WALTHAM, Mass., Oct. 17, 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, today
announced that it has entered into an exclusive worldwide license
agreement with Vitae Pharmaceuticals, Inc., a subsidiary of
Allergan plc, for a portfolio of preclinical, orally-available
small molecule inhibitors of the interaction of Menin with the
Mixed Lineage Leukemia ("MLL") protein. These compounds have
potential application in the treatment of a genetically-defined
subset of acute leukemias with chromosomal rearrangements in the
MLL gene ("MLL-r"). Syndax expects to initiate
clinical studies in 2019.
"This agreement represents another strategic addition to our
pipeline that we believe will enhance the long-term value of
Syndax," said Briggs W. Morrison,
M.D., Chief Executive Officer of Syndax. "Syndax is well positioned
to develop this unique product portfolio which holds the potential
to significantly change the treatment paradigm for acute leukemic
patients harboring MLL translocations, a disease that may meet the
guidelines for orphan designation."
"The Menin-MLL-r interaction is thought to play a central role
in the pathology of acute leukemia patients with MLL
translocations, a patient population routinely identified in
clinical practice today," said Michael L.
Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. "While
intensive chemotherapy regimens are often employed in these
patients, the 5-year survival rate remains significantly below 50%
due to the lack of effective treatment options. We believe that
this portfolio of compounds holds the potential to serve as an
effective oral therapeutic option for pediatric and adult patients
with MLL-r-driven leukemias."
Under the terms of the license agreement, Syndax will make a
one-time upfront payment to Allergan and will be responsible for
development, manufacturing and global commercialization of the
portfolio. Allergan will receive development and commercial stage
milestones and tiered royalties on net sales of commercialized
products.
About MLL Rearranged (MLL-r) Leukemias
Rearrangements of the MLL gene occur in 70-80% of infant acute
leukemias and up to 10% of adult acute leukemias and are associated
with a poor prognosis, with less than 40% of infants with MLL-r
surviving past 5 years. The protein products of MLL gene
rearrangements require interaction with a protein called Menin in
order to drive leukemic cancer growth. Disruption of the
Menin-MLL-r interaction has been shown to halt the growth of MLL-r
leukemic cells. MLL-r leukemias are routinely diagnosed through
currently available genetic screening techniques in leukemic cells,
but there are currently no approved therapies indicated for MLL-r
leukemias.
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 in combination with exemestane 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 colony stimulating factor 1
(CSF-1) receptor and may also block the function of immune
suppressive cells in the tumor microenvironment. SNDX-6352 is being
evaluated in a 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, the potential use of the
acquired compounds to treat pediatric and adult patients with MLL-r
driven leukemias, the timing of the clinical development of the
acquired compounds, the amount of cash, cash equivalents and
marketable securities needed to fund payment obligations and
development efforts and Syndax's potential payment of upfront and
milestone payments and royalties. 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.
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
Eliza Schleifstein
Argot Partners
eliza@argotpartners.com
Tel 973.361.1546
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.