Agenus, which has been going through a reorganization after the FDA put the brakes on the biotech's regulatory plan for its cancer combo, inked a deal that transfers two California manufacturing plants to Indian drugmaker Zydus Lifesciences.
The agreement is designed to accelerate development Agenus’ cancer combination of botensilimab/balstilimab (BOT/BAL), as well as scale global manufacturing and grow the combo's potential reach, the company said in a June 3 press release.
Botensilimab is Agenus’ CTLA-4 blocking antibody, while balstilimab is the company's PD-1 drug.
Last July, the FDA stymied Agenus’ plan to file for accelerated approval of the combo to treat patients with relapsed/refractory microsatellite stable colorectal cancer based on phase 2 response data. The news sent the company’s stock down 38% and triggered an aggressive reorganization.
Under its partnership with Zydus, Agenus will receive $75 million in cash for its 25,000-square-foot facility in Berkeley, California, which performs clinical manufacturing, as well as its 83,000-square-foot plant in Emeryville, California, which is set up for commercial manufacturing.
Additionally, Massachusetts-based Agenus is in line to receive up to $50 million in contingent payments triggered by future BOT/BAL production orders.
Zydus, which plans to leverage the U.S. facilities to launch its BioCDMO business, will also shell out about $16 million to acquire an estimated 2.1 million shares of Agenus at $7.50 per share.
“We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally,” Sharvil Patel, Zydus’ managing director, said in the release. “We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer.”
From Agenus' perspective, the money raised from the share sale will be used for working capital and to further the development of BOT/BAL, the company said.
Agenus appeared headed for an approval of balstilimab in 2021 to treat cervical cancer, but was passed by Merck’s Keytruda, which scored an early expansion in the indication. The Keytruda approval negated Agenus’ ability to win its potential accelerated nod, the company said at the time, so it withdrew its application.
In 2023, Agenus let go of a quarter of its workforce to focus solely on its BOT/BAL combo.