Business
Syndax Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Clinical and Business Update
- Presentation of Phase 1 data from AUGMENT-101 trial of SNDX-5613 and initiation of Phase 2 on track for early 2021 - - Company provides update on axatilimab
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Presentation of Phase 1 data from AUGMENT-101 trial of SNDX-5613 and initiation of Phase 2 on track for early 2021 -\n - Company provides update on axatilimab development plan in cGVHD following recent FDA interactions; expects to commence pivotal trial by year-end -\n - Data from Phase 1 trial of axatilimab in patients with cGVHD to be highlighted during oral presentation at ASH Annual Meeting in December -\n - Company to host conference call today at 4:30 p.m. ET -\n\n\nWALTHAM, Mass., Nov. 2, 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 third quarter ended September 30, 2020. In addition, the Company provided a clinical and business update. \n\"We continue to make exciting progress in the Phase 1 portion of the AUGMENT-101 trial of SNDX-5613, our highly selective, potent, oral menin inhibitor, in adult and pediatric patients with acute leukemias that harbor MLL-r and NPM1 genetic alterations,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"We are highly encouraged by initial data from this study, which demonstrated clear clinical activity in this difficult to treat population of patients with genetically defined acute leukemias. We remain on track to present Phase 1 data from AUGMENT-101 and commence the Phase 2 portion in early 2021.\" \nDr. Morrison added, \"In addition, following recent interactions with the FDA, we are excited to take the next step of initiating a pivotal trial for axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD which we expect by the end of this year. We are encouraged by the clinical activity and overall safety we've seen in the ongoing trial, and firmly believe axatilimab has the potential to serve as an effective intervention for patients with cGVHD. We look forward to sharing updated results from the Phase 1 trial during an oral presentation at the ASH Annual Meeting in December.\"\nPipeline Updates\nSNDX-5613\nIn August 2020, the Company enacted the following enhancements to the Phase 1 portion of the AUGMENT-101 trial in patients with MLL-r and NPM1 mutant acute leukemias: focusing enrollment exclusively on patients with mixed lineage leukemia rearrang...