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Aug 6, 2008

Medarex : Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105

Aug. 5, 2008 - Medarex, Inc. (Nasdaq: MEDX)announced today the allowance of an investigational new drug application (IND) filedwith the U.S. Food & Drug Administration (FDA) forMDX-1105, for the treatmentof patients with selected advanced or recurrent solid tumors, specifically renalcell carcinoma, melanoma, non-small cell lung cancer or epithelial ovarian cancer. MDX-1105 is a fully human antibody that targets the PD-L1 pathway to promote enhanced T-cell immune responses against cancer and reverse T-cell inactivation in chronic infectious disease.
The open-label, multi-dose, dose-escalation Phase 1 clinical trial is expected to enroll up to 46 patients with selected advanced or recurrent solid tumors. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics and efficacy, of MDX-1105... Medarex's Press Release -