The FDA has accepted an investigational new drug (IND) application from Medarex, Inc., for MDX-1203, the company’s first antibody-drug conjugate (ADC).
The ADC is made of a potent cytotoxic prodrug chemically linked with an anti-CD70 antibody. CD70 is expressed in various cancers, including renal cell carcinoma (RCC), leukemias, and lymphomas.
The Princeton, N.J.-based company will sponsor a phase 1 clinical trial of MDX-1203 for the treatment of advanced/ recurrent RCC and relapsed/ refractory B-cell non-Hodgkin’s lymphoma.
It will be an open-label, multidose, dose-escalation study designed to establish and evaluate the safety, pharmacokinetics, and maximum tolerated dose.
“Antibody-drug conjugates are another important and innovative therapeutic approach used to fight cancer by effectively and selectively killing tumor cells overexpressing specific tumor antigens, so we are extremely excited in achieving the IND filing for MDX-1203,” said Howard H. Pien, chairman and CEO of Medarex.