Agios' (AGIO) Partner Celgene to File for Enasidenib, Stock Up

Agios Pharmaceuticals, Inc.’s AGIO shares were up almost 26% after the company revealed, in an 8-K filing, that its collaboration partner Celgene Corporation CELG will submit a new drug application (NDA) for enasidenib (AG-221) for the treatment of patients with relapsed and/or refractory acute myeloid leukemia (AML) by the end of 2016.

Enasidenib is a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-2 (IDH2). The NDA will be based on data from the ongoing phase I/II study on enasidenib, which is being conducted in patients with advanced hematologic malignancies with an IDH2 mutation. The study comprises a dose-escalation phase and five expansion cohorts, all of which have completed patient accrual.

Agios has also disclosed that patients with isocitrate dehydrogenase 1 (IDH1) mutant-positive AML, whose disease has progressed after standard therapies, have limited treatment options. The company thus intends to look for a similar regulatory path for another candidate, AG-120 (IDH1 mutant inhibitor). It plans to file for an FDA approval for AG-120 in 2017. The company plans to provide a regulatory update on AG-120 by the end of 2016.

In May 2016, Agios and Celgene announced a new global strategic collaboration focused on metabolic immuno-oncology for the discovery, development and commercialization of novel therapies utilizing Agios’ innovative cellular metabolism research platform. The companies also agreed to amend certain rights under their 2010 collaboration, with Agios gaining full global development and commercialization rights to AG-120. Previously, Agios only had U.S. rights to AG-120. No other changes were made to the IDH partnership (which covers enasidenib and AG-881) between Agios and Celgene.

Note that AG-881, which targets both mutated IDH1 and mutated IDH2, is currently in phase I dose-escalation and expansion studies in IDH mutant-positive hematologic malignancies and positive solid tumors.

Agios had entered into a discovery and development collaboration and license agreement focused on targeting cancer metabolism with Celgene in Apr 2010.

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We are encouraged by the latest development. Should enasidenib gain approval, Agios will be entitled to receive milestone payments and royalties from Celgene.

Agios also has a couple of pyruvate kinase deficiency candidates – AG-348 (phase II) and AG-519 (phase I) – in its pipeline.

With no approved product in its portfolio, successful development and subsequent approval of its pipeline candidates is crucial for Agios. We expect investor focus to remain on further pipeline updates from the company.

Agios currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Corcept Therapeutics Inc. CORT and Geron Corporation GERN. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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