INKT MiNK Therapeutics Inc

MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced the first patient dosed in a Phase 2 investigator sponsored study for agenT-797 in second line gastroesophageal cancer, led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center. The trial builds upon findings from MiNK’s recently published clinical trial (Carneiro et al. 2024 Oncogene) demonstrating that agenT-797 appears to overcome resistance to immune checkpoint inhibitors, with durable disease stabilization and a confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer.

“This study is an important step in new treatment combinations to improve outcomes for patients with refractory gastric cancers, an incurable disease with limited response to available therapies,” said Dr. Yelena Janjigian, Chief Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center. "AgenT-797, an off-the-shelf iNKT cell-based therapy, has shown the capacity to target cancerous cells in diseased tissues and is compatible with immune checkpoint inhibitors. This study builds upon the promising outcomes observed with iNKTs in gastric cancer and with botensilimab/balstilimab in GI cancers. By harnessing the immune-enhancing potential of agenT-797, we aspire to improve outcomes for a greater number of patients facing challenging GI cancers."

This Phase 2 Study will evaluate the clinical safety and efficacy of the combination of agenT-797 (iNKT cells), botensilimab, a novel fc-enhanced CTLA-4 inhibitor, plus balstilimab (anti-PD-1) with ramucirumab and paclitaxel for patients with previously treated, advanced esophageal, gastric, or gastro-esophageal junction (GEJ) adenocarcinoma. The study aims to enroll around 38 patients with advanced, unresectable, or metastatic forms of these cancers who have experienced disease progression after initial treatment.

"We are thrilled to collaborate with GI cancer expert Dr. Yelena Janjigian on this Phase 2 study, furthering the development of agenT-797 in refractory gastric cancer," stated Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. "This study is designed to provide crucial insights into the clinical efficacy of agenT-797, while also assessing its potential synergies with chemotherapy and next-generation immune checkpoint inhibitors, botensilimab and balstilimab. This milestone underscores our unwavering commitment to advancing iNKT cell therapies to address the pressing unmet needs in cancer care and highlights the strength of our collaboration with Agenus to access these novel and exciting combinations to deliver meaningful benefits to our patients."

About Botensilimab

Botensilimab is Agenus’ investigational multifunctional anti-CTLA-4 immune activator (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 750 patients have been treated with botensilimab 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 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 and curative potential of agenT-797 and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797 alone and in combination with other therapeutic candidates, for instance, anti-CTLA-4 and anti-PD-1, the anticipated benefits of agenT-797 and clinical development plans and timelines. 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 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.

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Media Contact781-674-4428communications@minktherapeutics.com