Partial Hold Lifted on MacroGenics Cancer Drug Trials

FDA has lifted a partial clinical hold against MacroGenics and its Phase 1 monotherapy and combination studies of cancer drug MGD009, a B7-H3 CD3 bispecific DART molecule. New patient enrollment has been cleared to proceed with the trials, the company says. The hold was placed 12/7/2018 following MacroGenics’ reporting of hepatic adverse events on the MGD009 trials to FDA. The company says it responded promptly to FDA concerns and the matter is now resolved.

MacroGenics describes MGD009 as a humanized molecule that recognizes both B7-H3 and CD3 and has a prolonged serum half-life. B7-H3 is a member of the B7 family of molecules involved in immune regulation and is over-expressed on a wide variety of cancer cells, including cancer stem cells, supporting tumor vasculature and underlying tissues, or stroma. “The intended mechanism of action of MGD009 is its ability to redirect T cells, via their CD3 component, to kill B7-H3-expressing cells.” it says.