Syndax Pharmaceuticals to Present Updated Data from Phase 1 Trial of Axatilimab in cGVHD During Oral Session at the 62nd ASH Annual Meeting
Key highlights of the abstract published today include:
- Objective responses observed in 7/12 patients with refractory disease and a median of five prior systemic therapies, including ibrutinib, ruxolitinib and belumosudil (KD-025)
- At time of abstract data cut-off, responses observed in joints/fascia (n=5/9), skin (n=3/8), eyes (n=3/10), esophagus (n=1/1) and mouth (n=1/7), with response data from additional organs to be described during the oral presentation
- Acceptable safety and tolerability in patients with advanced cGVHD; no treatment-related adverse events ≥ Grade 3 at the Phase 2 dose of 1 mg/kg every two weeks
The abstract can be viewed here. The oral presentation will include data as of a more recent cutoff date.
"We are excited to see a high response rate in patients with multiple organ system involvement with axatilimab treatment in a highly refractory population of patients with cGVHD," said
In addition, the Company today announced that it plans to host a conference call featuring two experts in the science and treatment of cGVHD to discuss how axatilimab may fit in the current and evolving treatment landscape.
Oral Presentation Details:
Title: Phase 1 Study of Axatilimab (SNDX-6352), a CSF-1R Humanized Antibody, For Chronic Graft-Versus-Host Disease after 2 or More Lines of Systemic Treatment
Session Time: 9:30 a.m. -
Presentation Time: 10:45 a.m. PT (
Abstract Number: 358
Conference Call and Webcast Details:
The conference call and webcast, which will take place on
Conference ID: 8698086
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/ddupdib6
For those unable to participate in the live conference call or webcast, a replay will be available on the Investors section of the Company's website, www.syndax.com.
About Chronic Graft Versus Host Disease
Chronic graft versus host disease (cGVHD), an immune response of the donor-derived hematopoietic cells against recipient tissues, is a serious, potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HSCT) which can last for years. cGVHD is estimated to develop in approximately 40% of transplant recipients, and affects approximately 14,000 patients in the
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, and block the development of cutaneous and pulmonary cGVHD. Axatilimab is currently being evaluated in a Phase 1/2 clinical trial in patients with cGVHD, and to date has demonstrated compelling clinical activity and a well-tolerated safety profile. Syndax plans to commence a pivotal trial, AGAVE-201, by the end of 2020.
Syndax's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the
2. Bachier, CR. et al. ASH annual meeting 2019; abstract #2109 Epidemiology and Real-World Treatment of Chronic Graft-Versus-Host Disease Post Allogeneic Hematopoietic Cell Transplantation: A
3. Kantar 2020 GVHD Expert Interviews N=32 interviews
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