Drugs and FDA
Kyverna reports sustained benefits from autoimmune CAR-T therapy
Kyverna said a single dose of miv-cel was linked to sustained mobility gains at 12 months in 26 patients with stiff person syndrome.
Kyverna Therapeutics reported updated trial data showing sustained benefits from miv-cel, its investigational CAR-T therapy for autoimmune diseases. The company plans to add the one-year stiff person syndrome results to its FDA rolling submission and said it remains on track to complete the application in the fourth quarter.
In the Kysa-8 trial, 26 patients with stiff person syndrome had a median 49% improvement on the timed 25-foot walk test after 12 months versus baseline. Eight of 12 patients who had needed a walking aid before treatment still did not need one at one year. Kyverna said 92% of patients remained free of chronic immunotherapies.
In the phase 2 portion of the Kysa-6 trial for generalized myasthenia gravis, all five patients with at least one year of follow-up sustained clinically meaningful improvements, according to Kyverna. The company reported no high-grade cases of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, and no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome events.
