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Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults with Relapsed/Refractory Acute Leukemias
- Preliminary Phase 1 results represent first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Preliminary Phase 1 results represent first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias -\n - Data featured in New Drugs on the Horizon oral session at the 2020 AACR Virtual Annual Meeting I -\n - U.S. FDA grants orphan drug designation to SNDX-5613 for the treatment of adult and pediatric acute myeloid leukemia -\n\n\nWALTHAM, Mass., April 27, 2020 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (\"Syndax,\" the \"Company\" or \"we\") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presents preclinical and initial clinical data for SNDX-5613, the Company's potent, highly selective oral menin inhibitor. The oral presentation will be featured during the New Drugs on the Horizon session at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I. The New Drugs on the Horizon session will take place today at 4:50 p.m. ET and features discussions of innovative small molecules and biologics that have recently entered Phase 1 clinical trials.\n\"Within months of initiating the Phase 1/2 AUGMENT-101 trial, we are excited to present to the cancer research community the first clinical evidence that disrupting the interaction between menin and MLL1 with our potent and selective inhibitor, SNDX-5613, can induce response in patients with genetically-defined acute leukemias,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"Notably, clinical activity was achieved rapidly after a single, 28-day cycle, a highly encouraging sign in this population of patients who face a particularly poor prognosis with few effective treatment options. We look forward to presenting additional findings from this trial in the fourth quarter.\" \nThe Company also announced today that SNDX-5613 was recently granted Orphan Drug Designation for the treatment of adult and pediatric acute myeloid leukemia (AML) by the U.S. Food and Drug Administration (FDA). \nPreliminary AUGMENT-101 Data\nAs of the April 17th data cutoff date, a total of six patients have been treated in the Phase 1 portion of the ongoing open-label AUGMENT-101 trial at increasing dose levels of SNDX-5613. Responses were observed in two of three patients harboring an MLL rearrangement. This included one patient...