Tonix Concludes Phase 1 Clinical Trial of TNX-1500 in Volunteers

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical corporation, has finished the clinical phase of its Phase 1 trial for TNX-1500, a humanized monoclonal antibody (mAb) designed to prevent organ transplant rejection and treat autoimmune diseases. This study, which assessed single escalating doses in healthy individuals, aims to address the significant need for better treatments in organ transplantation. The trial tested the antibody in three dosage groups and monitored participants for 120 days.

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, highlighted the need for improved transplant therapies and emphasized the potential of TNX-1500 to improve graft survival while minimizing thrombosis risks present in earlier mAbs. Preclinical tests in non-human primates showed promising results without thrombotic issues.

TNX-1500, which interacts with CD40-ligand, may also benefit patients with autoimmune diseases. The trial is expected to continue into a Phase 2 trial involving kidney transplants, with initial results anticipated in the third quarter of 2024.

Other companies are also working on anti-CD40L therapies. Sanofi reported positive outcomes using their own Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis. Eledon Pharmaceuticals is developing tegoprubart for kidney transplant rejection prevention.

Overall, TNX-1500 and similar therapies may represent a significant improvement in the management of transplant rejection and potentially other serious health conditions.

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