MiNK Therapeutics Reports Phase II Data on Immune Reprogramming and Durable Survival in PD-1 Refractory Gastroesophageal Cancer

Rhea-AI Summary

MiNK Therapeutics (NASDAQ: INKT) reported Phase II data (n=17) of agenT-797 with botensilimab and balstilimab in PD-1 refractory gastroesophageal cancer, presented at AACR April 17–22, 2026. The regimen produced a 77% disease control rate, induction-associated median PFS 6.9 vs 3.5 months (HR 0.19; p=0.015), and longer median OS (9.5 vs 5.2 months) with 43% of induction patients alive at 12 and 18 months. Correlatives showed intratumoral T cell and dendritic cell infiltration and tertiary lymphoid structure formation. The study did not meet its primary ORR endpoint; safety was consistent with component agents.

Positive

• DCR 77% observed in treated patients
• PFS improvement with induction: 6.9 vs 3.5 months (HR 0.19; p=0.015)
• OS benefit signal: 9.5 vs 5.2 months with induction; 43% alive at 12/18 months
• Immune activation: intratumoral T cell and dendritic cell infiltration

Negative

• Study did not meet primary endpoint of objective response rate (ORR)
• Small sample size: n=17, limiting statistical power and generalizability
• Immune-related adverse events reported including colitis, hepatitis, gastritis

News Market Reaction – INKT

+0.57%

1 alert

+0.57% Session close to close

$64.61M Market Cap

1.2x Rel. Volume

In the Apr 17 session, INKT gained 0.57%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights Phase II data for agenT‑797 combinations in PD‑1 refractory gastroesoph...

Analysis

This announcement highlights Phase II data for agenT‑797 combinations in PD‑1 refractory gastroesophageal cancer, with a 77% disease control rate and improved progression‑free and overall survival in patients receiving induction therapy. It builds on earlier clinical‑trial work with agenT‑797 in other indications. Investors may track further biomarker analyses, durability of survival beyond 20 months, and upcoming conference updates, while also considering the existing $150,000,000 shelf and $50,000,000 ATM as part of the company’s funding toolkit.

Key Figures

Sample size: 17 patients (n=17) Disease control rate: 77% PFS with induction: 6.9 months vs 3.5 months +5 more

8 metrics

Sample size 17 patients (n=17) Phase II PD‑1 refractory gastroesophageal adenocarcinoma study

Disease control rate 77% All treated patients in Phase II study

PFS with induction 6.9 months vs 3.5 months Induction vs non‑induction cohorts

Hazard ratio for PFS HR 0.19 Induction vs non‑induction cohorts

P-value for PFS p=0.015 Comparison of induction vs non‑induction PFS

Overall survival 9.5 vs 5.2 months Induction vs non‑induction cohorts

12 & 18‑month survival (induction) 43% at 12 and 18 months Induction cohort survival rates

12 & 18‑month survival (non‑induction) 20% at 12 months, 0% at 18 months Non‑induction cohort survival rates

Previous Clinical trial Reports

1 past event · Latest: Jan 08 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Jan 08	Clinical trial start	Positive	-1.7%	Phase 1 GvHD trial of agenT‑797 with non‑dilutive funding support announced.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Prior clinical trial news saw a modest negative move of -1.7%; today’s +9.2% reaction to new Phase II data contrasts with that pattern.

Recent Company History

Recent news has focused on advancing the allo‑iNKT platform and clinical visibility. A prior Phase 1 trial for GvHD prevention announced on Jan 8, 2026 featured agenT‑797 with non‑dilutive funding and a safety/efficacy focus but coincided with a -1.7% move. Subsequent months brought collaborations, conference abstracts, and financial updates with generally modest positive reactions. Today’s gastroesophageal cancer Phase II data highlight survival and disease control, tying into the platform’s broader clinical development.

Key Terms

disease control rate, progression-free survival, overall survival, hazard ratio, +4 more

8 terms

disease control rate medical

"shows disease control rate (DCR) in 77% of patients"

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

progression-free survival medical

"improvement in PFS (HR 0.19; p=0,015) and survival rates"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"Median overall survival (OS) was 9.5 months in the induction cohort"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

hazard ratio medical

"PFS (6.9 vs. 3.5 months; HR 0.19; p=0.015)"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

tertiary lymphoid structures medical

"the formation of organized tertiary lymphoid structures in on-treatment biopsies"

Clusters of immune cells that form in non-lymph node tissues, acting like pop-up immune hubs where white blood cells gather, communicate and organize a local defense. They matter to investors because their presence or absence can change how a disease progresses and how well immunotherapies work, so they can serve as biomarkers or influence the commercial prospects and regulatory outlook of drugs and diagnostics.

immune-related adverse events medical

"Immune-related adverse events included dermatitis, colitis, gastritis, enteritis"

Immune-related adverse events are side effects that occur when a treatment that stimulates the immune system causes the body to attack its own organs or tissues, like a home security system that overreacts and damages the house. They can range from mild to life-threatening and often require additional treatment or stopping the therapy. Investors watch these events because they influence clinical trial outcomes, regulatory approvals, product labeling, and the cost and marketability of immune-based medicines.

gastroesophageal adenocarcinoma medical

"patients with advanced PD-1 refractory gastroesophageal adenocarcinoma"

Gastroesophageal adenocarcinoma is a cancer that starts in the gland-like cells lining the lower part of the esophagus where it meets the stomach. Think of those lining cells as plants that have grown out of control and invaded nearby tissue. It matters to investors because its prevalence, survival outlook and available treatments drive demand for drugs, clinical trials, regulatory approvals and potential revenue for companies developing therapies or diagnostics.

allogeneic invariant natural killer T (allo-iNKT) cell therapies medical

"pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies"

Allogeneic invariant natural killer T (allo‑iNKT) cell therapies are off‑the‑shelf treatments made from immune cells collected from healthy donors, then engineered or expanded to use a special kind of T cell that can recognize and attack diseased cells. They matter to investors because, like ready‑made tools versus custom orders, they promise faster patient access and lower production costs than bespoke cell therapies, but carry technical, safety and regulatory risks that determine commercial success.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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

FAQ

What were the key Phase II results for MiNK Therapeutics (INKT) on April 17, 2026?

The study showed a 77% disease control rate and induction-linked PFS benefit (6.9 vs 3.5 months; HR 0.19; p=0.015). According to MiNK, induction-treated patients also had longer OS (9.5 vs 5.2 months) and 43% alive at 12 and 18 months.

How did induction sequencing affect PFS and OS in the INKT Phase II gastroesophageal cancer trial?

Induction sequencing was associated with longer PFS (median 6.9 vs 3.5 months) and longer median OS (9.5 vs 5.2 months). According to MiNK, the data support immune priming and treatment sequencing as potentially important variables for benefit.

What safety signals did the agenT-797 plus BOT and BAL combination show in the INKT trial?

Safety was consistent with component agents, with common events like fatigue, fever, diarrhea, and mucositis. According to MiNK, immune-related events included dermatitis, colitis, gastritis, enteritis, hepatitis, and hypothyroidism.

Did the Phase II MiNK (INKT) study meet its primary endpoint on April 17, 2026?

No, the trial did not meet its prespecified primary endpoint of objective response rate (ORR). According to MiNK, disease control and durable survival signals nonetheless support further study of this approach.

What biomarker or tumor microenvironment changes were reported in the INKT Phase II presentation?

Correlative analyses showed increased intratumoral T cell and dendritic cell infiltration and formation of tertiary lymphoid structures in on-treatment biopsies. According to MiNK, these findings indicate immune activation and tumor immune reprogramming linked to clinical benefit.