MiNK Therapeutics and University of Wisconsin–Madison Launch Phase 1 Clinical Trial of AgenT-797 to Prevent Graft-Versus-Host Disease

Trial Overview and Funding Support

The investigator-sponsored trial will be led by Dr. Hongtao Liu, MD, PhD, Associate Professor of Medicine at the University of Wisconsin School of Medicine and Public Health, alongside co-investigator Dr. Kalyan V. G. Nadiminti, MD. The study aims to evaluate the safety, tolerability, and preliminary efficacy of AgenT-797 in lowering the risk of graft-versus-host disease (GvHD), relapse, and other complications in patients with high-risk leukemias and other blood cancers.

Funding Sources

This trial is supported by two significant public-private funding awards:

• An NIH STTR grant from the National Institute of Allergy and Infectious Diseases (NIAID), which helps fund the preclinical development of AgenT-797.
• The Mary Gooze Clinical Trial Award from the University of Wisconsin–Madison, which funds enrollment and operational costs for the Phase 1 trial.

These awards facilitate the simultaneous execution of translational and clinical studies aimed at GvHD prevention using immunotherapies.

Implications for Patients and Clinical Advancements

GvHD is a leading cause of morbidity and mortality post-HSCT, impacting nearly half of transplant recipients. Dr. Jennifer Buell, PhD, President and CEO of MiNK Therapeutics, emphasized the importance of this trial, stating it expands their iNKT platform into GvHD, targeting significant complications of stem cell transplantation where current therapeutic options are insufficient.

Dr. Buell noted, "Our objective is to reduce GvHD and relapse while supporting immune reconstitution, potentially improving survival and quality of life for transplant patients—without the cytotoxic burden of lymphodepleting conditioning regimens."

AgenT-797 and Its Unique Benefits

AgenT-797 stands out as an off-the-shelf, donor-derived iNKT cell therapy, designed to operate without the need for lymphodepletion or human leukocyte antigen (HLA) matching, indicating a significant evolution in treatment options for those at risk of GvHD.

Research and Development Background

The collaboration includes support from the University of Wisconsin Carbone Cancer Center's More for Stage IV philanthropic fund, directly associating with the Mary Gooze Clinical Trial and Translation Award. This collaborative effort aims not only to conduct clinical trials but also to investigate the mechanisms through which iNKT cells can control leukemia.

Expert Insights and Future Directions

Dr. Hongtao Liu stated the study's focus, saying, "As a transplant physician, I see firsthand the toll GvHD takes on patients and families. This study aims not only to reduce this life-threatening complication but also to enhance immune reconstitution and mitigate relapse risk."

Additionally, Dr. Jenny Gumperz, a key researcher in iNKT biology, remarked, "Our research indicates that iNKT cells can restore immune balance and promote healthy engraftment. This trial signifies the culmination of years of translational work, enabling clinical evaluation of an innovative immune-regulating therapy for patients in need."

About MiNK Therapeutics

MiNK Therapeutics focuses on pioneering allogeneic iNKT cell therapies and precision-targeted immune technologies. Their lead candidate, AgenT-797, is currently undergoing clinical trials for GvHD, solid tumors, and acute pulmonary inflammation, utilizing a scalable cryopreserved manufacturing process.

Conclusion and Next Steps

The Phase 1 trial of AgenT-797 represents a significant landmark for MiNK Therapeutics (NASDAQ: INKT) and its partnership with the University of Wisconsin–Madison, aiming to address a critical unmet need in post-transplant care. Continuous updates regarding the trial's progress and results will be essential as the medical community seeks to improve outcomes for patients facing severe blood cancers.