On January 9, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2024 milestones ahead of its presentation at J.P. Morgan’s 42nd annual healthcare conference (Press release, Cogent Biosciences, JAN 9, 2024, View Source [SID1234639152]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Given the foundation that was established in 2023, we are well positioned to move Cogent forward aggressively this year, including a cash runway expected to carry us into 2026," said Andrew Robbins, President and CEO of Cogent Biosciences. "We strongly believe in bezuclastinib’s potential to become the best-in-class cKIT exon 17/18 inhibitor, and in 2024, we plan to complete enrollment in both the PEAK and APEX trials, each of which have the potential, if successful, to support a regulatory approval for bezuclastinib. In addition, we are excited to further describe the differentiation that bezuclastinib offers patients when presenting the results from the complete SUMMIT Part 1 at AAAAI, setting us up to initiate our third bezuclastinib pivotal trial in the first half of the year. Beyond bezuclastinib, the Cogent Research team is creating exceptional molecules, including a growing portfolio of potential best-in-class breast cancer programs."
In 2024, the Company plans to achieve the following milestones:
Bezuclastinib – Systemic Mastocytosis (SM)
Present data from the complete SUMMIT Part 1 trial in patients with Non-Advanced Systemic Mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) annual conference in February
Initiate SUMMIT Part 2 in 1H 2024, a global, registration-directed, randomized, placebo-controlled trial of bezuclastinib in NonAdvSM patients
Finalize, including alignment with regulators, Cogent’s MS2D2, a novel patient reported outcomes (PRO) tool designed to measure symptomatic severity and improvement for patients enrolled in the SUMMIT study. Once available, provide Total Symptom Score (TSS) results from SUMMIT Part 1 utilizing MS2D2
Complete enrollment in the registration-directed APEX Phase 2 trial in patients with Advanced Systemic Mastocytosis (AdvSM)
Bezuclastinib – Gastrointestinal Stromal Tumors (GIST)
Complete enrollment of global, randomized Phase 3 PEAK trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in imatinib-resistant GIST patients
CGT4859 (FGFR2 inhibitor)
Initiate Phase 1 trial of the first Cogent-discovered pipeline program, designed as a potent, selective, reversible FGFR2 inhibitor with best-in-class potential
Preclinical Pipeline
Initiate IND-enabling studies for lead candidate from potent, selective ErbB2 program, highlighted by potential best-in-class brain penetrant properties
Select lead candidate and initiate IND-enabling studies from ongoing PI3Kα program, designed to potently and selective target the H1047R driver mutation, which affects >30,000 cancer patients each year
J.P. Morgan Presentation Details
Cogent will participate in a presentation and Q&A session at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco today, Tuesday, January 9, 2024, beginning at 4:30 p.m. PT (7:30 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.