Agenus Presents New Botensilimab/Balstilimab Data in Gastric Cancer at AACR IO Annual Meeting
Agenus (NASDAQ: AGEN) presented new data at the AACR IO Annual Meeting regarding their Phase 2 study combining botensilimab (BOT) and balstilimab (BAL) with MiNK Therapeutics' agenT-797 in refractory gastric cancer patients.
The key findings demonstrate that adding agenT-797 (an allogeneic invariant natural killer T cell therapy) to BOT/BAL treatment resulted in:
- Robust immune activation with elevated interferon-gamma levels
- Increased tumor-infiltrating lymphocytes
- Enhanced peripheral memory T-cell activation
- Potential for improved outcomes when administered before standard chemotherapy
The research suggests this combination therapy could effectively transform immunologically 'cold' tumors into 'hot' immune inflamed tumors, potentially offering new treatment options for late-line gastric cancer patients, including those who are PD-1 refractory.
Agenus (NASDAQ: AGEN) ha presentato nuovi dati al Congresso Annuale AACR IO riguardo al loro studio di Fase 2 che combina botensilimab (BOT) e balstilimab (BAL) con l'agenT-797 di MiNK Therapeutics nei pazienti con cancro gastrico refrattario.
I risultati chiave dimostrano che l'aggiunta di agenT-797 (una terapia cellulare T naturale invariata allogenica) al trattamento BOT/BAL ha portato a:
- Una robusta attivazione immunitaria con livelli elevati di interferone-gamma
- Aumento dei linfociti infiltranti il tumore
- Attivazione migliorata delle cellule T di memoria periferiche
- Potenziale per risultati migliori se somministrato prima della chemioterapia standard
La ricerca suggerisce che questa terapia combinata potrebbe trasformare efficacemente i tumori immunologicamente 'freddi' in tumori 'caldi' infiammati immunologicamente, offrendo potenzialmente nuove opzioni di trattamento per i pazienti con cancro gastrico in fase avanzata, inclusi quelli refrattari a PD-1.
Agenus (NASDAQ: AGEN) presentó nuevos datos en la Reunión Anual AACR IO sobre su estudio de Fase 2 que combina botensilimab (BOT) y balstilimab (BAL) con agenT-797 de MiNK Therapeutics en pacientes con cáncer gástrico refractario.
Los hallazgos clave demuestran que la adición de agenT-797 (una terapia de células T naturales invariantes alogénicas) al tratamiento BOT/BAL resultó en:
- Una robusta activación inmune con niveles elevados de interferón-gamma
- Aumento de linfocitos infiltrantes del tumor
- Mejor activación de células T de memoria periféricas
- Potencial para mejores resultados cuando se administra antes de la quimioterapia estándar
La investigación sugiere que esta terapia combinada podría transformar efectivamente tumores inmunológicamente 'fríos' en tumores 'calientes' inflamados inmunológicamente, ofreciendo potencialmente nuevas opciones de tratamiento para pacientes con cáncer gástrico en etapas avanzadas, incluidos aquellos refractarios a PD-1.
Agenus (NASDAQ: AGEN)는 AACR IO 연례 회의에서 botensilimab (BOT)와 balstilimab (BAL)을 MiNK Therapeutics의 agenT-797와 병용한 2상 연구에 대한 새로운 데이터를 발표했습니다. 이 연구는 난치성 위암 환자를 대상으로 진행되었습니다.
주요 발견은 BOT/BAL 치료에 agenT-797(동종 불변 자연 살해 T 세포 요법)를 추가하면:
- 인터페론 감마 수치가 상승하며 강력한 면역 활성화가 이루어짐
- 종양 침윤 림프구 증가
- 말초 기억 T 세포 활성화 향상
- 표준 화학요법 전에 투여할 경우 개선된 결과 가능성
이 연구는 이 조합 요법이 면역학적으로 '차가운' 종양을 '뜨거운' 면역 염증 종양으로 효과적으로 변환할 수 있음을 시사하며, PD-1에 난치적인 환자를 포함한 말기 위암 환자에게 새로운 치료 옵션을 제공할 수 있습니다.
Agenus (NASDAQ: AGEN) a présenté de nouvelles données lors de la Réunion Annuelle AACR IO concernant leur étude de Phase 2 combinant botensilimab (BOT) et balstilimab (BAL) avec l'agenT-797 de MiNK Therapeutics chez des patients atteints de cancer gastrique réfractaire.
Les résultats clés montrent que l'ajout de l'agenT-797 (une thérapie par cellules T naturelles invariantes allogéniques) au traitement BOT/BAL a entraîné:
- Une activation immunitaire robuste avec des niveaux élevés d'interféron-gamma
- Une augmentation des lymphocytes infiltrants tumoraux
- Une activation améliorée des cellules T mémoire périphériques
- Un potentiel d'amélioration des résultats lorsqu'il est administré avant la chimiothérapie standard
La recherche suggère que cette thérapie combinée pourrait transformer efficacement les tumeurs immunologiquement 'froides' en tumeurs 'chaudes' enflammées immunologiquement, offrant potentiellement de nouvelles options de traitement pour les patients atteints de cancer gastrique avancé, y compris ceux qui sont réfractaires au PD-1.
Agenus (NASDAQ: AGEN) präsentierte neue Daten auf dem AACR IO Jahresmeeting zu ihrer Phase-2-Studie, die botensilimab (BOT) und balstilimab (BAL) mit agenT-797 von MiNK Therapeutics bei refraktären Magenkrebspatienten kombiniert.
Die wichtigsten Ergebnisse zeigen, dass die Hinzufügung von agenT-797 (einer allogenen invariant natürlichen Killer-T-Zelltherapie) zur BOT/BAL-Behandlung zu:
- Robuster Immunaktivierung mit erhöhten Interferon-Gamma-Spiegeln
- Erhöhten tumorinfiltrierenden Lymphozyten
- Verbesserter Aktivierung von peripheren Gedächtnis-T-Zellen
- Potenzial für bessere Ergebnisse bei Verabreichung vor der Standard-Chemotherapie
Die Forschung deutet darauf hin, dass diese Kombinationstherapie immunologisch 'kalte' Tumoren in 'heiße' immunentzündete Tumoren effektiv umwandeln könnte, was potenziell neue Behandlungsoptionen für fortgeschrittene Magenkrebspatienten, einschließlich derjenigen, die PD-1-refraktär sind, bieten könnte.
- Early-stage data shows strong immune response activation in refractory gastric cancer patients
- Treatment combination demonstrates effectiveness in PD-1 refractory patients
- Therapy shows potential to transform 'cold' tumors into 'hot' immune inflamed tumors
- Study is still in Phase 2, indicating long path to potential commercialization
- No efficacy or survival data presented in the PR
Insights
The latest data from Agenus's Phase 2 study represents a significant advancement in immuno-oncology combination strategies for gastric cancer. The triple combination of botensilimab (BOT), balstilimab (BAL), and agenT-797 demonstrates several key advantages that could potentially transform the treatment landscape:
The study's focus on PD-1 refractory patients is particularly noteworthy, as this population represents a substantial unmet medical need in gastric cancer treatment. The observed immune activation, marked by elevated IFNγ levels and increased tumor-infiltrating lymphocytes, suggests the combination therapy can effectively overcome resistance mechanisms that limit the efficacy of current standard treatments.
Three critical aspects of the data stand out from a clinical perspective:
- The successful transformation of 'cold' tumors into 'hot' immune-inflamed environments indicates potential broader applicability across patient populations
- The expansion of memory T-cells suggests the possibility of durable responses, a important factor for long-term survival benefits
- The optimal sequencing strategy with chemotherapy demonstrates sophisticated trial design that could maximize therapeutic impact
From a market perspective, this combination approach could position Agenus favorably in the competitive gastric cancer landscape. The collaboration with MiNK Therapeutics through agenT-797 also demonstrates strategic synergy in developing next-generation immunotherapy combinations. The biomarker data presented could facilitate patient selection and potentially improve the probability of successful outcomes in future trials.
However, it's important to note that while these early Phase 2 results are encouraging, larger confirmatory studies will be needed to validate these findings and establish the combination's role in the treatment paradigm. The complexity of a triple combination therapy may also present challenges in terms of cost and administration logistics that will need to be addressed for successful commercialization.
Combination of Botensilimab/Balstilimab with MiNK Therapeutics’ AgenT-797 Shows Strong Immune Activation and Potential to Enhance Outcomes in Refractory Gastric Cancer
“These latest data demonstrate the remarkable potential of combining BOT/BAL with a novel iNKT cell therapy to broaden and intensify immune responses against resistant gastric tumors,” said Dr. Dhan Chand, Vice President of Research at Agenus. “By driving strong IFNγ production, deep T-cell infiltration, and memory T-cell activation—even in PD-1–refractory patients—the addition of agenT-797 to BOT/BAL could redefine what’s possible in late-line gastric cancer. We’re particularly encouraged by how these therapies work in concert with standard-of-care chemotherapy to transform immunologically 'cold' tumors into 'hot' immune inflamed tumors, potentially offering a new therapeutic paradigm for patients facing this challenging disease.”
Highlights
- Broad Immune Activation: The addition of MiNK’s allogeneic iNKT therapy, agenT-797, to BOT/BAL drove robust immune activation, including elevated interferon-gamma (IFNγ) levels, indicating potent systemic engagement and overcoming immunosuppressive pathways in PD-1–refractory gastric tumors.
- Enhanced T cell Infiltration and Memory T-Cell Expansion: A marked increase in tumor-infiltrating lymphocytes (TILs), together with heightened peripheral memory T-cell activation, underscores the potential for long-lasting anti-tumor immunity when combining BOT/BAL with agenT-797 (allo-iNKTs).
- Optimized Sequencing with Chemotherapy: Early administration of agenT-797 alongside BOT/BAL, before standard chemotherapy significantly amplifies immune responses, potentially reducing tumor recurrence through optimal T-cell priming, activation and mobilization.
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,
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 Agenus website at https://agenusbio.com/publications/ following the start of the conference session.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in
About Botensilimab (BOT)
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.
Approximately 1,100 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.
About Balstilimab (BAL)
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.
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
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 its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus 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 Agenus undertakes 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250224368708/en/
Investors
917-362-1370
investor@agenusbio.com
Media
510-323-5188
communications@agenusbio.com
Source: Agenus Inc.
FAQ
What are the key findings of Agenus's Phase 2 study for gastric cancer treatment?
How does the AGEN combination therapy work in PD-1 refractory gastric cancer?
What is the optimal timing for AGEN's gastric cancer combination therapy?
What type of cancer is Agenus (AGEN) targeting with their BOT/BAL/agenT-797 combination?
