Syndax Pharmaceuticals to Present Updated Data from SNDX-5613 and Axatilimab Clinical Programs During Oral Sessions at 63rd ASH Annual Meeting
"We are pleased to share that both our innovative pipeline programs will be highlighted during oral presentation sessions at the upcoming ASH Annual Meeting," said
"We are also excited to share updates from the Phase 1/2 trial of axatilimab for the treatment of chronic graft-versus-host disease (cGVHD). With additional patients and longer follow up, we have observed a high rate of durable responses and multiorgan clinical benefit in patients refractory to multiple therapeutic agents. We are encouraged by the continued trend we are seeing, notably in those treated in the 1 mg/kg Phase 2 expansion cohort, and look forward to presenting additional updated data for both programs in December."
A copy of the abstract published today can be viewed here. The oral presentation will include updated Phase 1 data from additional patients as of a more recent cutoff date, as well as further details on durability and complete response (CR) or CR with partial hematologic recovery (CRh) rate and mutational status.
The abstract highlights data from the Phase 1 portion of the Company's Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with MLLr and NPM1c mutant relapsed/refractory (R/R) acute leukemias as of a
Oral Presentation Details:
- Title: Safety and Efficacy of Menin Inhibition in Patients (Pts) with MLL-Rearranged and NPM1 Mutant Acute Leukemia: A Phase (Ph) 1, First-in-Human Study of SNDX-5613 (AUGMENT 101)
- Presenter: Eytan Stein, M.D.
- Session Name: 616: Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Targeted Therapies and Novel Therapies Session
- Session Date:
Monday, December 13, 2021
- Session Time: 2:45 –
4:15 p.m. ET
- Presentation Time: 3:15 p.m. ET
- Abstract/Publication Number: 699
A copy of the abstract published today can be viewed here. The oral presentation will include additional follow up on all patients enrolled.
The abstract published today highlights data from 40 patients treated in the Company's Phase 1/2 trial of axatilimab in patients with cGVHD as of a
Oral Presentation Details:
- Title: Safety, Tolerability, and Efficacy of Axatilimab, a CSF-1R Humanized Antibody, for Chronic Graft-Versus-Host Disease after 2 or More Lines of Systemic Treatment
- Presenter: Stephanie Lee, M.D, M.P.H.
- Session Name: 722: Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Treatment of Acute and Chronic Graft vs. Host Disease
- Session Date:
Saturday, December 11, 2021
- Session Time: 2:00 –
3:30 p.m. ET
- Presentation Time: 3:00 p.m. ET
- Abstract/Publication Number: 263
SNDX-5613 is a potent, selective, small molecule inhibitor of the menin-MLL binding interaction that is being developed for the treatment of mixed lineage leukemia rearranged (MLLr) acute leukemias including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and NPM1 mutant AML. In preclinical models of MLLr 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 preclinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. SNDX-5613 is currently being evaluated in the Company's AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias. SNDX-5613 was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with AML, and Fast Track designation for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged MLLr or NPM1 mutation.
Axatilimab is an investigational monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages. In pre-clinical models, inhibition of signaling through the CSF-1 receptor has been shown to reduce the number of disease-mediating macrophages along with their monocyte precursors, which has been shown to play a key role in the fibrotic disease process underlying diseases, such as chronic graft-versus-host disease (cGVHD) and idiopathic pulmonary fibrosis (IPF). Axatilimab data has demonstrated deep, durable responses and multiorgan clinical benefit in patients with cGVHD refractory to multiple therapeutic agents, and is currently being evaluated in the global pivotal Phase 2 AGAVE-201 trial in patients with cGVHD. Axatilimab was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD and IPF. In
Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's pipeline includes SNDX-5613, a highly selective inhibitor of the Menin–MLL binding interaction, axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, and entinostat, a class I HDAC inhibitor. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn.
Syndax's Forward-Looking Statements
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