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news.Medarex has announced the allowance of an investigational new drug application filed with the 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.
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The open-label, multi-dose, dose-escalation Phase I 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.
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.
Howard Pien, president and CEO of Medarex, said: “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.”