SAN FRANCISCO, March 27, 2017 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) today announced that it has begun
dosing in a Phase 1 clinical study evaluating NKTR-358, the
company's new biologic therapy, which is being developed to treat a
wide range of auto-immune diseases and inflammatory disorders.
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 auto-immune 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. The Phase 1
study will evaluate single-ascending doses of NKTR-358 in
approximately 50 healthy subjects.
"NKTR-358 has the potential to be a first-in-class key
resolution therapeutic in immunology," said Jonathan Zalevsky, Ph.D., vice president of
biology at Nektar Therapeutics. "Data from non-human primate
studies show that NKTR-358 drives proliferation and increased
functional activity of Regulatory T cells (Tregs). Suboptimal
Treg numbers and their lack of activity underlie many autoimmune
diseases, including lupus, Crohn's disease, psoriasis, rheumatoid
arthritis and multiple sclerosis. As the first potential
medicine to restore appropriate Treg levels and function, NKTR-358
could address a critical unmet need for patients with serious and
debilitating immune disorders."
The Phase 1 study is a dose-finding trial for NKTR-358 and will
measure observed changes and functional activity of regulatory T
cells. 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. A
multiple-ascending dose trial evaluating NKTR-358 in patients with
systemic lupus erythematosus (SLE) is planned for the second half
of 2017.
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 has demonstrated that it could
suppress antigen-driven inflammation in a model of cutaneous
hypersensitivity. NKTR-358 has also shown that it reduces markers
of progression in a mouse model of systemic lupus erythematosus
(SLE).
NKTR-358 is being developed as a once or twice-monthly
self-administered injection for a number of auto-immune
diseases.
About Nektar Therapeutics
Nektar
Therapeutics is a research-based development stage
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 expected ability to obtain useful data from the
Phase 1 clinical study to evaluate NKTR-358, the timing and
availability of clinical data for NKTR-358, the future clinical
development plans for NKTR-358, the timing of planned regulatory
filings, 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) clinical study outcomes,
including the Phase 1 clinical study outcome of NKTR-358, remain
very unpredictable and it is possible that a clinical study could
fail due to efficacy, safety or other important clinical findings;
(ii) NKTR-358 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 Phase 1
clinical study notwithstanding positive findings in preclinical
studies; (iii) our drug candidates are in various stages of
clinical development and the risk of failure is high and can
unexpectedly occur at any stage prior to regulatory approval for
numerous reasons including negative safety and efficacy findings
even after positive findings in previous preclinical studies; (iv)
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; (v)
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; (vi) 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 (vii) certain
other important risks and uncertainties set forth in our Annual
Report on Form 10-K for the year ended December 31,
2016 filed with the Securities and Exchange
Commission on March 1, 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 of Pure
Communications
973-271-6085
dan@purecommunications.com
i The American Autoimmune Related Diseases
Association. Autoimmune Statistics.
https://www.aarda.org/autoimmune-information/autoimmune-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/autoimmune-information/autoimmune-statistics/
iv The American Autoimmune Related Diseases Association.
Autoimmune Statistics.
https://www.aarda.org/autoimmune-information/autoimmune-statistics/
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SOURCE Nektar Therapeutics