Tonix Pharmaceuticals Publishes Phase 1 TNX-1500 Data, Paving Way for Kidney Transplant Study
Tonix Pharmaceuticals announced publication of Phase 1 data for TNX-1500, an anti-CD40L monoclonal antibody, showing favorable safety and pharmacodynamics, supporting advancement to a Phase 2 kidney transplant rejection study.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has published peer-reviewed Phase 1 data for TNX-1500, its investigational anti-CD40L monoclonal antibody, in the Journal of Clinical Immunology. The data highlight favorable safety, tolerability and pharmacodynamic results in healthy volunteers, supporting the advancement of the drug candidate toward a planned Phase 2 investigator-initiated study for kidney transplant rejection in the second half of 2026, pending FDA clearance.
The study found that TNX-1500 was generally well tolerated with no serious adverse events. It demonstrated sustained suppression of T cell-dependent antibody responses and showed a half-life that supports monthly intravenous dosing. These findings are critical as they indicate the potential for TNX-1500 to be a convenient and effective treatment for preventing organ rejection in transplant patients.
According to the press release, Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. The company’s recently approved flagship medicine, TONMYA™ (cyclobenzaprine HCl sublingual tablets 2.8mg), is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®.
Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. Additionally, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. In immunology, Tonix is advancing a pipeline that includes monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.
The advancement of TNX-1500 into Phase 2 represents a significant step forward for Tonix’s immunology pipeline. Kidney transplant rejection remains a major challenge in transplantation medicine, and effective prophylactic treatments are needed. The favorable safety profile and dosing convenience of TNX-1500 could offer a new option for patients if approved.
Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. For more information on the latest news and updates relating to TNXP, visit the company’s newsroom at https://ibn.fm/TNXP. The full press release can be viewed at https://ibn.fm/DHiKX.