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 growing physician-initiated interest in authorized access to the investigational immunotherapy combination of botensilimab plus balstilimab (BOT+BAL).
The expansion reflects increasing interest from treating oncologists worldwide who are 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 recent scientific milestones, including peer-reviewed publications, clinical data presented at major international scientific meetings, and the expansion of reimbursed compassionate access for BOT+BAL under France’s AAC framework, which now includes three tumor types.
This combination of scientific momentum and evolving regulatory access 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 been initiated by oncologists caring for patients with advanced solid tumors who have exhausted available standard-of-care options and require coordinated Medical Affairs oversight to support compliant access, safety monitoring, and cross-regional regulatory alignment.
Botensilimab is an Fc-enhanced, multifunctional anti-CTLA-4 antibody, and balstilimab is a PD-1 inhibitor. Together, BOT+BAL is a chemotherapy- and radiation-free immunotherapy regimen currently being evaluated in clinical trials.
Authorized early access pathways
Agenus’ early-access support is organized around two complementary authorized pathways:
- France’s AAC framework, under which BOT+BAL is provided in hospitals under a nationally standardized protocol and reimbursed for eligible patients across three advanced solid tumors: microsatellite-stable metastatic colorectal cancer (MSS mCRC) without active liver metastases, platinum-refractory or platinum-resistant ovarian cancer, and advanced or metastatic soft-tissue sarcomas; and
- Paid named patient programs (NPPs) in select countries where such programs are permitted and available under local regulatory frameworks. These programs are physician-initiated and patient-specific and may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions.
As clinical evidence for BOT+BAL continues to mature and physician engagement increases, Agenus has expanded its Medical Affairs infrastructure to ensure requests are supported responsibly and in alignment with applicable regulatory requirements. Medical Affairs plays a central role in enabling scientific exchange, coordinating appropriate access requests where permitted, supporting pharmacovigilance and safety reporting, and facilitating structured collection of real-world safety and outcomes data where applicable.
“As clinical evidence for botensilimab plus balstilimab continues to mature, we are seeing increasing inquiries from physicians seeking information about access for patients with limited therapeutic alternatives”
said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus.
“Expanding our global Medical Affairs infrastructure ensures that this interest is supported with the appropriate scientific rigor [and] safeguards, while positioning the organization for disciplined execution across authorized access pathways and late-stage clinical development.”
What drugs are Botensilimab (BOT) and Balstilimab (BAL)?
Botensilimab (BOT) is a next-generation, Fc-engineered CTLA-4 inhibitor designed to activate both innate and adaptive immune responses. It is specifically developed to work in “cold” tumors, which are typically resistant to standard immunotherapies. BOT enhances T-cell priming and activation, reduces suppressive regulatory T cells within tumors, activates myeloid cells, and may help generate long-lasting immune memory.
Balstilimab (BAL) is Agenus’s PD-1 inhibitor that blocks PD-1 interactions with its ligands, PD-L1 and PD-L2, thereby enhancing T-cell function and immune-mediated tumor killing. When used together, the BOT/BAL combination has demonstrated strong and durable anti-tumor activity across several difficult-to-treat cancers, including colorectal cancer and hepatocellular carcinoma (HCC).