Celgene and Agios Pharmaceuticals will partner to develop metabolic immuno-oncology therapies, under a strategic alliance that could generate about $1 billion-plus for Agios.

The companies said they will discover, develop, and commercialize new treatments focused on altering the metabolic state of immune cells to enhance the body’s immune response to cancer. The treatments will be based on Agios’ cellular metabolism research platform.

“This emerging discipline of metabolic immuno-oncology has great potential to provide novel insights and targets for cancer immunotherapy in solid and hematologic malignancies,” Celgene CSO Rob Hershberg, M.D., Ph.D., said in a statement.

Added Agios CEO David Schenkein, M.D.: “This strategic alliance will allow Agios to quickly expand our existing research platform into a third core area while leveraging Celgene’s capabilities and broad portfolio of immuno-oncology assets.”

Celgene will pay Agios $200 million upfront for an initial four-year research term, and holds an option to extend the partnership an additional two years for an undisclosed amount. Agios will lead exploratory research, drug discovery, and early development efforts.

The companies agreed to sign a global co-development and co-commercialization agreement with a worldwide 50/50 cost and profit share. Celgene will lead ex-U.S. development and commercialization for all programs, while alternating leadership with Agios of all 50/50 programs in the U.S., with Agios making the first program selection.

The agreement gives Celgene the right to designate collaboration programs upon the start of preclinical studies, with Celgene holding an option on each program up through Phase I dose escalation for at least a $30 million fee.

For each program, Agios is eligible for up to $169 million in clinical and regulatory milestone payments from Celgene.

Celgene will have one opportunity to select a metabolic immuno-oncology program for which costs and profits will be shared 65% by Celgene and 35% by Agios. For that program, Celgene will lead worldwide development and commercialization, in return for paying Agios up to $209 million in clinical and regulatory milestone payments.

Should the collaboration generate any inflammation or autoimmune programs, the companies said, Celgene has the option to enter into an exclusive worldwide license agreement and lead worldwide development and commercialization. For any such licensed products, Celgene agreed to pay Agios up to $386 million in clinical, regulatory and commercial milestone payments, as well as double-digit tiered royalties on any net sales.

The companies also agreed to amend a collaboration first signed in 2010, with Agios gaining full global development and commercialization rights to AG-120, a first-in-class, oral, potent inhibitor of mutant isocitrate dehydrogenase 1 (IDH1).

Agios is studying AG-120 for multiple indications, including as a single agent for relapsed/refractory acute myeloid leukemia (AML), as well as in combination with standard chemotherapy regimens in the frontline AML.

Agios said it plans to initiate pivotal trials in AML, and is exploring the use of AG-120 in several solid tumors, including cholangiocarcinoma and glioma.

Two cancer metabolism programs created under the 2010 collaboration—including a program focused on MTAP deleted cancers—will also be subject to 50/50 co-development and co-commercialization rights by both companies, with Agios also eligible for up to $169 million in clinical and regulatory milestone payments per program.

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