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
MWN-AI** Summary
C4 Therapeutics, Inc. (C4T), a clinical-stage biopharmaceutical company, has announced that the first patient has been dosed in its Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone for treating relapsed/refractory multiple myeloma (RRMM). This milestone comes as part of C4T's initiative to establish cemsidomide as a foundational therapy for patients facing this challenging cancer, which affects plasma cells. The drug is designed as an oral IKZF1/3 degrader, aiming to provide a safer and more convenient treatment option compared to existing therapies.
The MOMENTUM trial, a multicenter, open-label study, plans to enroll approximately 100 patients who have undergone at least three prior lines of anticancer therapy. The primary endpoint will assess the overall response rate according to the International Myeloma Working Group criteria, with secondary endpoints focusing on additional safety and efficacy measures. Cemsidomide is administered on a 14-day on and 14-day off schedule, while dexamethasone is given weekly. The trial is projected to complete enrollment by Q1 2027.
Additionally, C4T is on track to initiate a Phase 1b trial of cemsidomide in combination with elranatamab, an FDA-approved bispecific antibody targeting B-cell maturation antigen, in Q2 2026. Through these trials, C4T aims to create accelerated approval pathways for cemsidomide, reinforcing its broader development strategy.
Cemsidomide's promising results from the Phase 1 trial, which highlighted its differentiated safety profile and anti-myeloma efficacy, further support its potential as a transformative therapy. With ongoing developments in the treatment landscape, C4T remains committed to leveraging targeted protein degradation science to advance treatment options for RRMM patients.
MWN-AI** Analysis
C4 Therapeutics, Inc. (C4T) has made significant strides in its clinical development, notably with the commencement of the Phase 2 MOMENTUM trial for cemsidomide, a promising oral treatment for relapsed/refractory multiple myeloma (RRMM). This trial, now enrolling patients, is critical as it builds on positive Phase 1 data demonstrating cemsidomide's safety and efficacy. The dual approach of using cemsidomide in combination with dexamethasone and the scheduled Phase 1b trial with elranatamab positions C4T strategically in a competitive oncology landscape.
From a market perspective, investors should note several factors shaping C4T’s outlook. The successful enrollment and outcomes from the ongoing trials could enhance C4T’s valuation as it works towards potential accelerated approvals. With a dedicated focus on IKZF1/3 degradation, C4T's approach is aligned with innovative strategies that address unmet medical needs in MM, which could attract strong interest from both healthcare professionals and investors alike.
As C4T's pipeline progresses, particularly with anticipated data announcements in mid-2026 and enrollment benchmarks set for early 2027, the stock may experience volatility based on trial results and clinical milestones. Investors should also consider the global demand for new cancer therapies, given that multiple myeloma continues to challenge many patients despite existing treatments.
In conclusion, while C4T presents high potential, due diligence is essential. Monitoring trial developments and market reactions to interim data releases will be crucial for potential investors. A strategic approach, weighing the clinical prospects against inherent risks, will be vital in making informed investment decisions in C4 Therapeutics.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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
LSpreen@c4therapeutics.com
FAQ**
What specific steps is C4 Therapeutics Inc. CCCC taking to ensure the successful completion of patient enrollment for the Phase 2 MOMENTUM trial by Q1 2027, given the rigorous eligibility criteria for relapsed/refractory multiple myeloma patients?
How does C4 Therapeutics Inc. CCCC plan to address potential challenges in patient recruitment and retention for the Phase 2 MOMENTUM trial and the upcoming Phase 1b trial of cemsidomide combined with elranatamab?
What strategies will C4 Therapeutics Inc. CCCC implement to effectively communicate the trial's progress and results to stakeholders, particularly considering the critical nature of the Phase 2 MOMENTUM trial in advancing treatments for multiple myeloma?
In light of the anticipated enrollment completion for the Phase 2 MOMENTUM trial in Q1 2027, what are the expected regulatory pathways C4 Therapeutics Inc. CCCC is exploring for potential accelerated approvals of cemsidomide?
**MWN-AI FAQ is based on asking OpenAI questions about C4 Therapeutics Inc. (NASDAQ: CCCC).
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