France Expands Compassionate Access for Agenus' Immunotherapy in Ovarian Cancer and Soft-Tissue Sarcomas

Expanded Access to Innovative Cancer Treatment

France's National Agency for Medicines and Health Products Safety (ANSM) announced on January 12, 2026, an updated national treatment protocol that expands compassionate access for Agenus Inc.'s investigational immunotherapy combination, botensilimab (BOT) plus balstilimab (BAL). This expansion, granted under France's Autorisation d'Accès Compassionnel (AAC) framework, now includes eligible patients with certain ovarian cancers and soft-tissue sarcomas.

The decision aims to address a significant unmet medical need for patients suffering from these serious or life-threatening diseases, particularly when standard treatment options have been exhausted. The AAC pathway facilitates hospital-based access, and for eligible French patients, the treatment is fully reimbursed by France's national health system, Assurance Maladie.

Understanding the Immunotherapy Combination

Developed by Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, the BOT+BAL combination represents a chemotherapy- and radiation-free immunotherapy approach. The therapy consists of two distinct antibodies:

• Botensilimab (BOT): This is a human Fc-enhanced multifunctional anti-CTLA-4 antibody. It is designed to boost both innate and adaptive anti-tumor immune responses, aiming to extend immunotherapy benefits to 'cold' tumors—those that typically respond poorly to conventional treatments.
• Balstilimab (BAL): A novel, fully human monoclonal immunoglobulin G4 (IgG4), balstilimab works by blocking PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. This action helps sustain T-cell engagement and prevents immune shutdown.

Together, BOT and BAL are engineered to convert 'immune-cold' tumors into immune-active ones, making them more susceptible to attack by the body's immune system.

Clinical Efficacy and Access Framework

Clinical studies have shown promising antitumor activity for BOT+BAL in heavily pretreated patients, including those with tumor types historically resistant to standard immunotherapy. For ovarian cancer, the combination demonstrated a 23% overall response rate and a 31% clinical benefit rate in heavily pretreated patients, with a median duration of response of 9.7 months and a median overall survival of 14.8 months. In soft-tissue sarcomas, durable responses were observed across immunologically 'cold' types, with an overall response rate of 19.2% for the overall study population.

It is important to note that BOT+BAL remains an investigational therapy and has not yet received commercial marketing approval in France or other regions. Access to the treatment is exclusively through the ANSM-authorized AAC framework or ongoing clinical trials. The AAC program ensures that patients with serious conditions and no appropriate therapeutic alternatives can access innovative medicines under a nationally validated protocol, with comprehensive monitoring and treatment procedures in participating hospitals.