Agenus Expands Global Medical Affairs Infrastructure And Early-Access Support Capabilities In Response To Increasing Physician-Initiated Interest Regarding Authorized Access To BOT+BAL

Medical Affairs scale-up supports France's multi-tumor AAC access framework and expanding paid named-patient programs requests

Agenus Inc. (NASDAQ:AGEN), a leader in immuno-oncology innovation, today announced the expansion of its global Medical Affairs infrastructure and early-access support capabilities in response to increasing physician-initiated interest regarding authorized access to the investigational immunotherapy combination botensilimab plus balstilimab (BOT+BAL).

The expansion reflects increasing interest from treating oncologists worldwide seeking access to BOT+BAL for patients with advanced solid tumors through regulatory-authorized early access pathways, including France's Authorisation d'Accès Compassionnel (AAC) framework and paid named patient programs (NPPs) where permitted. This interest follows a series of recent scientific milestones, including peer-reviewed publications, clinical data presentations at major international scientific meetings and the recent expansion of reimbursed compassionate access for BOT+BAL under France's AAC framework that now includes three tumor types.

This scientific and regulatory validation has translated into real-world physician action. Patients have already been treated with BOT + BAL through regulatory-authorized paid named patient programs in multiple countries across South and Central America and Europe, including the United Kingdom and Switzerland, where permitted by local regulations. These requests have originated from treating oncologists managing patients with advanced solid tumors who have exhausted available standard-of-care treatment options, and require coordinated Medical Affairs oversight to support compliant access, safety monitoring, and regulatory alignment across regions.

Botensilimab is an Fc-enhanced multifunctional anti-CTLA-4 antibody, and BAL is an PD-1 inhibitor. Together, BOT+BAL is a chemotherapy- and radiation-free immunotherapy regimen currently being evaluated in clinical trials.