Date: 2017-03-13
Type of information: Milestone
Compound: metabolic immuno-oncology programs
Company: Celgene (USA - NJ) Agios Pharmaceuticals (USA -MA)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration
Action mechanism: MTAP-deletions are present in approximately 15 percent of all cancers. As described in a 2016 Cell Reports publication, Agios discovered a novel pathway in MTAP-deleted tumors which, when inhibited, results in robust anti-tumor activity in animal models. This pathway can be modulated by small molecule inhibitors, as demonstrated in a preclinical data presentation at the Keystone Tumor Metabolism meeting in Whistler, British Columbia on March 9, 2016.
Disease:
Details:
- • On May 17, 2016, Agios Pharmaceuticals and Celgene announced an agreement creating a new global strategic collaboration focused on metabolic immuno-oncology. The goal of the collaboration is to discover, develop and commercialize novel therapies based on Agios' innovative cellular metabolism research platform. The collaboration aims to discover novel metabolic pathways and their modulators that affect the metabolic state of immune cells, which may serve as potent anticancer therapies.
- In addition, Agios will focus on discovering molecular markers in order to identify patients who are most likely to respond to therapies.
- Exploratory research, drug discovery and early development will be led by Agios. Generally, collaboration programs may be designated by Celgene when preclinical studies begin, and Celgene will then have an option on each program up through Phase 1 dose escalation for at least a $30 million fee.
Financial terms:
- Agios will receive an upfront cash payment of $200 million for the initial four-year research term. Celgene has the option to extend the research term for up to two years for a pre-specified amount.
- For metabolic immuno-oncology programs, Celgene and Agios will enter into a global co-development and co-commercialization agreement with a worldwide 50/50 cost and profit share. Agios is eligible for up to $169 million in clinical and regulatory milestone payments for each program.
Celgene will have a one-time opportunity to select a metabolic immuno-oncology program for which costs and profits will be shared 65 percent by Celgene and 35 percent by Agios. Agios may also receive up to $209 million in clinical and regulatory milestone payments for this program.
- For any inflammation or autoimmune programs that may result from the collaboration, Celgene has the option to enter into an exclusive worldwide license agreement and lead worldwide development and commercialization. For any such licensed products, Agios may receive up to $386 million in clinical, regulatory and commercial milestone payments, as well as double-digit tiered royalties on any net sales.
Agios and Celgene will alternate leadership of all 50/50 programs in the U.S. territory, with Agios making the first program selection. Celgene will lead ex-U.S. development and commercialization for all programs. Celgene will lead worldwide development and commercialization for the 65/35 program.
Latest news:
- • On March 13, 2017, Agios Pharmaceuticals announced that Celgene Corporation has designated the development candidate focused on MTAP (methylthioadenosine phosphorylase) deleted cancers as a development candidate under the master research and collaboration agreement dated May 17, 2016. Celgene will pay Agios an $8 million designation fee for the MTAP pathway program. This fee is expected to be received in the second quarter of 2017.
- Exploratory research, drug discovery and early development on the MTAP pathway program is led by Agios, and Celgene will have an opt-in right on the program up through Phase 1 dose escalation for at least a $30 million fee.
Is general: Yes
