- First study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in gastroesophageal cancer shows disease control rate (DCR) in 77% of patients and long-term survival beyond 20 months in a subset of patients
- Induction strategy linked to improvement in PFS (HR 0.19; p=0,015) and survival rates at 12 and 18 months supported by evidence of immune activation and tumor immune reprogramming
NEW YORK, April 17, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, today announced data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agenT-797, MiNK's allo-iNKT cell therapy, in combination with botensilimab (BOT) and balstilimab (BAL), ramucirumab and paclitaxel in patients with advanced PD-1 refractory gastroesophageal adenocarcinoma. The data are being presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.
This Phase II trial-the first to evaluate agenT-797 in combination with BOT and BAL in patients with gastroesophageal cancer progressing after frontline therapy, was designed to assess the impact of immune priming and sequencing, with patients receiving induction (agenT-797 alone or with BOT/BAL) followed by combination therapy, or the combination without induction, alongside longitudinal biomarker analyses; in this study (n=17), treatment achieved a 77% disease control rate (DCR) with long-term survival beyond 20 months in a subset, with emerging signals in patients who received the induction strategy had meaningful improvements in PFS (6.9 vs. 3.5 months; HR 0.19; p=0.015) and OS (9.5 vs. 5.2 months), with 43% of patients alive at 12 and 18 months-highlighting durability and survival, rather than response rate, as the most relevant measures of clinical benefit in this PD-1 refractory setting.
"This study reinforces the potential of agenT-797 as an immune orchestrator capable of re-engaging anti-tumor immunity in highly resistant cancers," said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. "These findings suggest that sequencing of treatment may be as important as the treatment itself, as we observed longer survival without disease progression in patients who received an early immune-priming step before the full regimen, together with evidence of immune activation and tumor microenvironment remodeling. The durability of survival observed in induction-treated subset, together with evidence of immune activation, is central to how we, our potential partners, and the FDA evaluate meaningful outcomes and will shape our next phase of development in this hard to treat population."
Efficacy findings from the Phase II (n=17) study included:
- 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; however, disease control and longer-term survival observed in a subset of patients support further study of this approach.
Correlative analyses showed that treatment with BOT, BAL, and agenT-797 was associated with significant intratumoral T cell and dendritic cell infiltration, the formation of organized tertiary lymphoid structures in on-treatment biopsies from a patient with prolonged benefit, and activation of peripheral CD4 and CD8 T cells.
The safety profile was consistent with the component agents. The most common treatment-emergent adverse events among all patients included fatigue, fever, diarrhea, anorexia, nausea and mucositis- Immune-related adverse events included dermatitis, colitis, gastritis, enteritis, hepatitis and hypothyroidism-
Additional analysis of the full biospecimen dataset is ongoing and is expected to provide further insight into immune mechanisms, optimal sequencing, and potential biomarkers that could help identify patients most likely to benefit.
Presentation Details:
Abstract Title: A phase II study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in PD-1 refractory gastroesophageal cancer (GEC)
Presenter: Samuel L. Cytryn M.D.; Gastrointestinal Medical Oncologist, Memorial Sloan Kettering Cancer Center
Session Name: Phase II and Phase III Clinical Trials
Date/Time: April 20, 2026 | 2:00-5:00 PM PT; 5:00-8:00 PM EDT
Poster Section: 52
Abstract No.: CT166
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies. MiNK's proprietary platform is designed to restore immune balance and drive cytotoxic responses across cancer, immune-mediated diseases, and pulmonary immune failure. MiNK's lead candidate, agenT-797, is an off-the-shelf iNKT cell therapy currently in clinical development for GVHD, solid tumors, and severe pulmonary inflammation. With a scalable cryopreserved manufacturing process and differentiated biology bridging innate and adaptive immunity, MiNK is committed to developing next-generation immune reconstitution therapies. For more information, visit www.minktherapeutics.com or follow us on X @MiNK_iNKT.
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).
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, safety, and anticipated benefits of agenT-797; clinical trial design, timing, and enrollment; and MiNK's broader development plans. These statements are subject to risks and uncertainties detailed in MiNK's most recent filings with the Securities and Exchange Commission. MiNK cautions investors not to place undue reliance on these statements, which speak only as of the date of this release.
Contacts:
Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com
