Business
Syndax Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Clinical and Business Update
-- Emerging data for SNDX-5613 support several protocol enhancements to AUGMENT-101 to expand enrollment to pediatric patients and focus exclusively on
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"-- Emerging data for SNDX-5613 support several protocol enhancements to AUGMENT-101 to expand enrollment to pediatric patients and focus exclusively on patients with MLL-r and NPM1 mutant acute leukemias --\n -- Recommended Phase 2 dose for AUGMENT-101 anticipated by year end; full Phase 1 data presentation expected in early 2021 --\n -- Results from Phase 1 trial of axatilimab in patients with cGVHD expected in 4Q20 --\n -- Company to host conference call today at 4:30 p.m. ET --\n\n\nWALTHAM, Mass., Aug. 6, 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 reported its financial results for the second quarter ended June 30, 2020. In addition, the Company provided a clinical and business update. \n\"We are very pleased that the FDA has agreed to several proposed changes to the Phase 1 portion of AUGMENT-101 which build on emerging clinical data and help us maximize SNDX-5613's potential in as many appropriate patients as possible,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"This includes focusing enrollment exclusively on patients with MLL-r and NPM1 mutant acute leukemias, the ability to expand dose cohorts that demonstrate efficacy, and the inclusion of pediatric patients, which has long been a key component of our overall strategy for SNDX-5613. We remain on track to identify a recommended Phase 2 dose by the end of this year, with full Phase 1 data anticipated in early 2021.\"\nDr. Morrison added, \"Progress also continues with the Phase 1/2 trial of axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD, with Phase 1 results expected in the fourth quarter. We are actively committed to helping people with cancer live longer and better than ever before and look forward to further advancing this mission throughout the balance of the year.\"\nPipeline Updates\nSNDX-5613\nSyndax today announced that the U.S. Food and Drug Administration (FDA) has agreed to several enhancements to the Phase 1 portion of the AUGMENT-101 protocol. AUGMENT-101 is the Company's Phase 1/2 open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of orally administered SNDX-5613, its potent, highly selective oral men...