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TNX-1500 is a Fc-modified humanized monoclonal antibody that targets CD154 (also known as CD40 ligand). It functions as an immunomodulator by binding and functionally inhibiting CD40L, thereby modulating immune responses. TNX-1500 is being developed primarily for the prevention of allograft and xenograft rejection, prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation, and treatment of autoimmune diseases such as systemic lupus erythematosus, Sjogren’s syndrome, rheumatoid arthritis, multiple sclerosis, and allergy. The drug was engineered to improve safety over first-generation anti-CD40L antibodies by reengineering the Fc region to reduce thrombosis risk while preserving activity. It is administered intravenously and has demonstrated favorable pharmacokinetics with a half-life supporting potential monthly dosing. The drug is currently in clinical development with positive Phase 1 trial results showing good tolerability, safety profile without thromboembolic events reported, and effective immune modulation in healthy subjects.
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