MiNK Therapeutics Presents Clinical Activity and Long-Term Persistence of Allogeneic iNKT Cells in Solid Tumors at SITC 2023

• Clinical responses and durable activity with agenT-797 monotherapy and in combination with anti-PD-1
• First-of-a-kind persistence for an allogeneic cell therapy, with agenT-797 detected for up to 6 months without toxic pre-conditioning
• AgenT-797 advancing in a randomized phase 2 trial in 2L gastric cancer

NEW YORK, Nov. 03, 2023 (GLOBE NEWSWIRE) — 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 presented new agenT-797 data in solid tumor cancers at the Society for Immunotherapy of Cancer’s (SITC) 38^th Annual Meeting.

“These findings underscore the unique benefits of allogeneic unmodified iNKT cells, including their ability to amplify and accelerate immune response, promote tumor infiltration, and persist without toxic pre-conditioning in heavily pre-treated solid tumor cancers,” said Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. “AgenT-797 has the potential to overcome key barriers in cancer resistance and MiNK is committed to delivering these cells at scale for patients with cancer and other immune-mediated diseases.”

Single administration of agenT-797 alone or in combination with anti-PD-1 delivered clinical benefit in heavily pre-treated patients with solid tumors.

• Phase 1 trial of agenT-797 alone or in combination with pembrolizumab or nivolumab without lymphodepletion (n=34) showed durable clinical benefit, including:
  • Clinical response in MSI-high 3L gastric cancer patient after failure on pembrolizumab and nivolumab/FOLFOX.
  • Long-term disease stabilization (n=10), including in testicular cancer (SD 9 months) and anti-PD-1 relapsed/refractory non-small-cell lung cancer (SD > 10 months).
  • Tolerable safety profile with no dose-limiting toxicities and no grade >3 neurotoxicity or cytokine release syndrome.

AgenT-797 showed long-term persistence and induced a potent anti-tumor response, including increased infiltration of cytotoxic immune cells into tumors.

• AgenT-797 was detected in the periphery for up to 6 months and persistence was independent of HLA matching.
• An increased level of immune cell tumor infiltration and neoantigen driven expansion of anti-tumor cytotoxic T cells was observed following administration.
• AgenT-797 promoted a systemic and local pro-inflammatory cytokine signature.

Expansion of clinical programs are underway in additional solid tumor settings, including relapsed/refractory gastric cancer.

• Expected launch of a randomized phase 2 trial in 2L gastric cancer, led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center, by year-end 2023. The study will evaluate agenT-797 in combination with standard of care chemotherapy +/- Agenus’ botensilimab/balstilimab combination.
• Expansion of phase 1 study underway to evaluate further signals in select tumor types, including non-small cell lung cancer and testicular cancer, and evaluate multi-dosing of agenT-797.

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 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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