AgenT-797

iNKT therapy, agenT-797, delivers context-dependent immune reprogramming showing activation in cancer and anti-inflammatory benefit in ARDS — from the same manufacturing donor batch, without genetic engineering Findings underscore the intrinsic biology of iNKT cells and the manufacturing scale for a broadly deployable cell therapy capable of expansion in multiple disease indications without disease-specific engineering Clinical activity in both settings: tumor responses including complete metastatic remission in oncology; improved survival and pathogen clearance in severe ARDS Data support advancement into a randomized Phase 2 trial in acute lung injury (C-1300-02); preliminary data expected in 2026 NEW YORK, May 12, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics , Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune disorders, today announced data being presented at the American Society of Gene and Cell Therapy Annual Meeting (ASGCT 2026) in Boston, Massachusetts. The data demonstrate that agenT-797, MiNK’s off-the-shelf, allogeneic iNKT cell therapy produces fundamentally different, disease-appropriate immune responses in patients with solid tumors and patients with acute respiratory distress syndrome (ARDS), driven by the intrinsic biology of iNKT cells rather than genetic modification. The data, to be presented in Poster 3371 on May 14, 2026, by Dr. Yan demonstrates that the same agenT-797 product, manufactured from the same donor batch and administered without modification, drove a TH1 pro-inflammatory immune program in 34 patients with solid tumors and a TH2 anti-inflammatory immune response in 20 patients with ARDS. The findings were consistent across multiple manufacturing batches and donors, establishing platform reproducibility at scale. "The same off-the-shelf cell — from the same donor, same manufacturing batch — drives inflammation in a tumor and restores immune homeostasis in a failing lung. Without modification. Without engineering. That is intrinsic iNKT biology, and it is the foundation of a scalable platform we believe is applicable across oncology, critical illness, and beyond. To our knowledge, no prior cellular therapy platform has demonstrated this type of disease-directed immune response across two fundamentally different diseases from a single manufacturing run," said, J ennifer Buell, Ph.D., President and Chief Executive Officer, MiNK Therapeutics. These findings further support the scalability and consistency of MiNK’s proprietary manufacturing platform, which is designed to isolate donor-derived iNKT cells and reproducibly expand them to billions of cells per donor while preserving intrinsic biological activity across disease settings. agenT-797 is cryopreserved, HLA-independent, and requires no lymphodepletion, supporting potential use across acute critical care, oncology, and post-transplant immune dysfunction. ASGCT Poster 3371: Context-Dependent Immune Reprogramming in Cancer and ARDS Clinical evidence of effector function : agenT-797 was associated with tumor clearance and durable response in patients with cancer, including complete resolution of metastatic disease in germ cell testicular cancer treated with agenT-797 plus anti-PD-1 (Garmezy et al., Oncogene, 2025). In ARDS, agenT-797 was associated with improved survival and radiographic resolution of ARDS relative to in-hospital controls, including clearance of carbapenem-resistant Pseudomonas pneumonia in a 21-year-old patient on veno-venous ECMO. In 34 solid tumor patients (NCT05108623), agenT-797 infusion produced rapid IFN-gamma elevation — a TH1 pro-inflammatory signature consistent with anti-tumor immune activation. In 20 ARDS patients (NCT04582201), the same product from the same manufacturing donor batch produced IL-4 and IL-13 elevation — a TH2 anti-inflammatory signature consistent with immune restoration and lung injury recovery. Favorable safety profile : Immune activation across both oncology and ARDS settings occurred without evidence of uncontrolled cytokine release syndrome or pathologic hyperinflammation, supporting a favorable therapeutic index appropriate for the ICU setting. "What makes these findings compelling is that we are observing the same unmodified iNKT cell product generate fundamentally different immune responses across distinct disease states in a biologically coherent and clinically relevant manner,” said Terese C. Hammond, MD, Head of Inflammatory and Pulmonary Diseases, MiNK Therapeutics . “These findings support the idea that iNKT cells function as coordinated immune effectors capable of dynamically modulating inflammatory and restorative pathways based on the disease environment. In critical illness, effective therapy may require coordinated immune activation, restoration, and pathogen-directed response occurring simultaneously. The Phase 1/2 clinical data suggested this biology was possible; the ASGCT findings now provide mechanistic evidence supporting how agenT-797 may achieve those effects.” About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse. Its lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for agenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law. Contacts Investor Contact: 917-362-1370 | investor@minktherapeutics.com Media Contact: 781-674-4428 | communications@minktherapeutics.com