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Ono and Medarex Announce Allowance of Investigational New Drug Application for Fully Human Anti-PD1 Antibody
Date:10/29/2007

with cancer is currently progressing well and that this exploratory Phase I study in HCV may be a step toward potentially adding new infectious disease indications for therapeutic blockade of this important T cell regulatory molecule."

About MDX-1106/ONO-4538

PD-1 (programmed cell death 1) is one of the receptors expressed on the surface of activated lymphocytes (T-cells) and is involved in the system of negative regulation for the suppression of activated lymphocytes. An increasing number of studies have reported that tumor cells and certain chronic viruses, including HCV, may use the PD-1 pathway to evade host adaptive immune responses (which protect the host from both harmful pathogens and tumors), suggesting that blockade of the negative regulatory signal mediated by PD-1 may promote the host immune response to recognize tumor cells as foreign and eliminate viral pathogens. Preclinical studies suggest that blockade of the PD-1 signaling pathway by MDX-1106/ONO-4538, a fully human anti-PD-1 antibody, activates T-cell responses and promotes an immune response to fight tumors and infectious diseases. Medarex and Ono Pharmaceutical continue to investigate the potential of MDX-1106/ONO-4538 for cancer in an ongoing Phase I clinical trial and for hepatitis C.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. More than 30 of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials,
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SOURCE Medarex, Inc.
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