Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105
Tuesday August 5, 8:00 am ET
Clinical study planned for advanced or recurrent solid tumors
PRINCETON, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1105, for the treatment of patients with selected advanced or recurrent solid tumors, specifically renal cell 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.
"We are pleased that another product candidate from our proprietary pipeline has progressed into clinical trials," said Howard H. Pien, President and CEO of Medarex. "We believe that our fully human anti-PD-1 and anti-PD-L1 antibodies represent the next stage in immunotherapy beyond the anti-CTLA-4 antibodies. We look forward to exploring the potential of MDX-1105 as a possible new treatment option for patients with cancer and infectious disease." |
