Medarex, Inc, of Princeton, NJ, has announced the filing of an Investigational New Drug (IND) application in the Netherlands by its licensing partner, NovImmune SA of Geneva, Switzerland, for NI-0401, an antibody that targets the CD3 antigen for the treatment of organ transplant rejection as well as autoimmune diseases including Crohn's disease, multiple sclerosis, and rheumatoid arthritis. The antibody product was developed using Medarex's UltiMAb® technology.

NI-0401 is the first fully human antibody targeting the CD3 antigen, and may prove beneficial in the treatment of inflammatory and autoimmune diseases. NI-0401 may also induce long-term immune tolerance, which would allow control of these diseases over an extended period of time.

Medarex expects to receive an undisclosed milestone payment, and may receive future milestone payments and royalties if NI-0401 continues to progress through clinical development.

In May 2005, NovImmune granted Serono S.A. of Geneva, Switzerland, exclusive worldwide rights to develop and commercialize NI-0401 and NI-0501. NI-0501 targets interferon-gamma, a key cytokine involved in the regulation of immune and inflammatory responses. Interferon-gamma is overexpressed in autoimmune diseases such as systemic lupus erythematosus, Crohn's disease, and several forms of vasculitis.

Under the terms of the agreement with Serono, NovImmune is responsible for the development of the two products until the completion of phase IIa clinical trials, after which Serono will take over further development. 

—A. Techman