FDA grants Agenus meeting to discuss BOT/BAL Therapy for r/r MSS mCRC

Agenus announced it will conduct a Type B End-of-Phase 2 EOP2 meeting in July with the U.S. Food and Drug Administration or 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 FDA granted BOT/BAL fast track designation in April 2023. “Our upcoming End of Phase 2 meeting with the FDA represents a significant milestone in the ongoing development of BOT/BAL for patients diagnosed with metastatic MSS CRC who do not have active liver metastases,” stated Steven O’Day, M.D., Chief Medical Officer of Agenus. “The results from our Phase 1 and Phase 2 studies contribute valuable insights into the potential of this therapy for managing a specific and challenging subgroup of colorectal cancer. We remain dedicated to further exploring innovative immunotherapeutic strategies.” The Phase 2 data will be submitted to a major medical conference later this year. In addition to advancing BOT/BAL in colorectal cancer, Agenus remains committed to exploring the potential of this combination therapy in other cancer indications and is preparing to present further data at upcoming medical conferences.