MiNK Therapeutics presented late‑breaking data for its lead iNKT‑cell therapy, agenT‑797, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 8 2025. The presentation highlighted durable clinical, radiologic, and biochemical remissions in patients whose solid tumors had progressed after checkpoint‑inhibitor therapy and multiple prior lines of treatment.
The data set included 18 evaluable patients with PD‑1–refractory disease, of whom 11 achieved objective responses and 7 of those responses were durable for 12 months or longer. A single metastatic germ‑cell cancer patient achieved a complete remission that has persisted for more than two years after a single infusion of agenT‑797 combined with anti‑PD‑1. Median overall survival for the cohort was 23 months, and no dose‑limiting toxicities, grade ≥ 3 cytokine‑release syndrome, or neurotoxicity were observed. Common adverse events were fatigue and grade 3 anemia, consistent with the safety profile reported in earlier phase studies.
Mechanistically, the therapy activates dendritic cells, reprograms suppressive macrophages, and re‑engages exhausted T cells within the tumor microenvironment. The iNKT cells deliver direct cytotoxicity while also acting as a bridge between innate and adaptive immunity, a feature that distinguishes agenT‑797 from conventional checkpoint inhibitors. The observed immune reactivation provides a plausible explanation for the sustained responses seen in heavily pre‑treated patients.
From a business perspective, the results support MiNK’s plan to advance agenT‑797 into phase 2 trials. The durable responses and favorable safety profile reduce the risk profile of the pipeline and strengthen the company’s positioning as a pioneer in immune‑restorative therapy. The data also enhance investor confidence and could broaden partnership opportunities with larger pharmaceutical companies seeking to expand their oncology portfolios.
Market reaction to the announcement has been positive, with analysts noting the significance of a two‑year complete remission in a germ‑cell cancer patient and the potential for a new therapeutic class to address the unmet need of PD‑1–refractory solid tumors. The findings are expected to accelerate regulatory discussions and may increase the likelihood of future licensing or collaboration agreements.
In summary, MiNK’s presentation at SITC 2025 demonstrates that agenT‑797 can achieve durable, long‑lasting responses in a difficult-to‑treat patient population while maintaining a clean safety profile. The data provide a strong foundation for the company’s phase 2 plans and reinforce the commercial potential of its iNKT platform.
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