Cogent Biosciences announces planned milestones for 2023

Cogent Biosciences highlighted the company’s key 2023 milestones ahead of its presentation at J.P. Morgan’s 41st annual healthcare conference this week. In 2023, the Company plans to achieve the following milestones: Bezuclastinib – Systemic Mastocytosis: Phase 2 APEX trial – announce results from planned Part 1 analysis including approximately 25-30 AdvSM patients in mid-2023, enabling dose selection for Part 2 trial expansion. Phase 2 SUMMIT trial – present initial clinical data in patients with NonAdvSM in the second half of 2023. Clinical results will include safety/tolerability, pharmacokinetics and measures of clinical activity. Initiate clinical investigation of bezuclastinib in SM patients with associated hematologic neoplasms, allowing for concomitant use of AHN-directed therapies. Bezuclastinib – Gastrointestinal Stromal Tumors: Present updated clinical results from refractory GIST patients in the lead-in cohort of the Phase 3 PEAK trial of the pan-KIT mutant regimen, bezuclastinib plus sunitinib, during the first half of 2023. Enrollment in the Phase 3 PEAK trial for 2nd-line GIST patients remains on track, with expansion to over 100 global clinical sites expected before the end of this year. Preclinical Pipeline: Select FGFR2-mutant selective clinical candidate and initiate IND-enabling GLP toxicology studies in the first half of 2023. This program is designed as a potential best-in-class, reversible, FGFR1-sparing, potent pan-FGFR2 mutant inhibitor that includes coverage of both key gatekeeper and molecular brake mutations. Select ErbB2-mutant selective clinical candidate in the second half of 2023. This program is designed as an EGFR-sparing, CNS-penetrant ErbB2 inhibitor that includes coverage of key mutations inadequately addressed by currently approved therapies. Present initial preclinical data on two additional novel target programs with best-in-class potential out of the Cogent Research Team’s labs during 2023.