Agenus Collaborates with Zydus on BOT/BAL Development and U.S. BioCDMO Launch

• Agenus has entered into a strategic partnership with Zydus Lifesciences, transferring its US biologics CMC facilities for $75 million upfront and up to $50 million in milestone payments.

• Zydus will launch a BioCDMO business and gain exclusive BOT/BAL rights in India and Sri Lanka, while also investing $16 million in Agenus equity.

Agenus Inc. has signed definitive agreements with Zydus Lifesciences Ltd. to advance the clinical development and manufacturing of its immuno-oncology candidates, botensilimab and balstilimab (BOT/BAL). The collaboration includes a $75 million upfront payment to Agenus for the transfer of its biologics CMC facilities in Emeryville and Berkeley, California.

The agreement positions Zydus to launch a biologics contract manufacturing (CDMO) business in the United States, using the transferred sites as its flagship operations. Additionally, Agenus is eligible for up to $50 million in contingent payments based on BOT/BAL production orders.

Agenus will be Zydus’ first BioCDMO customer, entering into an exclusive manufacturing agreement to support the regulatory and launch preparation of BOT/BAL. The company will also license BOT/BAL exclusively to Zydus for development and commercialisation in India and Sri Lanka, earning a 5 percent royalty on net sales in those territories.

“We are excited to collaborate with Agenus on advancing BOT/BAL, which holds promise for helping thousands of patients each year in our key markets—India and Sri Lanka—and potentially millions of solid tumour patients worldwide. Our clinical development plans include trials in both early- and late-stage disease, as well as exploring its use beyond colorectal cancer in other major indications such as triple negative breast cancer,” said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd.

The transaction includes a $16 million equity investment by Zydus through the purchase of approximately 2.1 million Agenus shares at $7.50 per share. Agenus intends to use the proceeds to advance its clinical and commercial efforts for BOT/BAL.

“With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations,” said Dr. Garo Armen, CEO of Agenus.