Tonix Pharmaceuticals Presented an Update on Fc-modified anti-CD40L mAb, TNX-1500, at the 61st Annual Congress of the Japan Society for Transplantation
October 14, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Tonix Pharmaceuticals, biomarkers, clinical trials, immunomodulation, monoclonal antibodies
14 October 2025 — New Jersey, US — Tonix Pharmaceuticals Holding Corp, a fully integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled “The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Transplantation,” at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9–11, 2025, in Nagoya, Japan. The CD40-ligand (CD40L) is also known as CD154. A copy of the Company’s presentation is available under the Presentations tab of the Tonix website at https://ir.tonixpharma.com/presentations.
“We are encouraged by the favorable safety and biomarker data from the Phase 1 study, which support the continued development of TNX-1500 as a novel immunomodulatory approach in transplantation and autoimmune diseases,” said Dr. Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals. “Dimeric TNX-1500 was designed to target cell-associated CD40L, which we believe plays important roles in organ rejection. We look forward to engaging further with the transplantation and immunology communities as we move into next-stage studies.”
Dr. Lederman added, “Several studies have shown that anti-CD40L treatment of animals with transplanted organs is associated with an increase in the number and activity of T-regulatory cells (“T regs”). We are excited that Mary Brunkow, Fred Ramsdell and Shimon Sakaguchi were awarded the Nobel Prize in Physiology or Medicine 2025 for the discovery and characterization of these T regs and their role in peripheral immune tolerance just a few days before the conference. The growing recognition of the significance of T regs in the immune response has driven our interest in pursuing anti-CD40L treatment to prevent organ transplant rejection.”
Dr. Lederman’s presentation highlighted his discovery of CD40L as a therapeutic target, the evolution of anti-CD40L therapeutic monoclonal antibodies and featured data from the completed Phase 1 study of TNX-1500, Tonix’s third-generation Fc-modified dimeric anti-CD40L monoclonal antibody. The talk reviewed the molecule’s design to minimize thromboembolic risk while maintaining immunomodulatory activity, presented Phase 1 safety and pharmacodynamic results, and outlined next steps toward Phase 2 development for the prevention of kidney transplant rejection and the treatment of autoimmune indications.
Dr. Lederman’s presentation was part of a morning breakfast seminar sponsored by Tonix and chaired by Professor Takaaki Kobayashi, from Aichi Medical University School of Medicine, that included presentations by two academic Tonix collaborators: a presentation by Harvard Professor and Massachusetts General Hospital (MGH) surgeon Richard Pierson III titled, “CD154/CD40 blockade with Fc-modified anti-CD154 mAb for heart transplantation” and a presentation by Harvard Professor and MGH surgeon Tatsuo Kawai titled, “CD154/CD40 blockade with Fc-modified anti-CD154 for kidney transplantation.”
About Tonix Pharmaceuticals
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal potentiated oxytocin with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Visit: www.tonixpharma.com.
