AGEN News & Events

Agenus and BAP Pharma announced the exclusive appointment of BAP Pharma as Agenus' global partner for botensilimab plus balstilimab authorized global access programs. The partnership supports compliant, patient-focused access to BOT+BAL through authorized pathways where permitted by local regulations. Effective immediately, BAP Pharma will serve as Agenus' exclusive partner for the coordination of BOT+BAL global access program operations, including program requests, case coordination, distribution logistics, and related payment processing. These programs include France's Autorisation d'Acces Compassionnel pathway as well as paid named-patient programs in select countries outside the United States. As previously disclosed, Agenus has received more than 270 physician inquiries from more than 30 countries across these pathways. Under the collaboration, BAP Pharma will coordinate Agenus' global access operations across these programs. BAP Pharma brings extensive global medicines access experience, a professional and responsive approach to physician and site engagement, and the operational rigor required to streamline logistics, strengthen regional coordination, and support treating physicians navigating country-specific regulatory frameworks.

Agenus announced data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, investigating botensilimab (BOT) and balstilimab (BAL) in combination with agenT-797, MiNK's allo-iNKT cell therapy, ramucirumab and paclitaxel in patients with advanced PD-1 refractory gastroesophageal adenocarcinoma. The data are being presented at the American Association for Cancer Research Annual Meeting, taking place April 17-22, 2026, in San Diego, CA. This Phase II trial, which is the first to combine BOT and BAL with agenT-797 in patients with gastroesophageal cancer who progressed after frontline therapy, was designed to explore the role of immune priming and treatment sequencing. Patients received induction with agenT-797 (alone or plus BOT/BAL) followed by the full combination regimen, or initiated the combination without induction, with longitudinal biomarker sampling throughout. In this study, the regimen delivered a 77% DCR with long-term survival beyond 20 months in a subset, and the induction arm showed meaningful gains in PFS (6.9 vs. 3.5 months; HR 0.19; p=0.015) and OS (9.5 vs. 5.2 months), with 43% of induction-treated patients alive at both 12 and 18 months-underscoring that durability and survival may be the most clinically relevant endpoints in this PD-1 refractory population.

Agenus announced that the first patient has been enrolled in the landmark global phase 3 BATTMAN trial. This study is evaluating Agenus' immunotherapy combination of botensilimab plus balstilimab versus best supportive care in patients with refractory, unresectable microsatellite stable/mismatch repair proficient metastatic colorectal cancer, a population long considered resistant to immunotherapy. "Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program," said Dr. Steven O'Day, Chief Medical Officer, Agenus. "This study advances our goal of developing effective immunotherapies for patients who currently have few options. We're grateful to our partners at CCTG, GI Cancer Trials in Australia, and PRODIGE and to the dedicated investigators, site staff, and patients driving this global effort."

Agenus announced that it has triggered the first $20M contingent payment under its previously disclosed strategic collaboration with Zydus Lifesciences. The payment was triggered by contracted work orders for critical chemistry, manufacturing and controls and production activities related to botensilimab and balstilimab. These activities will allow Zydus to perform the initiation of its commercial supply of Agenus' lead programs. They also include additional manufacturing work to satisfy regulatory requirements for BLA and MAA readiness, to build upon existing inventory in anticipation of increasing demand across clinical development programs, authorized early access pathways, and to support potential global commercialization. This milestone marks the first operational activities between Agenus and Zylidac Bio, the U.S.-based biologics manufacturing subsidiary of Zydus Life Sciences.