Biopharma company Agios Pharmaceuticals, Inc. (AGIO) announced that it has initiated dosing patients for its phase I study on oncology candidate AG-221.
The study aims to enroll patients suffering from advanced hematologic malignancies with an isocitrate dehydrogenase-2 (IDH2) mutation, including acute myelogenous leukemia (:AML) and myelodysplastic syndrome.
The multicenter phase I study on AG-221 is being conducted to assess the safety and tolerability of AG-221 as a single agent administered orally twice daily in a 28-day cycle.
Agios is developing AG-221 in collaboration with Celgene Corporation (CELG) to treat patients with cancers that harbor IDH2 mutations.
We remind investors that Agios entered into a collaboration agreement with Celgene in Apr 2010 to develop drugs for cancer metabolism. The prime area of focus for Agios is cancer and the company has quite a few candidates in its pipeline to treat cancer and inborn errors of metabolism (:IEM).
We note that Agios filed an investigational new drug application (IND) for AG-221 in Jun 2013 which was subsequently accepted by the U.S. Food and Drug Administration (:FDA) in Jul 2013.
AG-221 is one of Agios’ most advanced oncology candidates. The other interesting candidate in Agios’ pipeline is AG-120, targeting mutant IDH1 and is expected to enter the clinic in 2014.
Since Agios does not have any marketed product in its portfolio, we expect investor focus to remain on updates of AG-221.