NEW YORK – The US Food and Drug Administration has given C4 Therapeutics the go-ahead to begin studying the activity of the BiDAC degrader CFT8919 in EGFR L858R-mutated non-small cell lung cancer patients.
Watertown, Massachusetts-based C4 Therapeutics designed CFT8919 on its Torpedo platform to be selective against NSCLC driven by EGFR L858R mutations. These tumor alterations are particularly prevalent in lung cancer patients of Chinese descent, showing up in approximately 40 percent of the around 277,000 patients diagnosed with EGFR-mutated NSCLC in the country in 2020.
In May, C4 Therapeutics inked a deal with Betta Pharmaceuticals to commercialize and develop CFT8919 in Greater China, including Hong Kong, Macau, and Taiwan. Betta, headquartered in Hangzhou, China, is overseeing the first-in-human trial of CFT8919 in China. Now, having garnered an investigational new drug application clearance from the FDA, allowing it to begin human trials of the drug in the US, C4 Therapeutics said it will launch studies outside of Greater China after Betta finishes a Phase I dose-escalation trial of CFT8919 in that region.
In preclinical studies, CFT8919 has shown to be active against in vitro and in vivo models of NSCLC driven by EGFR L858R mutations. According to C4 Therapeutics, the drug appears to also retain full activity against other EGFR resistance mutations that can co-occur with L858R, including T790M and C797S.
C4 Therapeutics, which spun out of Dana-Farber Cancer Institute in 2015, is also studying BRD9 and BRAF-V600X targeted protein degraders in the clinic. The BRD9 degrader CFT8634 is in a Phase I/II trial involving patients with synovial sarcoma and other SMARCB1-null tumors who have received prior systemic therapy or who have run out of options for relapsed, refractory, or metastatic disease. The BRAF-V600X degrader CFT1946 is undergoing a Phase I/II clinical trial in patients with BRAF V600-mutant solid tumors.