Kyverna Therapeutics has announced promising results from a study evaluating a one-time, personalized cell therapy for stiff person syndrome, a rare, neurological autoimmune disorder. The treatment demonstrated improvements in mobility and reductions in disabilities among patients, according to data presented on Tuesday.
The company intends to submit the therapy to the U.S. Food and Drug Administration (FDA) by the middle of 2024. If approved, this would mark a historic milestone as the first treatment for stiff person syndrome and the first personalized CAR-T therapy for any autoimmune disease to reach the market.
Currently, CAR-T therapies are approved exclusively for blood cancers. However, the use of engineered T cells to deplete B cells—effectively performing an immune system reset—has prompted a growing number of biotech firms to explore CAR-T applications in autoimmune diseases.
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