MedImmune, Inc. and Medarex Inc. have filed an investigational new drug application (IND) with the US FDA for MEDI-545, a fully human monoclonal antibody (MAb) targeting interferon-alpha. Preclinical data indicate that levels of interferon-alpha are elevated in many patients with active systemic lupus erythematosus (SLE or lupus) and other autoimmune disorders, and may be associated with disease activity. MEDI-545 binds to interferon-alpha and has been shown to neutralise its activity in preclinical studies.

"The growing body of data about the role of interferons in lupus disease activity supports MedImmune's approach to using this target for developing therapies that may reduce the effects of SLE, a disease for which treatment options are currently limited," said Anthony J. Coyle, MedImmune's senior director, research, and head, inflammation biology.

According to a company release, in November 2004, MedImmune entered into collaboration with Medarex to develop antibodies targeting interferon-alpha and the receptor to type I interferon, IFNAR1. The collaboration initially was to focus on two specific antibodies, one of which was MDX-1103, now known as MEDI-545. Under the terms of the agreement, MedImmune is currently fully responsible for all ongoing development activities.

Donald L. Drakeman, Medarex's president and chief executive officer said, "The entry of this antibody into a clinical programme would mark the twenty-fifth antibody utilising our UltiMAb technology in clinical studies."

MEDI-545 is a fully human antibody that is believed to target multiple interferon-alpha subtypes. Preclinical data indicate that MEDI-545 may suppress the abnormal immune activity associated with lupus by binding to the pattern of multiple interferon-alpha subtypes seen in the serum of lupus patients.