WALTHAM, Mass., May 21, 2020 /PRNewswire/ -- Syndax
Pharmaceuticals, Inc. (Nasdaq: SNDX) today announced receipt of the
final results of E2112, the Phase 3 clinical trial conducted by
ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the
National Cancer Institute (NCI), that evaluated the investigational
compound entinostat, Syndax's class I HDAC inhibitor, plus
exemestane in patients with advanced hormone receptor positive,
human epidermal growth factor receptor 2 negative (HR+, HER2-)
breast cancer who have progressed on a non-steroidal aromatase
inhibitor. The trial did not achieve the primary endpoint of
demonstrating a statistically significant overall survival (OS)
benefit over hormone therapy alone.
"We're disappointed that the combination of entinostat and
exemestane did not demonstrate a survival benefit in this
historically difficult-to-treat patient population," said
Briggs W. Morrison, M.D., Chief
Executive Officer of Syndax. "On behalf of the entire Syndax team,
we extend our sincerest gratitude to all the patients, their
families and the investigators who participated in this important
trial, as well as our colleagues at ECOG-ACRIN and the NCI. Based
on these results, we will not be filing a New Drug Application with
the U.S. Food and Drug Administration for metastatic breast
cancer."
Dr. Morrison added, "We remain focused on advancing our broader
portfolio, including our targeted therapy, SNDX-5613, an inhibitor
of the Menin-MLL interaction, and axatilimab, our anti-CSF-1R
monoclonal antibody. Later this year, we expect to present
additional clinical data from the AUGMENT-101 trial of SNDX-5613 in
adults with relapsed/refractory acute leukemias. Based on
preclinical data reported to date, as well as recent Phase 1
results representing the first clinical evidence that inhibition of
the Menin-MLL1 interaction can induce response in patients with
genetically-defined acute leukemias, we believe SNDX-5613 has the
potential to offer patients with both NPM1 mutant acute myeloid
leukemia and MLL-r acute leukemias a much-needed, effective
therapeutic option. We also anticipate the presentation of
additional results from our ongoing Phase 1/2 trial of axatilimab
in patients with chronic graft versus host disease in the fourth
quarter of this year."
The E2112 trial was designed and conducted independently by
ECOG-ACRIN under the sponsorship of the NCI, which is part of the
National Institutes of Health. The double-blind,
placebo-controlled trial randomized a total of 608 patients with
HR+, HER2- advanced breast cancer to receive exemestane in
combination with entinostat or placebo.
About Syndax Pharmaceuticals, Inc.
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 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 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.
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
Ted Held
GCI Health
ted.held@gcihealth.com
Tel 212.798.9842
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.