MiNK Therapeutics Presents First-in-Kind Allo-iNKTs Combination Data in 2L Gastric Cancer at AACR IO Annual Meeting
MiNK Therapeutics (NASDAQ: INKT) presented new translational data from its ongoing Phase 2 study of allo-iNKTs (agenT-797) at the AACR IO Annual Meeting. The study evaluates agenT-797 in combination with botensilimab and balstilimab (BOT/BAL) in patients with refractory gastroesophageal cancer.
The data demonstrated synergy between allo-iNKT cells, checkpoint inhibitors, and chemotherapy, showing robust immune reactivation in unresponsive tumors. Key findings include significant increases in interferon-gamma levels and enhanced tumor infiltration by T cells and antigen-presenting cells. The study revealed that optimal results were achieved when agenT-797 was administered concurrently with checkpoint inhibitors before chemotherapy.
MiNK's allogeneic manufacturing process can generate billions of donor-derived iNKT cells in a single run, producing thousands of doses for global distribution, potentially reducing costs and improving patient access.
MiNK Therapeutics (NASDAQ: INKT) ha presentato nuovi dati traslazionali dal suo studio di Fase 2 in corso sugli allo-iNKT (agenT-797) durante l'AACR IO Annual Meeting. Lo studio valuta l'agenT-797 in combinazione con botensilimab e balstilimab (BOT/BAL) in pazienti con cancro gastroesofageo refrattario.
I dati hanno dimostrato una sinergia tra le cellule allo-iNKT, gli inibitori del checkpoint e la chemioterapia, mostrando una robusta riattivazione immunitaria nei tumori non responsivi. I risultati chiave includono significativi aumenti dei livelli di interferone-gamma e un'infiltrazione tumorale potenziata da parte delle cellule T e delle cellule presentanti l'antigene. Lo studio ha rivelato che i risultati ottimali sono stati ottenuti quando l'agenT-797 è stato somministrato contemporaneamente agli inibitori del checkpoint prima della chemioterapia.
Il processo di produzione allogenica di MiNK può generare miliardi di cellule iNKT derivate da donatori in un'unica operazione, producendo migliaia di dosi per la distribuzione globale, potenzialmente riducendo i costi e migliorando l'accesso per i pazienti.
MiNK Therapeutics (NASDAQ: INKT) presentó nuevos datos traslacionales de su estudio en Fase 2 en curso sobre allo-iNKTs (agenT-797) en la Reunión Anual de AACR IO. El estudio evalúa el agenT-797 en combinación con botensilimab y balstilimab (BOT/BAL) en pacientes con cáncer gastroesofágico refractario.
Los datos demostraron sinergia entre las células allo-iNKT, los inhibidores de checkpoint y la quimioterapia, mostrando una robusta reactivación inmune en tumores no responsivos. Los hallazgos clave incluyen aumentos significativos en los niveles de interferón-gamma y una mayor infiltración tumoral por células T y células presentadoras de antígenos. El estudio reveló que se lograron los mejores resultados cuando el agenT-797 se administró simultáneamente con los inhibidores de checkpoint antes de la quimioterapia.
El proceso de fabricación alogénica de MiNK puede generar miles de millones de células iNKT derivadas de donantes en una sola ejecución, produciendo miles de dosis para distribución global, lo que potencialmente reduce costos y mejora el acceso de los pacientes.
MiNK Therapeutics (NASDAQ: INKT)는 AACR IO 연례 회의에서 allo-iNKT(agenT-797)에 대한 진행 중인 2상 연구의 새로운 변환 데이터를 발표했습니다. 이 연구는 내성 식도위암 환자에서 botensilimab 및 balstilimab(BOT/BAL)와 함께 agenT-797의 효과를 평가합니다.
데이터는 allo-iNKT 세포, 체크포인트 억제제 및 화학요법 간의 시너지를 보여주었으며, 반응하지 않는 종양에서 강력한 면역 재활성을 나타냈습니다. 주요 발견 사항으로는 인터페론 감마 수준의 유의미한 증가와 T 세포 및 항원 제시 세포에 의한 종양 침투의 증가가 포함됩니다. 이 연구는 agenT-797가 화학요법 전에 체크포인트 억제제와 동시에 투여될 때 최적의 결과가 달성된다고 밝혔습니다.
MiNK의 동종 제조 공정은 단일 실행으로 수십억 개의 기증자 유래 iNKT 세포를 생성할 수 있으며, 전 세계 배급을 위해 수천 개의 용량을 생산하여 비용을 절감하고 환자의 접근성을 향상시킬 수 있습니다.
MiNK Therapeutics (NASDAQ: INKT) a présenté de nouvelles données translationnelles de son étude de Phase 2 en cours sur les allo-iNKT (agenT-797) lors de la Réunion Annuelle de l'AACR IO. L'étude évalue l'agenT-797 en combinaison avec le botensilimab et le balstilimab (BOT/BAL) chez des patients atteints de cancer gastro-œsophagien réfractaire.
Les données ont démontré une synergie entre les cellules allo-iNKT, les inhibiteurs de checkpoint et la chimiothérapie, montrant une forte réactivation immunitaire dans les tumeurs non réactives. Les résultats clés incluent des augmentations significatives des niveaux d'interféron-gamma et une infiltration tumorale accrue par les cellules T et les cellules présentatrices d'antigènes. L'étude a révélé que les résultats optimaux ont été obtenus lorsque l'agenT-797 était administré simultanément avec les inhibiteurs de checkpoint avant la chimiothérapie.
Le processus de fabrication allogénique de MiNK peut générer des milliards de cellules iNKT dérivées de donneurs en un seul passage, produisant des milliers de doses pour une distribution mondiale, ce qui pourrait réduire les coûts et améliorer l'accès des patients.
MiNK Therapeutics (NASDAQ: INKT) hat auf dem AACR IO Annual Meeting neue translational Daten aus seiner laufenden Phase-2-Studie zu allo-iNKTs (agenT-797) präsentiert. Die Studie bewertet agenT-797 in Kombination mit botensilimab und balstilimab (BOT/BAL) bei Patienten mit refraktärem gastroösophagealen Krebs.
Die Daten zeigten eine Synergie zwischen allo-iNKT-Zellen, Checkpoint-Inhibitoren und Chemotherapie, wobei eine robuste Immunreaktivierung in nicht ansprechenden Tumoren sichtbar wurde. Zu den wichtigsten Ergebnissen gehören signifikante Erhöhungen der Interferon-Gamma-Spiegel und eine verbesserte Tumorinfiltration durch T-Zellen und antigenpräsentierende Zellen. Die Studie ergab, dass optimale Ergebnisse erzielt wurden, wenn agenT-797 gleichzeitig mit Checkpoint-Inhibitoren vor der Chemotherapie verabreicht wurde.
Der allogene Herstellungsprozess von MiNK kann Milliarden von spenderderivierten iNKT-Zellen in einem einzigen Durchgang erzeugen und Tausende von Dosen für die weltweite Verteilung produzieren, was potenziell die Kosten senkt und den Zugang für Patienten verbessert.
- Demonstrated synergy between allo-iNKT cells and existing treatments in refractory gastric cancer
- Significant increase in interferon-gamma levels and enhanced tumor infiltration
- Scalable manufacturing process capable of producing thousands of doses in a single run
- None.
Insights
The latest data from MiNK Therapeutics' Phase 2 study represents a significant advancement in cell therapy for gastric cancer treatment. The combination approach demonstrates three important advantages:
- The observed increase in interferon-gamma levels and enhanced tumor infiltration suggests robust immune system engagement, which typically correlates with improved survival outcomes in cancer patients
- The specific treatment sequencing discovery - administering agenT-797 with checkpoint inhibitors before chemotherapy - could establish a new standard protocol for combination therapy in gastric cancer
- The allogeneic, off-the-shelf nature of agenT-797 addresses major limitations of current cell therapies, particularly the manufacturing and logistics challenges that have historically restricted broader adoption
The gastric cancer market represents a substantial opportunity, with current second-line treatments showing efficacy. MiNK's approach could potentially address this unmet need through their scalable manufacturing process, which can generate thousands of doses from a single production run. This scalability is particularly significant as it could substantially reduce per-patient costs compared to traditional CAR-T therapies, which typically cost
The biomarker data suggesting enhanced tumor infiltration and memory T-cell activation is particularly noteworthy, as these indicators typically predict durable responses - a critical factor in cancer treatment success. The company's platform technology also presents opportunities for expansion into other solid tumors, potentially multiplying the addressable market.
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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