WALTHAM, Mass. and SAN FRANCISCO, May 30,
2018 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq:
SNDX), a clinical stage biopharmaceutical company developing an
innovative pipeline of cancer therapies, and Nektar Therapeutics
(Nasdaq: NKTR) today announced a non-exclusive, clinical
collaboration to evaluate the safety and efficacy of Nektar's
NKTR-214, a CD122-biased agonist, in combination with entinostat,
Syndax's oral, small molecule Class 1 specific HDAC inhibitor, in
patients with metastatic melanoma who have previously progressed on
treatment with an anti-PD-1 (programmed death receptor-1)
agent.
Under the terms of the agreement, Syndax and Nektar will
collaborate on a study to evaluate the combination. The Phase
1b portion of the trial aims to
establish safety and a recommended dose for the combination regimen
and will be followed by a Phase 2 portion designed to assess
efficacy, as defined by objective response rate and durability of
response. Progression free survival and overall survival will also
be evaluated. Correlative biomarker analyses that aim to identify
patients with enhanced responses to the combination, including
analyses exploring the potential of elevated levels of classical
peripheral blood monocytes, will be incorporated. Syndax will be
responsible for conducting the Phase 1b/2 trial and the agreement includes a provision
where the parties may extend the collaboration to include a pivotal
trial based on mutual interest.
"We are excited to be working with Nektar as we build upon our
strategy of establishing clinical collaborations to test novel
combinations of entinostat with leading edge immune therapies,"
said Briggs W. Morrison, M.D., Chief
Executive Officer of Syndax. "Previous Phase 2 data with entinostat
and high dose IL-2 in renal cell cancer1 and our
promising preclinical data generated with NKTR-214, laid the
scientific and clinical foundation for this collaboration. Working
with Nektar allows us to increase the potential impact entinostat
may have in the treatment of PD-1 refractory metastatic melanoma
patients, and complements the exciting data we have seen when
combining entinostat with KEYTRUDA® in a similar
population."
In preclinical testing, the results of which were recently
presented at the 2018 American Association of Cancer Research
Annual Meeting2, the combination of entinostat and
NKTR-214 significantly inhibited tumor growth in tumor models of
kidney and colon cancer. The anti-tumor activity of the combination
was accompanied by a dramatic increase in the activation and
cytotoxic activity of CD8+ T cells in the tumor, along with
modulation of immune suppressor cells found in the tumor
microenvironment.
"The combination of NKTR-214 and entinostat demonstrated a
unique synergy in our preclinical models which warrants further
study in the clinic," said Jonathan
Zalevsky, Ph.D, Senior Vice President and Chief Scientific
Officer of Nektar. "Importantly, we observed elevated levels of
cytokine-positive tumor-infiltrating cytotoxic T cells following
treatment with the combination. We believe this important
preclinical finding could translate to improved tumor responses in
patients who have become refractory to checkpoint inhibitors. We
look forward to working with Syndax as this combination advances
into the clinic."
Additional financial details and other terms of the agreement
were not disclosed.
About Entinostat
Entinostat is a once-weekly, oral, small molecule, class I HDAC
inhibitor 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, an
indication for which it has been granted Breakthrough Therapy
Designation by the FDA. Entinostat has been shown to block the
function of immune suppressive cells in the tumor microenvironment,
and is being evaluated in combination with several approved
PD-1/PD-L1 antagonists, including in ongoing Phase 1b/2 clinical trials combining 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 as well as
advanced hormone receptor positive, human epidermal growth factor
receptor 2 negative breast cancer; and with BAVENCIO®
from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer.
About NKTR-214
NKTR-214 is an experimental therapy designed to stimulate
cancer-killing immune cells in the body by targeting CD122 specific
receptors found on the surface of these immune cells, known as CD8+
effector T cells and Natural Killer (NK) cells. Growing these
tumor-infiltrating lymphocytes (TILs) in vivo and replenishing the
immune system is critically important as many patients battling
cancer lack sufficient TIL populations to benefit from approved
checkpoint inhibitor therapies. In preclinical studies, treatment
with NKTR-214 resulted in a rapid expansion of these cells and
mobilization into the tumor micro-environment.1,2 NKTR-214 has an
antibody-like dosing regimen similar to the existing checkpoint
inhibitor class of approved medicines.
About Syndax Pharmaceuticals, Inc.
Syndax, headquartered in Waltham, Massachusetts, is a biopharmaceutical
company developing an innovative pipeline of cancer therapies at
various stages of clinical and pre-clinical development. The
company's mission is to develop agents that extend and improve the
lives of cancer patients. For more information, please visit
www.syndax.com and follow us on Twitter and LinkedIn.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly-owned R&D pipeline of investigational medicines
in oncology, immunology and pain as well as a portfolio of approved
partnered medicines. Nektar is headquartered in San Francisco, California, with additional
operations in Huntsville, Alabama
and Hyderabad, India. Further
information about the company and its drug development programs and
capabilities may be found online at
http://www.nektar.com.
Citations
¹ Pili R., et al. (2017) Clin. Cancer Res., 23(23)
7199-7208.
2 Wang L., et al. (2018, April). AACR, Chicago, IL.
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.
Nektar's Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "believe," "aim," "expect,"
"designed" and similar references to future periods. Examples of
forward-looking statements include, among others, statements we
make regarding the therapeutic potential NKTR-214 in combination
with entinostat, the enrollment of future clinical trials, and
outcomes from clinical and preclinical studies of our new drug
candidates. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
only on our current beliefs, expectations and assumptions regarding
the future of our business, future plans and strategies,
anticipated events and trends, and other future conditions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of our
control. Our actual results may differ materially from those
indicated in the forward-looking statements. Therefore, you should
not rely on any of these forward-looking statements. Important
factors that could cause our actual results to differ materially
from those indicated in the forward-looking statements include,
among others: (i) our statements regarding the therapeutic
potential of NKTR-214 are based on pre-clinical and clinical
findings and observations; (ii) NKTR-214 is in early-stage clinical
development and there are substantial risks that can unexpectedly
occur for numerous reasons including negative safety and efficacy
findings in the ongoing clinical studies notwithstanding positive
findings obtained in prior studies; (iii) our statements regarding
the therapeutic potential of NKTR-214 are based on preclinical
findings and early observations in clinical studies; (iv)
scientific discovery of new medical breakthroughs is an inherently
uncertain process and the future success of potential new drug
candidates (such as NKTR-214) alone or in combination with
entinostat is therefore very uncertain and unpredictable; (v) the
timing of the commencement or end of clinical trials and the
availability of clinical data may be delayed or unsuccessful due to
regulatory issues, slower than anticipated patient enrollment,
manufacturing challenges, changing standards of care, evolving
regulatory requirements, clinical trial design, clinical outcomes,
competitive factors, or delay or failure in ultimately obtaining
regulatory approval in one or more important markets; (vi) patents
may not issue from our patent applications for our drug candidates,
patents that have issued may not be enforceable, or additional
intellectual property licenses from third parties may be required;
and (vii) certain other important risks and uncertainties set forth
in Nektar's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on May 10,
2018. Any forward-looking statement made by us in this press
release is based only on information currently available to us and
speaks only as of the date on which it is made. We undertake no
obligation to update any forward-looking statement, whether written
or oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
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
Nektar Contacts
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Jodi Sievers of Nektar
Therapeutics
415-482-5593
For Media:
Dan Budwick of 1AB
973-271-6085
dan@1abmedia.com
SNDX-G
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SOURCE Syndax Pharmaceuticals