To advance BOT+BAL and strengthen US manufacturing readiness
Agenus, a leader in immuno-oncology innovation, announced the closing of its previously disclosed strategic collaboration with Zydus Lifesciences Ltd. The agreement is designed to accelerate global development and potential commercialisation of Agenus’ botensilimab and balstilimab (BOT+BAL) immunotherapy combination programme.
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 commercialise BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories.
“Closing this collaboration with Zydus strengthens our balance sheet and, critically, secures dedicated US manufacturing capacity at a pivotal moment for Agenus,” said Dr Garo Armen, Chairman and Chief Executive Officer, Agenus. “With these foundations in place, our focus in 2026 is disciplined execution—advancing our Phase 3 program, broadening paid patient access through authorized pathways, and progressing toward regulatory submission supported by one of the most substantial clinical datasets generated in MSS colorectal cancer.”
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 US sites to support BOT+BAL supply needs for their clinical trials, global access programmes and future commercialisation.
Dr Sharvil P Patel, Managing Director, Zydus Lifesciences, stated, “With this deal, Zylidac Bio will now provide biologicals manufacturing sites offering CDMO services to biopharmaceutical companies globally. This supports the evolving landscape of biological product manufacturing in the US, which prioritises secure, domestic, and high-quality supply chains for advanced therapies. Zylidac Bio LLC offers a critical, compliant solution for global innovators and allows for a localised supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation.”
