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Systemic lupus erythematosus (SLE)
Phase 1b
Phase 1b data due at EULAR June 13, 2019, 11:15 CEST.

The potential importance of NKTR-358 goes way way way beyond this highly challenging autoimmune disease. If this is effective, it will likely change the entire approach to treating autoimmune disease.

At the heart of this is that NKTR-358 is a biologic drug designed to bring the population of regulatory T cells (called Tregs--pronounced Tee regs) up to healthy numbers in people who don't make enough of them. Tregs are one of the mechanisms that keep immune responses from becoming destructive, and they are essential in preventing a person's immune system from attacking it's own cells. When Tregs are too numerous, they can muzzle appropriate immune responses. And when there aren't enough of them, autoimmune diseases are the result. And it's very common for people with autoimmune issues to have several autoimmune diseases, not just one.

Their essential role in preventing autoimmune diseases was discovered by Misha Rosenbach, an immunodermatologist and immunologist at UCSF. This discovery is quite recent. I had learned about it, and gotten to know him, because I'd written an article on this research about 2 years ago. So the therapeutic approach would be to correct the deficit in patients with autoimmune diseases--bring low Treg numbers up to normal, ie, protective, levels. I know that Rosenbach was also working on a therapeutic, but don't think it was an IL-2-based agent. I'll have to look at my interview notes when I get a chance.

In any case, NKTR-358--if successful in treating systemic lupus and well tolerated by patients--will ultimately have value in the entire field of autoimmune disease. And that is pretty profound.

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