Company: INKT
Filing Date: 2025-11-07
Form Type: S-3
Source: 0001193125-25-272532
Chunk: 36

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-11-07
Form: S-3
Chunk 36
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 targeting across cancers and complex immune pathologies.

Our lead product candidate, agenT-797, is an allogeneic, native iNKT cell therapy in development for
both oncology and immune-mediated diseases. In a clinical trial (NCT05108623) involving patients with treatment-refractory solid tumors, agenT-797 was evaluated as monotherapy and in combination with PD-1 inhibitors nivolumab or pembrolizumab. Treatment was associated with reductions in target and non-target lesions and durable disease stabilization, including a partial
response in a patient with checkpoint-refractory gastric cancer. AgenT-797 also demonstrated long-term persistence in the bloodstream—up to six months—without HLA matching or lymphodepletion. The
therapy was well tolerated, with no cases of cytokine release syndrome (CRS) or GVHD.

These data were presented at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting in 2024. Preclinical data from the same program demonstrated that agenT-797, when combined with bispecific engagers targeting MUC16, HER2, Claudin 18.2, or DLL3,
enhanced tumor cell killing, T cell activation, and reduced exhaustion markers—supporting potential future combination strategies.

Further peer-reviewed data support the clinical activity of agenT-797. A case report published in
Oncogene in January 2024 described a patient with metastatic gastric cancer who achieved a 42% tumor reduction and more than nine months of progression-free survival after a single infusion of
agenT-797 plus nivolumab. More recently, on July 11, 2025, a landmark Oncogene publication reported a complete and durable remission in a patient with metastatic, treatment-refractory testicular
cancer. This patient, who had progressed on multiple prior therapies including chemotherapy, autologous stem cell transplant, and checkpoint blockade (anti–PD-1,

S-1

anti–CTLA-4, anti–TIGIT), received a single infusion of agenT-797 with nivolumab. The patient achieved
complete clinical, radiographic, and biochemical remission, with no evidence of disease more than two years later. Donor iNKT cells were detected in circulation for up to six months, and the regimen was well tolerated.

Based on these findings, a clinical trial (NCT06251973) is actively enrolling patients with previously