Tonix Pharmaceuticals Collaborates With Massachusetts General Hospital For Phase 2 Study Of TNX-1500 In Kidney Transplant Patients

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a commercial-stage biotechnology company, has announced a collaboration with Massachusetts General Hospital (MGH), a member of Mass General Brigham, to conduct a Phase 2 clinical trial of TNX-1500, an Fc-modified anti-CD40L monoclonal antibody (mAb), in kidney transplant recipients. The investigator-initiated trial, led by Dr. Ayman Al Jurdi at MGH, aims to evaluate the safety, tolerability, and effectiveness of TNX-1500 in preventing transplant rejection while reducing the need for conventional immunosuppressive drugs, which often carry serious long-term side effects such as infection and cardiovascular issues.

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, stated that the partnership with MGH will accelerate the development of TNX-1500, a candidate designed to block the function of cell-associated CD40L. The antibody has demonstrated favorable activity and tolerability in preclinical models and early-stage human studies, supporting monthly dosing. Tonix aims to establish TNX-1500 as a potential monotherapy capable of improving transplant outcomes by minimizing immunosuppressive burden.

Following institutional review board (IRB) approval and FDA clearance of an investigator-initiated investigational new drug application (IND), the open-label Phase 2 study will enroll five adult kidney transplant patients at MGH. Participants will receive induction therapy with anti-thymocyte globulin, TNX-1500, tacrolimus, and corticosteroids, with the latter tapered by Day 33. TNX-1500 will continue for 12 months, with potential extension, while tacrolimus will be reduced and discontinued by the end of the study. The primary endpoint will assess safety and adverse events over 12 months, with secondary measures including graft survival and renal function. The trial is expected to begin in the first half of 2026.