On November 4, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that updated data from the Company’s Phase 1 trial of axatilimab, its anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD) will be featured during an oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 5 – 8, 2020 in a virtual format (Press release, Syndax, NOV 4, 2020, View Source [SID1234569861]).

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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 Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "To our knowledge, axatilimab is the only agent in development for cGVHD that specifically targets the monocyte-macrophage lineage, which plays a key role in the fibrotic disease process, and we believe this is why we are seeing such robust efficacy. The promising efficacy, combined with a well-tolerated safety profile, led us to advance axatilimab into a pivotal trial in cGVHD that we anticipate starting by the end of this year. We look forward to presenting updated findings from our Phase 1 trial at the ASH (Free ASH Whitepaper) meeting in December."

In addition, the Company reported 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
Presenter: Mukta Arora, M.D., M.S., University of Minnesota
Session Name: 722. Clinical Allogeneic Transplantation; Acute and Chronic GvHD, Immune Reconstitution: Phase I and II Trials
Session Date: Sunday, December 6, 2020
Session Time: 9:30 a.m. – 11:00 a.m. PT (12:30 p.m. – 2:00 p.m. ET)
Presentation Time: 10:45 a.m. PT (1:45 p.m. ET)
Abstract Number: 358

Conference Call and Webcast Details:
The conference call and webcast, which will take place on Sunday, December 6, 2020 at 2:00 p.m. ET, will feature lead author of the ASH (Free ASH Whitepaper) presentation, Mukta Arora, M.D., M.S., Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota Medical School, and co-author, Geoffrey Hill, M.D., José Carreras/E. Donnall Thomas Endowed Chair for Cancer Research and Director of The Immunotherapy Integrated Research Center at Fred Hutchinson Cancer Research Center. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

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 U.S.1,2 cGVHD typically manifests across multiple organ systems, with the skin and mucosa being commonly involved, and is characterized by the development of fibrotic tissue.3

About Axatilimab

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.