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news.US-based biopharmaceutical company Medarex has announced the allowance of an investigational new drug application filed with the FDA for MDX-1203, the company's first antibody-drug conjugate candidate generated from its proprietary technology.
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MDX-1203 is comprised of a potent cytotoxic prodrug chemically linked with a fully human anti-CD70 antibody. CD70 is expressed in renal cell carcinoma (RCC), leukemias, lymphomas and other cancers.
An open-label, multi-dose, dose-escalation Phase I clinical trial will be conducted in patients with RCC and non-Hodgkin’s lymphoma (NHL). The Phase I study will evaluate MDX-1203 for the treatment of advanced/recurrent RCC and relapsed/refractory B-cell NHL. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary distribution, metabolism and pharmacokinetics of MDX-1203.
Howard Pien, chairman and CEO of Medarex, said: Antibody-drug conjugates (ADCs) are another important and innovative therapeutic approach used to fight cancer by effectively and selectively killing tumor cells over-expressing specific tumor antigens, so we are extremely excited in achieving the investigational new drug filing for MDX-1203, the first candidate from our proprietary ADC technology platform.
We developed our ADC technology to have significant competitive advantages over existing technologies and the Phase I trial for MDX-1203 will be the first study to evaluate these potential benefits.