Celgene and Agios confirmed the initiation of a new anticancer drug development program focused on methylthioadenosine phosphorylase (MTAP)-deleted cancers as part of their potentially $1 billion metabolic immuno-oncology collaboration, signed in May 2016.
Celgene has selected an Agios-originated MATP pathway candidate to take into development and will pay Agios an $8 million designation fee. Agios will head the program’s research, drug discovery, and early development, and Celgene retains an opt-in right to the program through to Phase I. Exercising the opt-in right would trigger another $30 million payment to Agios. The firms would then share global development and commercialization rights to the program under a 50/50 costs and profit-sharing arrangement. Agios could be eligible for up to $169 million in clinical and regulatory milestones.
“We are pleased that Celgene has designated this fourth development candidate discovered and developed at Agios since the beginning of our research collaboration with them in 2010,” said Scott Biller, Ph.D., CSO at Agios. “We have clearly demonstrated our ability to translate novel Agios discoveries into important precision medicines in areas of high unmet need with our isocitrate dehydrogenase (IDH) portfolio. We look forward to exploring the potential of our MTAP program in patients following our expected IND submission by the end of this year.”
Agios and Celgene initiated their global cancer metabolism collaboration in 2010. The partnership is headed by lead registrational-stage anticancer candidate enasidenib and includes the Phase I-stage candidate AG-881. Enasidenib is in development for treating cancers that express isocitrate dehydrogenase-2 (IDH2) mutations. Earlier this month Celgene confirmed that FDA had accepted its enasidenib NDA for treating relapsing or refractory acute myeloid leukemia (AML) with IDH2 mutations. FDA has granted the drug priority review, with a PDUFA date set for August 30, 2017.
Under the terms of the enasidenib agreement with Agios, Celgene retains worldwide development and commercialization rights to the drug, and the two firms will co-commercialize enasidenib in the U.S., with Celgene reimbursing Agios for relevant costs. Agios could receive up to $120 million in milestones and royalites on net sales.
AG-881 is a pan-IDH mutant inhibitor, which is being developed through a 50/50 development costs and 50/50 profit share global partnership between Agios and Celgene, agreed in April 2015. A Phase I study with AG-881 in patients with advanced solid tumors and an IDH mutation was initiated in June 2015.
In October 2016, Agios and Celgene each established collaboration agreements with Abbott to develop companion diagnostics for identifying IDH mutations in AML patients.