From 2004 to 2015,
"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,
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,
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
Jennifer Ruddock of Nektar Therapeutics
Jodi Sievers of Nektar Therapeutics
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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