On January 09, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2023 milestones ahead of its presentation at J.P. Morgan’s 41st annual healthcare conference this week (Press release, Cogent Biosciences, JAN 9, 2023, View Source [SID1234626046]).
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"We made tremendous progress in 2022 demonstrating bezuclastinib’s differentiated clinical profile in Systemic Mastocytosis while advancing an improved formulation of bezuclastinib through clinical studies that enabled the start of our global Phase 3 GIST trial," said Andrew Robbins, President and CEO of Cogent Biosciences. "In 2023, we look forward to continuing the rapid development of bezuclastinib toward leadership positions in both Systemic Mastocytosis and GIST, while we enhance our impressive, growing portfolio of targeted cancer therapeutics. By the end of 2023, we expect to have a portfolio of five distinct programs which will position us as a leader in precision medicine."
In 2023, the Company plans to achieve the following milestones:
Bezuclastinib – Systemic Mastocytosis (SM)
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 (SM-AHN), allowing for concomitant use of AHN-directed therapies.
Bezuclastinib – Gastrointestinal Stromal Tumors (GIST)
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 (V564I, N549K).
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 (YVMA, S310F, V842I, L755S) 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.
JPM Presentation Details
Cogent will participate in a presentation and Q&A session at the J.P. Morgan 41st Annual Healthcare Conference in San Francisco on Thursday, January 12, 2023, beginning at 7:30 a.m. PT (10:30 p.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.