Agenus Inc. , a leader in immuno-oncology innovation, announced the completion of its previously disclosed strategic collaboration with Zydus Lifesciences Ltd., a transaction designed to accelerate the global development and potential commercialization of Agenus’ botensilimab and balstilimab (BOT+BAL) combination immunotherapy program.
The collaboration strengthens Agenus’ financial position while securing long-term, dedicated biologics manufacturing capacity in the United States. This capacity will support the continued clinical development of BOT+BAL, authorized early access programs, and preparations for future commercial supply.
Under the agreement, Agenus granted Zydus exclusive rights to develop and commercialize botensilimab (BOT) and balstilimab (BAL) in India and Sri Lanka. Agenus remains eligible to receive royalties of 5% on net sales generated in those territories.
The collaboration, initially announced on June 3, 2025, carries total potential value of up to $141 million and includes several key financial components. Agenus received $75 million in upfront cash consideration related to the transfer of its biologics manufacturing facilities in Emeryville and Berkeley, California. Zydus also made a $16 million equity investment in Agenus through the purchase of approximately 2.1 million shares at $7.50 per share. In addition, Agenus is eligible to receive up to $50 million in contingent milestone payments tied to BOT+BAL production orders.
“The completion of this collaboration with Zydus strengthens our balance sheet and, critically, secures dedicated U.S. manufacturing capacity at a pivotal moment for Agenus,” said Dr. Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. “With this foundation in place, our focus in 2026 is disciplined execution—advancing our Phase 3 program, expanding access for paying patients through authorized pathways, and progressing toward regulatory submission, supported by one of the most robust clinical datasets ever generated in microsatellite-stable colorectal cancer.”
Clinical momentum for BOT+BAL continues to build. In 2025, the 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 microsatellite-stable metastatic colorectal cancer (mCRC) treated in the third-line or later setting, without active liver metastases. These results helped support the initiation of the global Phase 3 BATTMAN study, launched in collaboration with the Canadian Cancer Trials Group (CCTG), with study sites activated and recruiting readiness underway.
Following completion of the transaction, the Emeryville and Berkeley biologics manufacturing facilities will be transferred to Zydus and operated under a newly formed subsidiary, Zylidac Bio LLC. Agenus has secured committed manufacturing capacity at these U.S.-based facilities to meet its anticipated BOT+BAL supply needs across clinical trials, global access programs, and future commercialization.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, commented on the milestone: “With this agreement, Zylidac Bio LLC will offer high-quality biologics manufacturing and CDMO services to biopharmaceutical companies worldwide. This supports the growing importance of secure, domestic biologics supply chains in the U.S. and reinforces our ability to serve global innovators with reliability and innovation.”
Agenus was advised on the transaction by Porrima Ltd and Biotech Value Advisors (BVA), which provided support on partner selection, transaction structuring, and negotiations.
Beyond clinical trials, Agenus remains committed to responsible patient access to investigational medicines through authorized early access mechanisms. In France, BOT+BAL is currently available exclusively under the ANSM-authorized AAC program, with full reimbursement by the French national health system (Assurance Maladie) for eligible hospital-treated patients. Outside France, access may be available in select countries through regulated paid access programs, depending on local regulatory frameworks.
The BATTMAN Phase 3 study is a global, registry-based trial evaluating BOT+BAL versus best supportive care in patients with refractory, unresectable, microsatellite-stable, proficient mismatch repair colorectal cancer. Led by CCTG and supported by international academic networks, the study is expected to enroll approximately 800 patients across more than 100 centers worldwide.
Together, the completion of this strategic collaboration and the advancing clinical profile of BOT+BAL further position Agenus to execute its near- and long-term growth strategy as global interest in the program continues to expand.
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