MiNK Therapeutics reports Day 28 survival data from agenT-797 Phase 2
MiNK Therapeutics has shared initial observations from its ongoing Phase 2 trial of agenT-797 in patients with severe hypoxemic pneumonia, reporting that the first treated patients were alive at the primary 28-day endpoint with markedly improved respiratory function and infection control. The data were presented on 6 August at the 2026 Military Health System Research Symposium (MHSRS) in Kissimmee, Florida.
The trial, designated C-1300-02, is a randomised study comparing agenT-797 plus standard of care against placebo plus standard of care in adults meeting Global ARDS criteria. Enrolment is ongoing at the First Lviv Territorial Medical Union in Ukraine, with US sites now opening. Additional data from the programme are expected in early 2027.
What the early data show
According to the presentation, patients treated with agenT-797 were afebrile at Day 28 and had been removed from both mechanical ventilation and vasopressor support. Microbiological analyses indicated that baseline infections were brought under control. Serum and bronchoalveolar lavage samples showed reduced inflammatory markers alongside signals of immune recovery, epithelial repair and pulmonary vascular recovery. The company reported no major serious adverse events attributed to agenT-797 in the initial cohort.
Dr Terese Hammond, Head of Inflammatory Diseases at MiNK and the study's presenting author, said the biological changes observed were "promising and appear consistent with" data the company presented earlier this year at the American Society of Gene and Cell Therapy and the American Thoracic Society meetings.
MiNK chief executive Jennifer Buell highlighted the speed of deployment as a key differentiator: the company dosed its first patient within days of receiving regulatory clearance. Unlike autologous cell therapies requiring patient-specific manufacturing, agenT-797 is an off-the-shelf allogeneic invariant natural killer T-cell (iNKT) product that ships directly from inventory, requiring no apheresis, HLA matching or lymphodepletion. That operational profile is particularly relevant in conflict zones and resource-limited settings where conventional manufacturing timelines would be prohibitive.
Market context and competitive landscape
Severe ARDS carries high mortality and, as MiNK notes, currently has no approved therapy with a proven survival benefit, making it a genuinely unmet medical need with a large addressable patient population. The field has attracted interest from several directions. Regulatory agencies in the US and EU have issued guidance encouraging novel endpoints for acute lung injury studies, which has improved the pathway attractiveness for sponsors.
MiNK's iNKT cell approach sits within the broader allogeneic cell therapy space, which has been growing as a counterpoint to autologous CAR-T, precisely because the inventory-ready model reduces cost and lead time. Several biotechs are pursuing off-the-shelf NK and NKT cell platforms, though agenT-797's focus on barrier immunity and pathogen-agnostic inflammation control rather than direct tumour killing is a distinct positioning relative to most oncology-oriented programmes. The MHSRS setting is also notable: military health funding and government interest in resilient, field-deployable therapeutics could become a supplementary route to non-dilutive capital for MiNK as the programme advances.
These observations are exploratory and involve a small initial cohort; the company has not disclosed patient numbers, effect sizes or confidence intervals. Investors and clinicians will look for larger randomised readouts, full safety data and a named US enrolment figure before drawing firm conclusions about agenT-797's efficacy profile.