Bicycle Therapeutics’ BT8009 for bladder cancer to participate in FDA program

Bicycle Therapeutics announced that BT8009, the company’s lead investigational therapy in development to treat metastatic bladder or urothelial cancer, has been selected to participate in the Chemistry, Manufacturing and Controls CMC Development and Readiness Pilot, CDRP, Program recently launched by the U.S. Food and Drug Administration FDA . BT8009 is one of up to nine products selected for the first year of the CDRP Program, which the FDA created to facilitate CMC development for therapies with expedited clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. Through the CDRP Program, Bicycle Therapeutics plans to work closely with the FDA to facilitate CMC development and expedite commercial manufacturing readiness of BT8009. “We are honored to participate in the inaugural cohort of the FDA’s CDRP Program,” said Mike Hannay, D.Sc., FRPharmS, senior vice president and head of CMC at Bicycle Therapeutics. “We look forward to working closely with the FDA to ensure the commercial manufacturing readiness for BT8009 keeps pace with its expedited clinical development. We welcome the guidance we will receive through more frequent and dedicated CMC discussions with the FDA, and in turn we hope the agency will become more familiar with our novel Bicycle technology and its sophisticated manufacturing process.” The company plans to initiate the Duravelo-2 trial in the first quarter of 2024.