Tonix files patent for proprietary monoclonal antibody

By The Science Advisory Board staff writers

January 14, 2021 -- Tonix Pharmaceuticals has filed a patent application for TNX-1500, a humanized monoclonal antibody (mAb) directed against the CD40-ligand, with the World Intellectual Property Organization.

If the claims are granted, a patent could potentially provide U.S. patent coverage for the TNX-1500 composition of matter through the year 2040, excluding possible patent term extensions or patent term adjustments.

The third-generation anti-CD40-ligand mAb was designed by protein engineering to decrease crystallizable fragment receptor (FcγRII) binding and the potential for thrombosis, while retaining efficacy, according to the company. TNX-1500 incorporates the antigen binding fragment (Fab) region of hu5c8, which has been extensively characterized, including at the atomic level in complex with the CD40-ligand.

The patent application includes claims related to proprietary anti-human CD40-ligand mAbs that were engineered to have modified effector functions, including TNX-1500, which have a reduced potential for Fc binding to FcγRII. It also claims uses of TNX-1500 for the prevention and treatment of conditions, such as organ transplant rejection and autoimmune disorders.

The company expects good manufacturing practice production of TNX-1500 to begin in the third quarter of 2021.

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