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C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer

Excerpt from the Press Release:

WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for CFT8919, an orally bioavailable BiDAC™ degrader designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients.

This milestone marks C4T’s fourth IND clearance from its proprietary TORPEDO® platform. In May 2023, C4T and Betta Pharmaceuticals entered into an exclusive licensing agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan. In China, approximately 693,000 patients were diagnosed with NSCLC in 2020 and approximately 40% of these cases are driven by the EGFR mutation. The L858R mutation is the second most common EGFR mutation, found in approximately 40% of NSCLC patients with EGFR mutations in China. Betta Pharmaceuticals is responsible for preparing and submitting a Clinical Trial Application to the National Medical Products Administration in China and plans to commence a first-in-human clinical trial of CFT8919 in China. C4T expects to initiate clinical trial activities outside Greater China following the completion of Betta Pharmaceuticals’ Phase 1 dose escalation study in Greater China.

About CFT8919
CFT8919 is an orally bioavailable allosteric BiDAC™ degrader that is designed to be potent and selective against EGFR bearing an oncogenic L858R mutation. In preclinical studies, CFT8919 is active in in vitro and in vivo models of L858R driven non-small cell lung cancer.

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