On October 19, 2023 Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that BT8009, the company’s lead investigational therapy in development to treat metastatic bladder (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) (Press release, Bicycle Therapeutics, OCT 19, 2023, View Source [SID1234636136]). 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.
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"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."
"At Bicycle Therapeutics, we are pioneering an entirely new class of drugs with the goal of treating cancer and many other diseases. We believe BT8009 has the potential to be a transformative therapy for patients with metastatic bladder cancer, which is underscored by its selection for the FDA’s CDRP Program in addition to its Fast Track designation and recently announced expedited development plan and registrational pathway," said CEO Kevin Lee, Ph.D. "On behalf of our entire team, I would like to thank the FDA for their continued collaboration as we work with urgency to develop and deliver this promising therapy to patients."
In September, Bicycle Therapeutics announced its plan to expedite development of BT8009 in metastatic bladder cancer following alignment with the FDA on the therapy’s Phase 2/3 registrational trial, called Duravelo-2. The innovative trial design allows for the potential accelerated approval of BT8009 in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer. The company plans to initiate the Duravelo-2 trial in the first quarter of 2024.
About BT8009
BT8009 is an investigational Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen with elevated levels of expression in multiple tumor types, including bladder (urothelial) cancer. It is currently being evaluated in a Phase 1/2 clinical trial enrolling patients with Nectin-4 expressing advanced solid tumors. BT8009 will be evaluated in the Phase 2/3 Duravelo-2 trial, a global, multi-center, adaptive study designed to assess the safety and efficacy of the therapy for metastatic bladder cancer.