- France grants reimbursed access with patients having commenced treatment
- Two-year BOT/BAL survival presented at ESMO spanning more than five cancers in over 400 patients
- Phase 3 on track to commence in fourth quarter 2025
LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN) today reported quarterly results for the period ended September 30, 2025, and provided a business update. Highlights include government‑funded, reimbursed compassionate access (AAC) in France for botensilimab plus balstilimab (BOT/BAL), new survival data presented at ESMO and ESMO‑GI across more than 400 patients spanning more than five refractory cancers, and initiation of the global Phase 3 BATTMAN trial.
Access & Regulatory
- France authorizes reimbursed AAC for BOT/BAL. In September, France’s medicines agency (ANSM) authorized reimbursed compassionate access (Accès Compassionnel, AAC) for BOT/BAL in refractory MSS mCRC without active liver metastases—the first government-funded access for this population and the first reimbursed access provided for BOT/BAL by a regulatory agency. link
Clinical Highlights
BOT/BAL has demonstrated durable, long-term survival in patients with advanced solid tumors, reinforcing its potential to expand the reach of immunotherapy to those historically unresponsive to treatment.
- MSS metastatic colorectal cancer (ESMO‑GI 2025): In 123 heavily pretreated MSS mCRC patients without active liver metastases, BOT/BAL achieved 42% two‑year overall survival(OS) and 20.9‑month median OS. Median OS benchmarks in this third‑line‑plus setting is 8-14 i months with current standards of care. link
- Pan‑tumor cohort (ESMO 2025): Updated Phase 1b results in >400 patients demonstrated 39% two‑year OS across more than five refractory cancers, including colorectal, ovarian, sarcoma, lung, and hepatocellular tumors. Important to note that responses were seen after prior checkpoint inhibitor failure; immune‑related AEs were treatable and reversible. link
Phase 3 Program
- Global registrational trial initiated. The BATTMAN (CCTG CO.33) Phase 3 trial conducted with the Canadian Cancer Trials Group and supported by AGITG (Australasia), and PRODIGE (France)—is launching in Q4 2025 across 100+ sites in Canada, France, Australia, and New Zealand to evaluate BOT/BAL versus best supportive care in refractory, unresectable MSS/pMMR colorectal cancer. link
Q3 2025 Financial Highlights
- Zydus transactions: In October, Agenus and Zydus agreed to a $10 million bridge facility ahead of the anticipated $91 million upon closing of the transaction which also includes an equity investment at $7.50 per share.
- MiNK deconsolidation: In July 2025, Agenus’ ownership of MiNK fell below 50%, resulting in deconsolidation in Q3 2025. This generated approximately $100.9 million gain, resulting in net income for the three‑month and nine-month period ended September 30, 2025.
Upcoming Catalysts
- BATTMAN patient enrollment to commence before year-end 2025
- BOT/BAL paid access programs: government reimbursed in France and self-pay in several European countries as well as other regions – patients currently under treatment in both pathways.
- Investigator‑initiated trials: Neoadjuvant and frontline data updates expected 1H 2026
- France AAC: Will generate real world evidence
