Agios gains on Phase I data for AG-221
Agios Pharmaceuticals Inc. (NASDAQ:AGIO) gained $9.87 (28%) to $45.35 on Monday after presenting preliminary data at the American Association for Cancer Research meeting in San Diego from an open-label, dose-escalation Phase I trial evaluating AG-221 to treat advanced hematologic malignancies with an isocitrate dehydrogenase 2 (IDH2) mutation. In seven evaluable patients in the first two cohorts of the trial, twice-daily 30 and 50 mg oral AG-221 led to three complete remissions, two complete remissions with incomplete platelet recovery (CRp) and one partial response. AG-221 was well tolerated with no dose-limiting toxicities (DLTs) reported.
The trial has enrolled 22 patients in four cohorts to receive twice-daily 30, 50 or 75 mg AG-221 or once-daily 100 mg AG-221, an inhibitor of mutated IDH2. Agios said the maximum tolerated dose (MTD) has not yet been reached. Disease-specific expansion cohorts are slated to begin enrollment late this year at the MTD or biologically-relevant dose. ...