Zydus signs deal with Agenus for BOT and BAL cancer therapies in India

Zydus Lifesciences has partnered with Agenus to license the cancer immunotherapies Botensilimab and Balstilimab for India and Sri Lanka, expanding its oncology offerings

Zydus Lifesciences Limited has signed a definitive agreement with Agenus Inc. to acquire commercial rights for India and Sri Lanka for the investigational combination therapy Botensilimab (BOT) and Balstilimab (BAL).

 

Agenus is a clinical-stage immuno-oncology company focused on developing immune therapies for the treatment of cancer.

 

“Our licensing partnership with Agenus aligns with Zydus' overarching biologics vision and our aim to advance novel solutions for high-unmet need areas,” said Dr Sharvil Patel, Managing Director of Zydus Lifesciences.

 

BOT and BAL: A next-generation immunotherapy platform 

The BOT and BAL combination is a next-generation immunotherapy platform aimed at enhancing and sustaining the immune system’s ability to respond to tumour cells.

 

 

BOT is an investigational anti-CTLA-4 antibody designed to activate immune cells and generate durable immune responses. BAL is an investigational anti-PD-1 antibody that blocks the PD-1 pathway, thereby supporting T cell activity against cancer cells. 

 

This combination is currently in advanced clinical trials and has shown clinical activity in more than 1,200 patients across nine types of cancer, including colorectal cancer, melanoma, lung cancer, ovarian cancer, gastric cancer, pancreatic cancer and non-small cell lung cancer. The trials cover both late-stage and neoadjuvant (pre-surgery) treatment settings.

 

Zydus to lead development and regulatory approvals in region 

Under the terms of the agreement, Zydus will be responsible for clinical development and regulatory approvals of the licensed products in India and Sri Lanka. Upon successful approval and commercialisation, Zydus will pay a 5 per cent royalty on net sales.

 

“Agenus' robust pipeline and research in immuno-oncology, along with Zydus’ reach as the largest Indian oncology player, mark a significant step forward in our collective fight against cancer. We are confident that this collaboration will bring transformative therapies to patients who need them most in the India and Sri Lanka markets,” Dr Patel added.

 

Plans for expanding therapeutic reach in oncology 

Zydus also stated its intention to broaden the use of the BOT and BAL combination therapy beyond current indications. The company aims to expand into other high-unmet-need indications, earlier lines of treatment, and additional neoadjuvant applications. 

CDMO agreement

 

In a parallel development, Zydus Lifesciences announced its entry into the global biologics contract development and manufacturing organization (CDMO) sector through an agreement to acquire the biologics CMC facilities of Nasdaq-listed Agenus Inc. in the United States.

 

As part of the CDMO agreement, Zydus will purchase two biologics manufacturing sites located in Emeryville and Berkeley, California, for an upfront payment of $75 million. An additional $50 million will be paid over a period of three years, contingent on the achievement of specified revenue milestones.

 

Market.us estimates the global biologics CDMO market will reach approximately $84.9 billion by 2034, with a compound annual growth rate of 15.7 per cent from 2025 to 2034.