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Syndax Pharmaceuticals Announces FDA Clearance of IND Application for Targeted Menin Inhibitor SNDX-5613 for Relapsed/Refractory Acute Leukemias
WALTHAM, Mass., July 10, 2019 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"WALTHAM, Mass., July 10, 2019 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to begin a Phase 1/2 trial for SNDX-5613, a targeted Menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemias.\n\"The FDA's acceptance of our IND for SNDX-5613 represents an important event in the development of targeted therapies for patients with acute leukemias,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"The advancement of SNDX-5613 builds on three decades of scientific investigation that explored the Menin-MLL-r interaction and its importance in a subset of genetically defined leukemias. Our preclinical results strongly support the therapeutic potential of SNDX-5613 for patients with MLL-r and NPM1 mutant leukemias, many of whom do not derive a durable benefit from existing treatments. We look forward to moving this program into the clinic.\" \nThe Phase 1/2 open-label trial will assess orally administered SNDX-5613 in patients with R/R acute leukemias. The Phase 1 portion of the study will assess the safety, tolerability and pharmacokinetics of SNDX-5613, and will seek to establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Remission rate, across three expansion cohorts enrolling adult patients with MLL-rearranged (MLL-r) acute lymphoblastic leukemia (ALL), MLL-r acute myeloid leukemia (AML), and NPM1 mutant AML. \nMLL rearrangements occur in approximately 80% of acute leukemia cases in infants and up to 10% of all leukemias. In preclinical models of MLL-r acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple pre-clinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. \nAbout Mixed Lineage Leukemia Rearranged (MLL-r) \nRearrangements of the MLL gene give rise to MLL-r acute leukemias, known to have a poor prognosis, with less than 55% of patients surviving past 5 years. MLL rearrangements produce...