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MiNK Therapeutics and First Lviv Territorial Medical Union Initiate Randomized Phase 2 Trial of agenT-797 in Acute Lung Injury and Critical Illness
Randomized Phase 2 trial evaluates off-the-shelf invariant natural killer T (iNKT) cell therapy in patients with acute lung injury and hypoxemic respiratory
About this update from Mink Therapeutics, Inc.
[{"type":"text","content":"Randomized Phase 2 trial evaluates off-the-shelf invariant natural killer T (iNKT) cell therapy in patients with acute lung injury and hypoxemic respiratory failure Study initiates in Lviv, Ukraine, in partnership with First Lviv Medical and UNBROKEN Ukraine, expands development into a high-acuity critical care setting with U.S. sites in parallel Trial is designed to evaluate clinically meaningful ICU endpoints including survival, ventilator-free days, and secondary infections, with preliminary data expected in the second half of 2026 Preliminary data expected in the second half of 2026 NEW YORK and LVIV, Ukraine, May 14, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic iNKT cell therapies for cancer and immune disorders, and First Lviv Territorial Medical Union today announced the initiation of a randomized Phase 2 clinical trial evaluating agenT-797, MiNK’s off-the-shelf allogeneic invariant natural killer T cell therapy (iNKTs), in patients with severe acute lung injury (ALI). The study has received authorization from the Ministry of Health of Ukraine and is supported by an active U.S. IND. The trial, designated C-1300-02, is a randomized, placebo-controlled study evaluating agenT-797 plus standard of care compared with placebo plus standard of care in patients with ALI meeting Global ARDS criteria. The study is designed to evaluate whether treatment with donor-derived iNKT cells may improve clinically meaningful outcomes in critically ill patients, including survival, ventilator-free days, ICU recovery, pathogen control, and reduction of secondary infections. Inflammatory Lung Disease ALI and ARDS remain among the most serious unresolved conditions in critical care. ARDS affects an estimated 3 million people globally and approximately 200,000 people annually in the United States, accounting for nearly one-quarter of mechanically ventilated ICU patientsi. Mortality remains high, particularly in severe diseaseii, and there are currently no approved therapies shown to reduce mortality. Prior therapeutic approaches in ARDS have struggled in part because they targeted isolated inflammatory pathways rather than the broader immune dysfunction that emerges during critical illness, including impaired pathogen control, secondary infection susceptibility, myeloid...