AgenT-797 / MiNK Therapeutics - LARVOL DELTA

AgenT-797, an Allogeneic iNKT Cell Therapy, Demonstrates Durable Clinical Activity in Solid Tumors: Updated Phase 1 Findings (SITC 2025) - P1 | "This data supports the potential of agenT-797 in solid tumors. MiNK Therapeutics are currently evaluating agenT-797 in a Phase 2 trial in patients with gastric cancer.Acknowledgements We are deeply grateful to the patients and their families for their participation in this clinical trial.Trial Registration NCT05108623Ethics Approval Institutional Review Board (IRB) approval was obtained at each participating site, and all patients provided written informed consent prior to enrollment."

Clinical • Late-breaking abstract • P1 data • Appendix Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Testicular Cancer • TIGIT

Peripheral and tissue persistence of agenT-797, an allogeneic iNKT cell-based cell therapy for the treatment of cancer (SITC 2023) - P1 | "Such persistence and clinical activity were observed in the absence of traditional lymphodepletion regimens employed in nearly all other forms of immune cell therapy. The observed persistence of agenT-797 in the absence of lymphodepletion, therefore, uniquely allows it to unfold its maximal potential though directing integral endogenous immune responses, which otherwise would be severely compromised by lymphodepleting agents."

Oncology • Solid Tumor

A phase II study of agenT-797 (invariant natural killer T-cells), botensilimab (Fc-enhanced CTLA-4 inhibitor) and balstilimab (anti-PD-1) in patients with advanced, refractory gastroesophageal adenocarcinoma. (ASCO-GI 2025) - "Given their complementary mechanisms of action in modulating anti-tumor immunity, we aimed to evaluate the safety and efficacy of combining BOT, BAL, and agenT-797 with standard ramucirumab (anti-vascular endothelial growth factor receptor-2 antibody) and paclitaxel chemotherapy in patients with advanced EG cancer who have progressed on frontline therapy. To date, 12 patients have been enrolled and started on treatment. This trial is registered with ClinicalTrials.gov, NCT06251793."

Clinical • Metastases • P2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • KDR

Allogeneic iNKT Cell Therapy (agenT-797) After SCT (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: University of Wisconsin, Madison

New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases (clinicaltrials.gov) - P2 | N=17 | Recruiting | Sponsor: Darren Sigal, MD | Not yet recruiting ➔ Recruiting

Enrollment open • pMMR • Colorectal Cancer • Oncology • Solid Tumor

A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: MiNK Therapeutics

New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Respiratory Diseases

AgenT-797 Allogeneic iNKT Cell Therapy Demonstrates Adaptive Immune Modulation in Cancer and ARDS (ASGCT 2026) - P1, P2 | "This context-dependent activity, combined with meaningful clinical responses in both settings, validates iNKT cell therapy as a versatile platform with broad therapeutic potential. These findings support ongoing development of agenT-797 across oncology, infectious diseases, and GvHD, where immune dysregulation drives pathology."

Acute Respiratory Distress Syndrome • Graft versus Host Disease • Immune Modulation • Immunology • Infectious Disease • Oncology • Respiratory Diseases • Solid Tumor • IFNG • IL4

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Active, not recruiting | N=37 ➔ 20

Enrollment change • Enrollment closed • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Randomized Phase 2 trial initiated for agenT-797 in severe acute lung injury and respiratory distress, with preliminary data expected in the second half of 2026 (The Manila Times) - "The trial has received authorization from the Ukraine Ministry of Health, is supported by an active U.S. IND, and remains subject to FDA clearance for planned U.S. site activation."

Approval • P2 data • Acute Lung Injury

Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS) (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: ImmunityBio, Inc. | N=20 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock

Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: ImmunityBio, Inc. | N=10 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock

A phase II study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in PD-1 refractory gastroesophageal cancer (GEC) (AACR 2026) - "Second line treatment with ramucirumab (RAM) and paclitaxel (PAC) has poor outcomes with an objective response rate (ORR) of 28% and median progression free survival (PFS) of 4.4 months (mo). This was an investigator initiated trial (NCT06251793) of patients with GEC who received one prior line of therapy evaluating BOT (Fc-enhanced anti-CTLA-4), BAL (anti-PD-1), and agenT-797 (allogeneic invariant natural killer T [iNKT] cells) with RAM/PAC. This is the first study to evaluate agenT-797/BOT/BAL in GEC. Although robust systemic and intratumoral immune activation was observed, ORR and median PFS/OS were not improved compared to historical controls. Long term survival in a subset of patients and superior PFS in the induction cohort suggest patient selection and therapeutic sequencing are key determinants of benefit."

P2 data • Gastroesophageal Cancer • Oncology • Solid Tumor • CD8 • IFNG • PD-1

BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases (clinicaltrials.gov) - P2 | N=17 | Not yet recruiting | Sponsor: Darren Sigal, MD

New P2 trial • pMMR • Colorectal Cancer • Oncology • Solid Tumor

MiNK Therapeutics Reports Phase II Data on Immune Reprogramming and Durable Survival in PD-1 Refractory Gastroesophageal Cancer (Yahoo Finance) - "DCR was observed in 77% of all treated patients, and long-term survival beyond 20 months was seen in a subset of patients; Patients treated with an induction cycle had longer progression-free survival (PFS) than those treated without induction, with median PFS of 6.9 months versus 3.5 months (HR 0.19; p=0.015), supporting the potential importance of immune priming and treatment sequencing; Median overall survival (OS) was 9.5 months in the induction cohort versus 5.2 months without induction, with 43% of induction-treated patients alive at both 12 and 18 months, compared with 20% and 0%, respectively, in the non-induction cohort; The study did not meet its primary endpoint of ORR...Additional analysis of the full biospecimen dataset is ongoing and is expected to provide further insight into immune mechanisms..."

P2 data • Gastroesophageal Cancer

Agenus…announced that data from an investigator-initiated Phase II trial conducted at Memorial Sloan Kettering Cancer Center will be presented at the American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "The study evaluates botensilimab (BOT) and balstilimab (BAL) in combination with agenT-797, an allogeneic iNKT cell therapy developed by MiNK Therapeutics, in patients with PD-1 refractory gastroesophageal cancer (GEC)..."

P2 data • Gastroesophageal Cancer

MiNK Therapeutics, Inc…announced that an abstract featuring its investigational iNKT cell therapy, agenT-797, has been accepted for presentation at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, taking place May 11-15, 2026, in Boston, MA. (MiNK Press Release)

Preclinical • Oncology

Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock

MiNK-215, an IL-15 armored FAP-targeting CAR iNKT cell therapy, effectively treats human organoid models of treatment-refractory MSS colorectal cancer (CRC) liver metastases (AACR 2024) - "Here we describe MiNK-215, an IL-15 armored FAP-targeting CAR iNKT cell therapy, derived from the AgenT-797 allogeneic iNKT platform, as a potential novel therapeutic approach for patients with CRC liver metastases.To better model ICB refractory human MSS CRC liver metastases, we developed an ex vivo human organoid model that recapitulates the histological and immunological features of human disease...Models were treated with Fc-enhanced anti-CTLA-4 (botensilimab) and anti-PD-1 (balstilimab) antibodies, or MiNK-215 to assess tumor killing and immune activation.Botensilimab and balstilimab enhanced T cell activation and cytotoxicity of CRC tumor cells in the absence of "normal" liver cells and in lung organoids...Tumor killing in CRC liver organoid models by MiNK-215 was associated with depletion of immune suppressive FAP-expressing stellate cells and increased CD8+ T cell infiltration.Our findings demonstrate that in treatment-refractory CRC-liver metastatic..."

Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • CTAG1B • FAP • IL15

Novel Interleukin-15 Superagonist (n-803) and Invariant Natural Killer T Cell (agent-797) Combination Immunotherapy for Unresolving Coccidioides Immitis Infection (ATS 2026) - No abstract available

Infectious Disease • IL15

MiNK Therapeutics and University of Wisconsin–Madison Announce Phase 1 Clinical Trial of Allo-iNKT Cell Therapy (AgenT-797) to Evaluate Prevention of Graft-Versus-Host Disease (GlobeNewswire) - "The trial...will evaluate the safety, tolerability, and preliminary efficacy of agenT-797 in reducing graft-versus-host disease (GvHD), relapse, and other post-transplant complications in patients with high-risk leukemias and other blood cancers."

New P1 trial • Graft versus Host Disease

A Clinical Trial to Evaluate the Safety of agenT-797 in COVID-19 Participants With ARDS (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: MiNK Therapeutics | Phase classification: P1/2 ➔ P1

Phase classification • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

MiNK Therapeutics Reports Durable Responses and Immune Reactivation with Allo-iNKT Cell Therapy agenT-797 in PD-1–Refractory Solid Tumors at SITC 2025 (MiNK Press Release) - "agenT-797, alone or in combination with anti-PD-1, demonstrated durable responses and disease stabilization in multiple checkpoint-refractory solid tumors, including germ cell testicular (OS>33+mos), thymoma (OS>39+), 2L gastric (OS>27mos), cholangiocarcinoma (>21mos), renal and adenoid cystic cancers (OS>30+), highlighting its potential to overcome resistance and extend benefit across tumor types. Complete and sustained remission beyond two years in metastatic germ-cell/testicular cancer, with full resolution of hepatic lesions and normalization of tumor markers."

P1 data • Adenoid Cystic Carcinoma • Cholangiocarcinoma • Gastric Cancer • Renal Cell Carcinoma • Testicular Cancer • Thymoma

MiNK Therapeutics to Present Late-Breaking Data on AgenT-797 in Solid Tumors at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting (GlobeNewswire) - "The presentation...will highlight updated safety and efficacy results from the company’s ongoing Phase 1 study of AgenT-797 in patients with advanced solid tumors."

Late-breaking abstract • P1 data • Solid Tumor

Highlights from Q2 2025 - Durable Complete Remission in Metastatic Testicular Cancer: (MiNK Press Release) - "Nature’s Oncogene publication of a landmark case of a patient with treatment-refractory metastatic testicular cancer who achieved a durable complete remission following a single infusion of agenT-797 (allo-INKTs) in combination with checkpoint blockade. The patient remains disease-free more than two years post-treatment."

Case report • Testicular Cancer

Progress in Phase 2 Gastric Cancer Study: (MiNK Press Release) - "Phase 2 trial of agenT-797 in second-line gastric cancer anticipated additional clinical readouts in 2025."

P2 data • Gastric Cancer