WALTHAM, Mass., Jan. 10, 2018 /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 a new clinical collaboration with Genentech, a member of
the Roche Group. As part of the collaboration, the two companies
will evaluate the combination of Syndax's entinostat, an oral,
small molecule, class I HDAC inhibitor, and Genentech's programmed
cell death ligand 1 (PD-L1) blocking antibody, atezolizumab
(TECENTRIQ®), in patients with second-line hormone
receptor positive, human epidermal growth factor receptor 2
negative (HR+, HER2-) metastatic breast cancer.
The planned Phase Ib/II, open-label, multicenter, randomized
trial will enroll patients with metastatic HR+, HER2- breast cancer
who have experienced disease progression during or following
first-line therapy. Genentech will be responsible for conducting
the trial. The trial will be conducted as part of MORPHEUS, Roche's
novel cancer immunotherapy development platform. MORPHEUS is a
Phase Ib/II adaptive platform to develop combinations of cancer
immunotherapies more rapidly and efficiently.
"This collaboration represents further validation of the ongoing
interest to test the potential ability of Syndax's entinostat to
enhance the effectiveness of an immuno-oncology therapy in an area
of unmet medical need," said Briggs W.
Morrison, M.D., Chief Executive Officer of Syndax. "While checkpoint inhibitors have shown
initial promise in triple-negative breast cancer, there is a clear
need to augment the effectiveness of such therapies in the setting
of HR+, HER2- breast cancer."
In August 2015, Syndax announced a
separate collaboration with Genentech for ENCORE 602, a Phase Ib/II
trial to examine the safety, tolerability and clinical activity of
entinostat in combination with TECENTRIQ in triple-negative breast
cancer. ENCORE 602 is expected to complete enrollment in the Phase
II portion of the trial in the first half of 2018.
Financial and other terms of the agreement were not
disclosed.
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 clinical stage 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.
TECENTRIQ® (atezolizumab) is a registered trademark
of Genentech, a member of the Roche Group.
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.
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
David Rosen
Argot Partners
Tel 212.600.1902
david.rosen@argotpartners.com
SNDX-G
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SOURCE Syndax Pharmaceuticals