On March 19, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported dosing of the first patient in a Phase 1 study of AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor (Press release, Agios Pharmaceuticals, MAR 19, 2018, View Source [SID1234524881]). This open-label, dose-escalation and expansion study investigates AG-270 in patients with solid tumors or lymphoma with deletion of the metabolic gene methylthioadenosine phosphorylase (MTAP).
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"In addition to significant milestones for our late-stage portfolio this year, we are pleased to demonstrate the continued productivity of our research engine by advancing our sixth internally discovered molecule into the clinic," said Scott Biller, M.D., chief scientific officer of Agios. "As a first-in-class MAT2A inhibitor, AG-270 has the potential to benefit the large number of patients whose cancer is characterized by the loss of MTAP. We look forward to conducting the early clinical work that will explore the pharmacology and clinical activity of MAT2A inhibition in tumors carrying this deletion."
"We are excited to participate in the development of this novel and targeted approach to cancer treatment," said Howard (Skip) Burris, M.D., chief medical officer and president of clinical operations at Sarah Cannon. "Bringing AG-270 into the clinic represents an opportunity for Sarah Cannon and Agios to continue a partnership that began with the IDH inhibitors and remains focused on transforming cancer care and personalizing treatment."
AG-270 Phase 1 Study Design
The purpose of this Phase 1 multi-center, open-label study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-270 in approximately 50 patients with advanced solid tumors or lymphoma with MTAP deletion. AG-270 will be administered as a single agent dosed orally once daily in 28-day cycles. The first part of the study is a dose-escalation phase in which cohorts of patients will receive ascending doses of AG-270 to determine the maximum tolerated dose (MTD) or optimal dose. The second part of the study is a dose expansion phase where additional patients will receive AG-270 at the MTD or optimal dose to further evaluate its safety, tolerability and clinical activity as a potential dose for future studies. Patients must have evidence of loss of the MTAP protein from their tumor tissue, or evidence of loss of the CDKN2A tumor suppressor gene (commonly co-deleted with the MTAP gene), in order to be eligible for the study. Please refer to www.clinicaltrials.gov for additional clinical trial information.
About the MAT2A Inhibitor AG-270
AG-270 is part of a 2016 global research collaboration agreement with Celgene Corporation. Through Phase 1 dose escalation, Celgene has the option, for a fee of at least $30 million, to participate in a worldwide cost and profit share with Agios. Upon exercise of the option the parties will share all development costs, subject to specified exceptions, and any profits on net sales and Agios will be eligible for up to $169 million in clinical and regulatory milestone payments for the program. As described in a 2016 Cell Reports publication, Agios discovered that MAT2A is a component of a novel pathway in MTAP-deleted tumors which, when inhibited, results in robust anti-tumor activity. Preclinical data presented at the 2017 Keystone Tumor Metabolism meeting demonstrated that small molecule inhibitors of MAT2A are efficacious in MTAP-deleted tumor xenograft models.