Agenus Reveals Enhanced Phase 1 Outcomes and Advances in MSS CRC Treatment with BOT/BAL Combo Therapy

Agenus Inc., a biopharmaceutical firm specializing in immunological treatments for cancer, has reported new findings from its Phase 1 clinical study of BOT/BAL combination therapy for patients with metastatic colorectal cancer (CRC) that lacks microsatellite instability-high (MSS) or deficient mismatch repair (dMMR). The study involved 77 patients and showed a 23% overall response rate (ORR) with a median follow-up of 13.6 months as of March 1, 2024. The 12-month and 18-month overall survival (OS) rates were 71% and 62%, respectively, and the median OS was 21.2 months. 

The company, which has seen promising results from BOT/BAL across various cancer types, is set to discuss the interim outcomes of its Phase 2 trial with the FDA. They also aim to present the Phase 2 data at a significant medical conference later in 2024. Agenus is preparing to submit a Biologics License Application (BLA) for BOT/BAL in treating refractory MSS CRC, pending discussions with the FDA. 

Agenus' Chief Medical Officer, Steven O’Day, M.D., highlighted the significance of these results for metastatic CRC, a leading cause of cancer-related deaths in the U.S. The company is focused on rapidly advancing this combination therapy to help patients in need. The clinical data suggests that BOT/BAL could significantly impact the treatment of solid tumors that are typically challenging to address. Agenus is dedicated to developing a diverse range of immunological agents for cancer and infectious diseases, with a vision to broaden the reach of cancer immunotherapy through innovative combination therapies. The company's headquarters are in Lexington, Massachusetts, and it maintains an active online presence for investor relations and media inquiries.

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