WATERTOWN, Mass., Sept. 13, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced initial clinical data from the ongoing clinical trial of CFT1946, an orally bioavailable small molecule degrader of BRAF V600 mutations in solid tumors. These data, the first clinical results for a BRAF V600X degrader, were shared as a proffered paper in an oral presentation by Maria Vieito, M.D., MSc, medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain, at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13 – 17 in Barcelona, Spain.
“We are thrilled to share initial CFT1946 monotherapy data and highlight how this molecule, the first and only clinical-stage degrader of BRAF V600 mutants, may disrupt the current treatment landscape as it quickly progresses through clinical development,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “In addition to addressing the needs of patients with BRAF V600 mutant solid tumors, we believe these clinical data further reinforce the potential of our TORPEDO® platform to design innovative small molecule degraders that excite the medical community and have the potential to improve patients’ lives.”
“The data presented at the ESMO Congress 2024 are impressive given the early stage of development of CFT1946 and the novel modality,” said Dr. Vieito. “I am especially encouraged by the safety and tolerability of CFT1946, which may allow for additional monotherapy exploration as well as combination approaches to better understand how this oral degrader medicine may support the needs of patients refractory to BRAF inhibitor therapies.”
“We are pleased with the safety profile CFT1946 has demonstrated over a range of doses, as well as its pharmacokinetics, pharmacodynamics and initial anti-tumor activity. Taken together, these data support our hypothesis that degradation may offer a new therapeutic option over inhibition for BRAF V600 mutant solid tumors,” said Len Reyno, M.D., chief medical officer of C4 Therapeutics. “We are deeply appreciative of the contributions from patients, caregivers and the oncology community that have enabled us to deliver this preliminary monotherapy data and we look forward to continuing these important relationships as we progress CFT1946 toward additional milestones in 2025 and beyond.”
At the ESMO Congress 2024, C4T reported initial monotherapy data from the ongoing dose escalation Phase 1 clinical trial evaluating twice daily oral dosing of CFT1946, a degrader of BRAF V600 mutants, in patients with BRAF V600X solid tumors who have received at least one prior standard of care therapy for unresectable locally advanced or metastatic disease. Prior therapy must include a BRAF inhibitor, unless access is limited by regional regulatory approvals or reimbursement. As of the data cutoff date of July 19, 2024, a total of 36 patients received CFT1946 monotherapy across five dose escalation cohorts (20 mg BID, 80 mg BID, 160 mg BID, 320 mg BID and 640 mg BID). Patients received a median of three prior therapies; 35 patients (97 percent) had received prior BRAF inhibitor therapy. Thirty-three patients (92 percent) had a BRAF V600E mutation, two patients (six percent) had a BRAF V600K mutation and one patient (two percent) had a BRAF V600R mutation. Fourteen patients (39 percent) had melanoma, 14 patients (39 percent) had colorectal cancer, two patients (six percent) had non-small cell lung cancer and six patients (17 percent) had other cancers. All patients had unresectable, locally advanced or metastatic disease, and 32 patients (89 percent) entered the study with Stage IV cancer.
Safety and Tolerability: CFT1946 has a well-tolerated safety profile that supports further clinical development as monotherapy and in combination with MEK and EGFR inhibitors.
Pharmacokinetics (PK) and Pharmacodynamics (PD): Initial data demonstrating dose-dependent bioavailability and degradation of BRAF V600E protein support CFT1946 proof of mechanism.
Anti-Tumor Activity: CFT1946 demonstrates evidence of monotherapy anti-tumor activity, supportive of early proof of degrader concept.
Next Steps and Future Milestones for CFT1946
The CFT1946 Phase 1 trial is ongoing and multiple indication-specific cohorts are advancing. Next steps and related milestones for CFT1946 include:
C4T Webcast for Analysts and Investors
C4T will host an investor webcast today, September 13, 2024, at 12:00 pm ET. To join the webcast, please visit this link or the “Events & Presentations” page of the Investors section on the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived and available following the event.
About BRAF V600 Mutant Solid Tumors
BRAF mutations are found in approximately five percent of all cancers, including melanoma, colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and other malignancies. Of these BRAF mutation cancer diagnoses, up to 90 percent contain an activating BRAF V600 mutation. BRAF V600 mutations are observed in up to 50 percent of patients with melanoma, nearly 10 percent of patients with CRC and approximately five percent of patients with NSCLC. Resistance to FDA-approved BRAF inhibitors results in median progression-free survival rates of less than 15 months across all indications.
About CFT1946
CFT1946 is an investigational, orally bioavailable small molecule degrader of BRAF V600 mutations in solid tumors currently being evaluated in a Phase 1/2 global clinical trial in patients refractory to BRAF inhibitors. CFT1946 is designed to be potent and selective against the BRAF V600 mutant form. Initial clinical data from the Phase 1 trial demonstrate that CFT1946 has a well-tolerated safety profile, demonstrates dose-dependent bioavailability and degradation of BRAF V600E protein, and demonstrates evidence of monotherapy anti-tumor activity. CFT1946 is the only degrader of BRAF V600 mutant solid tumors in clinical trials. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT05668585).
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 or cohort initiation; 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 potential timing for updates on our clinical and research programs; 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 the results of preclinical studies and/or clinical trials will or will not be predictive of results in connection with future studies or trials. 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.
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C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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