Zydus Lifesciences has entered into an exclusive licensing agreement with US-based Agenus Inc to bring the investigational cancer immunotherapy combination of Botensilimab (BOT) and Balstilimab (BAL) to patients in India and Sri Lanka. The deal positions Zydus to commercialize what could become a transformative treatment option for cancer patients across multiple tumor types.
Strategic Partnership Details
Under the terms of the agreement announced on June 3, Zydus will pay Agenus a 5% royalty on net sales following successful regulatory approval and commercialization of the products in the specified territories. Zydus will assume full responsibility for clinical development and regulatory approvals for the licensed products within India and Sri Lanka.
The agreement grants Zydus access to Agenus' next-generation immunotherapy platform, which is designed to enhance and sustain the immune system's fight against tumor cells. This collaboration aligns with Zydus' biologics vision and strategy to advance novel solutions for high-unmet medical need areas.
"Our licensing partnership with Agenus aligns with Zydus' overarching biologics vision and our aim to advance novel solutions for high-unmet need areas," stated Dr Sharvil Patel, Managing Director of Zydus Lifesciences. "Agenus' robust pipeline and research in immuno-oncology along with Zydus' reach as the largest Indian oncology player, is a significant step forward in our collective fight against cancer."
Clinical Performance and Mechanism of Action
The BOT/BAL combination therapy is currently in advanced clinical trials and has demonstrated significant clinical activity across nine cancer types in over 1,200 patients, including both late-stage and neoadjuvant (pre-surgery) settings. This broad efficacy profile suggests the potential for the therapy to address multiple cancer indications.
Botensilimab (BOT) is an Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. The therapy shows particular promise in 'cold' tumors that typically don't respond well to existing immunotherapies. Balstilimab (BAL) is a novel monoclonal antibody that blocks PD-1 from interacting with its ligands, creating a complementary mechanism of action when combined with BOT.
Investment and Development Strategy
In a parallel development, Zynext Ventures, the venture capital arm of Zydus Lifesciences, has announced a strategic investment in Agenus Inc. This investment is designed to accelerate development of the BOT/BAL programme and strategically expand into high-unmet need indications and earlier lines of treatment.
"Our investment in Agenus aligns perfectly with our vision to advance life-changing therapies and offer novel solutions anchored on science, innovation and health to empower patients," said Dr. Sharvil Patel. "Our extensive global partner network will also play a key role in supporting Agenus' entry into new indications and geographies, allowing these innovative therapies to reach more patients, faster."
Beyond capital, Zynext Ventures will provide deep expertise in data analytics and access to a broad global network of biotech, regulatory, and clinical partners. This synergistic approach aims to unlock new avenues for Agenus, enabling the company to broaden the application of its BOT/BAL programme into earlier lines of treatment and address a wider spectrum of cancers with significant unmet medical needs.
Market Expansion Plans
Zydus plans to expand the reach of the BOT/BAL therapy beyond its initial indications, exploring usage in other areas of high unmet medical need, earlier lines of treatment, and neoadjuvant settings. The company's established clinical development and regulatory capabilities position it well to navigate the complex approval process in the Indian and Sri Lankan markets.
Dr. Garo Armen, Chairman and CEO of Agenus, expressed enthusiasm about the partnership: "We are delighted to partner with Zynext Ventures in a truly synergistic relationship. BOT/BAL's remarkable results across nine distinct cancers, in both late-stage and neoadjuvant settings, inspire us to push the boundaries of what is possible in oncology. Zydus' commercial reach and expertise make them an ideal partner to accelerate the delivery of this potentially transformative therapy."
The collaboration represents a significant step in bringing advanced immunotherapy options to cancer patients in South Asia, leveraging Zydus' position as the largest Indian oncology player and Agenus' innovative therapeutic platform.
