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NovImmune seeks to move autoimmune drug into clinic

Medarex's licensing partner NovImmune has filed an investigational new drug application in the Netherlands for NI-0401 for the treatment of autoimmune disease.

NI-0401 is a fully human antibody that targets the CD3 antigen, a key regulator in the activation of T-cells. The proliferation of activated T-cells is a hallmark of many autoimmune diseases, including insulin-dependent diabetes, Crohn’s disease, multiple sclerosis and rheumatoid arthritis, and of organ transplant rejection.

The product candidate, which is believed may have therapeutic potential in a broad range of autoimmune diseases, was developed using Medarex’s UltiMAb technology. Medarex expects to receive an undisclosed milestone payment and may receive future milestone payments and royalties should this product candidate progress through clinical development.

“We are pleased with the progress that our partner, NovImmune, has achieved in filing an investigational new drug application (IND),” said Donald Drakeman, president and CEO of Medarex. “With the advancement of the NovImmune antibody into clinical trials, there are now twenty nine fully human antibodies generated from Medarex’ technology that are in clinical development by Medarex and its partners.”