TRACT Therapeutics
Clinical-stage biotechnology company developing autologous regulatory T cell therapies for solid organ transplant and autoimmune diseases. The organization develops a vein-to-vein cell therapy workflow that includes patient cell collection, ex vivo selection and expansion of regulatory T cells, cryopreservation and infusion, and has completed a Phase 1 kidney transplant trial. The company is part of a larger group with strategic manufacturing partnerships to support cGMP scale-up and global clinical development.
Industries
Nr. of Employees
small (1-50)
TRACT Therapeutics
Chicago, Illinois, United States
Products
Autologous regulatory T cell therapy (patient-derived expanded Tregs)
A personalized cell therapy produced from a patient’s own regulatory T cells that are isolated, expanded ex vivo, and administered intravenously to promote immune tolerance in organ transplant recipients and autoimmune disease patients.
TRK-001
A personalized regulatory T cell therapy product consisting of a patient's own regulatory T cells expanded in a laboratory and infused as a single dose to establish immune tolerance in solid organ transplant and autoimmune disease patients.
Autologous regulatory T cell therapy (patient-derived expanded Tregs)
A personalized cell therapy produced from a patient’s own regulatory T cells that are isolated, expanded ex vivo, and administered intravenously to promote immune tolerance in organ transplant recipients and autoimmune disease patients.
TRK-001
A personalized regulatory T cell therapy product consisting of a patient's own regulatory T cells expanded in a laboratory and infused as a single dose to establish immune tolerance in solid organ transplant and autoimmune disease patients.
Services
Design and execution of early-phase clinical studies, safety monitoring and biomarker assessment for patient-derived regulatory T cell therapies.
Coordination of process transfer to GMP manufacturing partners to enable larger-scale clinical production of autologous cell therapies.
Design and execution of early-phase clinical studies, safety monitoring and biomarker assessment for patient-derived regulatory T cell therapies.
Coordination of process transfer to GMP manufacturing partners to enable larger-scale clinical production of autologous cell therapies.
Expertise Areas
- Cell therapy manufacturing (autologous Treg products)
- Clinical trial management for early-phase cell therapies
- Translational immunology and Treg biology
- Regulatory strategy and orphan-drug interactions
Key Technologies
- Autologous regulatory T cell adoptive transfer
- Leukapheresis-based cell collection
- Ex vivo T cell selection and polyclonal expansion
- Cryopreservation and cold-chain logistics
News & Updates
Successful transfer of the regulatory T cell platform technology to an external GMP cell manufacturing facility to support a global Phase 2 clinical trial.
Poster presentation announcing Phase 2 study design and methods for regulatory T cell therapy to achieve immunosuppression reduction in living donor kidney transplant recipients.
Announcement that the investigational autologous regulatory T cell therapy received orphan-drug designation from the U.S. Food and Drug Administration for prevention of graft rejection following solid organ transplantation.
Completed Phase 1 living donor kidney transplant study reporting no infusion-related serious adverse events and two-year biopsies without rejection; associated increases in circulating regulatory T cells were observed.
Completed transfer of cell therapy manufacturing technology to an external GMP facility to support Phase 2 development.
Successful transfer of the regulatory T cell platform technology to an external GMP cell manufacturing facility to support a global Phase 2 clinical trial.
Poster presentation announcing Phase 2 study design and methods for regulatory T cell therapy to achieve immunosuppression reduction in living donor kidney transplant recipients.
Announcement that the investigational autologous regulatory T cell therapy received orphan-drug designation from the U.S. Food and Drug Administration for prevention of graft rejection following solid organ transplantation.
Completed Phase 1 living donor kidney transplant study reporting no infusion-related serious adverse events and two-year biopsies without rejection; associated increases in circulating regulatory T cells were observed.
Completed transfer of cell therapy manufacturing technology to an external GMP facility to support Phase 2 development.