SAN FRANCISCO, July 10, 2017 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) today announced positive preclinical
results for NKTR-358, a first-in-class resolution therapeutic for
autoimmune disease. The new preclinical data demonstrate that
treatment with NKTR-358 induces profound regulatory T cell effects
and suppresses inflammation in multiple preclinical models. The
data were highlighted in an oral presentation at the
13th Annual World Congress on Inflammation on
July 9, 2017.
"These studies show that NKTR-358 increases the suppressive
capacity and prolongs activation and proliferation of regulatory T
cells with limited effects on conventional T cells in order to
address the imbalance found in many autoimmune diseases," said
Jonathan Zalevsky, PhD, Senior Vice
President, Biology and Preclinical Development at Nektar
Therapeutics. "NKTR-358 also demonstrated suppression of
antigen-driven inflammation in multiple preclinical models
including systemic lupus erythematosus. We are very excited about
NKTR-358's potential as a resolution therapy in autoimmune
disease."
More than 23 million Americans have an autoimmune disease -
nearly eight percent of the U.S. population - and the
prevalence is continuing to rise.i,ii There are
more than 80 known types of autoimmune diseases, including lupus,
Crohn's disease, psoriasis and rheumatoid
arthritis.iii
Autoimmune diseases cause the immune system to mistakenly attack
healthy cells in a person's body.iv A failure of the
body's self-tolerance mechanisms enables the formation of the
pathogenic auto-reactive T lymphocytes that conduct this attack.
NKTR-358 works by optimally targeting the interleukin-2 (IL-2)
receptor complex in order to stimulate proliferation and activation
of regulatory T cells. By increasing the number of regulatory
T cells, the pathogenic auto-reactive T cells can be controlled and
the proper balance of effector and regulatory T cells can be
achieved to restore the body's self-tolerance mechanisms.
In preclinical studies, NKTR-358 demonstrates attenuated and
optimized affinity for human IL-2 receptors to promote biological
activity favoring activation of regulatory T cells over
conventional T cells. This preferential activity combined with
prolonged exposure in vivo led to significant Treg
mobilization in blood and spleen following a single subcutaneous
administration in rodents. Increases in regulatory T cells were
sustained for 7 to 10 days, and were concomitant with increases in
cytometric markers of activation and increased suppressive
capacity.
In non-human primates, a single administration of NKTR-358 led
to increases in Treg mobilization and activity sustained for over
14 days, a response greatly superior in magnitude, duration and
specificity compared to an equivalent total dose of rhIL-2
administered daily for five days. In a mouse model of cutaneous
hypersensitivity, NKTR-358 administration significantly suppressed
antigen-induced inflammatory responses, an effect which was
antigen-specific and associated with establishment of Treg memory.
Similar results were achieved in analogous model using non-human
primates. Finally, NKTR-358 was efficacious in a spontaneous mouse
model of systemic lupus erythematosus (SLE). Repeat
administration over 12 weeks result in sustained Treg elevation
with corresponding significantly reduced blood urea
nitrogen. In addition, NKTR-358 resulted in a return to normal
of urine protein levels and kidney histopathology in the treated
animals.
About NKTR-358
NKTR-358 selectively stimulates the growth and activation of
regulatory T cells in the body in order to restore the body's
self-tolerance mechanisms. Unlike immunosuppressant medicines
that treat the symptoms of autoimmune disease by inhibiting the
entire immune system, which can cause unwanted side effects,
NKTR-358 is designed to correct the underlying immune system
dysfunction found in patients with immune disorders.
NKTR-358 is being developed as a once or twice monthly
self-administered injection for a number of autoimmune diseases and
is currently in a Phase 1 dose-finding trial. The Phase 1 study
will measure observed changes and functional activity of regulatory
T cells in approximately 50 healthy subjects. The objective of the
trial is to establish a range of dose levels that could be advanced
in further clinical trials. The Phase 1 study will also
evaluate pharmacokinetics and safety.
About Nektar
Nektar Therapeutics is a research-based biopharmaceutical
company whose mission is to discover and develop innovative
medicines to address the unmet medical needs of patients. Our
R&D pipeline of new investigational medicines includes
treatments for cancer, auto-immune disease and chronic pain. We
leverage Nektar's proprietary and proven chemistry platform in the
discovery and design of our new therapeutic candidates. 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.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "potential," "intend," "plan,"
"expect," "believe," "should," "may," "will" and similar references
to future periods. Examples of forward-looking statements include,
among others, statements we make regarding the therapeutic
potential of NKTR-358, the timing and availability of
clinical data for NKTR-358, the future clinical development plans
for NKTR-358, the commercial and therapeutic potential of NKTR-358,
and the potential of our technology and drug candidates in our
research and development pipeline. 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, the economy 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-358 are based on
findings and observations from preclinical findings and ongoing
clinical studies; (ii) NKTR-358 is in early-stage clinical
development and the risk of failure remains high and failure can
unexpectedly occur due to efficacy, safety or other unpredictable
factors even after positive findings in previous preclinical
studies; (iii) the timing of the commencement or end of clinical
trials and the availability of clinical data may be delayed or
unsuccessful due to regulatory delays, 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; (iv) scientific discovery of new medical breakthroughs is
an inherently uncertain process and the future success of applying
our technology platform to potential new drug candidates (such as
NKTR-358) is therefore highly uncertain and unpredictable and one
or more research and development programs could fail; (v) patents
may not issue from our patent applications for NKTR-358, patents
that have issued may not be enforceable, or additional intellectual
property licenses from third parties may be required; and (vi)
certain other important risks and uncertainties set forth in our
Quarterly Report on Form 10-Q with the Securities and Exchange
Commission on May 10, 2017. 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.
Contact:
For Investors:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585
Jodi Sievers of Nektar
Therapeutics
415-482-5593
For Media:
Dan Budwick
1AB Media
973.271.6085
i The American Autoimmune Related Diseases
Association. Autoimmune Statistics.
https://www.aarda.org/news-information/statistics/
ii Johns Hopkins University. Autoimmune
Disease Research Center.
http://autoimmune.pathology.jhmi.edu/faqs.cfm
iii The American Autoimmune Related Diseases
Association. Autoimmune Statistics.
https://www.aarda.org/news-information/statistics/
iv The American Autoimmune Related Diseases
Association. Autoimmune Statistics.
https://www.aarda.org/news-information/statistics/
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SOURCE Nektar Therapeutics