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Kyverna Therapeutics Gets FDA Permission to Study CAR T-Cell Therapy in Multiple Sclerosis

NEW YORK – The US Food and Drug Administration has cleared Kyverna Therapeutics' investigational new drug (IND) application, allowing it to begin studying the CD19 autologous CAR T-cell therapy KYV-101 in multiple sclerosis.

According to the Emeryville, California-based firm, it will conduct a Phase II, open-label study, dubbed KYSA-7, involving patients with treatment-refractory progressive multiple sclerosis who lack treatment options.

More than 2.8 million people worldwide have multiple sclerosis, a neurodegenerative autoimmune disease. "As a patient-centered organization, we are thrilled to see KYV-101 being cleared for a large patient demographic as part of our KYSA-7 trial," Kyverna CEO Peter Maag said in a statement. "This is a clear paradigm shift for autoimmune diseases, and a testament to our commitment to expand potentially life-changing therapeutic benefits to multiple indications."

KYV-101 is designed to specifically target CD19 expressed on B cells, which are implicated in different autoimmune diseases. The US National Institutes of Health originally developed the cell therapy and tested it in 20 cancer patients in a Phase I trial.

The latest IND in multiple sclerosis is the seventh application the FDA has cleared for KYV-101. Kyverna is also studying KYV-101 in lupus nephritis and further aims to test it in systemic sclerosis and myasthenia gravis.

Last year, Kyverna began working with Alphabet subsidiary and Google sister firm Verily to use its immune mapping platform, called Immune Profiler, to identify biomarkers of response to KYV-101.