Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease

Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in partnership with the National Institutes of Health, licensing the asset for autoimmune indications in January 2022.

Preclinical data showed the therapy's potency, durability and an improved safety profile compared with existing lymphoma CAR-T products, suggesting broader use in B-cell driven autoimmune diseases such as lupus. Analysts at William Blair note that miv-cel is positioned to be the first CAR-T approved for an autoimmune indication.

Kyverna's small size is presented as an advantage, allowing it to focus on development despite the commercialization and manufacturing challenges that have hampered smaller biotech firms in the cell-therapy space. The company's CEO Warner Biddle highlighted this strategic positioning in a recent interview.