Press Release Details

Cogent Biosciences Presents Preclinical Data Highlighting Precision Oncology Pipeline at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

October 14, 2023

– Novel selective and reversible FGFR2 inhibitor exhibits strong potency across key primary and resistance driver mutations with potential advantages over covalent approaches –

- IND and initiation of clinical trial planned in 2H 2024 -

WALTHAM, Mass. and BOULDER, Colo., Oct. 14, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, announced updated preclinical data from the Company’s next-generation selective fibroblast growth factor receptor 2 (FGFR2) program being presented today in a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston.

“We are excited to share these new data on our internally discovered and developed FGFR2 candidate, highlighting the strength and scientific expertise of the Cogent Research Team,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We believe CGT4859 has the potential to become the best-in-class FGFR2 inhibitor, as it delivers coverage across all known resistance mutations, with selectivity to avoid FGFR1-mediated toxicity, along with a reversible profile which may improve upon tolerability challenges seen with other FGFR2-targeted agents. IND-enabling studies for CGT4859 are ongoing, putting us in position to initiate clinical trials in the second half of 2024.”

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

Title: Identification of a Reversible Selective FGFR2 Clinical Development Candidate with Potency Against Gatekeeper and Molecular Brake Mutations
Session: Poster Session C
Session Date and Time: Saturday, October 14, 2023 - 12:30 PM – 4:00 PM ET
Location: Level 2, Exhibit Hall D, Hynes Convention Center, Boston, MA
Poster Number: C161
Abstract Number: 35488

FGFR inhibitors are well-established oncogenic drivers in multiple diseases, but approved medicines fail to capture the full landscape of FGFR altered tumor types, with FGFR1-mediated hyperphosphatemia serving as the most common dose-limiting toxicity for pan-FGFR inhibitors. The poster presented today describes Cogent’s internally-developed FGFR2 inhibitor which exhibits low nM potency on WT FGFR2 and FGFR2 mutations and is selective against the kinome and a panel of channels and receptors. Exploratory pharmacokinetics (PK) studies conducted across species showed CGT4859 to be a low-clearance compound with high oral bioavailability. Further, in an AN3 CA model, CGT4859 demonstrated dose-responsive tumor growth inhibition with complete regressions at 5 mg/kg PO and was well-tolerated. Cogent plans to file an IND, and pending clearance from the FDA, initiate clinical trials in 2024.

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 FGFR2 and ErbB2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at Follow Cogent Biosciences on social media: Twitter and LinkedIn. Information that may be important to investors will be routinely posted on our website and Twitter.

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 advantages of the company’s FGFR2 candidate, including the potential to become the best-in-class FGFR2 inhibitor, and clinical development and regulatory plans and timelines. 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 Quarterly Report on Form 10-Q filed 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. 

Christi Waarich
Senior Director, Investor Relations

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