Phase I

Phase II

Phase III

Organ Transplant Rejection / Autoimmune Disorders
Phase I — Clinical phase complete


TNX-1500 is a humanized monoclonal antibody (mAb) directed against CD40-ligand, which is also known as CD154, T-BAM, 5c8 antigen, TRAP and gp39. TNX-1500 incorporates the antigen binding fragment (Fab) region of hu5c8 (recombinant monoclonal antibody to CD40-ligand), that has been extensively characterized at the molecular level in complex with the CD40-ligand. TNX-1500 is being studied and evaluated for its role in preventing or treating organ transplant rejection and for treating autoimmune disorders.

The CD40-ligand is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function. CD154 is a member of the Tumor Necrosis Factor (TNF) Super Family. No mAb against CD154 has been approved for commercial use anywhere in the world. Other TNF Super Family members have been successfully targeted by antagonist mAbs.

Tonix is collaborating with Mass General Hospital on heart and kidney transplantation in non-human primates.


First Generation: Development halted due to thromboembolic (TE) complications—blood clots—traced to Fc gamma receptor (FcγR)

Second Generation: Eliminated the FcγR TE complication but potency and half life was reduced, limiting utility

Third Generation: Re-engineered to better modulate the binding of FcγR while preserving FcRn function

Expected to deliver efficacy without compromising safety


TNX-1500 is an investigational new biologic and has not been approved for any indication.