Escend Pharmaceuticals, Inc., Receives IND Clearance from the FDA for ES-3000 Phase I Study in Relapsed or Refractory Acute Myeloid Leukemia (AML)

On July 15, 2022 Escend Pharmaceuticals, Inc., a privately held company focused on the development of small molecule therapeutics for oncology orphan diseases, reported that the United States Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for its lead drug candidate, ES-3000 for a Phase I clinical trial in relapsed or refractory (R/R) acute myeloid leukemia (AML) (Press release, Escend Pharmaceuticals, JUL 15, 2022, View Source [SID1234616711]).

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The primary aim of the Phase I study is to determine the safety and tolerability of ES-3000 in subjects with R/R AML. The FDA Office of Orphan Products Development has previously granted ES-3000 orphan designation for the treatment of acute myeloid leukemia (AML) and chronic myeloid leukemia (CML). The FDA orphan drug designation provides 7 years of marketing exclusivity and certain incentives, including federal grants, tax credits, and waiver of new drug application (NDA) fees.

"The IND clearance strengthens our deep commitment to the development of ES-3000, which can potentially offer a new treatment option for durable remissions and reduce relapse by targeting leukemic stem cells, which play a central role in resistance to therapy", said Saira Bates, MBA, Co-founder & CEO. "We are very excited to be able to initiate our US study. ES-3000 is a novel small molecule with promising pre-clinical data that supports targeting leukemic stem cells." said Dennis Brown, PhD, Co-founder & Chairman.

About ES-3000
ES-3000 is an orally bioavailable small molecule which ablates leukemic stem cells by reducing β-catenin expression through a novel mechanism of action. The Wnt/β-catenin pathway is critical for the survival of cancer stem cells. ES-3000 is also in development for the treatment of chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS), and triple negative breast cancer (TNBC).