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Agios Reports New Data on Hematologic Malignancy Drugs - Analyst Blog

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Agios Pharmaceuticals, Inc.AGIO announced new data from the dose-escalation phase and expansion cohorts from the ongoing phase I study evaluating a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-2(IDH2), AG-221, in advanced hematologic malignancies.

As of May 1, 2015, data from the study revealed that advanced hematologic malignancies treated with AG-221 showed durable clinical activity and a favorable safety profile. The study had an overall response rate of 40% and a complete remission rate of 16%.

Agios plans to continue to advance AG-221 and initiate combination studies to evaluate AG-221 as a potential frontline treatment for patients with acute myeloid leukemia (AML) and a broad range of hematologic malignancies in the second half of 2015. The company also plans to initiate a worldwide phase III registration-enabling study in relapsed/refractory AML patients who harbor an IDH2 mutation in the second half of 2015 and continue dose escalation in the phase I/II study in patients with advanced solid tumors, including glioma and angioimmunoblastic T-cell lymphoma who carry an IDH2 mutation in 2015.

Meanwhile, Agios announced new data from the ongoing phase I study evaluating a first-in-class, oral, selective, potent IDH1 drug, AG-120, for advanced hematologic malignancies. As per available data (as of May 1, 2015), the study had an overall response rate of 31% and a complete remission rate of 15%.

We remind investors that Agios has a collaboration agreement with Celgene Corporation CELG for both AG-221 and AG-120.

Apart from AG-221 and AG-120, Agios also reported new, final data from its phase I multiple ascending dose study of AG-348 in healthy volunteers. Data from the study supports the hypothesis that AG-348 enhances pyruvate kinase-Ractivity and has the potential to correct the underlying defect of pyruvate kinase deficiency. The company plans to initiate enrollment for the DRIVE PK phase II study on AG-348.

Agios currently carries a Zacks Rank #2 (Buy). Other well-placed stocks in the health care sector include Actelion Ltd. ALIOF and Gilead Sciences Inc. GILD . Both sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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