based combinations suggest the potential to meaningfully extend clinical benefit in this setting.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
References
FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C–mutated colorectal cancer. Published June 21, 2024. Accessed April 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer
Bennouna J. Lancet Oncol (14):29-37, 2013
Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, and projected outcomes of the Company’s planned clinical study of pelareorep, including the potential for accelerated regulatory approval; its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Paulness
2月前
NEWS -- Oncolytics Aligns with FDA on Planned Pivotal Anal Cancer Study
Company to leverage strong durability and survival data in second-line and later metastatic squamous cell anal carcinoma
Pivotal study expected to focus on patients in a post-standard-of-care patient population with no FDA-approved therapiesSAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced that a Type C meeting with the U.S. Food and Drug Administration (“FDA”) has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal (“SCAC”).
“We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments,” said Jared Kelly, Chief Executive Officer of Oncolytics. “While a single-arm study was possible in this setting, following a productive discussion with the FDA and in consideration of recent regulatory decisions regarding similar studies, we have aligned on a randomized controlled trial designed to potentially support both accelerated approval and full approval within the same study. This approach directly addresses relevant and rigorous evidentiary standards while allowing for approval based on multiple endpoint assessments.”
SCAC is a rare gastrointestinal malignancy affecting more than 10,000 patients annually in the United States. Patients whose disease progresses following first-line chemotherapy/checkpoint inhibitor treatment have no FDA-approved therapeutic options and limited National Comprehensive Cancer Network recommended treatments. In a recent study combining pelareorep with a checkpoint inhibitor in second-line and later SCAC, the combination achieved a median duration of response of 15.5 months versus 9.5 months and 12-month survival of 82% versus 45.7%, each measured against the current standard of care.1
“The post-first-line SCAC setting remains an area of significant unmet need,” said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX. “Pelareorep provides a strong rationale for evaluation in this population, and the study design represents a thoughtful and appropriate approach to advancing new options for these patients.”
The Company plans to incorporate FDA feedback into the final protocol, which is expected to be a single, randomized controlled trial for which accelerated approval and full approval could be applied at different points in time.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Reference
1. Rao S, et al. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, and projected outcomes of the Company’s planned clinical study of pelareorep, including the potential for accelerated regulatory approval; its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Paulness
3月前
NEWS -- Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer
SAN DIEGO, April 06, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced that it has scheduled a Type C meeting with the U.S. Food and Drug Administration (“FDA”) on April 16, 2026, to discuss a potential registrational development path in anal cancer.
The meeting will focus on the potential to initiate a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor in patients being treated with second-line and later therapy for squamous cell anal carcinoma (“SCAC”). Patients will have received a checkpoint inhibitor and chemotherapy in the first-line, which means all patients treated in this study would have no alternative approved therapies available at this stage of treatment. The Company intends to discuss a study design enrolling approximately 60 to 70 patients with objective response rate (“ORR”) as the primary endpoint to support a potential full approval.
Pelareorep, in combination with a checkpoint inhibitor, has demonstrated encouraging clinical activity in SCAC. In Cohort 4 of the GOBLET study, the combination achieved approximately 30% ORR with a median duration of response in late-line patients of 17 months. These results compare favorably to real-world outcomes, where response rates are approximately 10-14% with a median duration of response of approximately 9.5 months in this setting.1
“We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single-arm study in second-line and later SCAC. In a setting with limited approved therapies, we believe the strength and durability of our data support this approach, and recent regulatory discussions in oncolytic virus development underscore the importance of demonstrating clear, durable clinical benefit with checkpoint inhibition. With few late-line options and no confounding checkpoint inhibitor data, SCAC offers a clearer efficacy signal and a potentially more efficient path to approval for pelareorep.”
SCAC is a rare cancer with limited treatment options in the second-line and later setting, and outcomes remain poor following progression on first-line treatment. The World Health Organization estimates that there are approximately 54,000 cases of anal cancer globally each year, and the anal cancer market is expected to double to $2.3 billion from 2025 to 2035.2, 3
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies; its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its upcoming FDA meeting on a potential registrational development path for pelareorep in anal cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
References
Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: https://doi.org/10.1016/j.annonc.2020.08.2272.
International Agency for Research on Cancer. (2020). Anus fact sheet. Global Cancer Observatory. World Health Organization. https://gco.iarc.who.int/media/globocan/factsheets/cancers/10-anus-fact-sheet.pdf.
Market Research Future. (n.d.). Anal cancer market research report – Forecast to 2030. https://www.marketresearchfuture.com/reports/anal-cancer-market-1530.Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Paulness
3月前
NEWS -- Oncolytics Biotech® Completes Domicile Change to the United States
SAN DIEGO, April 01, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the completion of the previously announced change in the jurisdiction of incorporation of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States (the “Domestication”) through a series of transactions in which the Company first continued its existence from the Province of Alberta in Canada to the Province of British Columbia in Canada on March 17, 2026. The Company will retain its office in Calgary, while the San Diego office will become the Company’s new headquarters.
The Domestication was approved by the Company’s shareholders at the Special Meeting of Shareholders held on January 15, 2026. The Company completed the Domestication on March 31, 2026, when necessary filings were submitted to, and made effective by, the Nevada Secretary of State. The Company’s common stock will continue to trade on The Nasdaq Stock Market LLC under the ticker symbol “ONCY.” Effective today, the CUSIP number applicable to the Company’s common stock will be 68237V 103, and the ISIN will be US68237V1035.
Today, most of the Company’s investors, management team, and capital markets activity are U.S.-based. We expect this transition to bring several benefits to the Company and its stockholders, including greater operational efficiency, a streamlined regulatory structure, and improved access to U.S. capital markets.
“We are encouraged by the potential benefits that Nevada’s corporate legal environment presents to biotech companies, especially given our focus on operational efficiency across the company,” said Jared Kelly, Chief Executive Officer of Oncolytics. “As we no longer qualified as a “foreign private issuer” under applicable U.S. securities laws, it made sense to overhaul our corporate structure and change Oncolytics’ jurisdiction of incorporation to reflect its status as a U.S. domestic issuer. While our clinical data and regulatory strategy will ultimately give us the best opportunity to create long-term value, we believe our new corporate structure will streamline our ability to execute on our goals.”
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”).
Forward-looking statements contained in this press release include statements regarding the Company’s offices in Calgary, Alberta and San Diego, California; the expected benefits from Oncolytics’ new corporate structure, including the change in the jurisdiction of incorporation of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States; the potential benefits that Nevada’s corporate legal environment presents to biotech companies, such as Oncolytics; beliefs as to the potential, registration, mechanism of action, and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives, and its potential to create long-term value for Oncolytics; expectations around the design, milestones, anticipated timelines, and expected outcomes for current and future studies; and its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic, and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
US Market News
3月前
Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of CareMarch 19, 2026 10:00 AM
PR Newswire (US)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, March 19, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary — The global oncology market is valued at $279.98 billion in 2026 and is on track to reach $748.17 billion by 2035[1], a structural realignment driven by the shift from single-agent treatments toward synergistic combination platforms and next-gen cell therapies. The immuno-oncology segment alone is projected to expand from $65.22 billion in 2025 to $170.19 billion by 2032[2], as a wave of combination therapy approvals converts tumors once resistant to immunotherapy into viable targets. Institutions are positioning for this shift through companies like Oncolytics Biotech (NASDAQ: ONCY), Gilead Sciences (NASDAQ: GILD), enGene Holdings (NASDAQ: ENGN), TScan Therapeutics (NASDAQ: TCRX), and Day One Biopharmaceuticals (NASDAQ: DAWN) (soon to be Servier), which are each advancing translational data or near-term regulatory milestones in the 2026 cycle.Goldman Sachs has projected 2026 will be a record-breaking year for biopharma dealmaking, with pharma and biotech companies remaining the primary target as a patent cliff looms which could result in the loss of hundreds of billions in revenue[3]. This structural shift creates a window for companies with asymmetric upside in high-value solid tumor markets, as the FDA's expanded accelerated approval framework—now covering gene therapies and next-generation combination regimens—compresses the timeline from translational data to commercial launch, making regulatory milestones the primary value driver for the 2026 immuno-oncology investment cycle[4]. Oncolytics Biotech (NASDAQ: ONCY) is presenting new mechanistic and translational data at the American Association for Cancer Research (AACR) Annual Meeting in San Diego this April, data that adds scientific depth to the company's push into some of cancer's hardest-to-treat corners.The two abstracts, drawn from the AWARE-1 breast cancer study and the GOBLET gastrointestinal cancer trial, both center on the same question: can pelareorep, the company's lead drug, make tumors more vulnerable to immunotherapy? The short answer, based on these findings, appears to be yes. In AWARE-1, biopsies showed pelareorep triggering the formation of tertiary lymphoid structures, essentially localized immune hubs that help the body mount a sustained attack on cancer cells.Tumors that would otherwise stay "cold" and invisible to the immune system showed signs of becoming "hot." In GOBLET Cohort 1, patients with pancreatic cancer who showed early immune activation after four weeks on a pelareorep-based regimen lived longer without their disease progressing than those who did not, 7.5 months compared to 5.6 months. That same treatment combination previously posted a 62% objective response rate in first-line pancreatic cancer patients, more than double what chemotherapy alone has historically produced.The data matter because they help explain the results Oncolytics has already reported in colorectal cancer, where the backdrop is equally encouraging. The company recently launched REO 033, a randomized Phase 2 trial testing pelareorep alongside bevacizumab and FOLFIRI in second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer, a patient group with very few good treatment options today.The trial builds on earlier results from REO 022, where the same drug combination produced 27 months of overall survival, 11.2 months of progression-free survival, and a 33% objective response rate, against 16.6 months, 5.7 months, and roughly 10% for the standard of care. The FDA took notice, granting the regimen Fast Track Designation earlier this year. The second-line KRAS-mutant colorectal cancer market is estimated at $3 to $5 billion annually. REO 033 expects to open its first site next month, with preliminary data targeted for year-end 2026.Oncolytics is a clinical-stage biotechnology company that has spent years building a scientific case for pelareorep across multiple tumor types. Across anal cancer, pancreatic cancer, and now colorectal cancer, the drug is accumulating a consistent body of evidence as something that may make other gastrointestinal cancer treatments work better. That kind of backbone role, if confirmed in larger trials, could position Oncolytics as a meaningful partner in the broader immuno-oncology landscape, where combination strategies are increasingly where the field is heading.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:Gilead Sciences (NASDAQ: GILD) reported fourth quarter and full year 2025 financial results showing oncology revenues of $3.2 billion for the year, anchored by a 6% increase in Trodelvy sales to $1.4 billion on higher breast cancer demand, while Yescarta received a label update removing a limitation around Primary Central Nervous System Lymphoma, making it the only CAR-T therapy in relapsed or refractory large B-cell lymphoma to have that restriction lifted. The company also presented positive pivotal Phase 2 iMMagine-1 data for its Arcellx-partnered CAR T-cell therapy anitocabtagene autoleucel in 4L+ relapsed or refractory multiple myeloma at the 2025 American Society of Hematology meeting, with two additional cancer therapy launches anticipated in 2026."In 2026, our potential new launches include two cancer therapies and an additional HIV treatment option, and we look forward to building on the launches of Yeztugo and Livdelzi for liver disease," said Daniel O'Day, Chairman and CEO of Gilead Sciences.Gilead Sciences closed 2025 with $10.6 billion in cash and marketable debt securities and generated $10.0 billion in operating cash flow for the full year. For 2026, Gilead Sciences guides for total product sales of $29.6 billion to $30.0 billion and non-GAAP diluted EPS of $8.45 to $8.85, with anticipated oncology launches expected to contribute meaningfully to growth alongside continued HIV franchise momentum.enGene Holdings (NASDAQ: ENGN) reported Q1 2026 financial results reflecting continued advancement of its lead non-viral gene therapy candidate, detalimogene voraplasmid, toward a Biologics License Application submission targeted for the second half of 2026. The company's pivotal LEGEND cohort of 125 BCG-unresponsive NMIBC patients demonstrated a 63% complete response rate at any time and a 62% CR rate at 6 months, while enGene Holdings closed Q1 with $312.5 million in cash and marketable securities."As data from LEGEND's pivotal cohort in high-risk, BCG-unresponsive NMIBC continues to mature, we look forward to providing an update at a spring medical conference," said Ron Cooper, President and CEO of enGene Holdings. "With RMAT and CDRP designations for detalimogene, we are in active dialogue with the FDA to ensure regulatory and manufacturing readiness as we plan for a BLA submission in the second half of this year and potential launch in 2027."enGene Holdings expanded its Hercules Capital debt facility to $125 million in January 2026, providing additional non-dilutive capital ahead of its planned commercial launch. The company expects its current cash position to fund operations into the second half of 2028, and 12-month complete response data from the LEGEND pivotal cohort is expected in 2H 2026.TScan Therapeutics (NASDAQ: TCRX) reported Q4 and full year 2025 financial results while providing updates on its TCR-engineered T cell hematologic malignancies program, including the completion of enrollment in Cohort C of the Phase 1 ALLOHA trial and FDA clearance of INDs for two new CD45-targeting candidates, TSC-102-A01 and TSC-102-A03. Full year 2025 collaboration and license revenue reached $10.3 million versus $2.8 million in 2024, with cash and equivalents of $152.4 million expected to fund operations into 2H 2027."The regulatory and operational progress we have made over the last several months related to our heme program is exciting," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We expect the momentum to continue into the second quarter when we plan to share the initial data from patients enrolled into Cohort C in the ALLOHA study as well as initiate TScan's first Phase 3 trial. The data we presented at ASH in December 2025 continue to support our decision to focus the Company's efforts on development of therapeutics for patients with heme malignancies. Additionally, the recent FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 will allow us to bring our TCR-T therapies to twice as many patients who currently have limited options in the post-transplant setting."TScan Therapeutics discontinued its PLEXI-T solid tumor trial in November 2025 to concentrate resources on hematologic malignancies, and anticipates sharing preclinical proof-of-concept data from its autoimmunity program in 2H 2026. Updated Cohort C data and initiation of a Phase 1 study for TSC-102-A01 and TSC-102-A03 are both expected in the second half of 2026.Day One Biopharmaceuticals (NASDAQ: DAWN) announced a definitive acquisition agreement under which Servier will acquire all outstanding shares of Day One Biopharmaceuticals for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. The offer price represents a premium of approximately 68% over Day One Biopharmaceuticals' closing price on March 5, 2026, and approximately 86% over its one-month volume weighted average price, reflecting significant value recognition for the company's lead pediatric low-grade glioma program and broader oncology pipeline."Servier's successful track record in rare cancers and its commitment to advancing targeted therapies makes it the ideal home for our portfolio as part of Day One Biopharmaceuticals' mission to bring medicines to patients of all ages with life threatening diseases," said Jeremy Bender, Ph.D., CEO of Day One Biopharmaceuticals. "Joining Servier represents a unique opportunity to extend the reach of our science and our lead program in pediatric low-grade glioma."The transaction is subject to customary closing conditions, including shareholder tender and U.S. antitrust clearance, and is expected to close in Q2 2026. Day One Biopharmaceuticals' Board of Directors has unanimously recommended that shareholders tender their shares, and Servier expects to fund the acquisition through existing cash and investments.Article Source: usanewsgroup.comCONTACT:USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035https://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-ashttps://www.foley.com/insights/publications/2025/09/patent-cliff-ma-activity-for-companies-right-now/https://www.pharmexec.com/view/fda-s-new-accelerated-approval-draft-guidanceLogo - https://mma.prnewswire.com/media/2838876/5873016/USA_News_Group_Logo.jpg
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Original: Combination Therapies Reshape Oncology: A $748B Market Shifts Standard of Care
Paulness
3月前
NEWS -- Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026
Oncolytics Biotech, Inc.
Pelareorep treatment drives coordinated immune activation and tertiary lymphoid structure formation
Translational data suggest potential to boost response to immunotherapy and targeted therapy in RAS-driven tumors
Pelareorep’s ability to engage the innate and adaptive immune system results in doubling or nearly tripling response rates in breast and gastrointestinal cancers
SAN DIEGO, March 19, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced two abstracts across distinct tumor types were accepted for presentation at the American Association for Cancer Research (“AACR”) Annual Meeting 2026, at the San Diego Convention Center from April 17-22, 2026. Pelareorep is an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways via double-stranded RNA signaling, driving interferon production, dendritic cell activation, and cytotoxic T-cell priming.
“These new translational findings strengthen our understanding of pelareorep as a systemic immune-priming agent that reshapes the tumor microenvironment,” said Jared Kelly, Chief Executive Officer of Oncolytics. “The coordinated immune activation and tertiary lymphoid structure formation we are observing support pelareorep as a foundational backbone for combination therapy across multiple tumor types, including RAS-driven cancers. RAS mutations are especially prevalent in deadly cancers, including roughly 95% of pancreatic cancers and 45% of colorectal cancers. As we advance registrational programs in gastrointestinal cancers, we believe pelareorep will enhance immunotherapy activity and potentially help patients who did not respond initially.”
Biomarker data from cohort 1 of the Phase 1/2 GOBLET trial in advanced pancreatic cancer suggest pelareorep plus atezolizumab and gemcitabine/nab-paclitaxel can shift tumors toward a more immune-active state. Patients with an immune activation signature after four weeks were more likely to achieve durable clinical benefit, supporting a potential biomarker. Pancreatic cancer continues to pose a significant unmet clinical need, with approximately 510,000 new cases reported globally each year.1
Additionally, new first-of-its-kind data from AWARE-1 show pelareorep can drive coordinated anti-tumor immune responses, including tertiary lymphoid structure (“TLS”) formation, helping make immunologically cold tumors more susceptible to immunotherapy. This could include patients who have failed checkpoint inhibitors, representing a significant portion of the patient population and a meaningful unmet need in oncology.
Pelareorep has also been shown to stimulate RAS-specific T-cell clones in gastrointestinal cancers, which may enhance its ability to target RAS-mutated tumor cells. The Company will present more data on this topic at an upcoming scientific meeting.
Together, the data support pelareorep as a novel immune-priming strategy capable of enhancing the activity of multiple therapeutic classes, including checkpoint inhibitors, targeted therapies, chemotherapy, and emerging immuno-oncology modalities.
Abstract: Pelareorep combined with atezolizumab and chemotherapy shows immune conversion activity in advanced pancreatic cancer: Biomarker results of cohort 1 of the GOBLET trial
New biomarker data from cohort 1 of the Phase 1/2 GOBLET study demonstrated that pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel led to meaningful immune activation in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”).
An exploratory analysis integrating routine serum markers, a 172-protein circulating panel, selected T-cell receptor sequencing, and clinical outcomes found early on-treatment changes showed increases in adaptive immune and cytotoxicity-associated proteins, including interferon signaling and CD8+/NK-related markers, alongside decreases in tumor/stroma-associated proteins. A 14-protein signature linked to oncolytic activity stratified patients at Week 4 into ‘hot’ vs. ‘cold’ immune phenotypes relative to baseline. Patients demonstrating immune activation signatures experienced longer median progression-free survival (7.5 months) compared with patients who did not exhibit similar immune responses (5.6 months).
As previously reported, the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel demonstrated a 62% objective response rate in first-line mPDAC patients, more than double the response rates historically observed with chemotherapy alone.
Abstract: Imaging mass cytometry of pelareorep treated early breast cancer samples reveals developing tertiary lymphoid structures
AWARE-1 is a window-of-opportunity study evaluating the effects of pelareorep in early-stage breast cancer. In biopsies from Cohort 2 (n=8), cellular neighborhood analysis identified immune-cell clusters, including cytotoxic T cells, dendritic cells, T helper cells, activated T helper cells, B cells, differentiated B cells, and M2 macrophages. Interactions between these cells developed into TLS in select patients. TLS function as localized immune hubs that facilitate antigen presentation, T-cell activation, and sustained anti-tumor immune responses. Published studies link TLS formation with improved responses to immunotherapy.
These findings support pelareorep’s potential to expand cytotoxic T cells, activate dendritic cells, and promote TLS formation, helping to convert immunologically ‘cold’ tumors into immune-responsive ‘hot’ tumors.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.
Reference
Leiphrakpam PD, Chowdhury S, Zhang M, et al. Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its Histologic and Molecular Subtypes. J Gastrointest Cancer. 2025 Feb 24;56(1):71.About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the timing of the AACR Annual Meeting 2026; expectations as to the content and potential opportunities associated with the findings from the various studies expected to be presented via abstracts in the future; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies; anticipated timelines and objectives for future meetings with regulatory bodies, including the FDA; and its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers as well as breast cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
US Market News
4月前
Next-Generation Cancer Therapies Post Breakthrough Results Across Multiple Tumor TypesMarch 5, 2026 9:00 AM
PR Newswire (US)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, March 5, 2026 /PRNewswire/ -- Equity-Insider.com News Commentary — The five-year cancer survival rate in the United States has reached a record 70%, reflecting decades of progress in early detection, targeted therapy, and immunotherapy[1]. Yet cancer remains the second-leading cause of death worldwide, with an estimated 2.1 million new diagnoses expected in 2026 alone and mortality rates still climbing among younger populations[2]. Companies delivering next-generation oncology treatments across multiple tumor types include Oncolytics Biotech (NASDAQ: ONCY), Vir Biotechnology (NASDAQ: VIR), Iovance Biotherapeutics (NASDAQ: IOVA), C4 Therapeutics (NASDAQ: CCCC), and Immunocore (NASDAQ: IMCR).
The global oncology market is projected to nearly triple from $279.98 billion to $748.17 billion by 2035, with North America commanding a 43% market share[3]. The immuno-oncology segment alone is expected to grow at a compound annual rate of approximately 21% over the next five years, driven by checkpoint inhibitors, cell therapies, and cancer vaccines collectively redefining standards of care[4].Oncolytics Biotech (NASDAQ: ONCY) has launched a study that could reshape how doctors treat one of the most stubborn forms of colorectal cancer. The company's randomized Phase 2 trial, REO 033, will evaluate pelareorep in combination with bevacizumab and FOLFIRI in second-line RAS-mutated (which includes KRAS), microsatellite-stable metastatic colorectal cancer, a patient population where current treatments offer limited benefit and new options are urgently needed."I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way," said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey. "The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration."The confidence behind REO 033 stems from compelling data generated in a previous clinical study. Pelareorep combined with bevacizumab and FOLFIRI demonstrated 27 months of overall survival and 16.6 months of progression-free survival, compared to 11.2 and 5.7 months for the standard of care. Objective response rate was 33% versus approximately 10% for the standard of care, more than tripling the benchmark in a notoriously difficult-to-treat population. Notably, this treatment regimen was granted Fast Track Designation by the FDA earlier this year."The potential to improve clinical outcomes compared to the standard of care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer," said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. "An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more patients being diagnosed with colorectal cancer."The global market for second-line treatment in KRAS-mutant, microsatellite-stable metastatic colorectal cancer runs between $3-5 billion annually. The study will randomize 60 patients to either the pelareorep combination or a control arm of bevacizumab and FOLFIRI, with objective response rate as the primary endpoint. Oncolytics expects to open the first study site later this month, with additional clinical sites added in quick succession, and preliminary data is expected by year-end 2026.CONTINUED… Read this and more news for Oncolytics Biotech at:https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:Vir Biotechnology (NASDAQ: VIR) has reported positive Phase 1 results for VIR-5500, a PSMA-targeting T-cell engager in metastatic prostate cancer. Dose-dependent anti-tumor activity was observed, with 82% PSA50 and 53% PSA90 declines and objective responses in 45% of RECIST (Response Evaluation Criteria in Solid Tumors)-evaluable patients at higher dose cohorts, representing a meaningful signal in a heavily pretreated population."We are encouraged by VIR-5500's safety and tolerability profile and the early signals of durable anti-tumor activity in a heavily pre-treated population, which validate our PRO-XTEN® masking strategy aimed at achieving a differentiated therapeutic index," said Marianne De Backer, CEO of Vir Biotechnology. "Based on these data, we are advancing dose-expansion cohorts and plan to initiate our registrational trial in 2027. We want to thank the patients in our Phase 1 program and their families for participating in the development of VIR-5500."The company has entered a global collaboration with Astellas to develop and commercialize VIR-5500, providing financial validation of the PRO-XTEN platform's potential to address unmet needs across solid tumor indications.Iovance Biotherapeutics (NASDAQ: IOVA) has announced positive results from the first clinical trial of TIL cell therapy in advanced undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS). The study demonstrated a 50% objective response rate with one-time treatment of lifileucel in soft tissue sarcoma subtypes where treatment options remain severely limited."In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with lifileucel demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care," said Lauren Baker Banks, MD, PhD, Sarcoma Medical Oncologist at Memorial Sloan Kettering Cancer Center. "Patients with UPS and DDLPS suffer from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options. In the second-line setting, mPFS for many patients is only a few months with mOS less than a year. We look forward to presenting these results at a medical conference in 2026."Iovance's AMTAGVI became the first FDA-approved TIL therapy in February 2024, establishing the company as the pioneer in commercially available tumor-infiltrating lymphocyte treatments.C4 Therapeutics (NASDAQ: CCCC) has dosed the first patient in the Phase 2 MOMENTUM trial of cemsidomide, an oral IKZF1/3 degrader for relapsed or refractory multiple myeloma. The study will evaluate cemsidomide in combination with dexamethasone, building on the compelling anti-myeloma activity observed in early-phase studies."Initiating the Phase 2 MOMENTUM trial, which builds upon the compelling anti-myeloma activity and differentiated safety profile established in the Phase 1 trial, is a critical step for cemsidomide to become a foundational therapy for multiple myeloma patients, who are in need of a safe, oral, and convenient treatment option," said Len Reyno, Chief Medical Officer of C4 Therapeutics. "With this milestone accomplished, we are also on track to initiate the Phase 1b trial of cemsidomide in combination with elranatamab in the second quarter, as we continue to advance our regulatory strategy that could deliver two accelerated approval paths in multiple myeloma."The company is also advancing a Phase 1b combination study with elranatamab on track for the second quarter of 2026. Oral targeted protein degradation represents a growing modality in hematologic oncology, with multiple companies racing to validate degrader-based approaches in myeloma.Immunocore (NASDAQ: IMCR) has reported results headlined by $400 million in KIMMTRAK sales for full-year 2025, a 29% increase year over year. The ImmTAC platform is advancing clinical programs across melanoma, non-small cell lung cancer, and additional solid tumor indications."With $400 million in KIMMTRAK sales and a diverse clinical portfolio, Immunocore had a productive year of growth and progress," said Andrew Baum, CEO of Immunocore. "Our priority for 2026 is the clear execution of our clinical trials, particularly as we anticipate key data in oncology and begin our first trial in autoimmune disease. We remain focused on the long-term goal of developing medicines that can significantly improve patient lives."Immunocore's ImmTAC platform engineers bispecific T-cell receptors capable of redirecting the immune system to recognize intracellular cancer targets, a fundamentally different approach from checkpoint inhibitors or cell therapies.Article Source: equity-insider.comCONTACT:
EQUITY INSIDER
info @athomedadDISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:1. https://www.curetoday.com/view/cancer-five-year-survival-rate-hits-record-70-2026-report-shows
2. https://pressroom.cancer.org/cancer-statistics-report-2026
3. https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035
4. https://www.pharmiweb.com/press-release/2026-02-09/immuno-oncology-io-market-size-share-growth-analysis-and-forecast-to-2030Logo - https://mma.prnewswire.com/media/2840019/Equity_Insider_Logo.jpg
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Original: Next-Generation Cancer Therapies Post Breakthrough Results Across Multiple Tumor Types
Paulness
4月前
NEWS -- Oncolytics Biotech® Launches Randomized Colorectal Cancer Study
Controlled study designed to confirm previous compelling efficacy with preliminary data expected by the end of 2026
Pelareorep-based treatment regimen recently granted Fast Track Designation in 2L KRAS-mutant MSS metastatic colorectal cancer, confirming its potential in this large indication
SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the initiation of a metastatic colorectal cancer (“mCRC”) Phase 2 study that will be referred to as REO 033.
In this trial, second-line (“2L”) RAS-mutated (which includes KRAS), microsatellite-stable (“MSS”) mCRC patients will be randomized to a control arm of bevacizumab (Avastin®) and fluorouracil, leucovorin, irinotecan (“FOLFIRI”) or an experimental arm of pelareorep, bevacizumab, and FOLFIRI. The study is powered for statistical significance, with each study arm expected to enroll 30 patients. All participants will have failed their initial treatment with platinum-based chemotherapy. The primary endpoint of the study is objective response rate (“ORR”), with progression-free survival (“PFS”), overall survival (“OS”), safety, and biomarker analysis as other endpoints. The trial will be sponsored by Oncolytics with Sanjay Goel, M.D., M.S., FASCO, Professor of Medicine at Rutgers Cancer Institute of New Jersey, as the Lead Investigator. The Company is expecting to initiate the first study site later this month and provide preliminary data by year-end.
“I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way,” said Dr. Goel. “The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration.”
The previous REO 022 clinical study of pelareorep, bevacizumab, and FOLFIRI in this population demonstrated a median OS of 27 months and a median PFS of 16.6 months, both of which substantially exceed the median 11.2- and 5.7-month OS and PFS, respectively, observed for standard-of-care therapy. Similarly, ORR in the same study was 33% for pelareorep-containing therapy compared to approximately 10% for standard-of-care treatment.1-2 Last month, the Company announced that pelareorep in combination with bevacizumab and FOLFIRI was granted Fast Track Designation by the U.S. Food & Drug Administration in 2L KRAS-mutant, MSS mCRC.
“The potential to improve clinical outcomes compared to the standard-of-care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer,” said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, and member of the Oncolytics Biotech Gastrointestinal Scientific Advisory Board. “An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more younger patients being diagnosed with colorectal cancer.”
References
Bennouna J. Lancet Oncol (14):29-37, 2013
Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the anticipated design, size, management, timelines, milestones, and outcomes of current and future studies; the Company’s goals, strategies, and objectives; and its belief in the clinical promise of pelareorep in colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
US Market News
4月前
Immuno-Oncology Investments Accelerate as Pipeline Catalysts Multiply in 2026February 25, 2026 9:00 AM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Feb. 25, 2026 /CNW/ -- Equity Insider News Commentary, The immuno-oncology market is forecast to grow from $65.22 billion in 2025 to $170.19 billion by 2032, fueled by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines[1]. Five companies positioned at the forefront of this expansion include Oncolytics Biotech (NASDAQ: ONCY), ImmunityBio (NASDAQ: IBRX), CRISPR Therapeutics (NASDAQ: CRSP), BioNTech (NASDAQ: BNTX), and Novocure (NASDAQ: NVCR).
The broader oncology market is projected to nearly triple from $279.98 billion to $748.17 billion by 2035, with North America commanding a 43% market share[2]. Targeted therapy remains the fastest-growing segment within the $335.2 billion cancer drugs market projected for 2033, as personalized medicine reshapes treatment paradigms[3].Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval.The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication.With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs."GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution."The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment.KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026.Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy.The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.CONTINUED… Read this and more news for Oncolytics Biotech at:https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:ImmunityBio (NASDAQ: IBRX) recently announced a partnership with Accord Healthcare to expand European access to ANKTIVA for bladder cancer patients across 33 countries. ANKTIVA achieved a 71% complete response rate in BCG-unresponsive non-muscle invasive bladder cancer, with approvals spanning the U.S., EU, UK, and Saudi Arabia."Our partnership with Accord marks a significant step in our European growth strategy and our mission to redefine cancer care," said Richard Adcock, President and CEO of ImmunityBio.The company continues to advance its IL-15 receptor agonist platform.CRISPR Therapeutics (NASDAQ: CRSP) provided a business update reporting encouraging clinical data from its allogeneic CAR-T candidate, zugocabtagene geleucel (zugo-cel), in both autoimmune disease and oncology indications. CASGEVY generated $116 million in full-year 2025 revenue, with patient initiations increasing nearly three-fold year-over-year."We made meaningful advances across multiple clinical and preclinical programs, including encouraging data from zugo-cel in autoimmune disease and oncology, continued global uptake of CASGEVY, and important developments across our in vivo liver editing portfolio," said Samarth Kulkarni, Ph.D., Chairman and CEO of CRISPR Therapeutics.The company is building a differentiated oncology platform with its allogeneic CAR-T approach, which could enable off-the-shelf cancer therapies without patient-specific manufacturing.BioNTech (NASDAQ: BNTX) outlined its 2026 strategy at the J.P. Morgan Healthcare Conference, detailing plans to initiate six additional Phase 3 clinical trials this year. The company now has more than 25 ongoing Phase 2 or 3 oncology trials spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies."We see 2026 as a year when science translates into tangible results," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.The company held approximately 17.2 billion euros in cash as of December 2025, positioning it to fund at least 17 late-stage data readouts expected by 2030.Novocure (NASDAQ: NVCR) received FDA approval for its Optune Pax system in locally advanced pancreatic cancer, the first new treatment approved for this indication in approximately 30 years. The Phase 3 PANOVA-3 trial demonstrated a statistically significant improvement in overall survival."Systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells," said Frank Leonard, CEO, Novocure.The Tumor Treating Fields platform is also approved in certain countries for glioblastoma and malignant pleural mesothelioma, with additional pipeline candidates in development.Article Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/CONTACT:
EQUITY INSIDER
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-ashttps://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035https://www.prnewswire.com/news-releases/oncologycancer-drugs-market-to-reach-335-2-billion-by-2033-globally-at-7-2-cagr-allied-market-research-302683974.htmlLogo - https://mma.prnewswire.com/media/2840019/5821165/Equity_Insider_Logo.jpg
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Original: Immuno-Oncology Investments Accelerate as Pipeline Catalysts Multiply in 2026
US Market News
4月前
Oncology Market Set to Nearly Triple: Here Are Five Companies Leading the ChargeFebruary 24, 2026 10:58 AM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Feb. 24, 2026 /CNW/ -- USA News Group News Commentary, The global oncology market is on track to nearly triple in value over the next decade, growing from $279.98 billion in 2026 to an estimated $748.17 billion by 2035[1]. Cancer drug revenues alone are projected to reach $335.2 billion by 2033, driven by a surge in targeted therapies and immunotherapy adoption[2]. Five companies advancing novel approaches in the oncology sector include Oncolytics Biotech (NASDAQ: ONCY), Exelixis (NASDAQ: EXEL), Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and Gilead Sciences (NASDAQ: GILD).
The immunotherapy drugs market is experiencing significant growth as rising cancer prevalence accelerates demand for targeted treatments and combination therapies[3]. The immuno-oncology segment specifically is forecast to expand from $65.22 billion in 2025 to $170.19 billion by 2032, representing a compound annual growth rate of 14.9%[4].Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval.The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication.With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs."GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution."The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment.KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026.Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy.The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.CONTINUED… Read this and more news for Oncolytics Biotech at:https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other industry developments:Exelixis (NASDAQ: EXEL) reported strong results for fiscal year 2025, with U.S. net product revenues from its cabozantinib franchise reaching $2.1 billion. The FDA accepted the company's New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer."The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities," said Michael M. Morrissey, Ph.D., President and CEO of Exelixis.The company has a target FDA action date of December 2026 for zanzalintinib, which could establish a second major oncology franchise.Eli Lilly (NYSE: LLY) announced positive results from its Phase 3 LIBRETTO-432 trial, showing that Retevmo delivered a highly statistically significant improvement in event-free survival as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer. The trial is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor in this population."We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, executive vice president and president of Lilly Oncology.The company plans to present detailed results at an upcoming medical congress and discuss findings with global health authorities.Merck (NYSE: MRK) received FDA approval for KEYTRUDA and its subcutaneous formulation KEYTRUDA QLEX plus paclitaxel for adults with PD-L1-positive platinum-resistant ovarian cancer. KEYTRUDA is the first PD-1 inhibitor approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma."For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback, it's when options can become limited, and the reality patients face can change very quickly," said Dr. Bradley Monk, gynecologic oncologist at Florida Cancer Specialists and Research Institute.The KEYNOTE-B96 trial demonstrated a 28% reduction in the risk of disease progression or death and a 24% reduction in the risk of death compared to placebo.Gilead Sciences (NASDAQ: GILD) received an updated label for its Kite subsidiary's Yescarta CAR T-cell therapy, with the FDA removing previous limitations of use in relapsed or refractory primary central nervous system lymphoma. Yescarta is now the only CAR T-cell therapy approved for large B-cell lymphoma with this designation."This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options," said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute.Article Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035https://www.prnewswire.com/news-releases/oncologycancer-drugs-market-to-reach-335-2-billion-by-2033-globally-at-7-2-cagr-allied-market-research-302683974.htmlhttps://www.globenewswire.com/news-release/2026/02/17/3239494/28124/en/Immunotherapy-Drugs-Market-Research-and-Forecast-Report-2020-2025-2025-2026-with-Analyst-Recommendations-Adoption-of-AI-in-Drug-Discovery-Combination-Therapies.htmlhttps://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-asLogo - https://mma.prnewswire.com/media/2838876/5821139/USA_News_Group_Logo.jpg
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Original: Oncology Market Set to Nearly Triple: Here Are Five Companies Leading the Charge
Paulness
4月前
NEWS -- Oncolytics Biotech® to Prioritize Registration-Focused Programs in Anal and Colorectal Cancer
Company to wind down the GOBLET gastrointestinal study to focus on registration path in the U.S.
With sufficient cash on hand to execute near-term milestones, the Company expects to avoid immediate material dilution
SAN DIEGO, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has concluded enrollment in the GOBLET study, having generated the necessary clinical and translational data to inform its next phase of development. With sufficient cash on hand to execute near-term milestones, the Company will now focus its efforts and resources on registrational and registration-enabling studies in squamous cell anal cancer (“SCAC”) and metastatic colorectal cancer (“CRC”).
“GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution.”
The promising efficacy signal observed in GOBLET Cohort 4 has defined a clear registrational path for pelareorep-based therapy in second-line and later SCAC, a setting in which available therapies offer only limited benefit. The Company is planning to move quickly to pursue regulatory approval through a U.S.-based study to ensure the enrollment of patients representative of the current standard of care.
Oncolytics expects to meet with the U.S. Food and Drug Administration (“FDA”) in mid-April. The objective of this meeting is to align on the design of a single-arm SCAC registrational study. Based on the observed efficacy signal in GOBLET Cohort 4, the Company believes a clinical trial of well under 100 subjects will be sufficient to secure FDA approval in this rare cancer indication.
Given its strategic focus on SCAC and CRC, and the desire to deploy capital efficiently, Oncolytics has elected to stop further enrollment in the GOBLET Cohort 5 metastatic pancreatic ductal adenocarcinoma (“PDAC”) cohorts at approximately 20 patients per arm. The Company believes the available data are sufficient to inform its future PDAC strategy while limiting additional spend on this indication at this time.
Current enrollment in GOBLET Cohort 5 allows responses to therapy, including overall survival, to be analyzed. The Company will continue to follow Cohort 5 patients currently on study, monitor their responses, and plan to report results once the data reach maturity.
“The GOBLET study has provided invaluable insights into the efficacy and safety of pelareorep in gastrointestinal cancers,” said Thomas Heineman, MD, Chief Medical Officer of Oncolytics. “These data have provided crucial support for our platform approach in GI cancers. They have, in fact, allowed us to identify a clear and efficient path forward as we move into registration-focused development of pelareorep in GI cancers.”
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the anticipated design, size, protocols strategy, priorities, timelines, milestones, and outcomes of current and future studies; the Company’s expectations regarding its cash position, liquidity, and funding requirements; the Company’s goals, strategies, and objectives; anticipated timelines and objectives for future meetings with regulatory bodies, including the FDA; and its belief in the clinical promise of pelareorep in anal, colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
US Market News
4月前
New Treatment Modalities Are Reaching Cancers That Resisted Everything ElseFebruary 17, 2026 11:25 AM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Feb. 17, 2026 /CNW/ -- Equity-Insider.com News Commentary – More than 2,100 oncology clinical trials were initiated globally in 2024, with targeted therapies representing the fastest-growing subsegment and over 100 antibody-drug conjugates now in active clinical development[1]. That pipeline depth extends to radiopharmaceuticals, cell therapies, and device-based platforms now generating survival data in tumor types that have resisted conventional approaches for decades. Oncolytics Biotech Inc. (NASDAQ: ONCY), Novocure (NASDAQ: NVCR), Perspective Therapeutics, Inc. (NYSE-A: CATX), ImmunityBio, Inc. (NASDAQ: IBRX), and Nuvation Bio Inc. (NYSE: NUVB) each represent distinct modalities advancing through clinical development in historically treatment-resistant cancers[2].
Leading researchers at the AACR forecast that 2026 will accelerate deployment of smarter delivery systems engineered to function in hostile tumor microenvironments, from armored T cells and off-the-shelf NK platforms to radiopharmaceuticals targeting stromal and receptor-specific biology[3]. That momentum is already visible in the clinic, where several programs are now converting early signals into registration-enabling data.Oncolytics Biotech Inc. (NASDAQ: ONCY) recently received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.The designation is based on clinical data showing pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy and Avastin®. More importantly, patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.This matters because KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually."Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate," said Jared Kelly, CEO of Oncolytics Biotech.The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: John McAdory as Executive Vice President of Strategy and Operations, who ran late-stage clinical trials at CG Oncology, and Yujun Wu as Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other recent industry developments and happenings in the market include:Novocure (NASDAQ: NVCR) secured FDA approval for Optune Pax, a wearable medical device delivering Tumor Treating Fields, for the treatment of locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel. The approval marks the first new treatment cleared for this patient population in nearly 30 years. In the Phase 3 PANOVA-3 trial, patients receiving Optune Pax achieved a median overall survival of 16.2 months versus 14.2 months for chemotherapy alone, a statistically significant two-month improvement that also extended median time to pain progression by 6.1 months."The FDA approval of Optune Pax marks the first new treatment in decades for people living with locally advanced pancreatic cancer," said Frank Leonard, CEO of Novocure. "Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells."The device was well-tolerated with no new safety signals, and one-year survival in the intent-to-treat group reached 68.1% versus 60.2% for chemotherapy alone. Results from PANOVA-3 were published in the Journal of Clinical Oncology, and Novocure plans a full commercial launch targeting the estimated 67,000 patients diagnosed annually with pancreatic cancer in the United States.Perspective Therapeutics, Inc. (NYSE-A: CATX) presented updated interim data from its Phase 1/2a trial of [212Pb]VMT-a-NET in neuroendocrine tumors at the 2026 ASCO Gastrointestinal Cancers Symposium, with a December 10, 2025, data cutoff providing approximately 13 additional weeks of follow-up since the prior ESMO presentation. Among 23 evaluable patients in Cohort 2 receiving 5.0 mCi, nine (39%) achieved objective response per RECIST v1.1 regardless of SSTR2 expression profile, and 76% of the 25 total evaluable patients remained progression-free and alive. Safety data across 56 patients showed no dose-limiting toxicities, no treatment-related discontinuations, and no clinically significant myelosuppression."With longer follow-up and a growing body of clinical experience, we continue to see evidence of sustained and deepening anti-tumor activity for VMT-a-NET at the dose level evaluated in Cohort 2, while the favorable tolerability profile is maintained, possibly even at a higher dose," said Vikas Prasad, MD, Professor of Radiology at Washington University School of Medicine.Cohort 3 (6.0 mCi) cleared its dose-limiting toxicity assessment, and Perspective has begun treating additional patients at the higher dose. Initial efficacy data are pending for another 23 patients in Cohort 2 and 8 in Cohort 3, with regulatory engagement planned for 2026 to advance toward a registrational trial.ImmunityBio, Inc. (NASDAQ: IBRX) launched ResQ215B, a Phase 2 clinical study evaluating a chemotherapy-free, lymphodepletion-free combination of its off-the-shelf CD19 CAR-NK cell therapy with ANKTIVA (nogapendekin alfa inbakicept) and rituximab in patients with indolent B-cell non-Hodgkin lymphoma (NHL), including Waldenström's Macroglobulinemia. The trial builds on Phase 1 QUILT-106 results in which all four evaluable patients with Waldenström's achieved disease control without lymphodepletion, including two rapid complete remissions ongoing at 7 and 15 months. Treatment is administered in outpatient 21-day cycles with no inpatient hospitalization required."Our BioShield platform, which combines cell therapy, our IL-15 superagonist, and a monoclonal antibody in an outpatient, chemotherapy-free setting, represents our vision for Immunotherapy 2.0," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio.The addition of ANKTIVA, an IL-15 superagonist designed to promote NK and CD8+ T-cell proliferation, aims to enhance CAR-NK cytotoxicity and rituximab-driven antibody-dependent cellular cytotoxicity. Previously published data showed a 78% complete response rate when an IL-15 superagonist was combined with rituximab in patients with relapsed indolent NHL who had failed prior rituximab therapy.Nuvation Bio Inc. (NYSE: NUVB) finalized a protocol amendment expanding its SIGMA study of safusidenib from Phase 2 to a pivotal Phase 3 trial in IDH1-mutant glioma, broadening eligibility to include grade 2 and 3 astrocytoma with high-risk features and grade 4 astrocytoma following standard-of-care radiation or chemoradiation. The registrational portion will now enroll 300 patients across the U.S., Australia, and China, up from the original 100, with progression-free survival as the primary endpoint. In earlier Phase 2 data, safusidenib demonstrated a 44.4% objective response rate in treatment-naive grade 2 IDH1-mutant gliomas with a 24-month event-free probability of 87.9%."These SIGMA protocol updates reflect alignment with U.S. regulators to support the potential approval of safusidenib as swiftly as possible for a patient population that is in dire need of options," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We substantially expanded the study to include most patients with an IDH1-mutant glioma who currently have no approved targeted therapies available."A new exploratory cohort for grade 3 IDH1-mutant oligodendroglioma has also been added, with initial data expected in 2027. Nuvation Bio's pipeline also includes taletrectinib (IBTROZI), a next-generation ROS1 inhibitor that generated approximately $15.7 million in Q4 2025 sales, signaling commercial traction alongside the company's expanding clinical portfolio.Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
Equity Insider
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.globenewswire.com/news-release/2026/01/20/3222140/0/en/Global-Oncology-Clinical-Trials-Market-Projected-to-Reach-US-25-61-Billion-by-2035-Supported-by-Advances-in-Precision-and-Targeted-Therapies-Says-Astute-Analytica.htmlhttps://www.aacr.org/blog/2026/01/06/fda-approvals-in-oncology-october-december-2025/https://www.aacr.org/blog/2026/01/08/experts-forecast-cancer-research-and-treatment-advances-in-2026/Logo : https://mma.prnewswire.com/media/2840019/5801169/Equity_Insider_Logo.jpg
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Original: New Treatment Modalities Are Reaching Cancers That Resisted Everything Else
US Market News
5月前
$207B Market Shift: The Race for Fast Track Approval in OncologyFebruary 5, 2026 9:35 AM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Feb. 5, 2026 /CNW/ -- USANewsGroup.com News Commentary – The FDA isn't just approving drugs; they are completely reshaping the landscape. In 2025 alone, the agency issued over 50 oncology approvals[1], but the real story is the aggressive pivot toward targeted therapies for high-unmet-need solid tumors. That momentum has accelerated in 2026 with a sudden flurry of expedited designations[2] for RAS inhibitors and rare malignancies. This regulatory velocity creates a clear validation framework, positioning Oncolytics Biotech Inc. (NASDAQ: ONCY), Relay Therapeutics (NASDAQ: RLAY), MAIA Biotechnology (NYSE-A: MAIA), Zai Lab (NASDAQ: ZLAB), and Arrivent BioPharma (NASDAQ: AVBP) directly at the convergence of urgent unmet medical need and commercial opportunity.
This is projected to be a $326.82 billion market opportunity by 2031[3], fueled by a robust expansion in antibody-drug conjugates and biomarker-driven regimens. But in biotech, time is the ultimate currency. Data confirms that Breakthrough Therapy Designation can slash late-stage development time by 30%[4]. For companies demonstrating clinical efficacy in difficult-to-treat populations, these expedited pathways are no longer just a bonus: they are the primary value drivers for scalable growth.Oncolytics Biotech Inc. (NASDAQ: ONCY) just received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.The designation is based on clinical data showing pelareorep combined with standard chemotherapy achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy alone. More importantly, patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.This matters because KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually."Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate," said Jared Kelly, CEO of Oncolytics Biotech.The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: John McAdory as Executive Vice President of Strategy and Operations, who ran late-stage clinical trials at CG Oncology, and Yujun Wu as Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:Relay Therapeutics (NASDAQ: RLAY) has announced FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer following progression on CDK4/6 inhibitor treatment. The designation was supported by clinical data from the ReDiscover trial with 600mg BID fasted and 400mg BID fed doses showing comparable exposures across all PIK3CA mutations."This Breakthrough Therapy designation underscores the FDA's recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date," said Don Bergstrom, President of R&D at Relay Therapeutics.Initial Phase 1/2 data of zovegalisib plus fulvestrant at the 400mg BID fed Phase 3 dose in CDK4/6-experienced patients will be presented at the ESMO Targeted Anticancer Therapies Congress on March 16. Relay Therapeutics developed zovegalisib as the first known allosteric, pan-mutant, and isoform-selective PI3Ka inhibitor designed to overcome limitations of traditional orthosteric inhibitors.MAIA Biotechnology (NYSE-A: MAIA) has advanced its ateganosine program as the first and only telomere-targeting anticancer agent in clinical development, securing FDA Fast Track designation for the treatment of non-small cell lung cancer (NSCLC). The company initiated a pivotal Phase 3 trial in third-line NSCLC and expanded its Phase 2 trial with a $2.3 million NIH grant while establishing agreements with Roche and BeOne Medicines for checkpoint inhibitor combinations."MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, CEO of MAIA Biotechnology. "Our statistical assessments of ateganosine imply a high probability of technical success in our concurrent Phase 3 and Phase 2 trials."The company targets potential commercial approval within 18 to 24 months, with 2026 milestones including interim Phase 3 efficacy data and Phase 2 trial conclusion. MAIA Biotechnology raised approximately $17.6 million in 2025 with board participation in nearly all transactions.Zai Lab (NASDAQ: ZLAB) announced that China's National Medical Products Administration has approved the supplemental New Drug Application for AUGTYRO™ (repotrectinib) for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The approval marks the second indication in China for the next-generation tyrosine kinase inhibitor, which demonstrated robust and durable efficacy and manageable safety in the pivotal Phase 1/2 TRIDENT-1 study."We are pleased with the NMPA's approval of AUGTYRO for patients with NTRK-positive solid tumors," said Rafael Amado, President, Head of Global Research and Development at Zai Lab. "This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population."The approval represents the first in China to span both TRK TKI-naïve and TRK TKI-pretreated patients across solid tumors. Zai Lab has an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China, following their acquisition of Turning Point Therapeutics.Arrivent BioPharma (NASDAQ: AVBP) announced first patient dosing in the global pivotal Phase 3 ALPACCA trial evaluating firmonertinib for first-line treatment of EGFR PACC mutant non-small cell lung cancer. The oral, once-daily, brain-penetrant therapy demonstrated 16-month median progression-free survival and 68% confirmed objective response rate in the FURTHER trial, supporting selection of the 240 mg dose for pivotal development."Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib," said Bing Yao, CEO of Arrivent BioPharma. "With a well-characterized safety profile and broad clinical systemic and central nervous system activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations."The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. Arrivent BioPharma estimates the global ex-China annual incidence of NSCLC patients with EGFR PACC mutations to be approximately 42,000 patients and the US annual incidence to be approximately 6,200 patients.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.aacr.org/blog/2026/01/06/fda-approvals-in-oncology-october-december-2025/https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicinehttps://www.mordorintelligence.com/industry-reports/solid-tumor-therapeutics-markethttps://pmc.ncbi.nlm.nih.gov/articles/PMC12758617/Logo : https://mma.prnewswire.com/media/2838876/5764584/USA_News_Group_Logo.jpg
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Original: $207B Market Shift: The Race for Fast Track Approval in Oncology
Paulness
5月前
NEWS -- Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer
Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population
Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026
Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers
SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin®) and leucovorin, fluorouracil, irinotecan (“FOLFIRI”) for the treatment of patients with KRAS (“Kirsten rat sarcoma”)-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”) in the second-line (“2L”) setting. As part of the Company’s increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation.
The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate (“ORR”) for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care (“SOC”) in this patient population.1-2 In addition, pelareorep combination therapy was associated with a median progression-free survival (“PFS”) of 16.6 months, compared to 5.7 months with SOC, and a median overall survival (“OS”) of 27 months, compared to 11.2 months with SOC.1
KRAS-mutant MSS metastatic colorectal cancer represents one of the most challenging diseases in gastrointestinal oncology, as few effective treatment options exist following first-line progression, and available immune-based therapies provide little benefit. There are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the 2L KRAS-mutant MSS mCRC subgroup.3-7
“This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible.”
Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming.
The Fast Track Designation enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval. Furthermore, clinical programs with Fast Track Designation may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. For conditions where an available treatment exists, a candidate therapy regimen must show some advantage over the available treatment, such as superior effectiveness, to be granted Fast Track Designation.
References
Bennouna J. Lancet Oncol (14):29-37, 2013
Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015
International Agency for Research on Cancer. (n.d.). Colorectal cancer. World Health Organization – IARC. https://www.iarc.who.int/cancer-type/colorectal-cancer/
Amado RG, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3. PMID: 18316791
Cohen R, et al. Association of Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer With Misdiagnosis of Microsatellite Instability or Mismatch Repair Deficiency Status. JAMA Oncol. 2019 Apr 1;5(4):551-555. doi: 10.1001/jamaoncol.2018.4942. PMID: 30452494; PMCID: PMC6459114.
Snider J, et al. Metastatic colorectal cancer (mCRC) treatment patterns in the Medicare population. J Clin Oncol. 2018;36(4_suppl):823. https://doi.org/10.1200/JCO.2018.36.4_suppl.823
American Health & Drug Benefits. (2013). Metastatic colorectal cancer: Treatment patterns and costs. https://ahdbonline.com/issues/2013/february-2013-vol-6-no-1-special-issue/article-1294About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the anticipated design, timelines, milestones, and outcomes of current and future studies; the estimated size of the total addressable market of the 2L KRAS-mutant MSS mCRC subgroup; expected benefits of the Fast Track Designation, including increased collaboration with regulatory bodies; the Company’s goals, strategies, and objectives; and its belief in the clinical promise of pelareorep in colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
US Market News
5月前
$170B Patent Cliff Ignites Biotech Deal Wave: Late-Stage Platforms Command PremiumJanuary 30, 2026 10:36 AM
PR Newswire (US)
Issued on behalf of Oncolytics Biotech Inc.Equity-Insider.com News Commentary VANCOUVER, BC, Jan. 30, 2026 /PRNewswire/ -- The oncology sector is undergoing a massive capital rotation driven by over 50 FDA approvals in 2025, with 20 arriving in Q4 alone[1]. This regulatory surge signals deep institutional confidence in late-stage platforms capable of commercial conversion. The trend accelerated in January 2026 as Big Pharma intensified its race to acquire assets ahead of a $170 billion patent cliff[2]. Acquirers are now bypassing early-stage speculation to secure validated Phase 3 data and manufacturing infrastructure. This structural shift has directed institutional focus toward Oncolytics Biotech Inc. (NASDAQ: ONCY), AbbVie (NYSE: ABBV), Genmab (NASDAQ: GMAB), ADC Therapeutics (NYSE: ADCT), and Greenwich LifeSciences (NASDAQ: GLSI). Institutions are prioritizing platforms that can navigate Phase 3 trials, where approximately 50% of candidates still fail[3]. Demonstrated regulatory alignment has become the critical de-risking factor for capital allocation. This environment creates asymmetric upside for organizations that have secured the FDA's flexible approach to BLA submissions and manufacturing validation[4]. The market is now placing a premium on specialized leadership combined with registration-enabling data in commercial-scale disease categories.Oncolytics Biotech Inc. (NASDAQ: ONCY) is building out its leadership team as it moves its cancer treatment pelareorep through late-stage clinical trials targeting several gastrointestinal cancers.The company recently announced two key hires: John McAdory as Executive Vice President of Strategy and Operations, and Yujun Wu as Vice President, Head of Biostatistics. McAdory comes from CG Oncology, where he ran late-stage clinical trials for oncolytic virus therapies (cancer-fighting viruses, similar to pelareorep). Wu joins from Morphic Therapeutic, where he led the statistics department through the company's sale to Eli Lilly, and previously designed multiple Phase 3 oncology trials at Takeda. Both bring the specific expertise needed to execute the complex, multi-country registration trials that determine whether a drug gets FDA approval."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These hires complete a significant management upgrade. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. The company also added three leading cancer specialists from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center to its gastrointestinal tumor scientific advisory board.The clinical data driving this expansion looks compelling. In colorectal cancer, pelareorep combined with chemotherapy and a vascular endothelial growth factor (VEGF) inhibitor achieved a 33% response rate in patients with KRAS mutations (a genetic marker found in about 40% of colorectal cancers). That's three times better than the 6-11% response rate chemotherapy and a VEGF inhibitor typically achieves in these patients. Response rate measures the percentage of patients whose tumors shrink significantly or disappear entirely.In anal cancer, where treatment options are extremely limited after first-line therapy fails, pelareorep is showing even stronger results. Third-line patients (those who've already failed two prior treatments) saw a 29% response rate with responses lasting around 17 months. That nearly triples the historical benchmarks in a setting where no FDA-approved treatments currently exist.In second-line patients, the 30% response rate more than doubled the 13.8% benchmark for the only FDA-approved immunotherapy available, with responses lasting 15.5 months versus 9.5 months for standard treatment.Oncolytics has also secured FDA agreement on its Phase 3 trial design for pancreatic cancer, clearing the way to launch what would be the only immunotherapy registration trial currently planned for this notoriously difficult-to-treat disease.CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other recent industry developments and happenings in the market include:AbbVie (NYSE: ABBV) along with partner Genmab (NASDAQ: GMAB) announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study demonstrated improvement in progression-free survival with a hazard ratio of 0.74, along with improvements in complete response rates and duration of response, though overall survival did not reach statistical significance.EPCORE DLBCL-1 is the first Phase 3 study to demonstrate PFS improvement in patients with relapsed/refractory DLBCL treated with a CD3xCD20 T-cell engaging bispecific monotherapy. AbbVie and Genmab will engage global regulatory authorities to discuss next steps while continuing to evaluate epcoritamab across treatment lines and hematologic malignancies.ADC Therapeutics (NYSE: ADCT) reported preliminary full-year 2025 ZYNLONTA net product revenue of approximately $73 million, up from $69.3 million in 2024, with fourth quarter revenue of approximately $22 million representing growth from $16.4 million in the prior-year period. Updated data from the LOTIS-7 Phase 1b trial demonstrated an 89.8% best overall response rate and 77.6% complete response rate across 49 efficacy-evaluable patients with relapsed or refractory diffuse large B-cell lymphoma."During 2025, we delivered meaningful progress across our ZYNLONTA clinical program and extended our expected cash runway at least to 2028," said Ameet Mallik, CEO of ADC Therapeutics. "Assuming positive results, we anticipate potential compendia inclusion for each in the first half of 2027 with LOTIS-5 regulatory approvals to follow."The company expects topline data from its LOTIS-5 Phase 3 confirmatory trial in second-quarter 2026, with cash and cash equivalents of approximately $261 million providing runway at least to 2028. ADC Therapeutics has also completed IND-enabling activities for its PSMA-targeting ADC program.Greenwich LifeSciences (NASDAQ: GLSI) announced the FDA has reviewed and approved the use of the first commercial lot of GP2 vials in its Phase III FLAMINGO-01 trial evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. Preliminary analysis from the non-HLA-A*02 arm shows approximately 80% reduction in recurrence rate, trending similarly to Phase IIb trial results."With our manufacturing investments in 2023 and 2024, and now the FDA's review and approval to use the first commercial lot of finished GP2 vials in FLAMINGO-01, we have taken major steps to further de-risk the filing of a BLA in the US," said Snehal Patel, CEO of Greenwich LifeSciences. "We plan to start using these new GP2 vials in the coming weeks at all 40 US sites."The 250-patient non-HLA-A*02 arm is now fully enrolled, representing five times more treated patients than the Phase IIb trial. Greenwich LifeSciences holds Fast Track designation for GLSI-100 and plans to submit manufacturing data to regulatory agencies in Europe, the United Kingdom, and Canada.Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
Equity Insider
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.aacr.org/blog/2026/01/06/fda-approvals-in-oncology-october-december-2025/ https://www.cnbc.com/2026/01/07/big-pharma-race-to-snap-up-biotech-assets-as-170-billion-patent-cliff-looms.html https://www.appliedclinicaltrialsonline.com/view/phase-iii-trial-failures-costly-preventable https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/flexible-requirements-cell-and-gene-therapies-advance-innovationLogo: https://mma.prnewswire.com/media/2840019/Equity_Insider_Logo.jpg
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Original: $170B Patent Cliff Ignites Biotech Deal Wave: Late-Stage Platforms Command Premium
US Market News
5月前
$668B Oncology Surge: 5 Platforms Cracking the Code on GI TumorsJanuary 30, 2026 10:19 AM
PR Newswire (US)
Issued on behalf of Oncolytics Biotech Inc.USANewsGroup.com News CommentaryVANCOUVER, BC, Jan. 30, 2026 /PRNewswire/ -- The global oncology sector is rocketing toward $668 billion in 2034[1], partly fueled by a massive structural pivot toward gastrointestinal cancers where clinical velocity is finally shattering historical benchmarks. With the FDA's 2026 framework explicitly prioritizing accelerated pathways for platforms showing superior objective response rates and durability[2], a select group of innovators is unlocking the immunologically "cold" GI tumors that have baffled researchers for decades. This regulatory tailwind places Oncolytics Biotech Inc. (NASDAQ: ONCY), Pfizer (NYSE: PFE), Verastem Oncology (NASDAQ: VSTM), Perspective Therapeutics (NYSE-A: CATX), and RenovoRx (NASDAQ: RNXT) directly at the intersection of pivotal execution and breakthrough immunotherapy. As the market charges toward a staggering $668 billion valuation by 2034, capital is rotating aggressively toward execution-ready platforms over speculative assets[3]. Fresh FDA guidance issued in December 2025 and January 2026 signals a decisive new era emphasizing overall survival and robust clinical benefit[4]. This shift creates asymmetric upside for companies demonstrating disciplined execution in high-stakes battlegrounds like colorectal, pancreatic, and anal cancers, where targeted immunotherapies are establishing entirely new treatment paradigms.Oncolytics Biotech Inc. (NASDAQ: ONCY) is building out its leadership team as it moves its cancer treatment pelareorep through late-stage clinical trials targeting several gastrointestinal cancers.The company recently announced two key hires: John McAdory as Executive Vice President of Strategy and Operations, and Yujun Wu as Vice President, Head of Biostatistics. McAdory comes from CG Oncology, where he ran late-stage clinical trials for oncolytic virus therapies (cancer-fighting viruses, similar to pelareorep). Wu joins from Morphic Therapeutic, where he led the statistics department through the company's sale to Eli Lilly, and previously designed multiple Phase 3 oncology trials at Takeda. Both bring the specific expertise needed to execute the complex, multi-country registration trials that determine whether a drug gets FDA approval."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These hires complete a significant management upgrade. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. The company also added three leading cancer specialists from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center to its gastrointestinal tumor scientific advisory board.The clinical data driving this expansion looks compelling. In colorectal cancer, pelareorep combined with chemotherapy and a vascular endothelial growth factor (VEGF) inhibitor achieved a 33% response rate in patients with KRAS mutations (a genetic marker found in about 40% of colorectal cancers). That's three times better than the 6-11% response rate chemotherapy and a VEGF inhibitor typically achieves in these patients. Response rate measures the percentage of patients whose tumors shrink significantly or disappear entirely.In anal cancer, where treatment options are extremely limited after first-line therapy fails, pelareorep is showing even stronger results. Third-line patients (those who've already failed two prior treatments) saw a 29% response rate with responses lasting around 17 months. That nearly triples the historical benchmarks in a setting where no FDA-approved treatments currently exist.In second-line patients, the 30% response rate more than doubled the 13.8% benchmark for the only FDA-approved immunotherapy available, with responses lasting 15.5 months versus 9.5 months for standard treatment.Oncolytics has also secured FDA agreement on its Phase 3 trial design for pancreatic cancer, clearing the way to launch what would be the only immunotherapy registration trial currently planned for this notoriously difficult-to-treat disease.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:Pfizer (NYSE: PFE) announced positive results from Cohort 3 of the pivotal BREAKWATER trial evaluating BRAFTOVI in combination with cetuximab and FOLFIRI in patients with previously untreated BRAF V600E-mutant metastatic colorectal cancer. The combination achieved a confirmed objective response rate of 64.4% compared to 39.2% with standard-of-care treatment, representing a statistically significant improvement."These data further strengthen the potential utility of BRAFTOVI for patients with BRAF V600E-mutant metastatic colorectal cancer. The significant improvement in response rates reflects the meaningful clinical benefit of this targeted combination therapy regimen for patients," said Jeff Legos, Chief Oncology Officer at Pfizer. "These results underscore the potential of BRAFTOVI as a standard of care for patients with this aggressive cancer."Among patients receiving the treatment regimen, 57.4% on BRAFTOVI plus cetuximab and FOLFIRI maintained response for six months or longer compared to 34.5% with standard therapy. Pfizer continues the BREAKWATER trial with an estimated completion in 2027.Verastem Oncology (NASDAQ: VSTM) announced it will discontinue its RAMP 203 Phase 1/2 trial in advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) to focus resources on clinical development of VS-7375, an oral KRAS G12D inhibitor. The decision reflects the evolving treatment landscape as next-generation G12C inhibitors establish higher response rate benchmarks."RAMP 203 has provided important insights into treatment strategies and demonstrated proof-of-concept. While avutometinib plus defactinib combined well with a G12C inhibitor to drive early and sustained anti-tumor responses, next generation G12C inhibitors are establishing a new benchmark with higher response rates," said John Hayslip, Chief Medical Officer at Verastem Oncology. "Accordingly, we are prioritizing our clinical development of VS-7375, a potentially best-in-class oral KRAS G12D (ON/OFF) inhibitor, that demonstrated a 69% response rate in advanced KRAS G12D NSCLC."In the doublet combination arm, 30 G12C-inhibitor treatment-naïve patients achieved an overall response rate of 40% with a median progression-free survival of 11.1 months. Verastem Oncology continues advancing RAMP 205, evaluating avutometinib plus defactinib with chemotherapy in first-line metastatic pancreatic cancer.Perspective Therapeutics (NYSE-A: CATX) presented updated interim data from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-a-NET in patients with neuroendocrine tumors at the 2026 ASCO Gastrointestinal Cancers Symposium. The radiopharmaceutical demonstrated a 39% objective response rate in Cohort 2 patients regardless of SSTR2 expression profile, with 76% of patients remaining progression-free and alive."The updated interim results presented at ASCO-GI continue to support VMT-a-NET's compelling overall clinical profile at the 5 mCi dose," said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. "With the robust clinical dataset being accrued from strong patient enrollment into our study, we believe we will be able to have meaningful engagement with regulatory agencies during 2026 on proceeding with VMT-a-NET into a registrational trial."The therapy continues to demonstrate favorable tolerability with no dose-limiting toxicities, treatment-related discontinuations, or clinically significant myelosuppression reported across 56 patients. Perspective Therapeutics has completed the Cohort 3 dose-limiting toxicity assessment and is cleared to enroll additional patients at the 6.0 mCi dose level.RenovoRx (NASDAQ: RNXT) announced continued commercial momentum with its RenovoCath FDA-cleared drug-delivery device now integrated at nine active U.S. cancer centers, up from five in September 2025. The company's TAMP therapy platform is designed to deliver chemotherapy near tumor sites, potentially enhancing effectiveness while minimizing systemic side effects associated with traditional intravenous administration."The growing adoption of RenovoCath by esteemed institutions like City of Hope Cancer Center and Moffitt Cancer Center, amongst others, is the driver of our commercial efforts and underscores the clinical need for more targeted oncology tools," said Shaun Bagai, CEO of RenovoRx. "We are encouraged by both the procedural feedback and the strong commercial interest we are seeing."The company generated approximately $900,000 in sales revenue through September 2025 and has strengthened its commercial team to drive growth in 2026. RenovoRx continues enrollment in its Phase III TIGeR-PaC trial evaluating intra-arterial gemcitabine delivery via RenovoCath for locally advanced pancreatic cancer.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.precedenceresearch.com/oncology-markethttps://lumanity.com/perspectives/the-8-fda-regulatory-trends-shaping-2026-and-beyond/https://www.globenewswire.com/news-release/2025/12/02/3198196/0/en/Oncology-Market-Size-Worth-USD-668-26-Billion-by-2034.htmlhttps://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents Logo: https://mma.prnewswire.com/media/2838876/USA_News_Group_Logo.jpg
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Original: $668B Oncology Surge: 5 Platforms Cracking the Code on GI Tumors
US Market News
5月前
Late-Stage Breakthroughs: How 2026's Top Clinical Platforms Are Redefining Cancer TreatmentJanuary 28, 2026 2:15 PM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC., Jan. 28, 2026 /CNW/ -- USANewsGroup.com News Commentary – As the global oncology clinical trials market surges toward a projected $25.61 billion valuation by 2035[1], a structural rotation is favoring 'registration-ready' platforms that demonstrate exceptional efficacy and pivotal-trial alignment with 2026's evolving FDA regulatory frameworks[2]. Investors are increasingly prioritizing late-stage and newly commercial companies poised for rapid maturation as sector fundamentals strengthen. This structural shift creates a window for Oncolytics Biotech Inc. (NASDAQ: ONCY), BioNTech (NASDAQ: BNTX), MAIA Biotechnology (NYSE-A: MAIA), Acrivon Therapeutics (NASDAQ: ACRV), and ImmunityBio (NASDAQ: IBRX).
With 2026 set to be a banner year for M&A as buyers facing patent cliffs compete for a limited pool of late-stage assets[3], companies demonstrating disciplined pivotal execution and FDA alignment command asymmetric upside in an environment where executive infrastructure determines valuation floors.Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population.The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:BioNTech (NASDAQ: BNTX) received FDA Fast Track designation for BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1. The designation was granted based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1, a cancer type with limited treatment options where patients experience median overall survival of 20.7 months under current standard of care.Head and neck squamous cell carcinoma is the seventh most common cancer type worldwide with increasing global incidence, with about one third of cases being HPV-positive and approximately 90% of oropharyngeal cancers driven by HPV16. BNT113 is designed to induce HPV16-specific anti-tumor immune responses by encoding the E6 and E7 proteins of HPV16 that are frequently found in HPV16+ solid tumors, with the FDA Fast Track designation enabling more frequent engagement with the FDA to support development and expedite regulatory review of this novel HPV-targeted chemotherapy-free treatment option.MAIA Biotechnology (NYSE-A: MAIA) advanced ateganosine into pivotal development with high probability of technical success based on exceptional efficacy data in third-line non-small cell lung cancer. The telomere-targeting agent secured FDA Fast Track designation and represents the first and only direct telomere-targeting anticancer therapy in clinical development, targeting an estimated $50+ billion global immunotherapy market."MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, M.D., founder and CEO of MAIA. "The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA's Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways."The company advanced concurrent Phase 3 and Phase 2 expansion trials targeting potential early commercial approval within 18 to 24 months. MAIA Biotechnology received a $2.3 million NIH grant supporting U.S. patient enrollment and is advancing second-generation molecules into Phase 1 development with enhanced expected efficacy.Acrivon Therapeutics (NASDAQ: ACRV) announced positive data from its ACR-368 Phase 2b registrational-intent trial showing 39% overall response rate in endometrial cancer with 52% confirmed response rate in serous subtype patients with up to two prior lines of therapy. The company submitted EU Clinical Trial Application for Arm 3 enrollment across more than 20 European sites in four major countries, with enrollment completion expected in Q4 2026."We are pleased with tangible progress accelerating across multiple high-value opportunities," said Peter Blume-Jensen, M.D., Ph.D., CEO of Acrivon. "We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate. This provides an attractive opportunity for rapid Arm 3 enrollment without the need for a pretreatment biopsy, both in the US and more than 20 newly selected sites in major EU countries."Acrivon Therapeutics has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 combined with anti-PD-1 therapy in frontline endometrial cancer based on strong preclinical synergy data. The company also reported initial ACR-2316 Phase 1 data showing tumor shrinkage in endometrial cancer, SCLC and squamous NSCLC, with ACR-6840 nominated as its next CDK11 inhibitor development candidate.ImmunityBio (NASDAQ: IBRX) announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company's supplemental Biologics License Application for ANKTIVA plus Bacillus Calmette-Guérin in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors. The Company presented more than five years of follow-up data demonstrating durable disease-specific survival of approximately 96% at 36 months with median survival not yet reached even with five years of follow-up, high rates of cystectomy avoidance of 92% and 82% at one and three years respectively, and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors."We appreciate the FDA's collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," said Richard Adcock, President and CEO of ImmunityBio. "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency's review."Based on discussions with the FDA, the Agency recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication, with this additional information not contemplating the initiation or design of a new clinical trial. ImmunityBio commercially launched ANKTIVA for NMIBC CIS with or without papillary tumors in the United States and has since expanded approvals to the United Kingdom and Saudi Arabia, with conditional approval in the European Union.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES CITED:https://www.globenewswire.com/news-release/2026/01/20/3222140/0/en/Global-Oncology-Clinical-Trials-Market-Projected-to-Reach-US-25-61-Billion-by-2035-Supported-by-Advances-in-Precision-and-Targeted-Therapies-Says-Astute-Analytica.html https://lumanity.com/perspectives/the-8-fda-regulatory-trends-shaping-2026-and-beyond/ https://www.biospace.com/business/with-biotech-back-analysts-make-their-picks-for-2026Logo: https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg
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Original: Late-Stage Breakthroughs: How 2026's Top Clinical Platforms Are Redefining Cancer Treatment
US Market News
5月前
Registration-Ready: How 2026's Clinical Leaders Are Beating Cancer BenchmarksJanuary 27, 2026 3:50 PM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Jan. 27, 2026 /CNW/ -- Equity-Insider.com News Commentary – The global oncology therapy market is charging toward a massive $668 billion valuation by 2034, as a ruthless capital rotation finally rewards execution-ready platforms over the "hopes and dreams" of speculative discovery assets[1]. With the FDA's accelerated approval pathway delivering survival wins across 65% of solid tumor indications, the 2026 regulatory landscape is demanding a new breed of registration-directed study designs that prioritize raw objective response rates and durability[2]. This structural shift creates an asymmetric investment window for Oncolytics Biotech Inc. (NASDAQ: ONCY), Moderna (NASDAQ: MRNA), Merck (NYSE: MRK), Vir Biotechnology (NASDAQ: VIR), and Coherus Oncology (NASDAQ: CHRS) at the intersection of pivotal execution readiness and combination immunotherapy innovation in high-unmet-need gastrointestinal and respiratory cancer markets.
As pharmaceutical giants face a staggering patent cliff, they are aggressively hunting for late-stage assets with clear, high-signal registration pathways[3]. In 2026, the market isn't buying "promise"—it's buying the disciplined execution of pivotal trials and the mechanistic clarity that determines valuation floors[4].Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population.The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other recent industry developments and happenings in the market include:Moderna (NASDAQ: MRNA) and Merck (NYSE: MRK) announced median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, demonstrating that adjuvant treatment with intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone in patients with high-risk stage III/IV melanoma following complete resection."Now with five years of follow-up data, today's results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA combination in patients with resected high-risk melanoma," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Oncology and Therapeutics. "We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNA's potential in cancer care."The companies have eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. Moderna and Merck plan to present further data from follow-up analyses of the study's primary and secondary endpoints at an upcoming medical meeting, with the Phase 3 INTerpath-001 trial for adjuvant melanoma fully enrolled.Vir Biotechnology (NASDAQ: VIR) provided updates on its oncology solid tumor portfolio, including new Phase 1 data from its PSMA-targeted PRO-XTEN dual-masked T-cell engager VIR-5500 in prostate cancer to be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium in February. VIR-5500 is currently being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors for the first-line treatment of metastatic castration-resistant prostate cancer, with the Phase 1 trial successfully clearing the second dose cohort.The Company is also currently enrolling patients in its Phase 1 dose escalation trials for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors, with Phase 1 dose escalation response data for VIR-5818 expected in the second half of 2026. Vir Biotechnology is progressing additional PRO-XTEN masked T-cell engagers in preclinical studies directed at clinically validated targets with potential applications across lung, colorectal and bladder cancers, all discovered using the Company's proprietary antibody and T-cell engager discovery platform including dAIsY, a proprietary artificial intelligence engine, and the universal PRO-XTEN masking technology.Coherus Oncology (NASDAQ: CHRS) announced publication in Molecular Cancer Therapeutics highlighting the strong pharmacology of investigational CCR8 antibody tagmokitug, demonstrating picomolar binding affinity with no off-target binding. The publication provides important scientific evidence showing tagmokitug selectively eliminates CCR8+ T regulatory cells without affecting other immune cells, with proof-of-mechanism established in first-in-human clinical studies showing selective reductions in CCR8+ Tregs."This publication presents the robust pharmacology of tagmokitug in preclinical and clinical studies, and with a selectivity profile and potent binding and killing of CCR8+ T regulatory cells and not other immune cells. These data provide evidence that tagmokitug has the potential for a differentiated profile," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer at Coherus. "The data show a high abundance of CCR8 target expression in a broad range of solid tumors suggesting the promise of the tagmokitug program."Coherus Oncology is currently evaluating tagmokitug in Phase 1b/2a clinical trials in patients with solid tumors, including head and neck, colorectal, gastric, and esophageal cancer. The company's immunotherapy pipeline focuses on enhancing innate and adaptive immune responses to enable robust antitumor activity in combination with the approved PD-1 inhibitor LOQTORZI.Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:Equity Insider
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.globenewswire.com/news-release/2025/12/02/3198196/0/en/Oncology-Market-Size-Worth-USD-668-26-Billion-by-2034.htmlhttps://www.oncologynurseadvisor.com/news/fda-accelerated-approval-oncology-drugs-improved-patient-survival/https://www.biospace.com/drug-development/biotech-investors-bet-on-a-2026-rebound-as-deal-activity-accelerateshttps://blog.crownbio.com/the-oncology-drug-development-landscapeLogo - https://mma.prnewswire.com/media/2840019/5737560/Equity_Insider_Logo.jpg
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Original: Registration-Ready: How 2026's Clinical Leaders Are Beating Cancer Benchmarks
Paulness
5月前
NEWS -- Oncolytics Biotech® Announces Results of Special Meeting of Shareholders
All resolutions passed, enabling the Company to streamline regulatory and operational processes
SAN DIEGO, Jan. 15, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the voting results from its Special Meeting of Shareholders (the “Special Meeting”) held on Thursday, January 15, 2026.
Each item of business described in the management information circular/prospectus of the Company dated December 9, 2025, was approved by the shareholders. The voting results for each item of business are set out below.
The approval of the first resolution authorized the Company to continue from the Province of Alberta in Canada to the Province of British Columbia in Canada (the “Continuance”). The approval of the second resolution authorized the Company to continue from the Province of British Columbia to the State of Nevada in the United States of America (the “Domestication”). The approval of the third resolution authorized the Company to implement the Oncolytics Biotech Inc. 2026 Incentive Award Plan (the “2026 Incentive Award Plan”), subject to and conditional upon the completion of the Continuance and Domestication.
The Company expects to consummate the Continuance and Domestication, and for the 2026 Incentive Award Plan to become effective at the end of the first quarter of 2026.
For more details on the matters covered at the Special Meeting, please refer to the Company’s public filings available on SEDAR+ at https://www.sedarplus.ca/home/ and on EDGAR at https://www.sec.gov/.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding the expected consummation of the Continuance and the Domestication and effectiveness of the 2026 Incentive Award Plan, and timing thereof; and the anticipated benefits of the Continuance, Domestication, and 2026 Incentive Award Plan. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
Paulness
6月前
NEWS -- Oncolytics Biotech® Appoints John McAdory as EVP of Strategy and Operations and Yujun Wu to Lead Biostatistics
Appointments strengthen late-stage clinical execution and statistical leadership as the Company advances multiple registration-directed programs in gastrointestinal cancers
SAN DIEGO, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the appointment of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics. These appointments are expected to enhance the Company’s operational, clinical, and regulatory capabilities as Oncolytics advances registration-directed development programs in pancreatic, colorectal, and anal cancers.
Mr. McAdory will oversee clinical development execution, operational strategy, and regulatory readiness across the Company’s portfolio. He brings extensive experience leading late-stage oncology programs, particularly in the oncolytic virus space. Most recently, Mr. McAdory served as Vice President, Clinical Operations at CG Oncology, Inc. (Nasdaq: CGON), a late-stage biotechnology company developing an intratumoral oncolytic virus. Over his career, he has managed large, registration-directed clinical trials involving hundreds of patients across multiple tumor types and supported global regulatory interactions.
“John’s background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics’ next phase of execution,” said Jared Kelly, Chief Executive Officer of Oncolytics. “As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment.”
Mr. Wu joins Oncolytics to lead Biostatistics, bringing deep expertise in statistical strategy, regulatory interactions, and late-stage trial design. Most recently, he served as Head of Biostatistics at Morphic Therapeutic, where he supported multiple clinical programs through late-stage development and played a key role during the company’s acquisition by Eli Lilly and Company. Previously, Mr. Wu led statistical strategy and regulatory execution for multiple Phase 3 and registration oncology programs at Takeda, Pharmaceutical Company Limited (NYSE: TAK), leveraging innovative trial designs to accelerate late-stage development and global regulatory approvals.
“Yujun’s experience designing and supporting late-stage studies and interacting with regulators significantly strengthens our internal capabilities,” added Mr. Kelly. “As we pursue accelerated approval strategies and pivotal trials, high-quality statistical leadership is essential, and Yujun brings that expertise at a critical time for the Company.”
These appointments directly support Oncolytics’ strategic focus on advancing pelareorep through the most efficient regulatory pathways available, prioritizing indications with high unmet medical need, clear clinical signals, and defined accelerated approval opportunities, including squamous cell anal cancer, pancreatic cancer, and KRAS-mutant colorectal cancer.
Inducement Awards
In connection with their appointments, the Company granted inducement equity awards to Mr. McAdory and Mr. Wu pursuant to Nasdaq Listing Rule 5635(c)(4), as an inducement material to their commencing employment with the Company.
John McAdory received an inducement award consisting of 500,000 stock options.
Yujun Wu received an inducement award consisting of 300,000 stock options.The stock options have an exercise price per share of US$0.97 and vest as to 50% of the underlying shares on the first anniversary of the grant date and 25% of the underlying shares in equal annual installments thereafter, subject to continued service with the Company.
In addition, Mr. McAdory received an award of 300,000 restricted share units that will vest in a single installment upon the occurrence of a material transaction, including, but not limited to, a merger, acquisition, or licensing transaction, subject to the terms of the applicable award agreement and his continued service to the Company.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the appointments of Messrs. McAdory and Wu enhancing the Company’s operational, clinical, and regulatory capabilities; the Company’s goals, strategies, and objectives; and its belief in the clinical promise of pelareorep in gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
Paulness
6月前
NEWS -- Oncolytics Biotech® Announces Updated Clinical Data from GOBLET Cohort 4 Demonstrating Activity of Pelareorep Plus Atezolizumab in Third-Line Anal Cancer
Compared to the historical benchmark, pelareorep-atezolizumab nearly tripled ORR
Combination achieved encouraging median DOR of almost 17 months
Data establishes clear path in indication with no approved therapySAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced updated clinical data from GOBLET Cohort 4 in patients with third-line metastatic squamous cell anal carcinoma (“SCAC”), a setting with no U.S. Food and Drug Administration (“FDA”)-approved treatment options. Previous analysis from this cohort has focused on second-line or later SCAC patients.
Updated GOBLET Cohort 4 Third-Line Anal Cancer Data
As of the current data cut, four of 14 evaluable third-line patients receiving pelareorep and atezolizumab achieved objective responses, resulting in an objective response rate (“ORR”) of approximately 29%. These responses included two complete responses and two partial responses. The median duration of response (“DOR”) is approximately 17 months (67 weeks), indicating both depth and durability of clinical benefit in a heavily pretreated population.
Patients enrolled in this cohort had progressed following multiple prior systemic therapies and represent a highly refractory disease population. In historical third-line SCAC studies, objective response rates are typically approximately 10% or less, with limited durability.1, 2 There are currently no FDA-approved therapies for patients with third-line anal cancer.
The observed response rate and emerging durability in GOBLET Cohort 4 compare favorably with historical outcomes and highlight the potential clinical relevance of pelareorep plus atezolizumab in this setting of significant unmet medical need.
“As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy,” said Jared Kelly, Chief Executive Officer of Oncolytics. “When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients’ lives who have no options.”
In the second-line setting, pelareorep and atezolizumab achieved a 30% ORR, more than doubling the 13.8% ORR that was approved by the FDA for the current standard of care therapy. Additionally, the median duration of response is 15.5 months for pelareorep and atezolizumab compared to 9.5 months (link to the PR).
Planned Registration Strategy and Accelerated Approval Pathway
If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. After initial encouraging feedback from KOLS and the FDA, Oncolytics is planning to have a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan.
References
Marabelle et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4.
Benson et al. Anal Carcinoma, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023 Jun;21(6):653-677. doi: 10.6004/jnccn.2023.0030.About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; expectations regarding the Company’s proposed design of potential registration studies, including plans to advance pelareorep plus atezolizumab into a registration-directed clinical study in second-line and later SCAC and potential meetings with the FDA; expectations relating to outcomes of ongoing and future studies, in addition to anticipated accelerated FDA approvals; the Company’s goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic anal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
Paulness
6月前
NEWS -- Oncolytics Biotech® Outlines Strategic Rationale for Proposal to Change Jurisdiction of Incorporation to Nevada
SAN DIEGO, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today provided additional context regarding its previously announced proposal to change the Company’s jurisdiction of incorporation from Alberta, Canada, to the State of Nevada in the United States.
The Company believes it is important to clearly communicate the strategic and operational reasons underlying this proposal as Oncolytics continues its transition into a U.S.-focused clinical-stage oncology company.
Over the past several years, Oncolytics’ operations, management team, shareholder base, and capital markets activity have become predominantly U.S.-based. In parallel, effective January 1, 2026, the Company became a domestic issuer under the rules of the U.S. Securities and Exchange Commission (the “SEC”) and lost its status as a “foreign private issuer” under those rules, resulting in increased regulatory complexity without corresponding benefits. As a result, management determined that maintaining a Canadian corporate domicile no longer aligns with the Company’s operations or long-term strategy.
The proposed domestication to the State of Nevada is intended to better position Oncolytics for its next phase of growth by simplifying its regulatory structure, improving operational efficiency, and enhancing access to U.S. capital markets. The State of Nevada was chosen because of its favorable corporate environment and comprehensive and flexible corporate laws.
“Our decision to seek to change the Company’s jurisdiction of incorporation to the State of Nevada reflects where Oncolytics is today and where we are headed,” said Jared Kelly, Chief Executive Officer of Oncolytics. “We are a U.S.-focused oncology company with U.S.-based leadership, operations, and investors. This move simplifies our structure, improves capital markets access, and positions us more effectively for future strategic opportunities, including partnerships and potential M&A activity. We believe Nevada offers a compelling long-term home for biotech companies like ours.”
The proposed domestication to the State of Nevada is subject to shareholder approval. Oncolytics shareholders of record as of December 9, 2025, will be asked to vote on a series of transactions that will change the jurisdiction of Oncolytics from Alberta, Canada, to the State of Nevada, among other things, at a special meeting (the “Special Meeting”) scheduled for January 15, 2026.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Additional Information and Where to Find It
The Company has filed a registration statement on Form F-4 (Registration No. 333-290954), as amended (the “Registration Statement”), with the SEC that includes a management circular/prospectus and other relevant documents in connection with the Company’s proposed domestication to the State of Nevada and certain other matters, and that Registration Statement has been declared effective by the SEC. The Company has delivered the definitive management circular/prospectus to shareholders for the Special Meeting. ONCOLYTICS SHAREHOLDERS ARE URGED TO READ CAREFULLY THESE DOCUMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED DOMESTICATION TRANSACTIONS. Investors may obtain a free copy of the management circular/prospectus and other filings containing information about Oncolytics and the proposed domestication to the State of Nevada from the SEC at the SEC’s website at http://www.sec.gov. In addition, copies of the management circular/prospectus and other filings containing information about Oncolytics and the proposed domestication to the State of Nevada can be obtained without charge by directing a request to Oncolytics Biotech Inc., Suite 804, 322 11th Avenue SW, Calgary, Alberta T2R 0C5 (telephone (403) 670-7377), or accessing them on the Company’s corporate website at https://www.oncolyticsbiotech.com.
Participants in the Solicitation
Oncolytics, its directors, executive officers, certain other members of management, and employees may be deemed to be participants in the solicitation of proxies from the shareholders of Oncolytics in favor of the proposed domestication to the State of Nevada. In addition, Oncolytics has engaged Laurel Hill Advisory Group to aid in the solicitation of proxies for the Special Meeting, and Laurel Hill Advisory Group may solicit proxies by personal interview, mail, telephone, facsimile, email, or otherwise. Oncolytics will pay Laurel Hill Advisory Group approximately CAD $35,000 for its proxy solicitation services, plus reasonable out-of-pocket expenses incurred in the process of soliciting proxies. Solicitations also may be made by mail, email, personal interview, telephone, or other electronic transmission by directors, officers, and other employees of Oncolytics without additional compensation.
Additional information regarding the interests of potential participants in the proxy solicitation is included in the management circular/prospectus and other relevant documents that the Company has filed and intends to file with the SEC in connection with the Special Meeting.
No Offer or Solicitation
This press release is not an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer or sale of securities in any jurisdiction where such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of the U.S. Securities Act of 1933, as amended, or an exemption therefrom.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ intention to hold a special meeting of shareholders to vote on, among other things, the proposed domestication to the State of Nevada, including the timing of the Special Meeting; beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics’ plan to continue actively pursuing strategic partnerships; Oncolytics’ goals, strategies and objectives; Oncolytics’ belief in the clinical promise of pelareorep in metastatic colorectal and other gastrointestinal cancers; Oncolytics’ transition into a U.S.-focused clinical-stage oncology company; and the anticipated benefits of the proposed change of Oncolytics’ jurisdiction of incorporation from Alberta, Canada to the State of Nevada. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, financial resources, access to capital markets, market dynamics, and the impact of any prolonged shutdown of the U.S. government. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
Paulness
6月前
NEWS -- Oncolytics Biotech® Provides Update on Intellectual Property Strategy and Patent Filings
Track 1 manufacturing patent application and additional planned filings to potentially extend patent coverage beyond 2044
SAN DIEGO, January 08, 2026--(BUSINESS WIRE)--Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today provided an update on the status of its intellectual property ("IP") portfolio and ongoing efforts to extend patent protection for pelareorep as part of the company’s long-term value creation and development strategy.
In early Q3 2025, Oncolytics filed a Track 1 prioritized examination patent application with the United States Patent and Trademark Office ("USPTO") focused on manufacturing-related innovations for pelareorep. If granted, this patent application could result in granted claims with a potential term extending to 2044, significantly lengthening the commercial runway for pelareorep.
The company received initial written feedback from the USPTO in Q4 2025. Based on the Track 1 timeline, Oncolytics expects a final action in Q3 2026 regarding this manufacturing patent application.
In addition, Oncolytics plans to file one or more additional patent applications relating to the manufacture and method-of-use covering novel therapeutic uses of pelareorep. If allowed, this could provide potential IP protection beyond 2044.
"Extending our intellectual property runway is a core pillar of our strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "As pelareorep continues to demonstrate meaningful clinical activity across gastrointestinal cancers, it is critical that we protect the innovation behind both how the therapy is manufactured and how it is used. These efforts are designed to give pelareorep the best possible chance to impact patients’ lives—particularly those with very limited treatment options—while also increasing long-term value for our shareholders."
Oncolytics stated that it expects to continue pursuing additional IP opportunities in 2026 as part of a comprehensive approach to supporting late-stage development, potential regulatory approvals, and future commercialization of pelareorep.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics’ Track 1 prioritized examination patent application with the USPTO, and the results and timing thereof; Oncolytics’ plan to file additional patent applications relating to pelareorep, the results of these patent applications, and the potential duration of the IP protection; expectations relating to outcomes of ongoing and future studies, and anticipated timing for the presentation of analysis and data from these studies; Oncolytics’ plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives, including with respect to IP protection; and its belief in the clinical promise of pelareorep in metastatic gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260108720932/en/
Contacts
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
Paulness
6月前
NEWS -- Oncolytics Biotech® Expands Its Gastrointestinal Tumor Scientific Advisory Board with the Addition of Dr. Eileen O’Reilly, Dr. Neil Segal, and Dr. Van Morris
New members bring deep experience in pancreatic, colorectal, and anal cancers to guide pelareorep’s development as a platform immunotherapy across GI tumors
Company continues to strengthen its clinical and strategic foundation to advance registration-enabling studies in high-value indications
SAN DIEGO, January 07, 2026--(BUSINESS WIRE)--Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced the expansion of its gastrointestinal ("GI") Tumor Scientific Advisory Board ("SAB") with the appointment of Dr. Eileen O’Reilly, Dr. Neil Segal, and Dr. Van Morris, three globally recognized experts in gastrointestinal oncology. The GI SAB was recently established to support Oncolytics’ growing portfolio of clinical programs in pancreatic, colorectal, and anal cancers and to guide the Company’s strategy as it advances pelareorep as a platform immunotherapy across GI tumors.
Dr. Eileen O’Reilly is the Winthrop Rockefeller Endowed Chair of Medical Oncology at Memorial Sloan Kettering Cancer Center ("MSK") and an internationally recognized leader in pancreatic cancer research and treatment.
"The data emerging with pelareorep across gastrointestinal cancers add to the growing evidence of immunotherapy’s potential in these diseases," said Dr. O’Reilly. "The opportunity to help guide a program that has demonstrated durable responses and encouraging survival signals across multiple tumor types is an important one."
Dr. Neil Segal is the Research Director of the Division of Gastrointestinal Oncology at MSK and an expert in translational oncology and biomarker-driven development.
"Pelareorep’s immunomodulatory potential across solid tumors warrants further evaluation as a potential therapeutic approach," said Dr. Segal. "I look forward to contributing scientific guidance as Oncolytics advances its clinical development program and explores collaborative opportunities."
Dr. Van Morris is an Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, where he also serves as the Section Chief for Colorectal Cancer.
"I have a strong belief in the potential of immunotherapies like pelareorep to help patients in the gastrointestinal cancer setting," said Dr. Morris. "This drug candidate has shown very promising findings in early trials for patients with colorectal and anal cancers, which should be further studied as soon as possible. I look forward to shepherding pelareorep through these next steps of its development."
Jared Kelly, Chief Executive Officer of Oncolytics Biotech, commented: "We’re thrilled to welcome Drs. O’Reilly, Segal, and Morris to our GI SAB. Each brings deep clinical and strategic expertise that will be instrumental as we advance pelareorep through late-stage development. Our focus remains on moving forward with studies that aim to deliver new treatments for patients with difficult GI tumors—programs with total addressable markets so significant that large pharma should take notice. Pelareorep represents a rare example of a true immunotherapy platform with broad applicability across gastrointestinal cancers, and we are strategically positioned to maximize its impact."
With the addition of these distinguished members, Oncolytics’ GI SAB now includes six global experts representing leading academic and clinical institutions across North America and Europe. The inaugural three members include Sanjay Goel, M.D., M.S., FASCO, Professor of Medicine and Director of the Phase I Program at Rutgers Cancer Institute of New Jersey; Deva Mahalingam, M.D., Ph.D., Professor of Medicine, GI oncologist and Director of the Developmental Therapeutics Program, Lurie Cancer Center at Northwestern University; and Dirk Arnold, M.D., Ph.D., FESMO, Principal Investigator of the GOBLET study, Professor of Medicine, and Director of Asklepios Tumorzentrum Hamburg, Germany. The GI SAB will continue to provide guidance on study design, clinical strategy, and translational initiatives as the Company advances its pancreatic, anal, and colorectal cancer programs toward registration-enabling trials.
Review of clinical data for pelareorep in GI cancers
In first-line pancreatic ductal adenocarcinoma, an aggregated analysis of pelareorep’s efficacy across multiple clinical studies and over 100 patients showed the two-year overall survival ("OS") rate was ~22.0% for pelareorep-based treatment regimens compared to a historical benchmark of ~9.0% (link to the PR).
The current approved standard of care for second-line or later squamous cell anal carcinoma patients is a checkpoint inhibitor monotherapy that recorded an objective response rate ("ORR") of 13.8%, whereas the combination of pelareorep and a checkpoint inhibitor generated an ORR of 30% (link to the PR).
Second-line KRAS-mutant metastatic colorectal patients who received pelareorep and FOLFIRI + bevacizumab recorded 16.6 months progression-free survival compared to 5.7 months for the historical control of FOLFIRI + bevacizumab, and 27.0 months compared to 11.2 months for OS (link to the PR). Further analysis of data from this study resulted in an ORR of 33% for patients receiving the pelareorep-based combination regimen compared to 6-11% for the historical benchmark (link to the PR).
Oncolytics is planning pivotal studies in all three of these indications and will continue to engage the U.S. Food and Drug Administration ("FDA") where needed while simultaneously moving each indication forward.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; expectations regarding the Company’s proposed design of potential pancreatic, colorectal, and anal cancer registration studies; expectations relating to outcomes of ongoing and future studies; the future role and composition of the Gastrointestinal (GI) Tumor Scientific Advisory Board; Oncolytics’ plan to continue actively pursuing strategic partnerships; the size of the total addressable market for pelareorep and the possibility or likelihood of large pharmaceutical companies taking notice of the total addressable market for pelareorep; its goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic pancreatic and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260107959522/en/
Contacts
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
mailto://oblaschak@lifescicomms.com
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