Agenus has announced a strategic collaboration with Zydus Lifesciences to advance the clinical development and global manufacturing of botensilimab and balstilimab (BOT/BAL).
The partnership aims to expand patient access to these immuno-oncology treatments.
The collaboration includes an exchange of Agenus’ biologics CMC facilities in Emeryville and Berkeley, California, for an upfront consideration of $75m.
Zydus, a pharmaceutical company based in India, will utilise these facilities to establish a BioCDMO business in the US, offering biologics contract manufacturing services globally.
Agenus will be Zydus’ first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL, ensuring the combination regimen’s BLA and launch readiness.
Agenus will receive up to an additional $50m in contingent payments from Zydus, triggered by production orders of BOT/BAL.
In addition, Zydus will gain an exclusive licence to develop and commercialise BOT and BAL in India and Sri Lanka, paying Agenus a 5% royalty on net sales in these countries.
Zydus will also make a strategic equity investment in Agenus by purchasing around 2.1 million shares of common stock at $7.50 per share, resulting in around $16m.
Agenus plans to use the net proceeds to support working capital and accelerate the clinical development and potential commercialisation of BOT/BAL.
Agenus CEO Garo Armen said: “We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics.
“This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States.
“The administration has created an environment that has brought these two trading partners together. The United States is the second-largest trading partner with India.”
The collaboration combines Agenus’s research and development expertise with Zydus’ global manufacturing and commercialisation capabilities.
The transaction is subject to customary closing conditions and due diligence, with the parties aiming to finalise agreements within 60 days.
The partnership is expected to advance cancer immunotherapy in India and beyond.
Zydus Lifesciences managing director Sharvil Patel said: “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 tumour patients globally.
“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.”
