Clinical Trials

Date: 2016-02-05

Type of information: Initiation of the trial

phase: 1-2

Announcement: initiation of the trial

Company: Celgene (USA - NJ)

Product: AG-120 - isocitrate dehydrogenase 1 (IDH1)-mutant inhibitor, AG-221 (enasidenib) and subcutaneous azacitidine

Action mechanism:

• enzyme inhibitor/isocitrate dehydrogenase inhibitor. AG-120 is a first-in-class, orally available, selective, potent inhibitor of the mutated IDH1 (Isocitrate dehydrogenase 1) protein. Isocitrate dehydrogenase (IDH) 1 and 2 are metabolic enzymes that are mutated in a wide range of hematologic and solid tumor malignancies, including acute myelogenous leukemia (AML) and glioma. Normally, IDH enzymes help to break down nutrients and generate energy for cells. When mutated, IDH creates a molecule that alters the cells’ genetic programming, and instead of maturing, the cells remain primitive and proliferate quickly.
• AG-221 is an orally available, selective, potent inhibitor of the mutated isocitrate dehydrogenase (IDH) 2 protein, making it a highly targeted investigational medicine for the potential treatment of patients with cancers that harbor an IDH2 mutation. AG-221 has received orphan drug and fast track designations from the FDA.
• AG-221 and AG-120 are part of Agios' global strategic collaboration with Celgene. Under the terms of the collaboration, Celgene has worldwide development and commercialization rights for AG-221. Agios continues to conduct clinical development activities within the AG-221 development program and is eligible to receive up to $120 million in payments on achievement of certain milestones and royalties on net sales. For AG-120, Agios retains U.S. development and commercialization rights. Celgene has an exclusive license outside the United States . Celgene is eligible to receive royalties on net sales in the U.S. Agios is eligible to receive royalties on net sales outside the U.S. and up to $120 million in payments on achievement of certain milestones.

Disease: acute myeloid leukemia (AML)

Therapeutic area: Cancer - Oncology

Country: United States, Australia, Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Portugal, Spain, Switzerland, United Kingdom

Trial details:

• This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine in subjects with newly diagnosed acute myeloid leukemia with an IDH1 or an IDH2 mutation, respectively. The study population consists of subjects who are not candidates to receive intensive Inductive chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage and a Phase 2 randomized stage. (NCT02677922)

Latest news:

• • On February 5, 2016, a Phase I trial sponsored by Celgene was published on the NIH website ClinicalTrials.gov for AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine  and is currently recruiting participants.

Is general: Yes