MiNK Therapeutics Opens 90-Patient Phase II ARDS Trial with H2 2026 Readouts
MiNK Therapeutics launched a randomized Phase II ARDS trial enrolling 90 patients 1:1 with endpoints of overall survival, ventilator-free days and ICU days, and expects early readouts in the second half of 2026. It has an INKT cell manufacturing process and is combining its therapy with Immunity Bio’s IL-15 superagonist Antiva targeting fungal pneumonia.
1. Phase II ARDS Trial Design
MiNK Therapeutics has initiated a randomized Phase II trial of Agent 797 in severe acute lung injury and respiratory distress enrolling 90 patients randomized one-to-one. The trial will measure overall survival, ventilator-free days and ICU days, with early data presentations planned for the second half of 2026.
2. Immunity Bio Collaboration
The company is partnering with Immunity Bio to combine its INKT cell therapy with the IL-15 superagonist Antiva in fungal pneumonia cohorts. This collaboration aims to enhance immune modulation in complex pulmonary infections and additional data will be shared at an upcoming ATS conference.
3. Scalable Manufacturing
MiNK has developed a robust INKT cell manufacturing platform capable of scaling donor-derived cells to billions per batch. The process supports consistent product delivery across indications and geographic regions, demonstrated by successful distribution even under wartime conditions in Ukraine.
4. ARDS Market Potential
Acute respiratory distress syndrome affects over 200,000 patients annually in the U.S. and more than 3 million globally, representing a significant commercial opportunity. MiNK plans to outline its distribution and commercialization strategy alongside trial efficacy and safety data later this year.