NKTR-358

About NKTR-358

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 a potential first-in-class resolution therapeutic 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.

¹The American Autoimmune Related Diseases Association. Autoimmune Statistics.

²Johns Hopkins University. Autoimmune Disease Research Center.