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Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions
GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021 CHATHAM, N.J., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021 CHATHAM, N.J., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the World Intellectual Property Organization has published a patent application filed under the Patent Cooperation Treaty covering TNX-1500, a humanized monoclonal antibody (mAb) directed against CD40-ligand, which is also known as CD154, T-BAM, 5c8 antigen, TRAP and gp39. The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. WO 2021/001458 A1. If claims are granted, a patent issuing from a national stage of this application could potentially provide U.S. patent coverage for the TNX-1500 composition of matter through 2040 excluding possible patent term extensions or patent term adjustments. Tonix’s President and Chief Executive Officer, Seth Lederman, M.D. said, “Nearly 30 years ago my laboratory at Columbia University generated the first anti-CD40-ligand mAb (5c8), discovered and characterized human CD40-ligand and elucidated the molecular basis of T cell helper function1. Collaborating with a team at Biogen Inc., we determined the crystal structure of CD40-ligand2, developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Our studies and those of others generated a substantial body of evidence in humans and animals that indicates anti-CD40-ligand mAbs have the potential to be an important therapeutic option for preventing or treating transplant organ rejection and for treating autoimmune disorders.” Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called FcγRII, which resulted in an increased risk of thrombosis. Second generation anti-CD40-ligand mAbs had dramatically reduced binding to FcγRII, but had other issues, including decreased efficacy3-5. TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease FcγRII binding and the potential for thrombosis,...