Nektar Therapeutics Announces Initiation of a Phase 1b Clinical Study of NKTR-358, a First-in-Class Regulatory T Cell Stimulator, in Patients with Systemic Lupus Erythematosus

SAN FRANCISCO, CA, USA I May 8, 2018 I Nektar Therapeutics (NASDAQ: NKTR) today announced that it has commenced dosing patients with systemic lupus erythematosus (SLE) in a Phase 1b clinical study evaluating NKTR-358, a first-in-class regulatory T cell stimulator. NKTR-358 selectively stimulates the proliferation and activation of regulatory T cells (Tregs) 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 such as SLE.

"NKTR-358 has the potential to address the immune system imbalance that underlies autoimmune diseases such as lupus by driving the expansion and functional activity of Tregs to restore immune homeostasis in the body," said Brian Kotzin, M.D., Senior Vice President, Clinical Development and NKTR-358 Program Lead at Nektar Therapeutics. "We are excited about the start of the clinical study and the potential of NKTR-358 to provide a positive benefit for patients with SLE."

The Phase 1b study is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and immunological effects of multiple ascending doses of NKTR-358 in approximately 50 patients with systemic lupus erythematosus (SLE). The study will also evaluate the effects of NKTR-358 on disease activity in SLE patients.

The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus. Systemic lupus erythematosus (SLE) accounts for 70% of all cases of lupus.1 SLE is a chronic autoimmune disease that can affect the joints, skin, brain, lungs, kidneys, and blood vessels, and cause widespread inflammation and tissue damage in the affected organs.

A progressive imbalance of regulatory T cells relative to conventional T cells is shared by many autoimmune diseases, including SLE.  During disease flares, the number of circulating Tregs decreases in SLE patients and their immune suppressive function is impaired contributing to a loss of self-tolerance, the production of autoantibodies, and development of disease manifestations.2,3

In July 2017, Nektar entered into a strategic collaboration with Eli Lilly and Company to develop and commercialize NKTR-358 in multiple autoimmune conditions.

About NKTR-358

Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person's body. 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 Tregs.  By increasing the number of Tregs, the pathogenic auto-reactive T cells can be controlled and the proper balance of effector and Treg 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.4 NKTR-358 has also shown that it reduces markers of progression in a mouse model of SLE.4 

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, autoimmune 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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