Paulness
2週前
NEWS -- Theriva™ Biologics Announces Results from VCN-01 Phase 1 Clinical Trial in Head and Neck Cancer Published in Clinical Cancer Research
Prolonged overall survival (OS) was observed in heavily pre-treated refractory Head & Neck Squamous Cell Carcinoma (HNSCC) patients administered IV VCN-01 prior to the immune checkpoint inhibitor durvalumab
Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results all support the proposed VCN-01 stroma-degrading and immune enhancing modes-of-action and resensitization of refractory tumors to durvalumab
Increased levels of PD-L1 positive T-cells and other biomarkers were found in patients after sequential administration of VCN-01 and durvalumab, consistent with reactivation of immune responsesROCKVILLE, Md., June 11, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that clinical and translational results from VCN-01’s Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) were recently published on-line first in the journal Clinical Cancer Research. The article, titled “Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy”, can be read here.
“We are very excited to see Clinical Cancer Research share the VCN-01 results in immunotherapy-refractory metastatic HNSCC patients with the broad oncology community,” said Ricard Mesia (Catalan Institute of Oncology, ICO), expert on HNSCC and coordinating investigator in this study. “The trial demonstrates the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab. Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results from the study all support the VCN-01 stroma-degrading mode-of-action, being investigated to enhance tumor penetration by VCN-01 and coadministered therapies and enable/enhance an anti-tumor immune response. There are very few treatment options available to immunotherapy-refractory metastatic HNSCC patients, and the clinically impactful findings from this report encourage further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies.”
Data summary – VCN-01 Phase 1 clinical trial (NCT03799744) in metastatic, immunotherapy-refractory Head & Neck Squamous Cell Carcinoma (HNSCC)
The trial enrolled 20 adult patients with refractory or metastatic HNSCC, whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors. Six patients were enrolled into the concomitant Arm I LD of the study and were administered IV low dose VCN-01 (3.3E12 virus particles; LD) four hours prior to a fixed IV dose of durvalumab (1500 mg/q4w). Eight patients were enrolled into the sequential Arm II LD of the study, receiving low dose IV VCN-01 14 days prior to IV durvalumab administration. An additional six patients were entered into Arm II HD, receiving high dose IV VCN-01 (1.0E13 virus particles; HD) 14 days prior to IV durvalumab administration.
Median progression-free survival (PFS) was 1.6 months in Arm I LD, 3.7 months in Arm II LD, and 2.1 months in Arm II HD.
Median overall survival (OS) was 10.3 months in Arm I LD, 15.5 months in Arm II LD, and 17.3 months in Arm II HD.
Circulating levels of the stroma-degrading hyaluronidase enzyme PH20 (expressed during selective VCN-01 intratumoral replication) increased significantly after VCN-01 administration in all tested patients, peaking on day 3-8 for most patients and detectable until day 28 in 11 of 12 patients.
Similarly, VCN-01 viral genome levels detected in patient blood exhibited an initial peak immediately following administration and a secondary peak on day 3-8, consistent with continued viral replication in tumors followed by a return of virus to circulation.
Upregulation of CD8 and IDO was observed in tumor biopsy samples, consistent with increased tumor infiltration by activated cytotoxic T cells – historically associated with increased HNSCC patient survival. Diminished levels of FoxP3, CD25, and CTLA4 were also observed, consistent with a reduction in tumor Tregs and inhibition of tumor immunosuppression.
Tumor biopsies revealed upregulation of PD-1 and PD-L1 in most patients following VCN-01 administration that correlated with patient survival, suggesting that immune system activity and heightened PD-L1 expression in tumors contributed to the improved outcomes from VCN-01 and durvalumab combination.About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidate is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial with SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients has completed 2 of 3 cohorts, with initiation of the third cohort dependent on additional funding. SYN-004 (ribaxamase) is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD). For more information, please visit Theriva™ Biologics’ website at https://www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding the development of therapeutics designed to treat cancer and related diseases in areas of high unmet need; the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab; pharmacokinetic, tissue biopsy, radiomic and transcriptomic results from the study supporting the VCN-01 stroma-degrading mode-of-action, being researched to enhance tumor penetration by VCN-01 and coadministered therapies and enable/enhance an anti-tumor immune response; the clinically impactful findings from the study report encouraging further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies; Theriva Biologics, S.L.’s development of a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system; and the initiation of the third cohort of the exploratory clinical trial with SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients, which remains subject to additional funding; the ability of SYN-004 (ribaxamase) to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE and reducing the incidence and severity of aGVHD.. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize protocols for future clinical trials evaluating VCN-01 with immune checkpoint inhibitors or other immune modulating agents; result of future trials supporting further clinical development of CVN-01; the Company’s ability to obtain development funding and/or partnerships; the Company’s commencement of planned clinical trials, which remains subject to sufficient financing; the Company’s ability to raise capital and/or enter into one or more strategic alternatives, that may include a business combination, merger or reverse merger; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in cancer patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat cancer patients; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations
Kevin Gardner
LifeSci Advisors, LLC
mailto://kgardner@lifesciadvisors.com
INV4
2月前
Theriva Biologics (TOVX) Stock Soars 63% on Promising Pancreatic Cancer Trial Results
April 20, 2026
• Shares of Theriva Biologics (TOVX) surged 63% following the release of encouraging VIRAGE Phase 2b clinical trial results
• Combination therapy using VCN-01 with conventional chemotherapy demonstrated enhanced overall survival compared to chemotherapy alone in metastatic pancreatic cancer
• Positive outcomes were observed across various patient subgroups, notably those presenting with liver metastases
• The biotechnology firm has secured regulatory alignment with both FDA and EMA for its upcoming Phase 3 pivotal study
• With a modest market capitalization of $11.7M and share price at $0.25, TOVX reflects the inherent risks of early-stage biotechnology investments
During the American Association for Cancer Research (AACR) Annual Meeting held in San Diego on April 20, 2026, Theriva Biologics unveiled updated findings from its VIRAGE Phase 2b clinical study.
Dr. Manuel Hidalgo from NYU Langone Health’s Perlmutter Cancer Center presented the data during a poster session.
The clinical investigation evaluated VCN-01 administered alongside gemcitabine and nab-paclitaxel versus standard chemotherapy alone in individuals recently diagnosed with metastatic pancreatic cancer.
Findings revealed that participants who received the VCN-01 combination therapy experienced superior overall survival and progression-free survival metrics compared to the control group receiving only chemotherapy.
The therapeutic responses observed in the VCN-01 treatment arm were characterized as emerging later in the treatment course, demonstrating greater magnitude, and exhibiting enhanced durability — suggesting what researchers believe represents an immune-mediated therapeutic mechanism.
The survival advantages remained relatively consistent across diverse patient populations. This notably included individuals with liver metastases, a subgroup traditionally associated with more challenging treatment outcomes.
Participants who were administered a second VCN-01 dose demonstrated potentially superior therapeutic benefits, which company officials interpret as supporting evidence for prolonged dosing strategies.
Regulatory Agencies Align on Phase 3 Study Design
Theriva Biologics announced it has successfully achieved regulatory alignment with both the U.S. Food and Drug Administration and the European Medicines Agency regarding the framework for a definitive Phase 3 clinical trial.
The planned Phase 3 investigation would assess multiple VCN-01 dosing regimens combined with gemcitabine and nab-paclitaxel in treatment-naive metastatic pancreatic cancer patients.
Additionally, the organization indicated intentions to conduct a supplementary investigation examining whether increased frequency or extended duration of VCN-01 administration could further enhance patient outcomes.
VCN-01 represents a systemically delivered oncolytic adenovirus platform. The therapeutic agent is engineered to selectively replicate within malignant cells and degrade tumor stromal architecture, theoretically enhancing penetration and efficacy of concurrently administered treatments.
To this point, the investigational therapy has been administered to 142 individuals across multiple clinical trials encompassing various malignancy types.
Market Response and Corporate Overview
TOVX shares experienced a 63% price increase following the announcement, though the organization maintains a relatively small market capitalization of merely $11.7 million with shares trading at $0.25.
This valuation underscores the considerable risks inherent in investing in clinical-stage biotechnology companies without revenue generation and facing continued capital consumption.
Wall Street Perspective
The latest analyst assessment on TOVX carries a Buy recommendation, establishing a price objective of $1.00. Analyst price targets span a range between $1 and $4.
A notable complication: Theriva recently failed to convene a Special Meeting of Stockholders due to insufficient quorum attendance. The gathering was scheduled to vote on a warrant exercise proposition. Management intends to reconvene the meeting.
Pancreatic ductal adenocarcinoma represents over 90% of all pancreatic malignancies, with approximately 50–60% of patients presenting with distant metastatic disease at initial diagnosis.
The AACR data presentation occurred on April 20 between 2:00–5:00 PM PDT at the San Diego Convention Center.
Link article
$TOVX 🗞️
Paulness
2月前
NEWS -- Theriva™ Biologics Announces Upcoming Presentation of Additional Data from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer at AACR 2026 Annual Meeting
Tumor reponse, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial support a VCN-01 immune-mediated mode of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver metastases
Data to be presented in a poster session at the American Association of Cancer Research (AACR) Annual Meeting in San Diego, California on Monday April 20, 2026ROCKVILLE, Md., April 17, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced an upcoming poster presentation of new data and subgroup analyses from the VIRAGE Phase 2b clinical trial evaluating VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel in newly-diagnosed metastatic pancreatic cancer patients. Tumor reponse, biomarker data, and subgroup analyses are to be presented at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from 17-22 April 2026.
Details of the poster presentation are below:
Presenting author: Dr. Manuel Hidalgo, NYU Langone Health Perlmutter Cancer Center, New York, NY
Title: Analysis of tumor and biomarker responses in the VIRAGE Trial, a randomized Phase IIb, open-label, study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC)
Poster #: CT162
Date and time: Monday April 20, 2026, 2:00-5:00 PM US PDT
Session: PO.CT01.05 - Phase II and Phase III Clinical Trials
Location: San Diego Convention Center, Hall B, Section 52, Board 26.“The new data and analyses to be presented at the AACR meeting further reinforce our confidence in the clinical potential of VCN-01 plus gemcitabine/nab-paclitaxel chemotherapy to help metastatic PDAC patients,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Taken together, the tumor response and biomarker data support an immune-mediated mode of action for VCN-01, which is consistent with the previously reported clinical observations, showing that patients treated with VCN-01 plus gemcitabine/nab-paclitaxel experienced a significantly protracted duration of response concomitant with a later-stage prolongation of survival compared to patients treated with gemcitabine/nab-paclitaxel alone. We have achieved alignment with both the FDA and the EMA on a proposed pivotal Phase 3 clinical trial to evaluate multiple doses of VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC patients, and we are planning a small study to assess whether more frequent and extended VCN-01 dosing could further improve outcomes.”
About Pancreatic Ductal Adenocarcinoma
Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.
About VCN-01
VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including pancreatic ductal adenocarcinoma (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at https://Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L. , has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial is also on-going with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva™ Biologics’ website at https://www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding the Company’s confidence in the clinical potential of VCN-01 plus gemcitabine/nab-paclitaxel chemotherapy to help metastatic PDAC patients; tumor response and biomarker data supporting an immune-mediated mode of action for VCN-01; alignment with the FDA and EMA on a proposed Phase 3 clinical trial evaluating multiple doses of VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC patients; and planning a small study to assess whether more frequent and extended VCN-01 dosing could further improve outcomes. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize the proposed pivotal Phase 3 study protocol and file a BLA; the Company’s ability to obtain development funding and/or partnerships; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in metastatic PDAC patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat patients with PDAC; regulatory limitations relating to the Company’s ability to promote or commercialize their product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Kevin Gardner
LifeSci Advisors, LLC
mailto://kgardner@lifesciadvisors.com
INV4
2月前
Theriva™ Biologics Announces Upcoming Presentation of Additional Data from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer at AACR 2026 Annual Meeting
April 17, 2026
• Tumor reponse, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial support a VCN-01 immune-mediated mode of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver metastases -
• Data to be presented in a poster session at the American Association of Cancer Research (AACR) Annual Meeting in San Diego, California on Monday April 20, 2026-
ROCKVILLE, Md., April 17, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced an upcoming poster presentation of new data and subgroup analyses from the VIRAGE Phase 2b clinical trial evaluating VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel in newly-diagnosed metastatic pancreatic cancer patients. Tumor reponse, biomarker data, and subgroup analyses are to be presented at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from 17-22 April 2026.
Details of the poster presentation are below:
• Presenting author: Dr. Manuel Hidalgo, NYU Langone Health Perlmutter Cancer Center, New York, NY
• Title: Analysis of tumor and biomarker responses in the VIRAGE Trial, a randomized Phase IIb, open-label, study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC)
• Poster #: CT162
• Date and time: Monday April 20, 2026, 2:00-5:00 PM US PDT
• Session: PO.CT01.05 - Phase II and Phase III Clinical Trials
• Location: San Diego Convention Center, Hall B, Section 52, Board 26.
“The new data and analyses to be presented at the AACR meeting further reinforce our confidence in the clinical potential of VCN-01 plus gemcitabine/nab-paclitaxel chemotherapy to help metastatic PDAC patients,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Taken together, the tumor response and biomarker data support an immune-mediated mode of action for VCN-01, which is consistent with the previously reported clinical observations, showing that patients treated with VCN-01 plus gemcitabine/nab-paclitaxel experienced a significantly protracted duration of response concomitant with a later-stage prolongation of survival compared to patients treated with gemcitabine/nab-paclitaxel alone. We have achieved alignment with both the FDA and the EMA on a proposed pivotal Phase 3 clinical trial to evaluate multiple doses of VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC patients, and we are planning a small study to assess whether more frequent and extended VCN-01 dosing could further improve outcomes.”
About Pancreatic Ductal Adenocarcinoma
Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.
About VCN-01
VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including pancreatic ductal adenocarcinoma (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L. , has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial is also on-going with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva™ Biologics’ website at www.therivabio.com.
Link article
$TOVX 🗞️
INV4
3月前
Theriva Biologics, Inc. (TOVX): Buy Rating Signals Potential Recovery amid Price Challenges
March 31, 2026
In a noteworthy update for investors, Theriva Biologics, Inc. (TOVX) has received a Buy rating from Jason McCarthy of Maxim Group as of March 31, 2026. This recommendation comes at a time when the stock is priced at $0.1958, with a significant upside potential towards the analyst’s price target of $1. This rating could serve as a catalyst for investor interest, suggesting that the company may have the potential to rebound from its recent struggles.
Recent Price Action
Theriva’s stock has experienced a tumultuous period, currently trading at $0.1958, down sharply from its 52-week high of $21.01, representing a staggering 86.87% decline. On the other end of the spectrum, the year’s low was strikingly close at just $0.1958, indicating the challenging environment the company has faced. Recently, the stock saw a slight upturn, with a change of $0.0106 or an increase of 5.72%. Despite this uptick, trading volumes have been relatively low, with recent sessions witnessing a volume of 1,980,521 shares compared to an average volume of 12,499,141. The market cap stands at $6,987,779. With a beta of 0.515, the stock shows less volatility compared to the broader market, suggesting that while it is prone to sharp movements, it doesn’t exhibit the extreme volatility of higher-beta stocks.
Link article
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JusDePomme
3月前
Merck to Acquire Terns Pharmaceuticals, Inc., Expanding Its Hematology Pipeline With TERN-701, a Novel Candidate for Chronic Myeloid Leukemia (CML)
Terns’ lead candidate TERN-701 is an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with CML
Merck to hold investor call at 8 a.m. EDT today
RAHWAY, N.J. and FOSTER CITY, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Terns Pharmaceuticals, Inc. (“Terns”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Terns for $53.00 per share in cash for an approximate equity value of $6.7 billion. This equates to approximately $5.7 billion net of acquired cash and represents an approximate premium of 31% to the 60-day and 42% to the 90-day volume-weighted average stock price on March 24, 2026.
“The acquisition of Terns builds on our growing presence in hematology with TERN-701, a potential best-in-class candidate for the treatment of certain patients with chronic myeloid leukemia,” said Robert M. Davis, chairman and chief executive officer, Merck. “This transaction further diversifies and strengthens our position in oncology as we continue to look for opportunities to broaden our portfolio into other therapeutic areas.”
Terns’ lead candidate, TERN-701, is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in the Phase 1/2 CARDINAL trial (NCT06163430) for patients with Philadelphia chromosome-positive (Ph+), chronic phase chronic myeloid leukemia (CML) previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. In March 2024, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of CML.
“This acquisition reflects our team’s deep commitment to innovation in oncology and developing high impact medicines,” said Amy Burroughs, chief executive officer, Terns. “By working together, we will advance TERN-701, leveraging the deep expertise and significant resources at Merck, a global biopharmaceutical leader with a proven track record of delivering cancer breakthroughs for patients who need them most. I am immensely proud of the Terns team and our work towards making a difference for people living with CML. Finally, we extend our heartfelt thanks to the investigators, patients, and community advocates whose dedication and support make the development of TERN-701 possible.”
In clinical trials to date, TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed by week 24. Importantly, this includes responses in patients with high disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations. No clinically meaningful changes in blood pressure have been observed, and rates of lipase elevation have been low.
“The first approval of a BCR::ABL1 tyrosine kinase inhibitor 25 years ago transformed the prognosis for many patients with chronic myeloid leukemia. Despite new therapeutic options, there is significant need for innovative, well-tolerated therapies with faster time to onset of molecular response leading to deeper responses and better disease control,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Based on early clinical evidence, TERN-701, a novel allosteric BCR::ABL1 inhibitor, may have the potential to provide a meaningfully differentiated option for certain patients living with CML.”
The transaction has been approved by both Merck’s and Terns’ Boards of Directors. Under the terms of the merger agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Terns. The acquisition is subject to a majority of Terns’ stockholders tendering their shares in a tender offer that will be initiated by a subsidiary of Merck. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to be accounted for as an asset acquisition and close in the second quarter of 2026, resulting in a charge of approximately $5.8 billion, or approximately $2.35 per share, included in both second quarter and full year 2026 GAAP and non-GAAP results.
A copy of the merger agreement for the transaction will be filed with the Securities and Exchange Commission (“SEC”) and will be publicly available free of charge at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge from Merck’s website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ 07065 USA, or (908) 740-4000. Copies of the documents filed with the SEC by Terns may be obtained at no charge from Terns’ website at www.ternspharma.com or by contacting Terns at 1065 East Hillsdale Blvd., Suite 100, Foster City, CA 94404 or (650) 525-5535 Ext.101.
Paulness
3月前
NEWS -- Theriva™ Biologics Announces Positive End-of-Phase 2 Meeting with U.S. FDA Regarding the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma
– Successful meeting with FDA enables advancement into proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC –
– Combined feedback from FDA and previously from EMA enables company to finalize protocol for pivotal Phase 3 clinical trial while pursuing strategic funding opportunities –
ROCKVILLE, Md., March 23, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC).
The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial. As announced in 2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival (OS), progression free survival (PFS) and Duration of Response (DoR) compared to SoC chemotherapy alone. Greater improvements in OS and PFS were observed in patients who received two doses of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes.
Consistent with scientific advice previously received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the FDA advised that a potential biologics licensing application (BLA) for VCN-01 in metastatic PDAC could be supported by Theriva’s proposed Phase 3 clinical trial (if successful) comprising a single, high-quality, randomized, double-blinded, study comparing VCN-01 plus gemcitabine/nab-paclitaxel SoC to gemcitabine/nab-paclitaxel SoC plus placebo. The FDA further agreed on the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated “macrocycles” (enabling more than 2 doses of VCN-01 to be administered in the Phase 3 trial), the proposed inclusion/exclusion criteria, the primary endpoint (overall survival), key secondary endpoints (including progression free survival), and the use of an adaptive design. The FDA also clarified statistical expectations regarding the proposed interim analyses and the quality of data required for potential sample size re-estimation or a demonstration of early efficacy.
“We are very pleased to align with the FDA on the key elements of our proposed pivotal Phase 3 trial evaluating VCN-01 plus gemcitabine/nab-paclitaxel SoC in metastatic PDAC patients,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Data from our VIRAGE Phase 2b study demonstrated improved outcomes in PDAC patients treated with 2 doses of VCN-01 and we believe that administering multiple macrocycles of VCN-01 and gemcitabine/nab-paclitaxel that may further improve patient outcomes. The combined feedback from the FDA and the EMA now enables us to finalize the protocol for a pivotal Phase 3 clinical trial and pursue development funding and/or partnerships, which, if successful, may deliver a novel and effective treatment option for patients with this difficult to treat solid tumor cancer.”
About Pancreatic Ductal Adenocarcinoma
Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.
About VCN-01
VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at https://Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial is also on-going with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva Biologics’ website at https://www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding advancing into a proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC; the feedback from the FDA and European regulatory agencies enabling a pivotal Phase 3 study protocol to be finalized and pursuit of non-dilutive strategic funding opportunities; the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes; the proposed Phase 3 clinical trial (if successful) supporting a potential BLA; administering multiple macrocycles of VCN-01 and gemcitabine/nab-paclitaxel improving improve patient outcomes; the combined feedback from the FDA and the EMA enabling the Company to finalize the protocol for a pivotal Phase 3 clinical trial and pursue development funding of partnerships; and delivering a novel and effective treatment option for patients with difficult to treat solid tumor cancer. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize the Phase 3 study protocol and file a BLA; the Company’s ability to obtain development funding and/or partnerships; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in PDAC patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat patients with PDAC; regulatory limitations relating to the Company’s ability to promote or commercialize their product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s and VCN’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Kevin Gardner
LifeSci Advisors, LLC
mailto://kgardner@lifesciadvisors.com
Source: Theriva Biologics, Inc.
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