TregCel (TRK-001) / HAV Vaccines, Tract Therap, Taiwan Bio - LARVOL DELTA

Treg Therapy to Minimize Immunosuppression (IS) in Living Donor Kidney Transplant (LDKTx) (WTC 2025) - "This Ph 2 trial aims to establish the safety and efficacy of TRK-001 in LDKTx pts while allowing for reduction of IS to monotherapy. Positive findings have the potential to improve Tx outcomes for pts and will serve as a foundation for a subsequent Phase 3 trial."

Fibrosis • Immunology • Nephrology • Transplant Rejection • Transplantation

RETIRE: REgulatory T Cell Therapy to Achieve Immunosuppression REduction (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Tract Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2031 ➔ Jun 2031 | Initiation date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Mar 2027 ➔ Jun 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Transplantation

New anti-rejection drug approved for Phase II clinical trial in Taiwan... [Google translation] (stock.yahoo) - "Taibao Biomedical...announced on the 4th that its new drug TregCel (TRK-001) for preventing rejection of solid organ transplants has obtained approval from the US FDA for Phase II clinical trials and has also been approved by the Taiwan Food and Drug Administration (TFDA) for Phase II clinical trials, becoming the first new drug company in the country to simultaneously conduct multinational multicenter regulatory T cell clinical trials in the United States and Taiwan. TRK-001 is a new regulatory T cell drug jointly developed by Taibao Biomedical and its US partner TRACT. It has obtained approval from the US FDA to conduct a Phase II clinical trial of anti-rejection after kidney transplantation, and is expected to enroll 34 patients."

New P2 trial • Transplant Rejection

Taiwan Bio and TRACT Therapeutics, Inc. Announce Strategic Partnership to Advance a Novel Therapeutic Approach for Preventing Rejection in Solid Organ Transplant (Businesswire) - "Taiwan Bio and TRACT Therapeutics are pleased to announce a new strategic partnership to advance a cellular therapy to revolutionize the prevention of allograft rejection in solid organ transplant. The partners will launch a multi-center Phase 2 clinical trial investigating the reduction of immunosuppressant drugs in living donor kidney transplant recipients in both the United States and Taiwan....The Phase 2 clinical trial represents the first collaborative effort between the two companies, and further updates on the trial's progress will be shared in the coming months."

Licensing / partnership • New P2 trial • Transplant Rejection