AgenT-797 / Agenus - 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

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

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

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

MiNK Therapeutics Announces Publication of Complete Remission Following Allogeneic iNKT Cell Therapy in Metastatic Testicular Cancer (The Manila Times) - P1 | N=34 | NCT05108623 | Sponsor: MiNK Therapeutics | "MiNK Therapeutics, Inc...announced the publication of another landmark case in Nature’s Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment with agenT-797, MiNK’s allogeneic iNKT cell therapy....The patient achieved a complete clinical, radiologic, and biochemical remission, with no evidence of disease over two years later. Donor iNKT cells were detectable up to six months post-infusion, and treatment was well-tolerated with no cytokine release syndrome (CRS) or graft-versus-host disease (GVHD)."

P1 data • Testicular Cancer

MiNK Therapeutics Awarded Prestigious NIAID Grant to Advance Allo-iNKT Cell Therapy for Prevention of GvHD in Stem Cell Transplant Patients (GlobeNewswire) - "MiNK Therapeutics, Inc...today announced it has been awarded a grant from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). The grant will support development of MiNK’s allo-iNKT cell therapy platform for the prevention and treatment of graft-versus-host disease (GvHD) following hematopoietic stem cell transplantation (HSCT), in collaboration with the University of Wisconsin."

Commercial • Graft versus Host Disease

Agenus’ BOT/BAL Selected for Two Presentations at Upcoming AACR IO Annual Meeting (Businesswire) - "Agenus...announced that BOT/BAL will be featured in two presentations at the upcoming American Association for Cancer Research (AACR) IO Annual Meeting that will take place on February 23-26 in Los Angeles, California. An oral presentation will highlight interim data from the ongoing Phase 2 study of botensilimab and balstilimab (BOT/BAL) in combination with MiNK Therapeutics’ iNKT cell therapy, AgenT-797, in patients with refractory (2L+) gastric cancer (NCT06251973). A Trial-in-Progress (TiP) poster will feature data from the ongoing Phase 1/2 study of BOT/BAL in first-line MSS colorectal cancer (NCT06268015)."

P2 data • Trial status • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer

MiNK Therapeutics Presents First-in-Kind Allo-iNKTs Combination Data in 2L Gastric Cancer at AACR IO Annual Meeting (GlobeNewswire) - P2 | N=37 | NCT06251973 | "The study evaluates agenT-797 in combination with botensilimab and balstilimab (BOT/BAL), in patients with refractory (2L+) gastroesophageal cancer (NCT06251973)....Highlights...Early induction with MiNK’s allogeneic iNKT product, agenT-797, drove broad immune activation—a hallmark of potential durable responses. Investigators report significant increase in interferon-gamma (IFNγ) levels, along with enhanced tumor infiltration by T cells and antigen-presenting cells (APCs), signaling robust systemic immune engagement. These biomarkers typically correlate with improved clinical outcomes and a sustained anti-tumor immune response, reinforcing the potential of this combination in solid cancers....The most pronounced immune expansion and strong peripheral memory T-cell activation were seen when agenT-797 was given concurrently with checkpoint inhibitors and before standard chemotherapy."

P2 data • Gastroesophageal Cancer

MiNK Therapeutics to Present Updated Data from Phase 2 Study Testing AgenT-797 in Gastric Cancer at AACR IO Annual Meeting (GlobeNewswire) - "MiNK Therapeutics...announced that it has been selected for an oral presentation at the upcoming American Association for Cancer Research (AACR) IO Annual Meeting that will take place on February 23-26 in Los Angeles, California. The oral presentation will highlight interim data from the company’s ongoing Phase 2 study testing AgenT-797 in combination with Agenus’ lead therapeutic combination, botensilimab and balstilimab (BOT/BAL), in patients with refractory (2L+) gastric cancer (NCT06251973)."

P2 data • Gastric Cancer • Gastroesophageal Cancer

Gastric Cancer (Businesswire) - "Agenus...shared new data on botensilimab (BOT) and balstilimab (BAL) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI)....Phase 2 BOT/BAL/AgenT-797 in Combination with Ramucirumab and Paclitaxel in Patients with Previously Treated, Unresectable or Metastatic Gastroesophageal Cancers (Abstract TPS515): The Phase 2 trial (NCT06251973) is investigating a novel combination approach, which leverages cellular therapy and immune modulation to address the unmet needs in gastroesophageal cancers....The novel approach demonstrated early signals of activity and tolerability in the second-line treatment setting, with additional efficacy data anticipated in 2H 2025."

P2 data • Trial status • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

MiNK Therapeutics to Present iNKT Cell Therapy in Gastric Cancer at ASCO GI Annual Meeting (GlobeNewswire) - "MiNK Therapeutics, Inc...today announced a presentation at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium that will take place on January 23-25, 2025, in San Francisco, California. The poster presentation will highlight the ongoing Phase 2 study of agenT-797 in combination with Agenus’ botensilimab/balstilimab in patients with refractory gastric cancer."

P2 data • Gastric Cancer

MiNK Therapeutics Reports Third Quarter 2024 Results and Business Update (GlobeNewswire) - "Graft-versus-Host Disease (GvHD) Program: MiNK is advancing initiation of Phase 1 trial with external financial support to investigate agenT-797 for the treatment of GvHD, in collaboration with leading research institutions in the U.S. and EU for dosing to start in 2025."

New P1 trial • Graft versus Host Disease

AgenT-797 cell therapy can be combined with next-generation immune checkpoint inhibitors (ICI) and/or bi-specific engagers to improve anti-cancer response (SITC 2024) - "Conclusions While combining cell therapy with antibody-based regimens has shown promise, particularly for immune-refractory tumors, adoptive cell therapy still faces several challenges. AgenT-797, with its intrinsic immunomodulatory and tumor-targeting capabilities, robust manufacturing process, and favorable safety profile, provides a strong platform to enhance the efficacy of clinical-stage treatments, making them beneficial to a significantly larger number of patients."

Checkpoint inhibition • Oncology

Ongoing Clinical Studies: AgenT-797 is advancing in an enrolling Phase 2 trial (GlobeNewswire) - "Ongoing Clinical Studies: AgenT-797 is advancing in an enrolling Phase 2 trial with an innovative five-treatment combination regimen that includes botensilimab, balstilimab, and standard-of-care chemotherapy. This trial targets 2L+ advanced gastroesophageal cancer patients and is being conducted at Memorial Sloan-Kettering Cancer Center, with results expected in 2025."

P2 data • Trial status • Gastroesophageal Cancer

AgenT-797 Combination Boosts Activity of Checkpoint Inhibitors and Bispecific Engagers in Challenging Solid Tumors (GlobeNewswire) - "AgenT-797 alone or in combination with anti-PD-1 (nivo or pembro) shows durable disease control in majority of heavily pretreated patients. AgenT-797 combined with bispecific engagers targeting antigens such as MUC16, HER2, Claudin 18.2, and DLL3, promote increased T-cell activation, efficient tumor cell killing, and reduced exhaustion and myeloid cell activity."

Preclinical • Oncology • Solid Tumor

MiNK Therapeutics and Autonomous Therapeutics Announce Collaboration to Develop Novel Therapies Targeting Metastatic Tumors (GlobeNewswire) - "This collaboration will leverage Autonomous’ precision encrypted RNA (encRNA) technology and MiNK’s innovative iNKT cell therapies, MiNK-215 and agenT-797....The goal is to develop novel therapies that effectively target metastatic cancer cells in patients while avoiding healthy cells—a challenge that existing cancer medicines have not been able to overcome. Based on the results, the companies plan to launch a Phase 1 clinical trial in patients with treatment-refractory metastatic solid tumors, including microsatellite stable (MSS) colorectal cancers."

Licensing / partnership • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

MiNK Therapeutics to Present Data From iNKT Cell Programs at SITC 2024 (GlobeNewswire) - "MiNK Therapeutics, Inc...announced two poster presentations at the Society for Immunotherapy of Cancer’s (SITC) 29th Annual Meeting on November 6-10, 2024, in Houston, Texas. The presentations will showcase new preclinical data from MiNK’s iNKT cell programs, agenT-797 and PRAME-TCR."

Preclinical • Oncology • Solid Tumor

MiNK Reports Second Quarter 2024 Results and Business Update (GlobeNewswire) - "MiNK is preparing to initiate a Phase 1 study of agenT-797 in Graft-versus-Host Disease (GvHD), with activation planned for 2Q 2024."

New P1 trial • Graft versus Host Disease

MiNK Reports Second Quarter 2024 Results and Business Update (GlobeNewswire) - "A Phase 2 Investigator-Sponsored Study of agenT-797 is progressing rapidly at Memorial Sloan Kettering Cancer Center (NCT06251973). The study’s swift advancement and early signals of activity highlight the promising potential of agenT-797 in treating challenging cancers, with initial data at an upcoming conference....MiNK-215 is an investigational IL-15 armored fibroblast activation protein (FAP) targeting CAR-iNKT cell therapy, that has demonstrated robust preclinical activity in solid tumor cancers, including MSS colorectal cancer liver metastases, and non-small-cell-lung cancer. Plans are in place to fast-track the IND filing to early 2025."

IND • P2 data • Colorectal Cancer • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: MiNK Therapeutics | Recruiting ➔ Completed

Checkpoint inhibition • Combination therapy • Trial completion • Oncology • Solid Tumor