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Agenus Inc. (Nasdaq: AGEN) said data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, California. The study evaluates botensilimab (BOT) and balstilimab (BAL) in combination with agenT-797, MiNK’s allo-iNKT cell therapy, along with ramucirumab and paclitaxel in patients with advanced PD-1 refractory gastroesophageal adenocarcinoma.
The Phase II trial is described as the first to combine BOT and BAL with agenT-797 in patients with gastroesophageal cancer who progressed after frontline therapy. The study was designed to explore 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. Longitudinal biomarker sampling was conducted throughout the study.
In the Phase II study (n=17), the company reported a 77% disease control rate (DCR) across all treated patients, with long-term survival beyond 20 months observed in a subset.
Agenus said correlative analyses showed that treatment with BOT, BAL, and agenT-797 was associated with significant intratumoral T cell and dendritic cell infiltration. The company also reported formation of organized tertiary lymphoid structures in on-treatment biopsies from a patient with prolonged benefit, along with activation of peripheral CD4 and CD8 T cells.
The safety profile was described as consistent with the component agents. The most common treatment-emergent adverse events among all patients included fatigue, fever, diarrhea, anorexia, nausea and mucositis. Immune-related adverse events included dermatitis, colitis, gastritis, enteritis, hepatitis and hypothyroidism.
Dhan Chand, Ph.D., Vice President of Research at Agenus, said the findings illustrate mechanistic synergy of agenT-797 with botensilimab and balstilimab in the PD-1 refractory setting. He added that the induction approach promoted intratumoral infiltration of T cells and dendritic cells, formation of organized tertiary lymphoid structures in on-treatment biopsy tissue from a patient with durable benefit, and activation of peripheral CD4 and CD8 T-cell populations.
Agenus said additional analysis of the full biospecimen dataset is ongoing and is expected to provide further insight into immune mechanisms, optimal sequencing, and potential biomarkers that could help identify patients most likely to benefit.
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