WALTHAM, Mass., Jan. 7, 2019 /PRNewswire/ -- Syndax
Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:
SNDX), a clinical stage biopharmaceutical company developing an
innovative pipeline of cancer therapies, today provided a 2019
clinical and corporate outlook.
"2019 is slated to be a milestone-rich time for Syndax, with
data expected from multiple trials within our ENCORE program
of entinostat in combination with checkpoint therapy in
platinum resistant ovarian cancer, triple negative breast cancer,
and anti-PD-1-pretreated melanoma, all of which we believe
represent underserved areas with significant market opportunity,"
said Briggs W. Morrison, M.D., Chief
Executive Officer of Syndax. "We also eagerly anticipate the next
interim overall survival analysis in the second quarter from the
Phase 3 E2112 trial of entinostat plus exemestane in HR+, HER2-
breast cancer and remain highly encouraged by the potential to
provide a survival benefit for HR+, HER2- breast cancer patients
who have stopped responding to first line treatment with hormone
therapy. Any positive overall survival assessment would enable the
company to file for full regulatory approval."
Dr. Morrison added, "In addition, we remain on track for an IND
filing for our Menin inhibitor, SNDX-5613, in the second quarter of
2019, followed by initiation of the clinical trial program. Acute
leukemias characterized by MLL-rearrangements and nucleophosmin
mutations represent areas of high unmet medical need, and the
preclinical data we've generated thus far provide strong support
that menin inhibition has the potential to serve as an effective
therapy for patients lacking viable options. Finally, we continue
to expect initial efficacy results for SNDX-6352 in chronic graft
versus host disease in the second half of 2019."
Anticipated Key Milestones for 2019:
Entinostat
- Topline results from the randomized Phase 2 portion of the
ENCORE 603 trial of entinostat in combination with Pfizer/Merck
KGaA's PD-L1 inhibitor, BAVENCIO® (avelumab), in
patients with ovarian cancer are expected in the first quarter of
2019.
- Presentation of clinical, biomarker and gene analysis data from
the anti-PD-1 pretreated melanoma cohort of the Phase 2 ENCORE 601
trial of entinostat in combination with KEYTRUDA®
(pembrolizumab) is expected in the first quarter of 2019.
- A decision on whether to advance to the second stage of the
ENCORE 601 cohort of patients with microsatellite stable colorectal
cancer (MSS-CRC) naïve to PD-1 therapy is expected in the first
quarter of 2019.
- Topline results from the randomized Phase 2 portion of the
ENCORE 602 trial of entinostat in combination with Genentech's
PD-L1 inhibitor, TECENTRIQ® (atezolizumab), in patients
with triple negative breast cancer are expected in the second
quarter of 2019.
- The next interim analysis for the overall survival (OS) primary
endpoint of E2112, the Phase 3 registration trial of entinostat
plus exemestane in advanced hormone receptor positive, human
epidermal growth factor receptor 2 negative (HR+, HER2-) breast
cancer, is expected in the second quarter of 2019. Additional
interim analyses will be conducted every six months until either an
OS benefit is observed, or the final target number of events occur.
Any positive OS assessment would enable the Company to file for
full regulatory approval.
- Syndax plans to commence a focused, biomarker-driven,
randomized registration trial comparing the
entinostat-pembrolizumab combination to standard of care
chemotherapy in non-small cell lung cancer (NSCLC) patients whose
disease has progressed after both platinum-based chemotherapy and
PD-1 antagonist therapy in the first half of 2019. The trial will
seek to validate peripheral classical monocytes as a marker of
response to the combination and to determine whether the
combination can improve progression free survival (PFS) over
standard of care chemotherapy in the high monocyte population.
SNDX-6352
- Topline results and a recommended Phase 2 dose and schedule
from the Phase 1/1b trial of
SNDX-6352, Syndax's anti-CSF-1R monoclonal antibody, alone or in
combination with IMFINZI® (durvalumab), AstraZeneca's
human monoclonal antibody directed against PD-L1, are expected in
the second quarter of 2019.
- Topline results and a recommended Phase 2 dose and schedule
from the Phase 1 trial of SNDX-6352 in patients with chronic graft
versus host disease (cGVHD) are expected in the third quarter of
2019.
Menin-MLLr Inhibitor Portfolio
- An Investigational New Drug (IND) filing with the FDA for
SNDX-5613, the Company's lead Menin inhibitor compound, is expected
in the second quarter of 2019, followed by the initiation of a
Phase 1 clinical trial in patients with a genetically defined
subset of acute leukemias.
Financial Guidance
Syndax ended 2018 with cash, cash equivalents and short-term
investments of approximately $80
million. For 2019, research and development expenses are
expected to be $54 to $58 million, and total operating expenses are
expected to be $68 to $73 million. Research and development expenses
and total operating expenses for 2019 are expected to include
approximately $2 million and
$6 million, respectively, of non-cash
stock compensation. The Company plans to announce financial results
from the fourth quarter and full-year 2018 later this quarter.
About Syndax Pharmaceuticals, Inc.
Syndax Pharmaceuticals is a clinical stage biopharmaceutical
company developing an innovative pipeline of cancer therapies. The
Company is developing its lead product candidate, entinostat, a
once-weekly, oral, small molecule, class I HDAC inhibitor, in
combination with exemestane and several approved PD-1/PD-(L)1
antagonists. The Company's pipeline also includes SNDX-6352, a
monoclonal antibody that blocks the colony stimulating factor 1
(CSF-1) receptor, as well as a portfolio of potent and selective
inhibitors targeting the binding interaction of Menin with MLL-r,
including its lead candidate SNDX-5613. 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, Syndax's full-year 2018 net cash used in
research and development and total operating activities, and
Syndax's expected 2019 research and development and total operative
expenses and 2019 non-cash stock compensation. 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.
Syndax Contacts
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
David Rosen
Argot Partners
david.rosen@argotpartners.com
Tel 212.600.1902
SNDX-G
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SOURCE Syndax Pharmaceuticals, Inc.