Agios Pharmaceuticals, Inc. AGIO announced that it has dosed the first patient in a phase I, multi-center, open-label, dose-escalation and expansion study on single agent AG-881, a second generation IDH inhibitor. The study will evaluate the safety, clinical activity, pharmacokinetics and pharmacodynamics of the candidate in patients with advanced solid tumors with an IDH mutation.
The first part of the phase I study is a dose escalation phase. Patients will receive ascending oral doses of AG-881 to determine the maximum tolerated dose (MTD) as well as the recommended phase II dose based on safety and tolerability. The second part of the study will be a dose expansion phase which will evaluate the safety and tolerability of the candidate as well as the clinical activity of the recommended phase II dosage.
AG-881 is scheduled to move into a second dose-escalating and expansion trial in patients with advanced IDH1 or IDH2 mutant-positive hematologic malignancies whose cancer has progressed on a prior IDH inhibitor therapy, shortly.
AG-881 is the third program in the company’s IDH mutant inhibitor portfolio to enter the clinic in less than two years. The other two IDH mutant inhibitors under development are AG-120 (IDH1 inhibitor) and AG-221(IDH2 inhibitor).
Earlier this month, Agios presented data from ongoing phase I studies on AG-221 and AG-120 in patients with advanced hematologic malignancies. The company intends to begin combination trials to evaluate both AG-221and AG-120 in patients with acute myelogenous leukemia (AML) and a broad range of hematologic malignancies in the second half of 2015. It is also looking to initiate global registration-enabling phase III studies for AG-221 and AG-120 in the second half of 2015 and the first half of 2016, respectively.
The FDA had granted Fast Track designation to both AG-221and AG-120 in addition to an orphan drug status to AG-120.
Agios is developing all three candidates under a collaboration agreement with Celgene Corporation CELG which dates back to Apr 2010.
Per the agreement on AG-881, both companies are to receive equal profits. Agios is also eligible to receive regulatory milestone payments of up to $70 million.
Agios currently carries a Zacks Rank #2 (Buy). Gilead Sciences Inc. GILD and Hospira Inc. HSP are also well-placed stocks in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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