Nektar Therapeutics Initiates Clinical Study of NKTR-358, a First-in-Class Regulatory T Cell Stimulator, Being Developed for the Treatment of Immune and Inflammatory Disorders

SAN FRANCISCO, CA, USA I March 27, 2017 I Nektar Therapeutics (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

SOURCE: Nektar Therapeutics

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