AgenT-797 / Agenus - LARVOL DELTA

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

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

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

A phase 1/2 clinical trial of invariant natural killer T cell therapy in moderate-severe acute respiratory distress syndrome. (PubMed, Nat Commun) - P1/2 | "Originally developed for use in cancer, agenT-797 is a donor-unrestricted allogeneic ex vivo expanded iNKT cell therapy...Cellular therapy using off-the-shelf iNKT cells is safe, can be rapidly scaled and is associated with an anti-inflammatory response. The safety and therapeutic potential of iNKT cells across diseases including infections and cancer, warrants randomized-controlled trials."

Journal • P1/2 data • P2 data • Acute Respiratory Distress Syndrome • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases

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

Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2 (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: MiNK Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Apr 2023 | Trial primary completion date: Aug 2023 ➔ Apr 2023

Trial completion • Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

MiNK Reports Fourth Quarter and Year-End 2023 Results (GlobeNewswire) - "As we move forward, our primary focus remains on advancing our lead program, agenT-797, particularly in indications where we have observed promising proof-of-concept data. We are pleased to announce the progression of this program into a Phase 2 study in gastroesophageal cancers and we anticipate sharing initial trial data later this year."

P2 data • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase 2 trial of AgenT-797 Combination for Gastric, Esophageal, GEJ Cancers (YouTube) - "Yelena Janjigian, MD...provides insight on a phase 2 trial evaluating AgenT-797 in combination with botensilimab, balstilimab, ramucirumab, and paclitaxel in the second-line setting for the treatment of gastric, esophageal, and gastroesophageal junction cancer."

Video

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=38 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

Combination therapy • Metastases • New P2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

First Refractory Gastric Cancer Patient Dosed in Phase 2 Trial with Novel Combination of MiNK’s Allogeneic INKT Cell Therapy and Agenus’ Botensilimab and Balstilimab (GlobeNewswire) - "MiNK Therapeutics...announced the first patient dosed in a Phase 2 investigator sponsored study for agenT-797 in second line gastroesophageal cancer, led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center....This Phase 2 Study will evaluate the clinical safety and efficacy of the combination of agenT-797 (iNKT cells), botensilimab, a novel fc-enhanced CTLA-4 inhibitor, plus balstilimab (anti-PD-1) with ramucirumab and paclitaxel for patients with previously treated, advanced esophageal, gastric, or gastro-esophageal junction (GEJ) adenocarcinoma. The study aims to enroll around 38 patients with advanced, unresectable, or metastatic forms of these cancers who have experienced disease progression after initial treatment."

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

MiNK’s AgenT-797 Offers New Hope in Overcoming ICI Resistance in PD-1 Refractory Gastric Cancer - Published in Oncogene (GlobeNewswire) - "'Gastric cancer remains an area of high unmet need, where the majority of patients develop disease progression related to tumor resistance,' said Dr. Benedito A. Carneiro...'Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors. The activity, tolerability, and ease of off-the-shelf administration of iNKT-based cell therapies position them as an attractive approach for overcoming cancer resistance.'"

Media quote

Overcoming resistance to programmed cell death protein 1 (PD-1) blockade with allogeneic invariant natural killer T-cells (iNKT). (PubMed, Oncogene) - "Activation of iNKT cells by tumor lipid antigens can trigger direct cytotoxicity and promote indirect anti-tumor immune responses such as recruitment and activation of T cells, NK cells, and dendritic cells through secretion of cytokines and IFNγ. We describe immune modulation leading to durable tumor response in a patient with microsatellite instability-high (MSI-H) advanced gastric adenocarcinoma treated with agent-797 after progression on standard chemotherapy and anti-PD-1 therapy."

Journal • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Immune Modulation • Immunology • Microsatellite Instability • Oncology • Solid Tumor • IFNG • MSI

MiNK’s AgenT-797 Offers New Hope in Overcoming ICI Resistance in PD-1 Refractory Gastric Cancer - Published in Oncogene (GlobeNewswire) - P1/2 | N=30 | NCT05108623 | Sponsor: MiNK Therapeutics | "MiNK Therapeutics, Inc...today announced the publication of a case report in Oncogene from its phase 1/2 study in patients with advanced solid tumors where one infusion of agenT-797 in gastric cancer refractory to anti-PD1 led to a durable confirmed partial response, highlighting the unique potential of iNKT cells to overcome resistance to immune checkpoint inhibitors (ICIs)....This case report describes a durable response (by RECIST 1.1 criteria) in a patient with a challenging clinical profile—a PD-L1 positive, HER-2 negative, MSI-H adenocarcinoma with a high mutational burden (84 mut/MB)....Following treatment with agenT-797, increased immune cell infiltration and proliferation were observed, which correlated with the radiographic partial response."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor