WALTHAM, Mass.
and PHILADELPHIA and INDIANAPOLIS, July
11 2017 /PRNewswire/ -- Syndax Pharmaceuticals, Inc.
("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage
biopharmaceutical company developing entinostat and SNDX-6352 in
multiple cancer indications, in collaboration with The Wistar
Institute and Indiana University Melvin
and Bren Simon Cancer Center, today announced the publication of a
preclinical report demonstrating that entinostat, Syndax's oral,
Class-I histone deacetylase inhibitor, enhances the antitumor
effect of PD-1 (programmed death receptor-1) blockade through the
inhibition of myeloid derived suppressor cells (MDSCs).
The article, titled "Entinostat Neutralizes Myeloid Derived
Suppressor Cells and Enhances the Antitumor Effect of PD-1
Inhibition in Murine Models of Lung and Renal Cell Carcinoma," was
published in Clinical Cancer Research and is available
online.
Researchers tested the effect of combining entinostat with an
anti-PD-1 monoclonal antibody that enhances the T cell-mediated
antitumor immune response. The studies were conducted in two mouse
models of renal cell carcinoma and lung cancer and included a
series of in vitro experiments aimed at characterizing the
effects of this combined treatment on the myeloid derived
suppressor cells (MDSCs), a highly immunosuppressive population of
tumor infiltrating immature myeloid cells. The results indicated
that entinostat has an inhibitory effect on MDSC immunosuppressive
function both in vivo and in vitro, which results in
enhanced anti-tumor activity of the combination.
"The use of PD-1 inhibitors in the treatment of solid tumors has
demonstrated significant benefit, but many patients still present
with progressive disease following treatment," said co-lead
researcher Dmitry I. Gabrilovich,
M.D., Ph.D., Professor and Program Leader, Translational Tumor
Immunology Program, The Wistar Institute. "We have previously
demonstrated the role of MDSCs as important mediators of resistance
to immune therapy approaches. The results from our new study
suggest that entinostat may enhance the anti-tumor efficacy of PD-1
targeted therapy through MDSC targeting, potentially providing an
effective combination treatment approach for patients with solid
tumors, including lung and renal cell carcinoma."
"Our group has previously reported that entinostat enhances the
antitumor effect of high dose interleukin 2 in renal cell carcinoma
both in mice and patients. These new findings confirm that the
combination of entinostat with immunotherapy has significant
immunomodulatory activity and may offer increased benefit for a
larger population of patients with renal cell carcinoma, non-small
cell lung cancer and other solid tumors with an immunosuppressive
tumor microenvironment," said co-lead researcher Roberto Pili, M.D., Robert Wallace Miller
Professor of Oncology and Professor of Medicine and Urology at IU
Simon Cancer Center. "We are pleased to have obtained the same
results in two different laboratories and we look forward to
translating these preclinical findings into combination approaches
with entinostat to enhance the clinical activity of immune
checkpoint inhibition."
"We are excited that these current data support and extend
initial observations generated at Johns
Hopkins," said Peter
Ordentlich, Ph.D., Chief Scientific Officer of Syndax.
"Entinostat has now been shown to impact MDSCs in multiple
preclinical tumor models across several laboratories as well as
from blood samples taken from entinostat treated patients. These
data collectively provide strong rationale for combining entinostat
with immunotherapies for the treatment of solid tumors. We look
forward to providing additional updates from the entinostat
clinical development program."
About Syndax Pharmaceuticals, Inc.
Syndax is a clinical stage biopharmaceutical company developing
an innovative pipeline of cancer therapies. Our lead product
candidate, entinostat, which was granted Breakthrough Therapy
designation by the FDA following positive results from our Phase 2b
clinical trial, ENCORE 301, is currently being evaluated in a Phase
3 clinical trial for advanced hormone receptor positive, human
epidermal growth factor receptor 2 negative breast cancer. Given
its potential ability to block the function of immune suppressive
cells in the tumor microenvironment, entinostat is also being
evaluated in combination with approved PD-1 antagonists. Ongoing
Phase 1b/2 clinical trials combine entinostat with
KEYTRUDA® from Merck & Co., Inc. for non-small cell
lung cancer, melanoma and colorectal cancer; with
TECENTRIQ® from Genentech, Inc. for triple negative
breast cancer; and with BAVENCIO® from Pfizer Inc. and
Merck KGaA, Darmstadt, Germany,
for ovarian cancer. Our second product candidate, SNDX-6352, is a
monoclonal antibody that blocks the CSF-1 receptor and may also
block the function of immune suppressive cells in the tumor
microenvironment. SNDX-6352 is being evaluated in a single
ascending dose Phase 1 clinical trial and is expected to be
developed to treat a variety of cancers.
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 studies,
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.
About The Wistar Institute
The Wistar Institute is an international leader in biomedical
research with special expertise in cancer research and vaccine
development. Founded in 1892 as the first independent nonprofit
biomedical research institute in the country, Wistar has held the
prestigious Cancer Center designation from the National Cancer
Institute since 1972. The Institute works actively to ensure that
research advances move from the laboratory to the clinic as quickly
as possible. wistar.org.
About Indiana University
Melvin and Bren Simon Cancer Center
The Indiana University Melvin and
Bren Simon Cancer Center is the only National Cancer
Institute-designated cancer center in Indiana that provides patient care. The NCI
designation recognizes that its collaborative research programs
meet the NCI's rigorous criteria for world-class, state-of-the-art
programs in multidisciplinary cancer research. The mission of the
IU Simon Cancer Center is to eliminate cancer's burden in
Indiana and beyond.
Cancer.iu.edu.
Contacts:
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Syndax
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The Wistar
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IU Simon Cancer
Center
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Investors:
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Tara
Yates
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Michael
Schug
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Melissa
Forst
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tyates@wistar.org
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maschug@iupui.edu
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Argot
Partners
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melissa@argotpartners.com
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Media:
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Eliza
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Argot
Partners
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eliza@argotpartners.com
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Tel
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SOURCE Syndax Pharmaceuticals, Inc.