Agenus Publishes Ovarian Cancer Trial Results
Agenus announced the publication of clinical results from the ovarian cancer cohort of its Phase 1b C-800-01 trial evaluating botensilimab plus balstilimab in The Journal for ImmunoTherapy of Cancer. In this heavily pretreated population, BOT+BAL demonstrated clinically meaningful activity and durable benefit in women with treatment-refractory ovarian cancer, a population with few remaining options. The combination achieved a 23% overall response rate and 31% clinical benefit rate, including durable responses with a median duration of 9.7 months. Median overall survival reached 14.8 months, with an estimated of 75% of patients alive at 12 months. These findings build on results from the broader C-800-01 dataset presented at ESMO 2025, where BOT+BAL showed activity across multiple refractory solid tumors. Collectively, these data reinforce the potential of BOT+BAL to generate meaningful immune responses in cancers historically considered unresponsive to immunotherapy.
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- Webcast Announcement: Agenus will host its first Stakeholder Webcast on January 28, 2026, at 4 PM ET, focusing on the global momentum of the BOT+BAL program, which is expected to attract significant investor interest.
- Expert Insights: The session will feature perspectives from CEO Garo Armen and an international oncology expert, sharing the latest developments in authorized access programs and clinical advancements, aimed at enhancing investor understanding of the company's strategy.
- Clinical Progress Report: Approximately 1,200 patients have been treated in the BOT+BAL program, demonstrating clinical responses across various metastatic cancers, further solidifying Agenus' leadership in the immuno-oncology sector.
- Future Outlook: This webcast marks the beginning of Agenus' 2026 Stakeholder Briefing Series, aimed at fostering ongoing discussions about BOT+BAL's clinical progress and patient access pathways, thereby strengthening the company's influence in the industry.

- Successful Transaction Closure: Zydus Lifesciences has finalized its asset purchase and exclusive licensing agreements with Agenus, receiving all necessary regulatory approvals, marking a significant advancement in its global biologics CDMO business.
- New Subsidiary Formation: The newly established Zylidac Bio LLC will focus on biologics manufacturing, offering CDMO services to meet the needs of biopharmaceutical companies globally, thereby enhancing Zydus's competitiveness in the U.S. market.
- Deepened Strategic Collaboration: This transaction allows Agenus to monetize its manufacturing assets while securing high-quality U.S. biologics capacity to support late-stage development of its immunotherapy candidates, thereby enhancing the market positions of both companies.
- Compliance Manufacturing Advantage: The establishment of Zylidac Bio LLC aligns with the BIOSECURE Act, providing a compliant U.S. manufacturing solution for global biopharmaceutical companies, ensuring supply chain security and agility.

- Successful Transaction: Zydus Lifesciences has completed the acquisition of assets and shares from Agenus Inc., receiving all necessary regulatory approvals, marking a significant expansion in the global biologics contract development and manufacturing sector.
- New Subsidiary Launch: The newly formed Zylidac Bio LLC will focus on providing high-quality CDMO services to biopharmaceutical companies, ensuring a secure, compliant, and efficient supply chain in the U.S., thereby enhancing Zydus's competitiveness in the biopharmaceutical industry.
- Deepened Strategic Collaboration: This transaction allows Agenus to monetize its manufacturing assets while securing high-quality biologics capacity in the U.S. to support the development of its immunotherapy candidates Botensilimab and Balstilimab, further advancing treatment options for patients globally.
- Policy Opportunity Seized: By establishing a domestic manufacturing footprint in California, Zydus aligns with the BIOSECURE Act requirements, providing compliant supply chain solutions for global biopharmaceutical companies and enhancing its strategic position in the industry.

- Expanded Eligibility: France's ANSM has approved an updated AAC protocol that broadens access to BOT+BAL for patients with certain ovarian cancers and soft tissue sarcomas, addressing significant unmet medical needs in these disease areas.
- Full Reimbursement Policy: Under the AAC framework, eligible French patients treated with BOT+BAL in hospitals will receive full reimbursement, significantly reducing the financial burden on patients and enhancing treatment accessibility.
- Multi-Tumor Early Access: The updated protocol provides a unified early access framework for colorectal cancer, ovarian cancer, and sarcoma patients, representing an uncommon level of national early-access authorization for a single investigational immunotherapy combination.
- Clinical Research Support: Clinical studies have demonstrated antitumor activity of BOT+BAL in heavily pretreated patients, and the updated protocol will facilitate access to this innovative therapy for more patients lacking effective treatment options.

- Regulatory Milestone: Oncolytics Biotech has secured FDA approval for its pivotal Phase 3 trial design for pelareorep in pancreatic cancer, marking a significant step in a field lacking existing immunotherapy options, potentially providing new treatment avenues for patients.
- Clinical Trial Design: The trial will compare standard chemotherapy with pelareorep, with overall survival as the primary endpoint, and success could solidify Oncolytics' position in a competitive market, enhancing its market standing.
- Market Potential: Analysts project the global immuno-oncology market will grow at a CAGR of 15.7% to reach $416.28 billion by 2034, positioning Oncolytics favorably within this rapidly expanding sector.
- Strategic Development: Oncolytics has also established a Gastrointestinal Scientific Advisory Board to advance pelareorep beyond pancreatic cancer, further expanding its market potential and demonstrating the company's strategic focus on multiple tumor types.






