Business
Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2022 Financial Results
Initiation of APEX Part 2 planned for mid-2023Updated clinical data from Phase 3 PEAK lead-in in GIST patients expected 1H23Initial clinical data from Phase 2
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"Initiation of APEX Part 2 planned for mid-2023Updated clinical data from Phase 3 PEAK lead-in in GIST patients expected 1H23Initial clinical data from Phase 2 SUMMIT trial in NonAdvSM on-track for 2H23Ended 2022 with $259.3 million in cash; sufficient to fund operations into 2025 WALTHAM, Mass. and BOULDER, Colo., March 14, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2022. “2022 was a pivotal year for Cogent marked by our promising clinical data with bezuclastinib in systemic mastocytosis, the initiation of our Phase 3 PEAK trial in GIST, and the build-out of the Cogent Research Team,” said Andrew Robbins, the company’s President and Chief Executive Officer. “We have laid the foundation for multiple catalysts in 2023 across all our programs. Based on the clinical performance of bezuclastinib, we believe it has the potential to be a best-in-class therapy for patients living with systemic mastocytosis and GIST. We continue to advance therapies that improve the lives of patients with genetically defined rare diseases while positioning ourselves as an industry leader in precision medicine.” Recent Highlights In March 2023, Cogent received approvals from European regulatory authorities to initiate the Phase 2 SUMMIT trial in patients with nonadvanced systemic mastocytosis (NonAdvSM). Beginning in April 2023, the company expects to start activating clinical trial sites across major countries in the European Union.In December 2022, Cogent reported positive updated clinical data from the ongoing Phase 2 APEX trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at the American Society of Hematology (ASH) annual meeting. As of the cutoff date, October 26, 2022, 11 patients were evaluable for response per the modified IWG-MRT-ECNM criteria. 89% ORR (including centrally adjudicated confirmed and unconfirmed responses) was seen in TKI therapy naïve patients, including 67% of patients achieving CR, CRh or PR, and 22% of patients achieving CR or CRh. Additionally, bezuclastinib demonstrated rapid reductions in serum tryptase, with an 85% mean reduction in serum tryptase, 14/16 patients ac...