Tonix Pharmaceuticals Publishes Phase 1 TNX-1500 Data Supporting Advancement into Phase 2 Kidney Transplant Rejection Study

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the publication of peer-reviewed Phase 1 data for TNX-1500, its investigational anti-CD40L monoclonal antibody, in the Journal of Clinical Immunology. The study highlighted favorable safety, tolerability and pharmacodynamic results in healthy volunteers, supporting the advancement of TNX-1500 into a planned Phase 2 investigator-initiated kidney transplant rejection study in the second half of 2026, pending FDA clearance.

The Phase 1 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 results are critical for the potential use of TNX-1500 in preventing kidney transplant rejection, a significant unmet medical need.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments. 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 is also advancing a pipeline of immunology programs, including TNX-1500 and TNX-4800 for Lyme disease prophylaxis.

The publication of this data marks an important milestone for Tonix as it continues to expand its immunology pipeline. For more information, visit the company's newsroom at https://ibn.fm/TNXP.

This press release was distributed by BioMedWire, a specialized communications platform focusing on the latest developments in the biotechnology, biomedical sciences and life sciences sectors. For more information, visit https://www.BioMedWire.com.