Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases

Core Insights - Tonix Pharmaceuticals announced positive topline results from its Phase 1 trial of TNX-1500, supporting the advancement to a Phase 2 trial for preventing kidney transplant rejection [1][2][4] - TNX-1500 demonstrated effective immune modulation by blocking primary and secondary antibody responses at doses of 10 mg/kg and 30 mg/kg [2][8] - The drug exhibited a favorable safety profile, with no serious adverse events reported [3][4] Group 1: Study Results - TNX-1500 was administered intravenously at doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg, with 26 participants enrolled [3] - The mean half-life of TNX-1500 was found to be 19.6 days at 3 mg/kg, 37.8 days at 10 mg/kg, and 33.7 days at 30 mg/kg, supporting monthly dosing [8] - The only treatment-emergent adverse event was mild aphthous ulcer, with no thromboembolic events reported [3][4] Group 2: Future Development - The company plans to discuss the Phase 1 results with the U.S. FDA in an End-of-Phase 1 meeting to align on the Phase 2 study [4] - TNX-1500 is being developed not only for kidney transplant rejection but also for autoimmune diseases and graft-versus-host disease [5][7] Group 3: Competitive Landscape - TNX-1500 is positioned as a next-generation anti-CD40L monoclonal antibody, designed to improve safety compared to first-generation therapies like ruplizumab [2][5] - The drug's design aims to preserve therapeutic activity while reducing the risk of thrombosis associated with earlier treatments [2][5]