Agios and Celgene gun for 2016 NDA with biotech's lead cancer asset

Agios and partner Celgene are gearing up to file a new drug app with the FDA by the end of the year for its most advanced cancer med, AG-221.

In its SEC 8-K filing, posted this morning, Agios ($AGIO) said its Celgene ($CELG)-backed med is a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-2 (IDH2) that is seeking to treat relapsed and/or refractory acute myeloid leukemia.

The NDA, which will according to the biotech be sent to the U.S. regulator by Celgene before 2017, is based on an ongoing Phase I/II study of AG-221 in patients with advanced forms of blood cancer with an IDH2 mutation.

This NDA has come swiftly off the back of just three years’ worth of work in the lab. Celgene owns the rights to the drug, with Agios in-line to get around mid-teens in royalties should it gain approval. 

Cambridge, MA-based Agios also said that it was “to explore a similar regulatory path” for its other med, AG-120, a first-in-class, oral, potent inhibitor of mutant IDH1.

This drug was also once part of a deal between Agios and long-term partner Celgene, but in May it handed back the ex-U.S. rights as part of a retooling of its original 2010 pact with the biotech.

Its latest data for the candidate, now wholly owned by Agios, “could lead to a NDA submission in 2017 in the U.S.,” the biotech noted, adding that it would provide a regulatory update on AG-120 “by the end of 2016.”

Agios, a 2009 Fierce 15 company, has been rolling since pulling off a $106 million IPO in the early days of biotech's protracted boom on Wall Street.

Celgene, a prolific dealmaker, has repeatedly affirmed its faith both in Agios’ platform technology and its pioneering approach to drug development in oncology. Despite backing away from AG-120 in May, Celgene has still kept the faith in the biotech and kept its hand very much in with the company it has helped nurture for so many years.

AG-120 has not however had a great time of it in recent months. In November, Agios posted what initially looked like promising data from a Phase I study against solid tumors, but the results fell short of some investors' expectations, sending the company's share value down about 10%.

Agios ended the day up by more than 2.6% yesterday with a market cap of $1.4 billion, before the 8-K was released, while Celgene was up 1.1.%, but down slightly afterhours. Agios was up nearly 20% by 10 EDT today, with Celgene marginally up by 0.5%.