– Results support axatilimab's promising
safety and efficacy profile, and reinforce its potential as a
first-in-class CSF-1R monoclonal antibody in chronic
graft-versus-host disease –
– Syndax and Incyte intend to
file a Biologics License Application (BLA) by year-end 2023
–
WALTHAM,
Mass., Nov. 2, 2023 /PRNewswire/ -- Syndax
Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical
company developing an innovative pipeline of cancer therapies,
today announced that results from the pivotal AGAVE-201 trial of
axatilimab, an anti-CSF-1R antibody, in adult and pediatric
patients with chronic graft-versus-host disease (cGVHD), will be
featured during the Plenary Scientific Session at the
65th American Society of Hematology (ASH) Annual Meeting
being held December 9-12, 2023, in
San Diego, California.
"Inclusion of AGAVE-201 in this year's ASH plenary session
further supports our belief that axatilimab has the potential to
serve as a highly differentiated therapeutic option for patients
with chronic GVHD," said Michael A.
Metzger, Chief Executive Officer. "We believe axatilimab's
best-in-category profile and unique mechanism of action positions
it as an important addition to the chronic GVHD treatment
armamentarium, if approved. We look forward to sharing the full
dataset next month."
The Company and its partner, Incyte, previously
announced positive topline data from the pivotal AGAVE-201
trial of axatilimab in patients with cGVHD following two or more
prior lines of therapy. All three dose cohorts, 0.3 mg/kg every two
weeks, 1.0 mg/kg every two weeks, and 3.0 mg/kg every four weeks,
met the primary endpoint. The overall response rate within the
first six months of treatment at the 0.3 mg/kg dose was 74%, and
60% of these patients were still responding at one year.
Furthermore, axatilimab was generally well tolerated, and the most
common adverse events were consistent with on-target effects and
prior trials. Syndax and Incyte expect to submit a BLA filing by
year-end 2023.
Abstract Number: 1
Title: Safety and Efficacy of Axatilimab at 3 Different
Doses in Patients with Chronic Graft-Versus-Host Disease
(AGAVE-201)
Presenter: Daniel Wolff, M.D.
Session Name: Plenary Scientific Session
Session Date: Sunday, December 10,
2023
Session Time: 2:00 – 4:00 PM
PT
Presentation Time: 2:00 PM PT
Axatilimab Preclinical Data
In addition, preclinical data detailing the anti-inflammatory
and anti-fibrotic mechanism through which axatilimab is thought to
impact the disease process in cGVHD will be featured during a
poster session.
Details for the presentation are as follows:
Abstract Number: 2540
Title: Axatilimab Ameliorates Inflammation and Fibrosis by
Targeting the Macrophages in a Preclinical Model of Chronic
GVHD
Presenter: Anamika Bajpai, Ph.D.
Session Name: 201. Granulocytes, Monocytes, and
Macrophages: Poster II
Session Date: Sunday, December 10,
2023
Presentation Time: 6:00 – 8:00
PM PT
A copy of each abstract is now available online via the ASH
website at www.hematology.org.
About Chronic Graft-Versus-Host Disease
Chronic graft-versus-host disease (GVHD), 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 which can last for years.
Chronic GVHD is estimated to develop in approximately 40% of
transplant recipients and affects approximately 14,000 patients in
the U.S.1,2. Chronic GVHD typically manifests
across multiple organ systems, with skin and mucosa being commonly
involved, and is characterized by the development of fibrotic
tissue3.
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, which has been shown to play a key role in the fibrotic
disease process underlying diseases such as chronic GVHD and
idiopathic pulmonary fibrosis (IPF). Axatilimab was granted Orphan
Drug Designation by the U.S. Food and Drug Administration for the
treatment of patients with chronic GVHD and IPF. In September 2021, Syndax and Incyte entered into an
exclusive worldwide co-development and co-commercialization license
agreement for axatilimab. Axatilimab is being developed under an
exclusive worldwide license from UCB entered into between Syndax
and UCB in 2016.
About AGAVE-201
The global Phase 2 AGAVE-201 dose-ranging trial evaluated the
efficacy, safety, and tolerability of axatilimab in 241 adult and
pediatric patients with recurrent or refractory active chronic GVHD
whose disease had progressed after two prior therapies. Patients
were randomized to one of three treatment groups that investigated
a distinct dose of axatilimab administered at 0.3 mg/kg every two
weeks, 1 mg/kg every two weeks or 3 mg/kg every four weeks. The
trial's primary endpoint is the proportion of patients in each dose
group who achieved an objective response as defined by 2014 NIH
Consensus Criteria for chronic GVHD by cycle 7 day 1. Secondary
endpoints include duration of response, percent reduction in daily
steroids dose, organ specific response rates and validated
quality-of-life assessments using the Modified Lee Symptom
Scale.
For more information about AGAVE-201,
visit https://clinicaltrials.gov/ct2/show/NCT04710576.
About Syndax
Syndax Pharmaceuticals is a clinical stage
biopharmaceutical company developing an innovative pipeline of
cancer therapies. Highlights of the Company's pipeline include
revumenib, a highly selective inhibitor of the menin–KMT2A binding
interaction, and axatilimab, a monoclonal antibody that blocks the
colony stimulating factor 1 (CSF-1) receptor. For more information,
please visit www.syndax.com or follow the Company
on Twitter and LinkedIn.
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," "could," "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, the reporting of clinical
data for Syndax's product candidates, the potential submission of a
BLA by year-end 2023, and the potential use of our product
candidates to treat various cancer indications and fibrotic
diseases. 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; 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 U.S. Securities and
Exchange Commission, including the "Risk Factors" sections
contained therein. Except as required by law, Syndax assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
References
- SmartAnalyst 2020 SmartImmunology Insights chronic GVHD
report.
- 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 U.S. Claims Analysis.
- Kantar 2020 GVHD Expert Interviews N=32 interviews.
Syndax Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.