Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 13

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1
Chunk 13
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 COVID-19 pandemic, we initiated a Phase 1 clinical trial evaluating agenT-797 for the treatment of moderate to severe viral acute respiratory distress syndrome (ARDS), a condition lacking approved therapies. The U.S. Food and Drug Administration ("FDA") has emphasized the importance of this indication, providing clear guidance on development approaches and specifying relevant patient populations. In a cohort of 21 mechanically ventilated patients, overall survival exceeded 70%, with an 80% survival rate observed specifically among patients (n=5) undergoing veno-venous extracorporeal membrane oxygenation ("VV ECMO"). These findings demonstrated a notable improvement compared to a 10% survival rate observed in the contemporaneous in-hospital control group. Comprehensive results from this study were published in Nature Communications in February 2024. Additionally, detailed clinical data highlighting translational and mechanistic insights from a complex severe ARDS case treated with agenT-797 were presented at the American Thoracic Society ("ATS") Annual Meeting in May 2024. Earlier data focused specifically on VV ECMO patients were also presented at the ATS Annual Meeting in 2023. Moving forward, we plan to advance agenT-797 for viral ARDS in an externally funded, large-scale platform trial. 

 2

In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced preclinical engineered programs are (1) MiNK-413, an IL-15 armored CAR-iNKT program targeting B cell maturation antigen ("BCMA"), and (2) MiNK-215, an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program. MiNK-413 has demonstrated tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies. MiNK-215 reported therapeutic activity in non-small cell lung cancer models, which resulted in substantial tumor elimination and improved survival compared to T cells alone. Data were reported at the 2023 American Society of Gene and Cell Therapy Annual Meeting. At the American Association for Cancer Research ("AACR") 2024 Annual Meeting, MiNK presented data that showcased MiNK-215’s activity in preclinical colorectal cancer models. In human organoid models of CRC with liver metastases, MiNK-215 potently enhanced tumor killing by T cells and was associated with depletion of immune suppressive FAP-expressing stellate cells and increased CD8+ T cell