The world's first regulatory T cell activator NKTR-358 enters the clinical 1b trial

May 11, 2018 Source: Sina Pharmaceutical

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On May 8, US biologist Nektar Therapeutics announced that it has begun Phase 1b clinical trials of patients with systemic lupus erythematosus (SLE) to evaluate a first-in-class regulatory T-cell stimulus. The safety and initial efficacy of NKTR-358.

NKTR-358 selectively promotes the proliferation and activation of regulatory T cells (Tregs) in vivo to restore the body's self-tolerance mechanism. NKTR-358 differs from immunosuppressive drugs used in the treatment of autoimmune diseases, which cause unwanted side effects by inhibiting the entire immune system. NKTR-358 is designed to correct disorders of the immune system function of patients such as SLE.

Dr. Brian Kotzin, senior vice president of clinical development at NKTR-358, Nektar, said: "NKTR-358 has the potential to address the immune system imbalance of autoimmune diseases such as lupus, which restores immunity by driving the expansion and functional activities of Tregs. Steady state. We are excited about the beginning of clinical research and the potential of NKTR-358 to provide positive benefits for SLE patients."

This clinical Phase 1b study was a double-blind, randomized, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics, and immunity of multiple doses of NKTR-358 in approximately 50 patients with systemic lupus erythematosus. effect. The study will also assess the impact of NKTR-358 on disease activity in patients with SLE.

The Lupus Foundation in the United States estimates that there are 1.5 million Americans, and at least 5 million people worldwide have lupus. SLE, which accounts for 70% of all lupus cases, is a chronic autoimmune disease that affects joints, skin, brain, lungs, kidneys, and blood vessels, and causes extensive inflammation and tissue damage in affected organs.

The progressive imbalance of regulatory T cells relative to traditional T cells is common to many autoimmune diseases, including SLE. During disease outbreaks, the number of circulating Tregs in SLE patients is reduced, and immunosuppressive function is impaired, leading to loss of self-tolerance, autoantibody production, and disease symptoms. Autoimmune diseases can cause the immune system to erroneously attack healthy cells in a person's body. Damage to the body's self-tolerance mechanism causes pathogenic autoreactive T lymphocytes to form, thereby making this attack. NKTR-358 stimulates proliferation and activation of Tregs by optimizing the targeting of interleukin-2 (IL-2) receptor complexes. By increasing the number of Tregs, it is possible to control pathogenic autoreactive T cells, achieve balance between effector cells and Treg cells, and restore the body's self-tolerance mechanism.

In July 2017, Nektar and Eli Lilly and Company reached a strategic cooperation, the two sides will develop and commercialize NKTR-358 in a variety of autoimmune diseases.

In preclinical studies, NKTR-358 has been shown to inhibit antigen-driven inflammation in a skin allergy model. It also shows progression markers that can reduce the SLE mouse model. NKTR-358 is being developed as a self-injection once or twice a month to treat some autoimmune diseases. (Sina Pharmaceutical Compilation / David)

Article Reference Source: 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

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