On January 13, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2025 milestones ahead of its presentation at J.P. Morgan’s 43rd annual healthcare conference (Press release, Cogent Biosciences, JAN 13, 2025, View Source [SID1234649646]).
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"2025 will be a transformational year at Cogent Biosciences," said Andrew Robbins, President and Chief Executive Officer. "During the year, we plan to report top-line results from all three registration-directed bezuclastinib studies, and if successful, move forward with our first New Drug Application (NDA) submission by the end of 2025. With both SUMMIT and PEAK enrollment finishing several months ahead of schedule, we are confident that physicians and patients are highly aware of bezuclastinib’s potential and are also eagerly awaiting these clinical trial results. We believe bezuclastinib could change the lives of thousands of patients fighting SM and GIST and has the potential to be the first potent, CNS-sparing, selective KIT mutant inhibitor. In addition, we continue to advance our pipeline of novel small molecule programs, including an ongoing Phase 1 study of our novel FGFR2 inhibitor, CGT4859, and plan to file INDs for both our ErbB2 and PI3Kα programs during the year. With a strong balance sheet, we are well positioned to prepare Cogent for our evolution into a commercial-stage company."
In 2025, the Company plans to achieve the following milestones:
Bezuclastinib – Systemic Mastocytosis (SM)
Report top-line results in July 2025 from the SUMMIT trial. SUMMIT is a registration-directed, global, randomized, placebo-controlled trial of bezuclastinib in patients with Non-Advanced Systemic Mastocytosis (NonAdvSM).
Report top-line results during the second half of 2025 from the APEX trial. APEX is a registration-directed, global, open-label trial of bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM).
Submit the first bezuclastinib New Drug Application (NDA) by the end of 2025.
Bezuclastinib – Gastrointestinal Stromal Tumors (GIST)
Report top-line results by the end of 2025 from the pivotal Phase 3 PEAK trial. PEAK is a global, blinded, randomized clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST).
Bezuclastinib – Expanded Access Program
During Q1 2025, initiate Expanded Access Programs (EAP) in the U.S. for SM and GIST patients to receive investigational bezuclastinib after meeting certain eligibility criteria.
CGT4859 (FGFR2 inhibitor)
Enroll patients in the ongoing Phase 1 trial with CGT4859, a reversible, selective FGFR2 inhibitor in patients with documented FGFR mutations, including advanced cholangiocarcinoma. The trial is designed to explore the safety, tolerability and clinical activity of escalating doses of CGT4859 with a goal of selecting an active and well tolerated dose for further clinical investigation.
Preclinical Pipeline
Submit an IND application for CGT4255, a potent, selective ErbB2 inhibitor, highlighted by potential best-in-class brain-penetrant properties.
Submit an IND application for CGT6297, a potent allosteric inhibitor of PI3Kα, with 25-fold selectivity over PI3Kα WT.
J.P. Morgan Presentation Details
Cogent will participate in a presentation and Q&A session at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, beginning at 7:30 a.m. PT (10:30 a.m. ET). A live webcast will be accessible in the "Investors & Media" section of the company’s website, www.cogentbio.com, and will be archived for 30 days following the event.