Celgene has exercised early its option for an exclusive license to Agios Pharmaceuticals’ AG-221, gaining worldwide development and commercialization rights for the leukemia compound, Agios said today.

By exercising its exclusive option, Celgene gains worldwide development and commercialization rights for AG-221. Agios said it will continue to conduct early clinical development and regulatory activities within the AG-221 development program in collaboration with Celgene, which is responsible for all development costs for AG-221.

AG-221 is an oral, first-in-class, potent inhibitor of the mutant IDH2 protein. Celgene had the option to license AG-221 through the end of a Phase I dose escalation study in patients that harbor an IDH2 mutation with advanced hematologic malignancies, including acute myeloid leukemia (AML).

Instead, Celgene acted days ahead of a planned presentation of Phase I results Saturday at the 19th Congress of the European Hematology Association, which is being held through Sunday in Milan, Italy. Agios will host conference call and webcast on those results Monday at 8:30 a.m. EDT.

“The emerging Phase I clinical data validate the preclinical and mechanistic work on IDH2 mutations in AML, and most importantly, advance a highly promising drug candidate for treatment of molecularly selected patients,” Thomas Daniel, M.D., president of research & early development at Celgene, said in a statement. “Celgene looks forward to deploying our worldwide development capabilities in hematological malignancies and to working with Agios to accelerate development.”

Agios uses cellular metabolism as a platform for developing new treatments for cancer and inborn errors of metabolism. Agios and Celgene launched their global strategic collaboration in 2010, with the aims of discovering, developing, and delivering new oncology therapies based on Agios’ cancer metabolism research platform.

At the time, Agios received a $130 million upfront payment, including an equity investment that comprised the company’s Series B financing round. Celgene received its up-to-Phase-I exclusivity, after which it had the option at the end of Phase I to develop any drugs emerging from Agios' cancer metabolism research.

Agios received a $20 million payment from Celgene after agreeing with Celgene in 2011 to extend the initial phase of Celgene's global strategic collaboration targeting cancer metabolism with Agios. The initial period of exclusivity was extended from three years to four years.

And in December, Agios extended the exclusivity period another year, allowing Celgene to maintain its exclusive option to all drug candidates emerging from Agios’ cancer metabolism research platform through April 2015. Agios received a $20 million payment, and agreed to extend the collaboration period with Celgene one year further for an additional payment.

Under their collaboration, Agios is eligible for up to $120 million in milestone payments and a tiered royalty on any net sales. Agios also has the right to conduct a portion of any commercialization activities for AG-221 in the U.S.

AG-221 is part of Agios’ IDH portfolio, which also includes AG-120. The IDH1 mutant inhibitor is in Phase I clinical trials in advanced solid tumors and hematologic malignancies. Agios retains U.S. rights to the IDH1 program, while Celgene has an exclusive option to ex-U.S. rights for the program. 

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