On November 10, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the third quarter ended September 30, 2021 and provided corporate updates (Press release, Cogent Biosciences, NOV 10, 2021, View Source [SID1234595050]).
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"We are pleased to announce that we have started the SUMMIT trial, a Phase 2 study of bezuclastinib in patients with nonadvanced systemic mastocytosis," said Andrew Robbins, President and CEO of Cogent Biosciences. "Based on recently presented preclinical data, we believe that bezuclastinib has best-in-class potential as a highly potent and selective KIT mutant inhibitor and look forward to initiating the PEAK trial for GIST patients in the coming weeks."
Recent Program and Corporate Highlights
SUMMIT trial initiated in NonAdvSM patients
Cogent initiated SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, 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).
SUMMIT is designed in three parts. Part 1 will enroll approximately 48 patients across 3 dose cohorts, plus one placebo arm, and is designed to confirm the optimal bezuclastinib dose. In addition, Part 1 will serve to validate a patient-reported outcomes (PRO) tool for use in assessing efficacy during Part 2 of the trial. Part 2 of SUMMIT will be randomized, double-blind, and placebo-controlled at a single dose level and will include a primary endpoint of disease improvement using the PRO tool from Part 1. After participation in Part 1 or Part 2, all patients may receive bezuclastinib in a long-term extension.
Learn more about the SUMMIT trial at cogentclinicaltrials.com
APEX trial on track for preliminary clinical data readout in the first half of 2022
Cogent is currently enrolling APEX, a Phase 2 clinical trial of bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) and expects to report preliminary clinical data at a scientific conference during the first half of 2022, including levels of serum tryptase, a validated biomarker of mast cell activity.
Learn more about the APEX trial at cogentclinicaltrials.com.
PEAK trial of bezuclastinib and sunitinib for GIST patients to start in 2021
Following recent positive interactions with the FDA, Cogent remains on track to initiate PEAK, a Phase 3 clinical trial of bezuclastinib in combination with sunitinib in imatinib-resistant GIST patients, during 2021.
Announces updated bezuclastinib formulation in partnership with Serán Biosciences
Leveraging Serán’s expertise in formulation and process optimization, an updated formulation of bezuclastinib has been developed. This formulation is expected to reduce the number of daily tablets, improving the overall patient experience.
Updated formulation will be used in PEAK trial beginning in 2021.
Presented new preclinical data supporting bezuclastinib as potential best-in-class KIT inhibitor
Preclinical data presented 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) showed further evidence of bezuclastinib as a differentiated, potent, and selective KIT inhibitor.
In head-to-head studies comparing several commercial and development-stage KIT mutant inhibitors, bezuclastinib demonstrated minimal activity against closely related kinases, including PDGFR.
In a nonclinical safety pharmacology study in rodents, bezuclastinib demonstrated minimal brain penetration with a low brain-to-plasma ratio.
Appointed Dana Martin as Chief Patient Officer & Senior Vice President, Medical Affairs
Dr. Martin joins with over 20 years of experience in the biopharmaceutical industry. Prior to joining Cogent, he held several roles of increasing leadership responsibility in the areas of clinical pharmacy, medical affairs, and patient advocacy at Genzyme Corporation, Synageva BioPharma, Sarepta Therapeutics, and Kiniksa Pharmaceuticals. Dr. Martin has contributed to the clinical development and/or product launch of multiple rare disease therapeutics, including first-to-market treatments for Fabry disease, Pompe disease, lysosomal acid lipase deficiency, and Duchenne muscular dystrophy. He holds a Bachelor of Science in pharmacy and a Doctor of Pharmacy from Massachusetts College of Pharmacy-Boston.
Appointed Courtney Watson as Vice President of Clinical Development Operations
Mrs. Watson joins Cogent with nearly 15 years of experience in the biopharmaceutical industry. Prior to joining Cogent, Mrs. Watson was the Head of Clinical Operations at Fusion Pharmaceuticals. Previously, she served in various Clinical Operations roles of increasing responsibility at Forma Therapeutics, Synageva BioPharma, and Ziopharm Oncology. Mrs. Watson holds a Bachelor of Arts from the University of Southern Maine.
Third Quarter 2021 Summarized Financial Results
R&D Expenses: Research and development expenses were $14.8 million for the third quarter of 2021 as compared to $5.0 million for the third quarter of 2020. Research and development expenses include non-cash stock compensation expense of $1.4 million for the third quarter of 2021 compared to $1.9 million for the third quarter of 2020.
G&A Expenses: General and administrative expenses were $5.0 million for the third quarter of 2021 as compared to $5.6 million for the third quarter of 2020. General and administrative expenses include non-cash stock compensation expense of $2.0 million for the third quarter of 2021 compared to $1.6 million for the third quarter of 2020.
Net Loss: Net loss was $19.1 million for the third quarter of 2021 as compared to a net loss of $50.0 million for the third quarter of 2020, which included $46.9 million resulting from the accounting treatment related to the asset acquisition of Kiq LLC. During the third quarter of 2021, the company spent $15.2 million of its cash and cash equivalents.
Cash and Cash Equivalents: As of September 30, 2021, Cogent had cash and cash equivalents of $202.9 million. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.