Tonix Pharmaceuticals Publishes Positive Phase 1 Data for TNX-1500 in Kidney Transplant Rejection Prevention

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has published peer-reviewed Phase 1 clinical trial data for TNX-1500, its investigational anti-CD40L monoclonal antibody, in the Journal of Clinical Immunology. The study, conducted in healthy volunteers, demonstrated a favorable safety and tolerability profile with no serious adverse events, along with sustained suppression of T cell-dependent antibody responses. The findings support advancement of TNX-1500 into a Phase 2 investigator-initiated study for the prevention of kidney transplant rejection, expected to begin in the second half of 2026, pending FDA clearance.

The Phase 1 trial evaluated TNX-1500 in healthy subjects and found that the drug was generally well tolerated. Key pharmacodynamic results showed sustained suppression of antibody responses, and the half-life of TNX-1500 supports monthly intravenous dosing, which could offer a convenient treatment regimen. These data are critical for moving forward into a patient population that faces significant unmet medical needs in transplant rejection prophylaxis.

“The publication of these Phase 1 data in the Journal of Clinical Immunology underscores the potential of TNX-1500 as a promising therapy for preventing kidney transplant rejection,” said a company spokesperson. The full press release is available at https://ibn.fm/DHiKX.

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 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. The company is also advancing a pipeline of immunology programs, including 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 is significant given the high unmet need in kidney transplantation. Current immunosuppressive therapies have limitations, including toxicity and risk of infection. TNX-1500’s mechanism as a CD40 ligand inhibitor aims to modulate the immune response more selectively, potentially improving outcomes for transplant recipients. The planned Phase 2 study will be an investigator-initiated trial focused on evaluating TNX-1500’s efficacy in preventing kidney transplant rejection.

For more information on Tonix Pharmaceuticals, visit the company’s newsroom at https://ibn.fm/TNXP.