MGA271: Phase I started

MacroGenics began the dose-expansion portion of an open-label, U.S. Phase I trial to evaluate 15 mg/kg IV MGA271 given for the first 3 weeks of a 4-week cycle in about 45 patients. The portion will enroll 3 cohort groups comprising 2 with specific tumor types and a third composed of other B7-H3-expressing tumor types. The start triggered a $10 million payment to MacroGenics from partner Servier (Neuilly-sur-Seine, France) under a November 2011 deal granting Servier the option to obtain an exclusive license to develop and commercialize MGA271 outside North America, Japan, Korea and India. Servier can exercise the option upon completion of the Phase I trial (see BioCentury, Dec. 5, 2011). MacroGenics said Servier indicated that it intends to evaluate MGA271 in 45 additional cancer patients representing additional tumor types starting next quarter.

The dose-escalating portion of the trial in 26 patients, representing 15 different tumor types, had 10 patients who received additional cycles of MGA271 and all had stable disease at the first tumor reassessment. The most frequent adverse events were mild or moderate infusion reactions, and no dose-limiting toxicity was observed. ...