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

Thursday, July 06, 2023

C4 Therapeutics, Inc. (C4T), a clinical-stage biopharmaceutical company focused on targeted protein degradation (TPD) science, has received FDA clearance for its investigational new drug (IND) application for CFT8919. CFT8919 is an orally bioavailable BiDAC™ degrader designed to target the EGFR L858R mutation in non-small cell lung cancer (NSCLC) patients.

This IND clearance marks an important milestone for C4 Therapeutics, as it is the fourth clearance obtained through its proprietary TORPEDO® platform. In May 2023, C4T entered into an exclusive licensing agreement with Betta Pharmaceuticals for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR, and Taiwan. This agreement is significant considering that in China, a substantial number of NSCLC cases (approximately 693,000 in 2020) are driven by the EGFR mutation, with L858R being the second most common mutation, accounting for around 40% of EGFR mutation cases.

Under the licensing agreement, Betta Pharmaceuticals will be responsible for submitting a Clinical Trial Application to the National Medical Products Administration in China. They plan to initiate a first-in-human clinical trial of CFT8919 in China, while C4 Therapeutics expects to commence clinical trial activities outside Greater China once Betta Pharmaceuticals completes their Phase 1 dose escalation study.

CFT8919 is an orally bioavailable allosteric BiDAC™ degrader that demonstrates potent and selective activity against the EGFR L858R mutation in preclinical studies. It has shown efficacy in both in vitro and in vivo models of L858R-driven NSCLC. Notably, CFT8919 remains active against other EGFR mutations that confer resistance to approved EGFR inhibitors, including L858R-C797S, L858R-T790M, and L858R-T790M-C797S.

With the FDA clearance of the IND application and the licensing agreement with Betta Pharmaceuticals, C4 Therapeutics and its partner are well-positioned to advance the development and potential commercialization of CFT8919, offering new treatment options for NSCLC patients, particularly in Greater China.

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