Press Release Details

IND-enabling studies expected to begin mid-2024

WALTHAM, Mass. and BOULDER, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program. The data are being presented in a poster session at the American Association for Cancer Research (AACR) 2024 Annual Meeting taking place in San Diego, California.

“We’re excited with the progress we’ve made on our ErbB2 program and look forward to sharing our differentiated profile at this year’s AACR meeting,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “These data further demonstrate Cogent’s capability to discover and advance potential best-in-class novel therapies for rare disease populations with high unmet medical need. Based on these results, we expect to initiate IND-enabling studies for our potent, selective, CNS-penetrant ErbB2 program in mid-2024.”

AACR Poster Details

Title: Characterization of a Novel Mutant Selective, EGFR Sparing, ErbB2 Inhibitor with Activity Across Activating Mutations in Systemic and CNS Tumors
Session Category: Chemistry
Session Title: Drug Design and in Silico Screening
Session Date and Time: Tuesday, Apr 9, 2024 9:00 AM - 12:30 PM PT (12:00 PM – 3:30 PM ET)
Location: Poster Section 20
Poster Board Number: 15
Published Abstract Number: 4486

The poster can be accessed on the ‘Posters and Publications’ page of Cogent’s website.

Cogent is developing a potential best-in-class EGFR-sparing, brain-penetrant ErbB2 inhibitor that includes potent coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification. The poster presented today describes CGT4255’s exceptional stability in human whole blood and liver cytosol fractions and high oral bioavailability and low clearance across preclinical species. In addition, CGT4255 demonstrated 80% brain penetrance in mice and was well-tolerated at 10x concentration, resulting in mouse tumor regression, suggesting potential best-in class properties.

About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, ErbB2 and PI3Ka. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential best-in-class properties of the Company’s ErbB2 inhibitor candidate, plans to initiate IND-enabling studies for the Company’s ErbB2 inhibitor candidate in mid-2024 and the company’s capability to discover and advance potential best-in-class novel therapies for rare disease populations with high unmet medical need. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Investor Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653