C4 Therapeutics Receives FDA Clearance to Investigate Potential Lung Cancer Treatment
C4 Therapeutics (Nasdaq: CCCC) has received FDA clearance for its Investigational New Drug Application for CFT8919, an orally bioavailable BiDAC™ degrader as a potential treatment for Non-Small Cell Lung Cancer (NSCLC).
The company’s share price rose 17% to $3.31 following the news.
Highlights
In May 2023, C4T entered 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.
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.
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.
In preclinical studies, CFT8919 is active in in vitro and in vivo models of L858R driven non-small cell lung cancer.
About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines that harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. C4T is advancing multiple targeted oncology programs to the clinic and expanding its research platform to deliver the next wave of medicines for difficult-to-treat diseases.
