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3日前
C4 Therapeutics Presents Phase 1 Data at European Hematology Association (EHA) 2026 Congress Highlighting Cemsidomide as a Potential Best-in-Class IKZF1/3 Degrader for Multiple Myeloma in Heavily Pretreated Relapsed/Refractory Population
At the 100 µg Recommended Phase 2 Dose (RP2D), Cemsidomide Demonstrated a 53% Overall Response Rate, Including Complete Responses and Minimal Residual Disease (MRD) Negative Status
Cemsidomide Was Well Tolerated With Minimal Discontinuations and Dose Reductions Related to Safety or Tolerability
Data Further Support Development Strategy Across Lines of Therapy and in Combination With Approved Therapies, Positioning Cemsidomide as a Potential Foundational Therapy for Relapsed/Refractory Multiple Myeloma
WATERTOWN, Mass., June 11, 2026 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, will present further analysis from its fully enrolled Phase 1 trial of cemsidomide, a next-generation oral IKZF1/3 degrader, in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM) in a poster presentation at the European Hematology Association (EHA) 2026 Congress on Friday, June 12, 2026 at 6:45 pm CEST / 12:45 pm ET.
The analysis is consistent with previous data disclosed from the Phase 1 clinical trial and highlights cemsidomide's anti-myeloma activity and differentiated safety profile, further supporting its development as a potential best-in-class IKF1/3 degrader. The poster will be presented by Sagar Lonial, M.D., FACP, FASCO, chief medical officer at the Winship Cancer Institute at Emory University, and an investigator in the cemsidomide clinical trials.
“Despite advances in multiple myeloma therapies, IKZF1/3 degradation remains a foundational treatment strategy across lines of therapy because it is the only approach that addresses the underlying biology of the disease and has the built-in ability to stimulate the immune function, becoming a natural partner for immune therapies. Next-generation IKZF1/3 degraders are expected to help advance treatment regimens for this persistent disease, given data demonstrating their efficacy and tolerability,” said Dr. Lonial. “The clinical activity and safety profile of cemsidomide are highly encouraging for patients with relapsed/refractory multiple myeloma as they continue to seek disease-altering treatment options. The data from the ongoing Phase 1 study support the continued development of cemsidomide for patients with relapsed/refractory multiple myeloma who may benefit from IKZF1/3 degradation.”
“The totality of cemsidomide data, particularly data showing that patients have experienced a deepening response over time, continue to demonstrate its potential to deliver a tolerable therapy that can provide sustained benefit for patients who have progressed through other treatment options,” said Len Reyno, M.D., chief medical officer of C4 Therapeutics. “We remain focused on advancing our clinical development strategy to capitalize upon cemsidomide’s differentiated profile in hopes patients at various stages of their treatment journey may be able to benefit from this important investigational therapeutic regimen.”
The poster presentation includes data on 73 patients with a data cutoff of February 27, 2026. Patients were heavily pretreated, receiving a median of seven prior lines of therapy. Fifty-five patients (75%) received prior BCMA therapy, and 55 patients (75%) received prior CAR-T or T-cell engager therapy (TCE).
At the RP2D and maximum tolerated dose (100 µg,) cemsidomide achieved a 53% overall response rate (ORR). At the 75 µg dose level, cemsidomide achieved a 40% ORR. Across all doses evaluated, cemsidomide achieved a 36% ORR.
Key new data include:
Responses deepened over time across the cemsidomide 75 µg and 100 µg dose levels: At 75 µg, one patient whose best response was previously a partial response (PR) deepened to a very good partial response (VGPR).At 100 µg, several patients achieved a deeper response: One patient whose best response was previously a PR deepened to a stringent complete response (sCR)One patient whose best response was previously a PR deepened to a VGPR Minimal residual disease (MRD) negativity was achieved in two patients who achieved a sCR and complete response (CR) at 100 µg.
ORR was consistent across key subgroups:
ORR % (95% confidence interval (CI))
All Doses
Prior CAR-T or TCE 37% (24, 51)
Prior BCMA 33% (21, 48)
Prior Lines of Therapy > 5 Lines 33% (20, 48)
100 µg (RP2D)
Prior CAR-T or TCE 53% (28, 77)
Prior BCMA 47% (21, 73)
Prior Lines of Therapy > 5 Lines 47% (21, 73)
Durable responses were observed across all dose levels: Patients experienced a median duration of response of 7.9 months (95% CI, 3.0 – non-evaluable).Seven patients remain on treatment currently.
Cemsidomide in combination with dexamethasone was generally well tolerated. Incidences of on-target neutropenia remained manageable; 42 patients (58%) experienced Grade 3/4 neutropenia. All treatment emergent adverse events were manageable with no discontinuations deemed related to cemsidomide and minimal dose reductions (five patients; 7%).
UPCOMING INVESTOR EVENTS
June 18, 2026 at 9 am ET: C4T will host an educational webinar with Nisha Joseph, M.D., associate professor at the Winship Cancer Institute at Emory University and investigator in the cemsidomide clinical trials to discuss the evolving multiple myeloma landscape, the role of IKZF1/3 degradation in treating multiple myeloma, and cemsidomide’s profile.
About Cemsidomide
Cemsidomide is an investigational, next-generation orally bioavailable MonoDAC® degrader (molecular glue) of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the fully enrolled Phase 1 trial show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.
About Multiple Myeloma
Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow. It is the second most common blood cancer, with approximately 36,000 people in the United States diagnosed each year. Multiple myeloma is characterized by cycles of remission and relapse, which leads to patients needing multiple lines of therapy to manage this persistent disease. More than 175,000 patients in the United States are estimated to be living with or in remission from myeloma. However, despite treatment advances, approximately 40% of patients do not survive beyond five years.
About IKZF1/3 Degradation
Targeted degradation of IKZF1 (Ikaros) and IKF3 (Aiolos) is a foundational therapeutic strategy to treat multiple myeloma, a blood cancer affecting plasma cells. IKZF1/3 degradation leads to downregulation of IRF4, which promotes myeloma cell death. IKZF1/3 degradation also activates T-cells, which contributes to broader anti-myeloma response. For decades, IKZF1/3 degradation has been used in approved therapies for multiple myeloma. Next-generation IKZF1/3 degraders are being developed to leverage advances in targeted protein degradation research while continuing to address the biology foundational to multiple myeloma.
About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).
About Cemsidomide in Combination With Elranatamab (ELREXFIO®)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide and dexamethasone in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to deeper and more durable responses. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO
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1月前
C4 Therapeutics Reports First Quarter 2026 Financial Results and Recent Business Highlights
Progressed Plans to Establish Cemsidomide as a Potentially Foundational Treatment for Multiple Myeloma; Enrollment Ongoing in Phase 2 MOMENTUM Trial and Phase 1b Trial in Combination with Elranatamab
Additional Phase 1b Trial Evaluating Cemsidomide in Combination with Approved Multiple Myeloma Therapies Expected to Initiate in the First Half of 2027
Expanded Long-Term Partnership with Roche Through New Collaboration Agreement Focused on Discovering and Developing Degrader Antibody Conjugates
Cash, Cash Equivalents and Marketable Securities of $268.3 Million as of March 31, 2026 with Cash Runway to the End of 2028
WATERTOWN, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, today reported financial results for the first quarter ended March 31, 2026, as well as recent business highlights.
“During the first quarter, we made strong progress advancing cemsidomide as a potential best-in-class IKZF1/3 degrader for the treatment of multiple myeloma, highlighted by the initiation of two new clinical trials and plans to begin an additional combination trial next year. We believe our clinical development path further supports the advancement of IKZF1/3 degradation – the only mechanism targeting a central transcriptional dependency in multiple myeloma – and will help position cemsidomide as a potentially foundational therapy for these patients with relapsed refractory disease,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “In addition to these clinical advances, we also expanded our partnership with Roche through a new collaboration focused on degrader-antibody conjugates, broadening the reach of targeted protein degradation in cancer. Supported by a strong balance sheet through key value inflection points, we remain focused on advancing our portfolio to deliver the next generation of targeted protein degrader medicines to patients.”
FIRST QUARTER 2026 HIGHLIGHTS AND RECENT ACHIEVEMENTS
Planning is underway to initiate an additional Phase 1b trial evaluating cemsidomide in combination with approved multiple myeloma (MM) therapies. The trial will include two treatment arms: (1) cemsidomide, dexamethasone, and a proteasome inhibitor, and (2) cemsidomide, dexamethasone, and a CD38 antibody, for the relapsed refractory (RR) MM patients. Trial initiation is expected in the first half of 2027 with the goal of further establishing cemsidomide’s profile as a potentially foundational therapy across multiple lines of MM treatment.
Data from the Phase 1 trial evaluating cemsidomide in combination with dexamethasone in RRMM was accepted as a poster presentation at the European Hematology Annual (EHA) Congress taking place from June 11 – June 14, 2026, in Stockholm, Sweden. Enrollment was completed in September 2025, and the poster presentation will include further analysis from the ongoing trial.
A trial-in-progress poster highlighting the Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone in RRMM was accepted at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 29 – June 2, 2026, in Chicago, Illinois.
The first patient was dosed in the Phase 1b trial in March 2026. The trial is evaluating cemsidomide and dexamethasone in combination with elranatamab (ELREXFIO®), B-cell maturation antigen CD3 targeted bispecific antibody, for earlier lines of MM treatment.
The first patient was dosed in the Phase 2 MOMENTUM trial in February 2026. The trial is evaluating cemsidomide in combination with dexamethasone in MM for the fourth line or later. The trial is expected to enroll approximately 100 patients and is on track to complete enrollment by the end of Q1 2027.
Based on the evolving treatment landscape for EGFR mutated non-small cell lung cancer (NSCLC), capital priorities, and available clinical data to date, C4T has made the decision to not advance CFT8919, an EGFR L858R degrader, into the next phase of clinical development outside of Greater China at this time.
C4T entered into a new collaboration agreement with Roche in April 2026, to advance research in the emerging degrader-antibody conjugate (DAC) modality. C4T and Roche will combine antibody-drug conjugation and targeted protein degradation to develop a new way to treat cancers. In May 2026, C4T received an upfront payment of $20 million.
UPCOMING MILESTONES
EHA Congress, June 11 – 14, 2026: Dr. Sagar Lonial, MD, FACP, FASCO, Chief Medical Officer at the Winship Cancer Institute at Emory University, will present a poster titled “Updated Results of a Phase 1 First-In-Human Study of Cemsidomide, a Novel MonoDAC® Degrader, with Dexamethasone in Patients with RRMM” at the EHA Congress on Friday, June 12, 2026 at 6:45 pm CEST / 12:45 pm ET.
2H 2026: Provide an update on the dose escalation progress from the Phase 1b trial evaluating the combination of cemsidomide, dexamethasone, and elranatamab.
By year-end 2026: Deliver at least one development candidate to a collaboration partner and advance collaborations toward key milestones.
UPCOMING INVESTOR EVENTS
May 26th at 2:30 pm ET: Management will participate in a virtual fireside chat at TD Cowen’s 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA, taking place virtually from May 26 – May 27, 2026.
June 3rd at 8:45 am ET: Management will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference taking place in New York, NY from June 2 – June 4, 2026.
June 10th: Management will participate in 1x1 meetings at the Goldman Sachs 47th Annual Global Healthcare Conference taking place in Miami, FL from June 8 – 10, 2026.
FIRST QUARTER 2026 FINANCIAL RESULTS
Revenue: Total revenue for the first quarter of 2026 was $6.2 million, compared to $7.2 million for the first quarter of 2025. The decrease in revenue resulted from the conclusion of the research collaboration with Merck and the prioritization of one KRAS project under the collaboration with Merck KGaA, Darmstadt, Germany (MKDG). This was partially offset by a $2.0 million milestone that was earned from Biogen during the period ended March 31, 2026.
Research and Development (R&D) Expense: R&D expense for the first quarter of 2026 was $24.6 million, compared to $27.1 million for the first quarter of 2025. The decrease in R&D expense was primarily related to the conclusion of the Merck collaboration and the prioritization of one KRAS project under the collaboration with MKDG.
General and Administrative (G&A) Expense: G&A expense for the first quarter of 2026 was $9.3 million, which was unchanged compared to the first quarter of 2025.
Net Loss and Net Loss per Share: Net loss for the first quarter of 2026 was $25.1 million, compared to $26.3 million for the first quarter of 2025. Net loss per share for the first quarter of 2026 was $0.20, compared to $0.37 for the first quarter of 2025.
Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of March 31, 2026 were $268.3 million, compared to $297.1 million as of December 31, 2025. The decrease in cash, cash equivalents and marketable securities during the first quarter of 2026 was primarily the result of the cash used to fund operations and advance our programs. The company expects that its current cash, cash equivalents and marketable securities will fund its operations to the end of 2028.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable molecular glue degrader (MonoDAC® degrader) of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the Phase 1 trial, which has completed enrollment, show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.
About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).
About Cemsidomide in Combination With Elranatamab (ELREXFIO®)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide and dexamethasone in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to deeper and more durable responses. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).
About Multiple Myeloma
Multiple myeloma (MM) is a rare blood cancer affecting plasma cells. Approximately 36,000 people in the United States are diagnosed with MM each year. Approved IKZF1/3 degraders remain foundational therapies across lines of MM treatment. Despite advances, including immune-directed approaches, most patients ultimately relapse, underscoring a growing need for new therapeutics options that continue to leverage IKZF1/3 degradation to drive myeloma cell death and T-cell activation.
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com.
Forward Looking Statements
This press release contains “forward-looking statements” of C4 Therapeutics, Inc., within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO® platform in the development of novel, selective, orally bioavailable BiDAC™ and MonoDAC® degraders; the potential timing, design and advancement of our preclinical studies and clinical trials, including the potential timing for and receipt of regulatory authorization related to clinical trials and other clinical development activities including clinical trial commencement and patient enrollment; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our ability to replicate interim or early-stage results from our clinical trials in the results obtained when those clinical trials are completed or when those therapies complete later-stage clinical trials; the potential timing and/or receipt of regulatory approval for our product candidates; regulatory developments
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2月前
C4 Therapeutics Expands Long-Term Partnership with Roche Through New Collaboration Agreement Focused on Discovering and Developing Degrader-Antibody Conjugates (DACs)
Agreement Focused on Developing DACs With Payloads For Two Oncology Targets, With an Option for a Third Target
C4T to Develop Degraders With Payload Properties; Roche to Conjugate Payloads to Targeted Antibodies
C4T to Receive $20 Million Upfront Payment and Eligible to Receive Over $1 Billion in Discovery, Development and Commercial Milestones, in Addition to Future Royalties
WATERTOWN, Mass., April 09, 2026 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science today announced that it has entered into a new collaboration agreement with Roche (SIX: RO, ROP; OTCQX: RHHBY) to advance research in the emerging degrader-antibody conjugate (DAC) modality. Working together, C4T and Roche will combine antibody-drug conjugation (ADC) and targeted protein degradation (TPD) to develop a new way to treat cancers that leverages both the specificity and catalytic efficiency of degraders with the delivery capabilities of ADCs.
“For the past decade, C4T and Roche have worked together to drive research in targeted protein degradation and to establish this modality as a new way to treat cancer,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “Our new collaboration leverages C4T’s ability to design highly catalytic and selective degraders, as well as degrader payloads for DACs, alongside Roche’s extensive experience developing ADCs with specific binding. Together, these capabilities build a powerful new modality that can offer transformative medicines for patients.”
“Roche has been a believer in targeted protein degradation and its potential for differentiation early on, when partnering with C4T for the first time in 2016,” said Boris Zaïtra, head of corporate business development, Roche. “Our relationship with C4 Therapeutics is built on a decade of trust and shared scientific ambition. We are pleased to enter into our third collaboration, expanding our long-standing partnership to pioneer the emerging modality of degrader-antibody conjugates (DACs).”
Under the joint research plan, C4T and Roche will collaborate on two programs to develop DACs against undisclosed oncology targets exclusive to the collaboration. C4T will use its proprietary TORPEDO® platform to design degrader payload candidates. Roche will select and design the antibody as well as conjugate the antibody to the degrader payload. Roche will be responsible for advancing DAC candidates through preclinical and clinical development as well as commercialization.
C4T will receive a $20 million upfront payment for the two programs. Should Roche exercise its option for a third target, C4T will receive an additional payment. Across the collaboration, C4T will receive near-term discovery milestone payments. C4T is eligible to receive over $1 billion in discovery, regulatory and commercial milestone payments. In addition, C4T is entitled to tiered royalties on future sales, subject to reductions under certain circumstances as described in the collaboration agreement.
About Degrader-Antibody Conjugates (DACs)
ADCs over the last 15 years have made important contributions to cancer therapy, but their clinical utility has historically been challenged by a limited therapeutic margin. Degrader-based ADCs, or degrader-antibody conjugates (DACs), represent a potential step-change in this modality. By utilizing degrader payloads that target specific cellular dependencies, DACs offer a superior therapeutic index. These small-molecule degraders are characterized by a catalytic mechanism of action—a feature unique to this approach—rendering them exceptionally well suited for targeted antibody delivery.
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its
US Market News
3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:
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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
subslover
4月前
C4 Therapeutics Announces First Patient Dosed in Phase 2 MOMENTUM Trial of Cemsidomide, an Oral IKZF1/3 Degrader, in Combination with Dexamethasone for Relapsed/Refractory Multiple Myeloma
Enrollment for Phase 2 MOMENTUM Trial Expected to Be Completed in Q1 2027
Phase 1b Trial of Cemsidomide in Combination with Elranatamab on Track to Initiate in Q2 2026
WATERTOWN, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that the first patient has been dosed in the Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM).
“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 Phase 2 MOMENTUM trial is an open-label, single-arm, multicenter study to assess anti-myeloma activity and further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of cemsidomide, an oral IKZF1/3 degrader, in combination with dexamethasone in RRMM patients for the fourth line or later. The trial will enroll approximately 100 patients to evaluate cemsidomide at the 100 µg dose level. Cemsidomide is administered with a daily dosing schedule of 14 days on and 14 days off, and dexamethasone is dosed once a week. The primary endpoint is the overall response rate per the International Myeloma Working Group response criteria as assessed by an independent review committee. Secondary endpoints will evaluate a range of additional safety and efficacy measures.
The Phase 2 MOMENTUM trial is part of a broader development strategy for cemsidomide, which also includes a Phase 1b study of cemsidomide in combination with elranatamab (ELREXFIO®). Elranatamab is an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. Together, these trials support cemsidomide’s use across multiple lines of treatment.
ANTICIPATED UPCOMING MILESTONES
Phase 1b trial of cemsidomide in combination with elranatamab is on track to initiate in Q2 2026.
Further analysis of the completed Phase 1 trial of cemsidomide in combination with dexamethasone is expected in mid-2026.
Enrollment for Phase 2 MOMENTUM trial is expected to be completed in Q1 2027.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable molecular glue degrader (MonoDAC® degrader) of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the Phase 1 trial, which has completed enrollment, show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.
About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm, study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).
About Cemsidomide in Combination With Elranatamab (ELREXFIO®)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).
About Multiple Myeloma
Multiple myeloma (MM) is a rare blood cancer affecting plasma cells. Approximately 36,000 people in the United States are diagnosed with MM each year. Approved IKZF1/3 degraders remain foundational therapies across lines of MM treatment. Despite advances, including immune-directed approaches, most patients ultimately relapse, underscoring a growing need for new therapeutics options that continue to leverage IKZF1/3 degradation to drive myeloma cell death and T-cell activation.
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com.
Forward Looking Statements
This press release contains “forward-looking statements” of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO® platform in the development of novel, selective, orally bioavailable BiDAC™ and MonoDAC® degraders; the potential timing, design and advancement of our preclinical studies and clinical trials, including the potential timing for and receipt of regulatory authorization related to clinical trials and other clinical development activities including clinical trial commencement and patient enrollment; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our ability to replicate interim or early-stage results from our clinical trials in the results obtained when those clinical trials are completed or when those therapies complete later-stage clinical trials; regulatory developments in the United States and foreign countries; the anticipated timing and content of presentations of data from our clinical trials; and our ability to fund our future operations. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing, advancement and conduct of preclinical and clinical studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will cost more to develop or may not be successfully developed and commercialized; and the risk that sufficient capital to fund our future operations will be available to us on acceptable terms or at the times required. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law.
Contacts:
Investors:
Courtney Solberg
Associate Director, Investor Relations
CSolberg@c4therapeutics.com
Media:
Loraine Spreen
Senior Director, Corporate Communications & Patient Advocacy
subslover
7月前
They need the $ to bribe the Government Mob. Called the crooked FDA🥵 $400,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
We may from time to time issue, in one or more series or classes, offer and sell an aggregate offering amount of up to $400,000,000 of our common stock, preferred stock, debt securities, warrants and/or units. We may offer these securities separately or together in units. We will specify in the applicable accompanying prospectus supplement the terms of the securities being offered. We may sell these securities to or through underwriters and also to other purchasers or through agents. We will set forth the names of any underwriters or agents, and any fees, conversions or discount arrangements, in the applicable accompanying prospectus supplement. We may not sell any securities under this prospectus without delivery of the applicable prospectus supplement.
You should read this document and any prospectus supplement or amendment carefully before you invest in our securities.
Our common stock is listed on The Nasdaq Global Select Market under the symbol “CCCC.” On November 20, 2025, the closing price for our common stock, as reported on The Nasdaq Global Select Market, was $2.38 per share. Our principal executive office is located at 490 Arsenal Way, Suite 120, Watertown, Massachusetts 02472.
Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties referenced under the heading “Risk Factors” contained in this prospectus beginning on page 2 and any applicable prospectus supplement, and under similar headings in the other documents that are incorporated by reference into this prospectus. You should read the entire prospectus carefully before you make your investment decision.
Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
subslover
8月前
C4 Therapeutics Announces Pricing of $125 Million Underwritten Offering
$125 Million in Upfront Proceeds Expected to Fund Next Phase of Cemsidomide Multiple Myeloma Development Including Registrational Phase 2 Trial in Combination with Dexamethasone and Phase 1b Trial in Combination with Elranatamab
Potential to Earn up to an Additional $225 Million in Proceeds
WATERTOWN, Mass., Oct. 16, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced the pricing of an underwritten offering to a select group of institutional investors consisting of 21,895,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase an aggregate of up to 28,713,500 shares of its common stock. Each share of common stock and each pre-funded warrant is accompanied by a Class A Warrant and a Class B Warrant, each to purchase one share of common stock (or pre-funded warrant in lieu thereof) at an exercise price of $2.22 per share.
The offering was led by RA Capital Management with participation from existing shareholders including OrbiMed, Soleus Capital, Lynx1 Capital Management, and Bain Capital Life Sciences.
The Class A Warrants are exercisable at any time through the earlier of (i) 30 days after the achievement of a trigger tied to the clinical results from the planned Phase 1b trial of cemsidomide with elranatamab, or (ii) five years from the date of issuance. The Class B Warrants are exercisable at any time prior to the fifth anniversary of the date of issuance and, under certain circumstances based on stock appreciation, C4T may require the mandatory exercise of the warrants. The shares of common stock (with accompanying Class A and Class B Warrants) are being sold at a combined price of $2.47 per share of common stock and accompanying warrants, and the pre-funded warrants (with accompanying Class A and Class B Warrants) are being sold at a combined price of $2.4699 per pre-funded warrant and accompanying warrants, which represents the per share price of the common stock less the $0.0001 per share exercise price for each pre-funded warrant.
All securities in the offering are being sold by C4T. The aggregate gross proceeds to C4T from the offering, before deducting underwriting discounts and commissions and offering expenses and excluding any proceeds from potential exercise of the Class A and Class B Warrants and nominal proceeds from potential exercise of the pre-funded warrants, are expected to be $125.0 million. If all Class A and Class B Warrants and pre-funded warrants are exercised, the aggregate gross proceeds to C4T from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $349.7 million. The offering is expected to close on or about October 17, 2025, subject to the satisfaction of customary closing conditions.
Together with its existing cash and cash equivalents and marketable securities, C4T intends to use the net proceeds of the offering to primarily fund its ongoing and planned clinical trials of cemsidomide, other research and development activities, and for working capital and general corporate purposes.
Jefferies, TD Cowen and Evercore ISI are acting as book-running managers for the offering.
The securities were offered by C4T pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) on October 31, 2024 and declared effective by the SEC on November 13, 2024 (File No. 333-282933). The prospectus supplement, accompanying prospectus and any free writing prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.
When available, copies of the prospectus supplement, accompanying prospectus and any free writing prospectus relating to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at TDManualrequest@broadridge.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering will be made only by means of the prospectus supplement and the accompanying prospectus.
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied
subslover
8月前
C4 Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Pfizer for the Combination of Cemsidomide and Elranatamab for the Treatment of Relapsed/Refractory Multiple Myeloma
WATERTOWN, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. Under the terms of the agreement, Pfizer will supply elranatamab (ELREXFIO®), a B-cell maturation antigen CD3 targeted bispecific antibody (BCMAxCD3 bispecific), to C4T for its upcoming Phase 1b trial.
The Phase 1b trial will evaluate the safety and tolerability of cemsidomide, an IKZF1/3 degrader, and dexamethasone in combination with elranatamab as a second line or later therapy for patients with multiple myeloma. This Phase 1b trial, which is expected to initiate in Q2 2026, will seek to establish an optimal dose for cemsidomide in combination with elranatamab. Under the terms of the agreement, Pfizer will supply elranatamab at no cost while C4T will sponsor and conduct the trial.
“We look forward to initiating this trial to evaluate cemsidomide in combination with elranatamab in the hopes we can develop a new treatment regimen and potentially improve outcomes for multiple myeloma patients in earlier lines of therapy,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “Our supply agreement with Pfizer creates an opportunity for cemsidomide to be combined with elranatamab, which is on the path to potentially becoming a standard of care BCMAxCD3 bispecific in a growing market.”
Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to higher quality of responses.
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