Addition of AgenT-797 with Checkpoint Inhibitors, BOT/BAL, and Chemotherapy Demonstrates Robust Immune Activation, Offering Potential to Overcome Refractory Gastric Cancers
NEW YORK, Feb. 24, 2025 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today presented new translational data from its ongoing Phase 2 study of allo-iNKTs, agenT-797, at the American Association for Cancer Research (AACR) IO Annual Meeting in Los Angeles, California. The study evaluates agenT-797 in combination with botensilimab and balstilimab (BOT/BAL), in patients with refractory (2L+) gastroesophageal cancer (NCT06251973).
“We are encouraged by these latest data that demonstrate a powerful synergy between MiNK’s allo-iNKT cells, checkpoint inhibitors, and approved chemotherapy, sparking robust immune reactivation and clinical activity in otherwise unresponsive tumors,” said Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. “These findings underscore our unique position in the cell therapy space, highlighting iNKT cells’ potential to transform both access and efficacy for patients. By intensifying immunologic activity, reinvigorating memory T cells, and driving anti-tumor immune cells into the tumor microenvironment, this combination has the potential to deliver durable clinical benefits. We are excited to further investigate the clinical impact of this promising combination.”
Highlights:
Combinations Optimize Anti-tumor Immunity
- 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.
Treatment Sequencing Matters
- 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. This underscores the critical importance of treatment sequencing, positioning early allo-iNKT induction as a key driver of therapeutic benefit.
Strategic Advantages
- Allogeneic, Off-the-Shelf Platform: MiNK’s scalable manufacturing process generates billions of donor-derived iNKT cells in a single run, yielding thousands of doses for rapid global distribution. This approach reduces logistical hurdles and lowers costs, enabling greater patient access worldwide.
- Differentiated Pipeline: MiNK’s iNKT platform supports expansion into additional hard-to-treat cancers, creating significant opportunities for pipeline breadth, partnerships, and long-term growth.
Presentation Details:
Abstract Title: Biomarker analysis from Phase 2 study of AgenT-797 (invariant natural killer T-cells), botensilimab (a Fc-enhanced CTLA-4 Inhibitor) with balstilimab (anti-PD-1) in PD-1 refractory gastroesophageal cancer (GEC)
Presenting Author: Dr. Samuel Cytryn, Memorial Sloan Kettering Cancer Center, New York, New York
Oral Session: Proffered Papers, Session 2; 1:39-1:45 p.m. PST
Poster Session: Poster Session, A; 1:45-4:45 p.m. PST
Date: Monday, February 24th
The presentation will be available on the publications page of the MiNK website at https://minktherapeutics.com/publications/ following the start of the conference session.
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels.
About AgenT-797
AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy that harnesses the dual power of innate and adaptive immunity. iNKTs function as “master regulators,” combining the cytotoxic capabilities of NK cells with T-cell–like antigen recognition and memory. This unique biology enables a robust, pathogen-agnostic immune response that can be directed against hard-to-treat tumors.
Manufactured by MiNK Therapeutics in Lexington, MA, agenT-797 is a scalable, off-the-shelf product designed to provide accessible, transformative treatment options. In clinical trials, agenT-797 can bolster peripheral memory T-cell activation, enhance tumor infiltration, and potentially improve outcomes for patients with solid cancers (Cytryn et al. AACR IO 2024, Oncogene. 2024) and to combat inflammation in critically ill patients with severe respiratory pathology (Nature Communications. 2024).
About Botensilimab (BOT) and Balstilimab (BAL)
Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies.
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Both molecules are manufactured by Agenus.
Forward Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, anticipated benefit, plans and timelines of iNKT cells, as well as the collaboration between MiNK and Agenus. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK and Agenus with no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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