FDA Grants Agenus Type B End-of-Phase 2 Meeting to Discuss BOT/BAL Therapy for Relapsed or Refractory Metastatic Colorectal Cancer

Author: Benzinga Newsdesk | May 16, 2024 07:40am

Agenus Inc. ("Agenus") (NASDAQ:AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced it will conduct a Type B End-of-Phase 2 (EOP2) meeting in July with the U.S. Food and Drug Administration (FDA) to discuss the botensilimab plus balstilimab (BOT/BAL) combination therapy studies in patients with relapsed/refractory metastatic colorectal cancer that is not MSI-high or dMMR (r/r MSS mCRC), as well as the critical elements of the program to support a future biologics license application (BLA) submission.

The meeting is scheduled as part of Agenus' ongoing efforts to expedite the development of this promising therapeutic option in CRC, considered to be one of the most challenging types of cancer due to its high incidence and mortality rates. It is also one of the fastest-growing cancer types in the U.S., particularly noted for its increasing prevalence among younger adults. Agenus aims to collaborate closely with the FDA to outline the path forward, including the Phase 3 study design and other elements needed to support a BLA filing under the FDA's accelerated approval pathway. The FDA granted BOT/BAL fast track designation in April 2023.

Posted In: AGEN