Zydus Manufacturing Deal Closes, France Access Expands, Phase 3 BATMAN Nears Launch

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Zydus collaboration closes: Agenus completed a delayed deal with Zydus Lifesciences that sold its Emeryville biologics facility and included an equity sale, providing capital, long‑term U.S. manufacturing capacity for BOT/BAL and rights for Zydus to develop and commercialize the drugs in India and Sri Lanka.

France AAC expansion: France’s reimbursed AAC program, which began for colorectal cancer, has expanded to include sarcoma and ovarian cancer, giving eligible patients full reimbursement for BOT/BAL and demonstrating regulator willingness to allow access while confirmatory trials continue.

BATMAN phase 3 and regulatory strategy: Agenus plans to launch the global randomized phase 3 BATMAN trial in MSS metastatic colorectal cancer imminently and is pursuing U.S. accelerated and European conditional approval pathways supported by both trial and real‑world evidence.

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Agenus (NASDAQ:AGEN) used its first 2026 stakeholder webcast to outline operational and clinical priorities tied to its botensilimab/balstilimab (BOT/BAL) immunotherapy program, highlighting a recently closed manufacturing collaboration with Zydus Lifesciences, the expansion of France’s reimbursed early access pathway, and preparations for a global phase 3 trial in microsatellite-stable (MSS) metastatic colorectal cancer.

CEO Dr. Garo Armen said the company entered 2026 with “greater clarity” following the closing of a collaboration with Zydus Lifesciences that had been announced in June 2025 but took additional time to complete due to government review. Armen described the transaction as including the sale of Agenus’ biologics facility in Emeryville, California, and an equity sale “at a significant premium to market price.” He said the deal strengthens Agenus’ ability to execute its strategy by providing capital and long-term U.S.-based biologics manufacturing capacity using the same team that built and operated the facility.

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Armen and Chief Communications Officer Stefanie Perna-Nacar said the timeline was extended beyond typical antitrust review, with Armen citing an additional national security-related process through the Committee on Foreign Investment in the United States (CFIUS), as well as a government shutdown during the review period. Armen said CFIUS ultimately worked through the process and the deal closed, enabling Agenus to move forward with 2026 plans.

Perna-Nacar and Armen also discussed how the arrangement aligns both companies’ interests: Zydus, described as a generics-focused company seeking a U.S. biologics manufacturing base for biosimilars, gains a U.S. facility; Agenus secures manufacturing for BOT/BAL for clinical trials and access programs. Armen said Zydus retained the Emeryville team, calling it a “superstar team,” and noted that Agenus Chief Manufacturing Officer Al Dodson would become a Zydus executive serving both companies.

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Armen added that the collaboration expanded beyond manufacturing after Agenus presented data to key opinion leaders in India. He said Zydus now has the ability to develop and commercialize BOT and BAL in India and Sri Lanka, pointing to Zydus’ hospital and clinical research capabilities in the region.

Management repeatedly emphasized the role of France’s reimbursed AAC program, which Armen said began in September with access for eligible colorectal cancer patients and “in the last few weeks” expanded to include sarcoma and ovarian cancer. Under the program, he said, the French government provides full reimbursement for BOT/BAL for eligible citizens.

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Armen framed the AAC expansion as evidence of urgency and a willingness to allow access while confirmatory trials continue. He also highlighted the company’s focus on MSS tumors, stating that MSS cancers represent more than 80% of solid tumors and roughly 95% of colorectal cancers, which he described as largely unresponsive to currently approved PD-1/PD-L1 therapies.

During a clinical discussion, sarcoma specialist Dr. Robin Jones described sarcomas as connective-tissue tumors that can occur anywhere in the body, accounting for about 1% of adult cancers and spanning more than 80 subtypes. He said localized treatment typically centers on surgery with or without radiation, while metastatic disease often relies on older chemotherapy regimens such as doxorubicin and ifosfamide, with immunotherapy historically showing limited impact outside certain exceptions.

Jones said the BOT/BAL combination drew interest based on early data discussed at ESMO in Berlin, citing promising provisional efficacy and tolerability. He also said he had seen patients derive durable benefit, arguing that durability is a key limitation of many existing sarcoma treatments. Regarding the French AAC decision, Jones called it “great news” for patients and said he hoped other countries would follow.

Chief Medical Affairs Officer Dr. Jose Iglesias said he joined Agenus due to what he characterized as the scientific uniqueness of botensilimab, particularly activity in tumors that “normally do not respond” to immune-oncology approaches. He said more than 1,200 patients have received the therapy across development efforts, including metastatic settings and newer areas such as neoadjuvant treatment.

Iglesias described access routes centered on France’s reimbursed compassionate access framework, as well as participation by non-French patients through cross-country healthcare arrangements, insurance reimbursement in their home countries, or self-pay options. He said Agenus had received 60 total physician inquiries in France at the time of his remarks, with additional activity in other European countries and Latin America through a Named Patient Program.

To manage demand and compliance requirements, Iglesias said Agenus is expanding medical affairs, including hiring a Europe-based vice president of medical affairs and building a team of medical science liaisons. He emphasized strict eligibility criteria and the need to collect and report real-world data, noting that regulators increasingly value such evidence alongside clinical trial results. He also stressed pharmacovigilance and monitoring for safety and efficacy across access programs.

Armen said a global randomized phase 3 trial called BATMAN is expected to launch “very, very soon” in MSS metastatic colorectal cancer. He cited investigator engagement and what he described as early efficacy from phase 1 and phase 2 work, saying the company has generated close to 500 patients’ worth of data in earlier studies. He characterized BATMAN as a key 2026 priority intended to provide confirmatory evidence in a population “long considered beyond the reach of currently approved immunotherapies.”

On regulatory strategy, Armen said Agenus intends to pursue pathways in both the U.S. and Europe, including revisiting accelerated approval in the U.S. despite prior challenges with the FDA’s oncology division. He said European regulators have been more receptive to conditional approval possibilities in discussions held to date.

In a Q&A segment, Chief Medical Officer Dr. Steven O’Day attributed BOT/BAL’s breadth of activity to immune-system activation rather than tumor-specific targeting, describing CTLA-4 and PD-1 as “primal checkpoints.” He said botensilimab is a next-generation CTLA-4 antibody that helps T cells recognize tumors more broadly, including those historically hidden from immune response.

Armen said Agenus’ operating cash burn is approximately $50 million per year, excluding potential revenue from paid access programs. He said the company’s cash position was “a little over $60 million” at the close of the Zydus transaction, reflecting various obligations and costs at closing, including equipment purchases, third-party amounts owed, closing costs, and $7.5 million placed into escrow for a period of time. Based on that burn rate and the possibility of access-related revenue, Armen said the company believes it can manage its affairs through the balance of the year and potentially into next year.

Throughout the webcast, leadership emphasized a three-part focus for 2026: expanding appropriate authorized access pathways, preparing for regulatory filings supported by both clinical and real-world evidence, and advancing the BATMAN randomized trial with what Armen described as urgency and rigor.

Agenus, Inc (NASDAQ:AGEN) is a clinical-stage immuno-oncology company headquartered in Lexington, Massachusetts. The company focuses on the discovery and development of therapies designed to modulate the immune system’s response to cancer. Leveraging proprietary platforms in checkpoint modulation, vaccine technology and adjuvant systems, Agenus aims to deliver combination regimens that enhance antitumor activity across a variety of solid tumors and hematological malignancies.

Agenus’ pipeline includes monoclonal antibodies targeting immune checkpoints, cytokine-based therapeutics and vaccine candidates built on its engineered heat shock protein (HSP) platform.

The article “Agenus Webcast: Zydus Manufacturing Deal Closes, France Access Expands, Phase 3 BATMAN Nears Launch” was originally published by MarketBeat.