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MiNK Therapeutics Targets Immune Reconstitution to Combat Advanced Gastroesophageal Cancers with Novel Combination of Allo-iNKTs plus BOT/BAL at ASCO GI

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MiNK Therapeutics (NASDAQ: INKT) announced a presentation at the ASCO GI Symposium, highlighting their novel combination therapy approach for advanced gastroesophageal cancers. The company is conducting a Phase 2 trial at Memorial Sloan Kettering Cancer Center, combining agenT-797 (iNKT cells) with botensilimab/balstilimab (BOT/BAL) plus ramucirumab and paclitaxel for previously treated patients.

Previous Phase 1 trial data showed durable responses and tolerability in PD-1 refractory cancers, with gastric cancer patients demonstrating significant clinical and immunologic responses. The company plans to provide a clinical update from the ongoing Phase 2 study in the second half of 2025.

CEO Dr. Jennifer Buell emphasized that iNKT cells play a important role in immune reconstitution, while BOT/BAL enhances T-cell priming and eliminates immunosuppressive regulatory cells, creating a comprehensive approach to make disease biologically unsustainable.

MiNK Therapeutics (NASDAQ: INKT) ha annunciato una presentazione al Simposio ASCO GI, evidenziando il loro approccio innovativo alla terapia combinata per i tumori gastroesofagei avanzati. L'azienda sta conducendo uno studio di Fase 2 presso il Memorial Sloan Kettering Cancer Center, combinando agenT-797 ( cellule iNKT) con botensilimab/balstilimab (BOT/BAL) più ramucirumab e paclitaxel per pazienti precedentemente trattati.

I dati dello studio di Fase 1 precedente hanno mostrato risposte durature e tollerabilità nei tumori refrattari al PD-1, con pazienti affetti da cancro gastrico che hanno dimostrato significative risposte cliniche e immunologiche. L'azienda prevede di fornire un aggiornamento clinico dallo studio di Fase 2 in corso nella seconda metà del 2025.

La CEO Dr. Jennifer Buell ha sottolineato che le cellule iNKT giocano un ruolo importante nella ricostituzione immunitaria, mentre BOT/BAL migliora la priming delle cellule T ed elimina le cellule regolatorie immunosoppressive, creando un approccio completo per rendere la malattia biologicamente insostenibile.

MiNK Therapeutics (NASDAQ: INKT) anunció una presentación en el Simposio ASCO GI, destacando su enfoque innovador de terapia combinada para cánceres gastroesofágicos avanzados. La empresa está llevando a cabo un ensayo de Fase 2 en el Memorial Sloan Kettering Cancer Center, combinando agenT-797 (células iNKT) con botensilimab/balstilimab (BOT/BAL) más ramucirumab y paclitaxel para pacientes previamente tratados.

Los datos del ensayo de Fase 1 anterior mostraron respuestas duraderas y tolerabilidad en cánceres refractarios a PD-1, con pacientes de cáncer gástrico demostrando respuestas clínicas e inmunológicas significativas. La empresa planea proporcionar una actualización clínica del estudio de Fase 2 en curso en la segunda mitad de 2025.

La CEO Dr. Jennifer Buell destacó que las células iNKT juegan un papel importante en la reconstitución inmune, mientras que BOT/BAL mejora la activación de células T y elimina las células regulatorias inmunosupresoras, creando un enfoque integral para hacer que la enfermedad sea biológicamente insostenible.

MiNK Therapeutics (NASDAQ: INKT)는 ASCO GI 심포지엄에서 진전된 위식도암을 위한 새로운 조합 치료 접근법을 강조하며 발표를 하였습니다. 이 회사는 Memorial Sloan Kettering Cancer Center에서 agenT-797 (iNKT 세포)와 botensilimab/balstilimab (BOT/BAL) 및 ramucirumab과 paclitaxel을 결합한 2상 시험을 진행 중입니다. 이는 기존 치료를 받은 환자들을 대상으로 합니다.

이전 1상 시험 데이터는 PD-1 내성 암에서 지속적인 반응과 내약성을 보여주었으며, 위암 환자들은 상당한 임상적 및 면역학적 반응을 나타냈습니다. 이 회사는 2025년 하반기에 진행 중인 2상 연구에 대한 임상 업데이트를 제공할 계획입니다.

CEO인 제니퍼 뷰엘 박사는 iNKT 세포가 면역 재구성에서 중요한 역할을 하며, BOT/BAL이 T세포 준비를 강화하고 면역 억제 조절 세포를 제거하여 질병을 생물학적으로 지속 불가능하게 만드는 포괄적인 접근 방식을 생성한다는 점을 강조했습니다.

MiNK Therapeutics (NASDAQ: INKT) a annoncé une présentation au Symposium ASCO GI, mettant en évidence leur approche novatrice de thérapie combinée pour les cancers gastro-œsophagiens avancés. L'entreprise mène un essai de Phase 2 au Memorial Sloan Kettering Cancer Center, combinant agenT-797 (cellules iNKT) avec botensilimab/balstilimab (BOT/BAL) ainsi que ramucirumab et paclitaxel pour des patients précédemment traités.

Les données de l'essai de Phase 1 précédent ont montré des réponses durables et une tolérance dans les cancers réfractaires au PD-1, les patients atteints de cancer gastrique montrant des réponses cliniques et immunologiques significatives. L'entreprise prévoit de fournir une mise à jour clinique de l'étude de Phase 2 en cours dans la seconde moitié de 2025.

La PDG Dr. Jennifer Buell a souligné que les cellules iNKT jouent un rôle important dans la reconstitution immunitaire, tandis que BOT/BAL améliore le priming des cellules T et élimine les cellules régulatrices immunosuppressives, créant ainsi une approche globale pour rendre la maladie biologiquement insoutenable.

MiNK Therapeutics (NASDAQ: INKT) kündigte eine Präsentation auf dem ASCO GI Symposium an und hob ihren neuartigen Ansatz der Kombinationstherapie für fortgeschrittene gastroösophageale Krebserkrankungen hervor. Das Unternehmen führt eine Phase-2-Studie im Memorial Sloan Kettering Cancer Center durch, bei der agenT-797 (iNKT-Zellen) mit botensilimab/balstilimab (BOT/BAL) sowie ramucirumab und paclitaxel für zuvor behandelte Patienten kombiniert werden.

Daten der vorherigen Phase-1-Studie zeigten anhaltende Reaktionen und Verträglichkeit bei PD-1-refraktären Krebserkrankungen, wobei Patienten mit Magenkrebs signifikante klinische und immunologische Reaktionen zeigten. Das Unternehmen plant, in der zweiten Hälfte des Jahres 2025 ein klinisches Update zu der laufenden Phase-2-Studie bereitzustellen.

CEO Dr. Jennifer Buell betonte, dass iNKT-Zellen eine wichtige Rolle bei der Immunrekonstitution spielen, während BOT/BAL das T-Zell-Priming verbessert und immun-suppressive regulatorische Zellen beseitigt und damit einen umfassenden Ansatz schafft, um die Krankheit biologisch unhaltbar zu machen.

Positive
  • Previous Phase 1 trial demonstrated long-term, durable responses in PD-1 refractory cancers
  • Significant clinical and immunologic responses observed in gastric cancer patients
  • Novel combination therapy showed signals of tolerability and activity in relapsed/refractory gastric cancer
Negative
  • None.

Insights

This Phase 2 trial represents a significant advancement in MiNK's gastroesophageal cancer program, building on encouraging Phase 1 data that demonstrated durable responses in PD-1 refractory patients. The novel five-drug combination (agenT-797 + BOT/BAL + ramucirumab/paclitaxel) takes a comprehensive approach by targeting multiple aspects of anti-tumor immunity:

The mechanism is particularly innovative, focusing on:

  • Immune reconstitution through iNKT cells
  • Enhanced T-cell priming via CTLA-4 blockade (botensilimab)
  • PD-1 pathway inhibition (balstilimab)
  • Standard chemotherapy backbone

The trial's location at Memorial Sloan Kettering, a leading cancer center, adds credibility. However, investors should note several key considerations:

  • Complex combination studies typically face higher regulatory scrutiny
  • The gastroesophageal cancer market is becoming increasingly competitive
  • Cost considerations for a five-drug regimen could impact commercial viability

Clinical updates expected in H2 2025 will be important for validating this approach. Early signs of tolerability are encouraging, but the true test will be demonstrating superior efficacy over current standards of care while maintaining a manageable safety profile.

NEW YORK, Jan. 23, 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 to treat cancer and other immune-mediated diseases, today announced a presentation at the American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium in San Francisco, California.

“INKT cells play a pivotal role in reconstituting lymphocytes, establishing a robust and responsive immune environment to address the complexities of advanced cancers. Agenus’ botensilimab/balstilimab combination (BOT/BAL) amplifies this effect by enhancing T-cell priming, eliminating immunosuppressive regulatory cells, and fostering long-term immune memory. This novel multi-immune combination treats the immune system itself, fundamentally reshaping the tumor environment to make disease biologically unsustainable,” said Dr. Jennifer Buell, Chief Executive Officer at MiNK Therapeutics. “We look forward to sharing further results from this study later this year.”

Phase 2 AgenT-797 plus BOT/BAL in Combination with Ramucirumab and Paclitaxel in Patients with Previously Treated, Unresectable or Metastatic Gastroesophageal Cancers (Abstract TPS515)

  • This investigator-initiated, single-arm Phase 2 trial, conducted at Memorial Sloan Kettering Cancer Center (NCT06251793), evaluates the novel combination of agenT-797 (iNKT cells), botensilimab, balstilimab, ramucirumab, and paclitaxel in advanced GE adenocarcinoma patients who have received at least one prior line of therapy.
  • Data from the prior Phase I trial (NCT05108623) demonstrated long-term, durable responses and tolerability in PD-1 refractory relapsed/refractory cancers, including testicular, appendiceal, lung, and gastric cancers. Notably, gastric cancer patients exhibited significant clinical and immunologic responses, including robust T cell infiltration and expansion compared to non-responders.
  • This novel, multi-immunologic combination demonstrated signals of tolerability and activity in patients with relapsed/refractory gastric cancer. MiNK plans to provide a clinical update from the ongoing Phase II study in the second half of 2025.

The presentation will be available on the publications page of the MiNK website at the start of the scheduled presentation session at https://minktherapeutics.com/publications/.

Presentation Details

Abstract Title: 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
Abstract Number: TPS515
Presenting Author: Dr. Samuel Cytryn
Session: Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Session Date and Time: 1/23/2025, 11:30 AM-1:00 PM PST

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.

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 and encrypted RNA, as well as the collaboration between MiNK and Autonomous Therapeutics. 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 Autonomous undertake 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.

Investor Contact
917-362-1370
investor@minktherapeutics.com

Media Contact
781-674-4428
communications@minktherapeutics.com


FAQ

What are the key components of MiNK Therapeutics' (INKT) combination therapy for gastroesophageal cancer?

The combination therapy includes agenT-797 (iNKT cells), botensilimab, balstilimab, ramucirumab, and paclitaxel for advanced gastroesophageal adenocarcinoma patients.

When will MiNK Therapeutics (INKT) provide the next clinical update for their Phase 2 gastric cancer study?

MiNK Therapeutics plans to provide a clinical update from the ongoing Phase 2 study in the second half of 2025.

What were the results from MiNK Therapeutics' (INKT) Phase 1 trial in gastric cancer patients?

The Phase 1 trial showed long-term, durable responses and tolerability in PD-1 refractory cancers, with gastric cancer patients showing significant clinical and immunologic responses, including robust T cell infiltration and expansion.

Where is MiNK Therapeutics' (INKT) Phase 2 gastroesophageal cancer trial being conducted?

The Phase 2 trial is being conducted at Memorial Sloan Kettering Cancer Center under trial number NCT06251793.

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