Agenus Inc. announced the closing of its previously disclosed strategic collaboration with Zydus Lifesciences Ltd. The agreement is designed to accelerate global development and potential commercialization of Agenus'botensilimab and balstilimab (BOT+BAL) immunotherapy combination program. The collaboration provides Agenus with strategic capital and committed, long-term biologics manufacturing capacity in the United States to support BOT+BAL clinical development, authorized early access pathways, and commercial supply preparation. As part of the collaboration, Agenus has granted Zydus exclusive rights to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories.
In 2025, the BOT+BAL combination demonstrated a two-year overall survival rate of 42% and a now-mature median overall survival of 21 months in an expanded cohort of 123 patients with third-line or later microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. Building on these results, Agenus, in collaboration with Canadian Cancer Trials Group (CCTG) has initiated the global BATTMAN Phase 3 trial, with sites activated and prepared to enroll patients. Following the closing, the Emeryville and Berkeley, California biologics manufacturing facilities will be transferred to Zydus and housed under a newly formed subsidiary named Zylidac Bio LLC.
Agenus has secured committed manufacturing capacity at these U.S. sites to support BOT+ BAL supply needs for their clinical trials, global access programs and future commercialization. This transaction further positions Agenus to execute on its near- and long-term strategy as interest in BOT+BAL continues to grow globally. As part of this effort, Agenus was advised by Porrima Ltd. and Biotech Value Advisors (BVA), who provided guidance on partner selection, transaction structure, and negotiations.
