On January 5, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that provided 2021 year-end updates and corporate guidance for 2022 (Press release, Cogent Biosciences, JAN 5, 2022, View Source [SID1234598209]).
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"I am proud of the substantial progress the Cogent team made in 2021. In addition to achieving our key corporate milestones of initiating three late-stage clinical trials of bezuclastinib, our highly potent and selective KIT mutant inhibitor, we also formed the Cogent Research Team which is focused on building a portfolio of best-in-class small molecules for patients with significant unmet medical need," said Andrew Robbins, President and CEO of Cogent Biosciences. "In 2022, we will advance the APEX, SUMMIT and PEAK clinical trials, with preliminary clinical data expected from APEX in the first half of 2022. In addition, we look forward to moving into our new research headquarters in Boulder and to sharing more details about the impressive research pipeline the Cogent Research Team has created in a very short period of time."
Key Highlights
Bezuclastinib now under investigation in three late-stage clinical trials
APEX clinical trial in patients with Advanced Systemic Mastocytosis (AdvSM): In mid-2021, Cogent initiated APEX, a Phase 2 clinical study of bezuclastinib in patients with AdvSM. APEX is an open-label, global, multicenter study evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. We expect to report preliminary clinical data at a scientific conference during the first half of 2022, including safety and tolerability data as well as bezuclastinib’s impact on serum tryptase levels, a validated biomarker of mast cell activity. Learn more about the APEX trial at cogentclinicaltrials.com/apex/.
SUMMIT clinical trial in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM): In the fall of 2021, Cogent initiated SUMMIT, a randomized, double-blind, placebo-controlled, global Phase 2 clinical trial. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM). Learn more about the SUMMIT trial at cogentclinicaltrials.com/summit/.
PEAK clinical trial in patients with Gastrointestinal Stromal Tumors (GIST): During the fourth quarter of 2021, Cogent initiated PEAK, a randomized, open-label, global Phase 3 clinical trial. The PEAK study is designed to explore the efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib.
Preclinical data highlights bezuclastinib as potent KIT inhibitor with minimal CNS activity and PDGFR inhibition
During the third quarter of 2021, Cogent presented preclinical data providing further evidence of bezuclastinib as a differentiated, potent, and selective KIT mutant inhibitor with minimal brain penetration that avoids targeting PDGFR isoforms. These data were presented in a virtual poster at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper).
Cogent Research Team created to generate robust pipeline of potential best-in-class molecules
Cogent Research Team: During the second quarter of 2021, the company announced the formation of its Cogent Research Team, a highly-experienced, Boulder-based discovery and research team focused on pioneering best-in-class, small molecule therapeutics to expand Cogent’s pipeline.
The Cogent Research Team is led by John Robinson, PhD, and already has grown to over 35 employees. This spring, the team will move into its newly-built, state-of-the-art research facility in Boulder.
Cogent Scientific Advisory Board: In mid-2021, the company formed the Cogent Scientific Advisory Board, which is comprised of world-class experts involved in the discovery and development of novel therapeutics for patients with genetically driven diseases. This group has been brought together to provide external perspective for the Cogent Research Team as it develops a robust portfolio of novel, small molecule discovery programs designed to address significant patient unmet needs.
R&D Investor Event: In April 2022, Cogent will host an R&D investor event to introduce the Cogent Research Team, outline its strategy and focus to create best-in-class small molecules, highlight additional preclinical data demonstrating the potential differentiated profile for bezuclastinib and present early data from its growing pipeline of novel, small molecule targeted therapy programs.