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Medarex Announces Initiation of Phase 1b Clinical Development Program with MDX-1106 for the Treatment of Cancer
Date:11/24/2008

h and product development up to the completion of a Phase 2 clinical study in each party's territory. Thereafter, each company will be fully responsible for any continued development and any commercialization in its exclusive territory; Medarex's exclusive territory is North America, and Ono's exclusive territory is all areas outside of North America.

About MDX-1106/ONO-4538

MDX-1106/ONO-4538 is a novel fully human antibody designed to target and inhibit the function of PD-1 (programmed cell death 1), a receptor expressed on the surface of activated lymphocytes (T-cells). The binding of PD-1 with one of two ligands (PD-L1 or PD-L2) is an important negative regulation pathway that suppresses or inhibits activated lymphocytes. Recent research has noted increased PD-1 expression levels on antigen specific T-cells in both the oncology and chronic infectious disease settings, as well as a strong correlation between increased PD-L1 expression on tumors and a negative survival prognosis in cancer patients. Preclinical studies indicate that antibodies targeting the PD-1 signaling pathway reinvigorate antigen-specific T-cell responses and promote an immune response to fight tumors and infectious diseases.

As previously presented at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO), interim Phase 1 data in patients with recurrent or treatment-refractory cancer indicated preliminary evidence of anti-tumor activity or tumor regression in patients with recurrent or treatment-refractory cancer, as well as a favorable safety, tolerability and pharmacokinetic profile of single-dose MDX-1106. Data from the completed Phase 1 study are expected to be presented at an upcoming medical meeting.

MDX-1106/ONO-4538 is being investigated in both the oncology and infectious disease settings. In addition to the Phase 1b study in cancer, a Phase 1 trial is ongoing for the
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SOURCE Medarex, Inc.
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