Company: INKT
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001193125-25-282905
Chunk: 5

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Item 2
Chunk 5
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, native iNKT cell therapy. iNKTs are a potent class of immune cells and serve as master regulators of immune response, possessing the killing power of NK cells and the memory of T-cells. Our proprietary manufacturing platform enables the infusion of these cells in billion-fold quantities, equipping the immune system to combat cancer and other life-threatening diseases. We have successfully established and launched in-house iNKT cell manufacturing and product release capacity, capable of supplying over 5,000 doses annually through a U.S. Food and Drug Administration (“FDA”)-cleared, scalable, fully closed, and automated process.

Our clinical development of agenT-797 is advancing in multiple therapeutic areas of significant unmet needs. These include a Phase 2 trial in 2L gastric cancer and viral acute respiratory distress syndrome (“ARDS”) in populations of patients where there are critical gaps in current treatment options.

In solid tumors, we have completed a Phase 1 trial of agenT-797 in both monotherapy and combination settings with anti-PD-1 checkpoint inhibitors pembrolizumab and nivolumab. The trial demonstrated durable clinical benefit with a favorable safety profile across heavily pre-treated cancers, including non-small cell lung cancer ("NSCLC"), testicular cancer, and gastric cancer. Median progression-free survival exceeded six months, and approximately 30% of patients achieved durable disease stabilization, including in cancers refractory to prior anti-PD-1 therapy.

Nature Oncogene highlights two landmark cases from this program, the most recent of which was published in July 2025:

•A patient with refractory metastatic testicular cancer who achieved a durable complete remission following a single infusion of agenT-797 in combination with checkpoint blockade after failing multiple lines of therapy, including platinum chemotherapy and immune checkpoint inhibitors. The patient remains disease-free more than two years post-treatment.

•A patient with advanced gastric cancer who achieved a durable partial response with agenT-797 plus checkpoint blockade, with meaningful tumor reduction and sustained disease control despite prior progression on standard therapies.

Building on these results, a randomized, Phase 2 investigator-sponsored trial led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center is actively enrolling patients with previously treated, advanced esophageal, gastric, or gastroesophageal junction adenocarcinoma. This study is evaluating a combination regimen of agenT-797, botensilimab (a novel Fc-enhanced CTLA-4 inhibitor),