MiNK Therapeutics Announces First Patient Dosed in Randomized Phase 2 Trial of agenT-797 in Acute Lung Injury and Critical Illness
Rhea-AI Summary
MiNK Therapeutics (NASDAQ: INKT) has dosed the first patient in its randomized Phase 2 trial of agenT-797 plus standard of care vs placebo in severe acute lung injury meeting Global ARDS criteria. The study, authorized in Ukraine and under an active U.S. IND, will assess ICU outcomes such as survival, ventilator-free days, ICU recovery, pathogen control, and immune function, with preliminary data expected in the second half of 2026.
AI-generated analysis. Not financial advice.
Positive
- First patient dosed in randomized Phase 2 trial of agenT-797 in acute lung injury
- Trial evaluates agenT-797 plus standard of care vs placebo plus standard of care
- Focus on clinically meaningful ICU outcomes including survival and ventilator-free days
- Off-the-shelf allogeneic iNKT cell therapy requiring no patient-specific manufacturing or HLA matching
- Authorization from Ukraine Ministry of Health and active U.S. IND with U.S. site expansion underway
- Preliminary Phase 2 data expected in the second half of 2026
Negative
- None.
News Market Reaction – INKT
On the day this news was published, INKT gained 19.84%, reflecting a significant positive market reaction. Argus tracked a peak move of +19.0% during that session. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $11M to the company's valuation, bringing the market cap to $64.32M at that time. Trading volume was exceptionally heavy at 7.1x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Pre‑news, INKT was down 2.49% while several cell therapy peers in biotechnology showed modest gains (e.g., ACET +2.15%, ALXO +2.60%, HOWL +4.26%), indicating stock‑specific factors rather than a broad sector move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 21 | Phase 2 melanoma data | Positive | -0.6% | Reported durable responses and survival data for BOT+BAL in refractory melanoma. |
| May 14 | ALI/ARDS trial start | Positive | -4.9% | Announced initiation of randomized Phase 2 agenT‑797 trial in severe acute lung injury. |
| Apr 17 | Phase II GEC data | Neutral | +0.6% | Shared Phase II data in PD‑1 refractory gastroesophageal cancer with mixed efficacy signals. |
| Jan 08 | Phase 1 GvHD trial | Positive | -1.7% | Announced Phase 1 allo‑iNKT trial of agenT‑797 to prevent graft‑versus‑host disease. |
Clinical-trial headlines for MiNK and its close peer have often been followed by modest negative price reactions, even when data or trial progress appeared constructive.
Over recent months, MiNK and its affiliate have repeatedly highlighted clinical progress across multiple iNKT‑based programs. A Phase 1 GvHD prevention trial and several Phase 2 datasets in melanoma and gastroesophageal cancer showed survival and disease‑control benefits, yet same‑tag news has averaged a -1.66% move. Earlier in May, MiNK announced initiation of this same randomized Phase 2 ALI/ARDS trial in Ukraine, with the stock trading down 4.89% afterward, underscoring a tendency for cautious market responses to trial updates.
Historical Comparison
Clinical‑trial headlines for MiNK and its close peer have averaged a -1.66% move, suggesting the market often reacts cautiously even to constructive data or trial initiations.
Across same‑tag events, agenT‑797 advanced from early safety and prevention trials into multiple Phase 2 studies for solid tumors and critical illness, while BOT+BAL delivered longer‑term survival signals in refractory melanoma.
Regulatory & Risk Context
An effective S‑3 shelf filed on 2025-11-07 allows MiNK to offer up to $150,000,000 of securities, including an ATM program for up to $50,000,000 of common stock. Based on a public float of $35,031,699, current ATM usage is capped at $6,641,284, with sales incurring a 3.0% fee to the agent. No usage has been recorded in the provided context.
Market Pulse Summary
The stock surged +19.8% in the session following this news. A strong positive reaction aligns with the company’s continued clinical progress, including dosing the first patient in a randomized Phase 2 ALI/ARDS trial. Historically, similar clinical‑trial headlines averaged a -1.66% move, so a large gain would mark a departure from past caution. Investors reviewing this context may also weigh MiNK’s $150M shelf and ATM capacity when assessing how future funding could interact with any sustained strength.
Key Terms
acute respiratory distress syndrome medical
ards medical
icu medical
allogeneic medical
inkt cell therapy medical
phase 2 medical
standard of care medical
AI-generated analysis. Not financial advice.
- First patient dosed marks rapid transition from trial activation to active treatment in patients with acute lung injury from all cause pneumonia meeting Global ARDS criteria
- Landmark advances a first-in-class immune therapy for critical illness where there are no approved mortality-reducing therapies
- Preliminary data expected in the second half of 2026
NEW YORK and LVIV, Ukraine, May 28, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic iNKT cell therapies for cancer and immune disorders, today announced that the first patient has been dosed in its randomized Phase 2 clinical trial evaluating agenT-797 with standard of care (SOC) vs placebo with SOC in patients with severe acute lung injury and critical illness.
The first patient was dosed at First Lviv Territorial Medical Union in Lviv, Ukraine, in collaboration with UNBROKEN Ukraine just days after approval from Ministry of health of Ukraine marking the rapid transition from trial activation to treatment administration in a real-world, high-acuity intensive care environment.
The randomized trial, designated C-1300-02, is evaluating agenT-797 plus standard of care compared with placebo plus standard of care in patients with acute lung injury meeting Global Acute Respiratory Distress Syndrome, or ARDS, criteria. The study is designed to evaluate clinically meaningful ICU outcomes, including survival, ventilator-free days, ICU recovery, and biologic measures associated with treatment activity and immune function.
“This milestone marks the advancement of a potentially new therapeutic paradigm for critical illness,” said Jennifer Buell, President and Chief Executive Officer of MiNK Therapeutics. “Patients with severe lung injury and respiratory failure continue to face extraordinarily high mortality despite modern intensive care. These conditions remain among the largest unresolved challenges in medicine, with no approved therapies demonstrated to reduce mortality. agenT-797 was designed for these moments, delivering an immediately available, donor-derived iNKT cell therapy that can be delivered without patient-specific manufacturing, lymphodepletion, or HLA matching. This milestone also demonstrates the practical feasibility of delivering an off-the-shelf cell therapy into a real-world critical care environment. With treatment now underway, we remain focused on efficient study execution and generating preliminary data by second half of 2026.”
Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care, with mortality exceeding 40
“Patients with severe acute lung injury often deteriorate because inflammatory injury, immune exhaustion, infection risk, and respiratory failure become interconnected,” said Terese Hammond, M.D., Head of R&D at MiNK Therapeutics. “The rapid activation of this trial allows us to evaluate agenT-797 in a real-world, critically ill population where immune restoration may be most meaningful. The study is designed to assess clinically important ICU outcomes, including survival, ventilator-free days, ICU recovery, pathogen control, and secondary infections.”
First Lviv Territorial Medical Union serves a high-acuity critical care population, including patients with severe pneumonia, trauma-associated lung injury, infectious complications, and respiratory failure. Clinical care standards are aligned with modern Western intensive care practices, supporting generation of data intended to inform future regulatory pathways in the United States and Europe.
“Physicians in Ukraine are confronting some of the most severe forms of respiratory failure, trauma, infection, and immune dysfunction seen anywhere in the world,” said Dr. Khrystyna Orlynska, MD, Head of the Department of Anesthesiology and Intensive Care and Principal Investigator. “The initiation of this study provides critically ill patients access to a novel investigational immunotherapy approach and marks the first clinical evaluation of iNKT cell therapy in Ukraine.”
“This study reflects the reality of modern critical care medicine, where severe respiratory failure, infection, trauma, and immune dysfunction frequently converge,” said Demian Kalysh, MD, Anesthesiology, Pulmonary Critical Care and Sub-Investigator. “For physicians caring for patients under these conditions, the ability to evaluate a rapidly deployable off-the-shelf immune restorative therapy in the ICU is both scientifically important and highly meaningful for patients with otherwise limited treatment options.”
The trial has received authorization from the Ukraine Ministry of Health and is supported by an active U.S. IND with US site expansion underway. Preliminary data are expected in the second half of 2026.
About C-1300-02 Trial
The C-1300-02 trial is a randomized Phase 2 study evaluating agenT-797 plus standard of care compared with placebo plus standard of care in adults with acute lung injury and critical illness, including moderate to severe acute hypoxemic respiratory failure, who meet Global ARDS criteria. The study is being initiated at First Lviv Territorial Medical Union in Lviv, Ukraine along with U.S. sites. The trial has received authorization from the Ukraine Ministry of Health, is supported by an active U.S. IND. Preliminary data are expected in the second half of 2026.
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf allogeneic iNKT cell therapies for life-threatening conditions driven by immune dysfunction. The company's lead program, agenT-797, is being evaluated in acute lung injury and critical illness, with a pipeline that extends across immuno-oncology, transplant medicine, and other settings where dysregulated immunity is a driver of morbidity and mortality. MiNK believes that iNKT cell biology, because of its regulatory role across innate and adaptive immunity, may represent a foundational approach to immune restoration applicable across a broad range of conditions. For more information, visit www.minktherapeutics.com.
About First Lviv Territorial Medical Union and UNBROKEN
First Lviv Territorial Medical Union is one of Ukraine’s largest and most advanced integrated healthcare systems, serving as a regional referral center for western Ukraine. The institution provides comprehensive care across trauma, critical illness, infectious disease, and complex surgery, with specialized capabilities in intensive care and post-acute recovery. Since the onset of the full-scale war, it has been at the forefront of treating both civilians and service members with severe injuries and infection-related complications, operating at a scale and acuity comparable to major Western medical care. For more information, visit First Lviv Territorial Medical Union.
UNBROKEN Ukraine is a nationally recognized medical and rehabilitation ecosystem based in Lviv, dedicated to the treatment and recovery of individuals affected by war. The program integrates acute care, reconstructive surgery, prosthetics, physical and psychological rehabilitation, housing, and long-term reintegration services. Since the start of the full-scale invasion, UNBROKEN has treated more than 24,000 wounded Ukrainians, including children, and has become a leading model for coordinated, multidisciplinary recovery in conflict settings. For more information, visit UNBROKEN Ukraine.
Contacts
Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com
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References
i Bellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality for Patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8):788–800.
