Kyverna Therapeutics, a clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced the designation as Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of patients suffering from refractory stiff-person syndrome.
“Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease,” said Amanda Piquet, M.D., director of the Autoimmune Neurology Program at CU Anschutz Medical Campus, Aurora, CO. “I look forward to the data that will emerge from the KYSA-8 trial as this trial could drastically change the treatment landscape for SPS.”
“We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system,” said Peter Maag, Ph.D., chief executive officer at Kyverna. “We are humbled by the resilience of the SPS patients and their hope for a potential paradigm-shifting treatment option that could provide durable, immunosuppressant-free remission.”
