Agios Pharmaceuticals AGIO announced its pipeline development strategy for its lead cancer metabolism and rare genetic metabolic disorders programs at its R&D Day. Agios does not have any approved product in its portfolio. The company currently has several candidates in its pipeline including the IDH2 mutant inhibitor – AG-221, IDH1 mutant inhibitor – AG-120 and the pan-IDH mutant inhibitor – AG-881.
These three candidates aim to improve treatment outcomes for patients whose cancer carries IDH mutations, including acute myeloid leukemia (AML) and glioma. Agios has a global, strategic collaboration with Celgene CELG for three of its candidates – AG-221, AG-120 and AG-881. The terms of the collaboration are different for each of them. While Celgene has worldwide development and commercialization rights to AG-221, it has only ex-U.S. rights to AG-120.
Agios announced the initiation of an international, multi-center, open-label, randomized phase III study (IDHENTIFY) to compare the efficacy and safety of AG-221 versus conventional care regimens in patients above 60 years with IDH2 mutant-positive AML that is refractory to or relapsed after second- or third-line therapy.
The company also announced a frontline combination development strategy involving AG-221 and AG-120. For newly diagnosed AML patients eligible for intensive chemotherapy, the company plans to initiate a phase Ib combination study of either AG-221 or AG-120 with standard induction and consolidation chemotherapy by the end of 2015. For newly diagnosed AML patients not eligible for intensive chemotherapy, the company plans to initiate a phase I/II combination study of either AG-221 or AG-120 with Celegene’s Vidaza in the first quarter of 2016.
The FDA has granted Fast Track designation to both AG-221and AG-120 in addition to an orphan drug status to AG-120.
Apart from these, Agios’ pipeline also includes a PKR activator, AG-348, currently being evaluated in a phase II study for pyruvate kinase deficiency. The company announced the development of its second PKR activator, AG-519. The company plans to initiate a phase I study on AG-519 by the first quarter of 2016.
However, several companies including AstraZeneca AZN and Roche RHHBY are actively engaged in the development of therapies in the field of cancer metabolism. These companies could develop drugs which may provide significant competition to Agios’ drugs (if approved).
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