FDA places hold on Phase I trials of MacroGenics' bispecific molecule due to hepatic events

MacroGenics Inc. (NASDAQ: MGNX) said FDA placed a partial clinical hold on two Phase I trials of MGD009 to treat cancer after the company reported hepatic adverse events in one of the trials that is evaluating MGD009 as monotherapy. MacroGenics said the events included reversible elevations of transaminases with or without concurrent elevations of bilirubin.

The second trial is evaluating MGD009 plus anti-PD-1 mAb MGA012. MDG009 is a bispecific molecule targeting CD3 and B7-H3 (CD276). The company said it plans to amend its existing MGD009 trials with additional supportive care to mitigate the hepatic adverse events...