Autoimmune disease affects more than 23 million Americans – nearly eight percent of the U.S. population – and the prevalence is continuing to rise.1,2 There are more than 80 known types of autoimmune diseases, including lupus, Crohn’s disease, psoriasis and rheumatoid arthritis.1 Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person’s body.1 Current systemic treatments for autoimmune disease, including corticosteroids and anti-TNF agents, suppress the immune system broadly and come with severe side effects.
NKTR-358 is an IL-2 conjugate Treg stimulator that addresses an underlying immune system imbalance in patients with many of these autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 can act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.
In July 2017, Nektar entered into a strategic collaboration with Lilly to develop and commercialize NKTR-358. Under the terms of the agreement with Lilly, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis. Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.
NKTR-358 is being developed as a once or twice-monthly self-administered injection for a number of auto-immune diseases. In March of 2017, Nektar began the first Phase 1 dose-finding trial of NKTR-358 to evaluate single-ascending doses of NKTR-358 in approximately 50 healthy subjects. In April 2018, Nektar initiated a Phase 1b 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.
About the Phase 1b Study of NKTR-358 in Patients with Systemic Lupus Erythematosus (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. For more information, please visit clinicaltrials.gov and search NCT03556007.
2019 EULAR European Congress of Rheumatology
- Oral Presentation: Selective Expansion of Regulatory T-Cells in Humans by a Novel IL-2 Conjugate T-reg Stimulator, NKTR-358, Being Developed for the Treatment of Autoimmune Diseases, Brian Kotzin, M.D.
Treg Directed Therapy for Autoimmune Disorders Meeting – May 2018
- NKTR-358: An IL-2 Pathway Agonist that Selectively Expands and Activates Regulatory T cells for the Treatment of Allergy and Autoimmune Disease
Antigen-Specific Immune Tolerance Drug Development Summit – April 2018
- NKTR-358: A Selective Regulatory T Cell Inducing Agent for the Treatment of Autoimmune and Inflammatory Diseases
American College of Rheumatology Annual Meeting, San Diego, CA
- Poster Abstract 2715: NKTR-358: A Selective, First-in-Class IL-2 Pathway Agonist Which Increases Number and Suppressive Function of Regulatory T Cells for the Treatment of Immune Inflammatory Disorders, Langowski, J., et al.
13th Annual World Congress on Inflammation
- Jun 13, 2019: First-in-Human Data Presented from Phase 1a Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at Annual European Congress of Rheumatology
- May 8, 2018: 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
- July 24, 2017: Lilly and Nektar Therapeutics Announce Alliance to Develop and Commercialize NKTR-358, A Novel Autoimmune Therapy
- July 10, 2017: Nektar Presents New Preclinical Data for NKTR-358, a First-in-Class Regulatory T Cell Stimulator, at 13th World Congress of Inflammation in London
- March 27, 2017: 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