Cogent Biosciences announced updated preclinical data from its precision therapy pipeline programs during the American Association for Cancer Research (AACR) 2023 Annual Meeting. The biotechnology company’s program includes a novel EGFR-sparing brain-penetrant ErbB2 inhibitor and next-generation selective fibroblast growth factor receptor 2 (FGFR2) program.
According to Cogent, the preclinical data displayed a novel EGFR-sparing, brain-penetrant ErbB2 inhibitor that is active against key oncogenic ErbB2 mutations. In vivo characterization shows that a selective, reversible FGFR2 inhibitor has potency against molecular brake mutations and potential advantages over covalent approaches.
Cogent is developing a potential best-in-class EGFR-sparing, brain-penetrant ErbB2 inhibitor that includes coverage of key mutations inadequately addressed by currently approved therapies. Cogent’s novel chemotype has further improved ErbB2 mutational potency and selectivity, increased estimated brain penetrance to 40% and improved human whole blood stability to almost 24 hours, suggesting a favorable profile for optimal clinical efficacy.
The company’s ongoing APEX trial involving bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) initiated part 2 in which trials will administer once-daily 150 mg optimized doses to patients. Based on bezuclastinib’s impressive and consistent clinical activity, safety, and tolerability, Cogent expects to provide clinical updates in the second half of 2023 from both APEX and SUMMIT, the trial of bezuclastinib in NonAdvSM patients, as well as updated clinical results from the PEAK lead-in trial in GIST patients this quarter.
Cogent’s APEX study evaluates bezuclastinib’s effectiveness on patients with AdvSM. The company designed several additional patient cohorts in Part 2 of the APEX trial to demonstrate the breadth of AdvSM patients who may benefit from bezuclastinib. These include up to 20 patients with systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) treated concomitantly with bezuclastinib and AHN directed therapies, up to 15 patients with inevaluable mIWG disease without C-findings, and approximately ten patients treated at a dose of 300 mg once-daily to explore the effect of exceeding IC90 KI.
Andrew Robbins, Cogent’s President, and Chief Executive Officer said, “We are pleased to share our progress highlighting the Cogent Research Team in their ongoing effort to discover and advance potential best-in-class novel therapies for rare disease populations with high unmet medical need.”
Cogent Biosciences is a biotechnology company that focuses on developing precision therapies for genetically defined diseases. The company has a pipeline of programs aimed towards developing drug therapies across oncology, immunology, and rare diseases.
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