SAN FRANCISCO, May 3, 2017 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced the appointment of
Brian Kotzin, M.D. as Head of
Clinical Development for Nektar's Immunology Program. In this
newly-created role, Dr. Kotzin will lead clinical development for
NKTR-358, a first-in-class regulatory T cell stimulator, being
developed for the treatment of immune and inflammatory
disorders.
"Dr. Kotzin is a highly respected clinical researcher with an
outstanding reputation and over 30 years of expertise in
inflammation and immunology," said Mary Tagliaferri, M.D.,
Senior Vice President of Clinical Development at Nektar
Therapeutics. "Throughout his career in both research and industry,
Dr. Kotzin has focused on auto-immune and inflammatory diseases
including systemic lupus erythematosus, rheumatoid arthritis,
psoriasis, and other immune-mediated disorders. Dr. Kotzin's
leadership skills, development experience and strategic guidance
will be invaluable to Nektar as we advance the
development of our immunology pipeline."
From 2004 to 2015, Dr. Kotzin was previously at Amgen, where he
served as Vice President, Global and Clinical Development and Head,
Inflammation Therapeutic Area, directing the global development
efforts for Amgen product candidates in the inflammation area.
During his time at Amgen, he also served as Vice President of
Medical Sciences, which encompassed early development, biomarker
development, and clinical immunology at Amgen.
"I am excited to join Nektar and lead the development strategy
for NKTR-358, which has the potential to be a first-in-class
therapeutic in immunology," said Dr. Kotzin. "We know that
suboptimal regulatory T cell (Treg) numbers, as well as their
inactivity, are characteristics of many autoimmune diseases,
including lupus, rheumatoid arthritis, inflammatory bowel disease,
psoriasis and multiple sclerosis. As a Treg stimulator,
NKTR-358 could help restore appropriate Treg levels and function
and address a critical unmet need for patients with these serious
and debilitating immune disorders."
Prior to joining Amgen, Dr. Kotzin served as head of Clinical
Immunology in the Department of Medicine and as director of the
Autoimmunity Center of Excellence at the University of Colorado Health Sciences Center in
Denver. He previously held the
position of professor in the Departments of Medicine, Pediatrics,
and Immunology at the National Jewish Medical and Research Center
in Denver. In addition to previous
academic posts in rheumatology and microbiology/immunology, Dr.
Kotzin served at the Veterans Administration Medical Center in
Denver as chief of the
Rheumatology Section. He received his medical degree from
Stanford and undergraduate degree in
Mathematics from the University of Southern
California. He is board certified in rheumatology and
internal medicine.
Dr. Kotzin has won numerous honors, including elected "Master"
of the American College of Rheumatology, the Kirkland Scholar Award
for Lupus Research, the Henry Claman Chair in Clinical Immunology,
the Gretchen Kramer Award for
Outstanding Contributions to Medicine, and Chairmanship of the
National Institutes of Health Autoimmunity Centers of Excellence.
He is an elected member of the American Association of
Clinical Investigation and the Association of American
Physicians. Dr. Kotzin has also served as an appointed member
of the Advisory Council of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases at the National Institutes of
Health and served as an industry representative, Arthritis Advisory
Committee, Center for Drug Evaluation and Research, Food and Drug
Administration (FDA). He currently serves as a member of the Board
of Directors, Federation of Clinical Immunology Societies (FOCIS).
Dr. Kotzin has published extensively and served on the editorial
boards of Arthritis and Rheumatism, The Journal of
Immunology and the Journal of Clinical
Investigation.
About NKTR-358
NKTR-358 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.
A Phase 1 dose-finding trial is underway to evaluate
single-ascending doses of NKTR-358 in approximately 50 healthy
subjects. A multiple-ascending dose trial evaluating NKTR-358
in patients with systemic lupus erythematosus (SLE) is planned for
the second half of 2017. NKTR-358 is being developed as a
once or twice-monthly self-administered injection for a number of
auto-immune diseases.
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,
rheumatoid arthritis, inflammatory bowel disease, psoriasis and
multiple sclerosis.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.
Data from non-human primate studies show that NKTR-358 drives
proliferation and increased functional activity of regulatory T
cells (Tregs). NKTR-358 has also demonstrated that it could
suppress antigen-driven inflammation in a preclinical model of
cutaneous hypersensitivity and that it reduces markers of
progression in a mouse model of systemic lupus erythematosus
(SLE).
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 therapeutic
potential of NKTR-358, future clinical development plans for
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 from the ongoing Phase 1
clinical study of NKTR-358, are 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 preclinical findings; (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
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