Balstilimab

Study will highlight novel iNKT cell-based combinations in checkpoint-refractory disease Data expected to inform immune modulation, treatment sequencing strategy, and clinical durability of response NEW YORK, April 03, 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 that 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), will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA. The study evaluates this multi-mechanistic immunotherapy regimen in patients with PD-1 refractory gastroesophageal cancer (GEC), an area of high unmet need where resistance to checkpoint inhibition remains a significant clinical challenge. “This study represents one of the first clinical evaluations of an iNKT cell therapy combined with dual checkpoint modulation in gastroesophageal cancer and marks an important step in understanding how to re-engage the immune system in patients who have progressed on prior checkpoint therapy,” said Jennifer Buell, Ph.D., President and CEO of MiNK Therapeutics . “These data build on the immune-modulating findings we reported last year and extend them into the clinical setting. agenT-797 is designed to bridge innate and adaptive immunity as an immune orchestrator, with the potential to reprogram the tumor microenvironment and restore immune responsiveness. We believe these data will provide important insights into how immune reprogramming and treatment sequencing can drive more durable outcomes in refractory cancers and inform the next generation of combination strategies.” 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. Cytyrn, MD; 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 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 Source : MiNK Therapeutics

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821). This study is evaluating Agenus’ immunotherapy combination of botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy. “Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program. This study advances our goal of developing effective immunotherapies for patients who currently have few options." This study is being conducted as a cooperative group trial led by the Canadian Cancer Trials Group (CCTG) from Canada and run across Canada, France, Australia and New Zealand. More than 100 sites will participate across the academic cooperative networks of CCTG, GI Cancer Trials in Australia and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium (including Unicancer, GERCOR and FFCD). The BATTMAN (CO.33) trial serves as the registrational-enabling study for BOT+BAL enrolling approximately 830 patients and is expected to complete global enrollment quickly, reflecting the unprecedented investigator and patient enthusiasm worldwide, including strong interest from sites and physicians engaged through Agenus’ paid named patient and French AAC access programs. “Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program,” said Dr. Steven O’Day, Chief Medical Officer, Agenus. “This study advances our goal of developing effective immunotherapies for patients who currently have few options. We’re grateful to our partners at CCTG, GI Cancer Trials in Australia, and PRODIGE and to the dedicated investigators, site staff, and patients driving this global effort.” “Our collaboration with Agenus builds on years of cooperative-group research aimed at bringing immunotherapy benefits to patients with microsatellite-stable colorectal cancer—those historically left without effective options,” said Dr. Chris O’Callaghan, DVM, PhD, Senior Investigator, Canadian Cancer Trials Group. “Earlier CCTG studies suggested that doublet immunotherapy could extend survival even in cold tumors, and the magnitude and durability of responses seen with botensilimab and balstilimab in earlier studies warrant their investigation in a phase 3 trial.” “The enthusiasm among investigators has been remarkable—within days of Health Canada submission, leading centers across Canada moved to open the study. We’re eager to advance this global effort and potentially transform outcomes for patients who have exhausted all other treatments,” said Dr. Jonathan Loree, MD, MSc, FRCPC, CO.33 Study Chair. About the BATTMAN (CO.33) Trial The BATTMAN (CCTG CO.33) (NCT07152821) trial is a global Phase 3, randomized, controlled study evaluating botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. Conducted as an international cooperative group study led by the Canadian Cancer Trials Group (CCTG), the trial will enroll approximately 830 patients across more than 100 sites in Canada, France, Australia, and New Zealand. Participating academic networks include CCTG, the GI Cancer Trials, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE), sponsored by UNICANCER. This registrational-enabling study is designed to support potential regulatory submissions for BOT+BAL in this difficult-to-treat patient population. Patients interested in learning more about the study, including eligibility and enrollment information, can visit: https://www.ctg.queensu.ca/patients/colorectal-cancer-clinical-trial-co33. 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. 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 Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Canadian Cancer Trials Group (CCTG) The Canadian Cancer Trials Group (CCTG) is a cancer clinical trials research cooperative that runs phase I–III trials to test anti-cancer and supportive therapies across Canada, and internationally. Headquartered at Queen’s University, CCTG has supported more than 700 trials enrolling 100,000 patients from 40 countries on 6 continents through a global network of 20,000 investigators and clinical trial staff. CCTG is the Canadian Coordinating Clinical Trial Network for the US NCTN and is a national program of the Canadian Cancer Society. CCTG’s aim is to improve survival and quality of life for all people with cancer. Learn more at cctg.ca. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 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. 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. Approximately 1,200 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. 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. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. 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 2024, 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.