MacroGenics Announces Removal of Partial Clinical Hold on MGD009 Program by FDA

MacroGenics (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase 1 monotherapy and combination studies of MGD009, a B7-H3 × CD3 bispecific DART molecule.

As quoted in the press release:

Enrollment of new patients in the U.S. has been cleared to proceed with these trials. MacroGenics previously announced on December 7, 2018, that the FDA had placed the program on partial clinical hold following MacroGenics’ reporting of hepatic adverse events on the MGD009 trials to the FDA. During the partial clinical hold, previously enrolled study participants were allowed to continue to receive drug at their pre-assigned dose.

“The MacroGenics team worked diligently and rapidly to provide a comprehensive response to the FDA in late December. As a result, we have been able to resolve the partial clinical hold without significant delay to this clinical program,” stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “The partial clinical hold did not involve our other B7-H3 programs, and, in fact, during the partial hold, we completed enrollment of the first dose escalation cohort for MGC018, our B7-H3-targeted ADC.”

Click here to read the full press release.