This section highlights FDA-related milestones and regulatory updates for drugs developed by C4 Therapeutics (CCCC).
Over the past two years, C4 Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
cemsidomide, CFT1946, and CFT8919. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
cemsidomide - FDA Regulatory Timeline and Events
cemsidomide is a drug developed by C4 Therapeutics for the following indication: IKZF1/3 Degrader.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- cemsidomide
- Announced Date:
- January 14, 2025
- Indication:
- IKZF1/3 Degrader
Announcement
C4 Therapeutics, Inc. announced its anticipated 2025 milestones as it continues its evolution into becoming a fully integrated biotechnology company focused on orally bioavailable degraders.
AI Summary
C4 Therapeutics, Inc. has outlined major milestones for 2025 as it evolves into a fully integrated biotechnology company specializing in orally bioavailable degraders. A key highlight is the development of cemsidomide, an oral degrader designed for treating relapsed/refractory multiple myeloma and non-Hodgkin’s lymphoma. Data presented at the ASH Annual Meeting indicate that cemsidomide may offer a best-in-class profile with promising activity. In 2025, the company plans to complete the Phase 1 dose escalation studies and share data later in the year, setting the stage for the next phase of clinical development, which is expected to begin in early 2026. This strategic effort is part of C4 Therapeutics’ broader focus on advancing innovative degrader medicines that leverage their unique technology platform to provide new treatment options for patients with challenging diseases.
Read Announcement- Drug:
- cemsidomide
- Announced Date:
- December 8, 2024
- Indication:
- IKZF1/3 Degrader
Announcement
C4 Therapeutics, Inc. today presented clinical data from the ongoing Phase 1 trial of cemsidomide, an orally bioavailable small molecule degrader of IKZF1/3, at the ASH Annual Meeting.
AI Summary
C4 Therapeutics, Inc. recently presented promising Phase 1 clinical data for cemsidomide at the ASH Annual Meeting. Cemsidomide is an orally bioavailable small molecule designed to degrade the proteins IKZF1 and IKZF3, which are key drivers in multiple myeloma and certain non-Hodgkin’s lymphomas. In the multiple myeloma arm of the study, cemsidomide was combined with dexamethasone. At the highest dose tested, the combination achieved a 36 percent overall response rate and a 45 percent clinical benefit rate, demonstrating potential effectiveness for patients with heavily pretreated disease. The safety profile was encouraging, with on-target neutropenia being manageable and no treatment-emergent adverse events leading to dose reductions. These findings support further development of cemsidomide as a backbone therapy in combination regimens for multiple myeloma and lymphoma patients in need of new treatment options.
Read Announcement
CFT1946 - FDA Regulatory Timeline and Events
CFT1946 is a drug developed by C4 Therapeutics for the following indication: A novel BiDAC™ degrader in mutant BRAF V600 solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CFT1946
- Announced Date:
- February 27, 2025
- Indication:
- A novel BiDAC™ degrader in mutant BRAF V600 solid tumors
Announcement
C4 Therapeutics, Inc. provided Recent Business Highlights
AI Summary
C4 Therapeutics, Inc. recently provided business highlights focused on advancing their clinical programs. In 2024, the company made significant progress with cemsidomide, an investigational degrader for multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). Clinical data showed promising overall response rates of 36% in MM and 38% in NHL, with the maximum tolerated dose not yet reached. Looking ahead, the company plans to advance cemsidomide into the next phase of development, aiming for patient dosing in early 2026 and expansion cohorts in the second half of 2025. In addition, the Phase 1/2 trial for CFT1946, targeting BRAF V600 mutant solid tumors, continues to enroll patients and show encouraging preclinical findings. The update also highlighted another candidate, CFT8919, which has entered clinical trials in Greater China. The company remains financially robust with $267.3 million in cash and related securities, funding operations through 2027.
Read Announcement- Drug:
- CFT1946
- Announced Date:
- January 14, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- A novel BiDAC™ degrader in mutant BRAF V600 solid tumors
Announcement
C4 Therapeutics, Inc. announced that CFT1946 Phase 1 Trial Continues to Progress in BRAF V600X Solid Tumors With Monotherapy Dose Escalation Expected to Complete in 1H 2025
AI Summary
C4 Therapeutics announced that its CFT1946 Phase 1 clinical trial continues to progress in patients with BRAF V600 mutant solid tumors. CFT1946 is an investigational oral degrader designed to target BRAF V600 mutations in cancers like melanoma and colorectal cancer. The trial’s monotherapy dose escalation is expected to complete in the first half of 2025. This early phase study is intended to determine the optimal dosing and to assess the drug’s safety and initial anti-tumor activity in patients who have not responded to other BRAF inhibitor therapies.
Data from the trial’s tumor-specific cohorts, including results from melanoma and colorectal cancer patients, are anticipated to be shared in the second half of 2025. These findings will help guide the next steps in developing CFT1946 as a potential new treatment for patients with BRAF V600 mutant solid tumors.
Read Announcement- Drug:
- CFT1946
- Announced Date:
- January 14, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- A novel BiDAC™ degrader in mutant BRAF V600 solid tumors
Announcement
C4 Therapeutics, Inc. announced that Data in Melanoma and Colorectal Cancer Expected in Second Half of 2025
AI Summary
C4 Therapeutics, Inc. announced key upcoming milestones for its pipeline in 2025. The company’s CFT1946 Phase 1 trial, which targets BRAF V600 mutations in solid tumors, is showing promising progress. The monotherapy dose escalation in patients with BRAF V600 mutant tumors is expected to complete in the first half of 2025. Importantly, the company plans to present Phase 1 data in the second half of 2025, focusing on melanoma and colorectal cancer. These data sets are designed to help guide the next steps in the development of CFT1946 for patients with these cancers.
This milestone follows other encouraging results in their pipeline, including the promising profile of cemsidomide observed at recent meetings. The upcoming data presentations are seen as critical for defining the future clinical development of these targeted therapies, positioning C4 Therapeutics to potentially offer new treatment options for patients with difficult-to-treat cancers.
Read Announcement- Drug:
- CFT1946
- Announced Date:
- September 8, 2024
- Indication:
- A novel BiDAC™ degrader in mutant BRAF V600 solid tumors
Announcement
C4 Therapeutics, Inc. announced the abstract sharing clinical data from its ongoing Phase 1 clinical trial of CFT1946, a novel BiDAC™ degrader, in mutant BRAF V600 solid tumors, was released in conjunction with the ESMO Congress 2024 scheduled for September 13 – 17, 2024 in Barcelona, Spain.
AI Summary
C4 Therapeutics, Inc. has announced the release of an abstract detailing clinical data from its ongoing Phase 1 trial of CFT1946, a novel BiDAC™ degrader. The trial targets mutant BRAF V600 solid tumors, which include cancers such as colorectal cancer, melanoma, and non-small cell lung cancer. The abstract, which includes data with a cutoff from April 12, 2024, is shared in conjunction with the ESMO Congress 2024 taking place in Barcelona, Spain from September 13 to 17, 2024. A more detailed presentation featuring data on 36 patients (cutoff from July 19, 2024), including safety profiles, pharmacokinetics, pharmacodynamics, and early evidence of anti-tumor activity by RECIST 1.1 criteria, is scheduled for an oral presentation on September 13, 2024, at the congress. This release underscores the ongoing commitment to advancing targeted protein degradation science in oncology.
Read Announcement- Drug:
- CFT1946
- Announced Date:
- August 14, 2024
- Indication:
- A novel BiDAC™ degrader in mutant BRAF V600 solid tumors
Announcement
C4 Therapeutics, Inc. announced the ESMO Congress decided to move C4T's previously accepted preliminary monotherapy Phase 1 abstract for CFT1946, a novel BiDAC™ degrader in mutant BRAF V600 solid tumors, to an oral presentation.
AI Summary
C4 Therapeutics, Inc. announced that the ESMO Congress has upgraded its previously accepted preliminary monotherapy Phase 1 abstract for CFT1946—a novel BiDAC™ degrader aimed at treating mutant BRAF V600 solid tumors—from a poster to an oral presentation. The oral session is set for Friday, September 13, 2024, from 4:00 to 5:30 pm CEST. This change allows the company to share early data from its ongoing Phase 1 study, highlighting the potential of CFT1946 in targeting tumors with BRAF V600 mutations, including those that have shown resistance to existing treatments.
Additionally, C4 Therapeutics will host an investor webcast on the same day to further discuss the monotherapy data from the CFT1946 trial. This development underscores the company’s commitment to advancing targeted protein degradation science and improving treatment options for patients with difficult-to-treat cancers.
Read Announcement
CFT8919 - FDA Regulatory Timeline and Events
CFT8919 is a drug developed by C4 Therapeutics for the following indication: Designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CFT8919
- Announced Date:
- January 14, 2025
- Indication:
- Designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients.
Announcement
C4 Therapeutics, Inc. announced that Phase 1 Data Will Inform Future Development Plans Outside of China
AI Summary
C4 Therapeutics, Inc. announced that data from the Phase 1 dose escalation study of its CFT8919 program in Greater China will inform its future development plans outside of the region. CFT8919, an oral degrader targeting the EGFR L858R mutation in non-small cell lung cancer, is being evaluated in a study led by partner Betta Pharmaceuticals. The Phase 1 data will help guide the next steps for its clinical development, potentially expanding its use beyond China. This approach supports C4 Therapeutics’ broader strategy of developing innovative, orally bioavailable degrader therapies for difficult-to-treat cancers. The company remains focused on leveraging its targeted protein degradation platform to drive progress in oncology, as it works to bring novel treatment options to patients and further advance its pipeline into pivotal clinical stages.
Read Announcement- Drug:
- CFT8919
- Announced Date:
- January 14, 2025
- Indication:
- Designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients.
Announcement
C4 Therapeutics, Inc. announced that CFT8919 Progressing Through Phase 1 Dose Escalation in Greater China
AI Summary
C4 Therapeutics announced that its partner, Betta Pharmaceuticals, is leading a Phase 1 dose escalation study of CFT8919 in Greater China. This early clinical trial focuses on non-small cell lung cancer patients carrying the EGFR L858R mutation. CFT8919 is an orally administered molecule designed to degrade the EGFR protein that drives the growth of these lung tumors.
The primary goal of the study is to evaluate the safety, tolerability, and initial effectiveness of CFT8919. Data from this trial will guide the company’s future development plans both inside and outside of China. C4 Therapeutics sees these early results as a key step in advancing treatment options and providing new hope for patients battling this aggressive form of cancer.
Read Announcement
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