Business
Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2022 Financial Results
Phase 3 PEAK trial initiated comparing bezuclastinib + sunitinib vs. sunitinib alone in second line gastrointestinal stromal tumor (GIST) patients; initial
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"Phase 3 PEAK trial initiated comparing bezuclastinib + sunitinib vs. sunitinib alone in second line gastrointestinal stromal tumor (GIST) patients; initial safety and pharmacokinetic data from lead-in phase to be presented at CTOS 2022 Phase 2 APEX trial in Advanced Systemic Mastocytosis (AdvSM); oral presentation at ASH 2022 including assessment of patient response Developed an optimized formulation of bezuclastinib with new dosage strength and over 40% improvement in clinical exposure; potential to extend patent protection into 2043 Ended 3Q 2022 with $289.1 million, providing cash runway into 2025 WALTHAM, Mass. and BOULDER, Colo., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the third quarter ended September 30, 2022.“We are excited to announce the initiation of our Phase 3 PEAK trial in imatinib-resistant, second line GIST patients and look forward to presenting an update from our Phase 2 APEX trial in ASM patients in an oral presentation at ASH 2022,” said Andrew Robbins, President and CEO of Cogent Biosciences. “Our team has made tremendous progress this year, advancing our three bezuclastinib clinical trials, PEAK, APEX, and SUMMIT, recently presenting new data on our novel FGFR2 and ErbB2 selective programs, and delivering an optimized formulation of bezuclastinib which will significantly improve the patient experience.” Recent Business Highlights Initiated the randomized portion of PEAK, a global Phase 3 clinical trial in GIST patients who have progressed following imatinib therapy. The trial is designed to explore the efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone. The experimental arm of the PEAK trial includes a 600 mg daily dose of an optimized formulation of bezuclastinib, supplied as 75 mg tablets, which in the lead-in portion of the study demonstrated clinical exposures equivalent to the 1,000 mg daily dose of the original formulation used in the GIST Phase 1/2 clinical trial. Presented preclinical data at the EORTC-NCI-AACR (ENA) annual meeting on a next-generation fibroblast growth factor receptor 2 (FGFR2) program, which retains potency across all primary, gatekeeper and molecular brake resistance mutations, ...