Autoimmune disease
Despite falling short of its primary Phase II objective, Nektar plans to push its T cell stimulator rezpeg into Phase III development.
Sanofi bought Dren’s DR-0201 program earlier this year for $600 million upfront and is running two Phase I trials in undisclosed inflammatory indications.
Vyvgart, an FcRn inhibitor already approved for generalized myasthenia gravis, is also being tested in myositis, Sjögren’s disease and the “clinically related” Graves disease.
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.
Kezar Life Sciences suffered multiple clinical holds and four patient deaths in a trial testing zetomipzomib for lupus—a program that has since been canned. The company is still pursuing development in autoimmune hepatitis, but recent FDA communications could delay its timeline.
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
Phase I/II data for rese-cel point to its therapeutic potential in systemic lupus erythematosus and lupus nephritis, as well as other autoimmune conditions.
Phase III data for dapirolizumab pegol presented at the 2025 conference of the American College of Rheumatology showed quality-of-life benefits in systemic lupus erythematosus that could see Biogen go head-to-head with GSK and AstraZeneca in a blockbuster space.
The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting mechanism of action gives it activity in improving kidney conditions in patients with lupus nephritis.
The partners have yet to disclose what their priority indications are, though EVOQ’s NanoDisc technology aims to enable the development of potentially curative treatments for autoimmune conditions such as celiac disease and type 1 diabetes.
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