Kyverna Therapeutics has revealed plans to progress to Phase II trials of KYV-101 for multiple sclerosis (MS) following a green light from the US Food and Drug Administration (FDA).
KYV-101 is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate for use in B cell-driven autoimmune diseases.
“This approval is a critically necessary step that paves the way to enrol patients with treatment-refractory progressive MS for whom there are no currently available treatment options in the KYSA-7 trial. This study offers participants a new hope for arresting relentless disability worsening and a potentially durable, treatment-free remission,” said Bruce Cree, Clinical Research Director and Professor of Clinical Neurology at the University of California, San Francisco, CA.
CAR T-cell therapy involves modifying a patient’s T cells to recognise and remove B cells in the patient’s body. KYV-101, specifically targets CD19, a protein expressed on the surface of B cells, which is involved in various types of autoimmune diseases.
“This very important study will answer whether CAR T-cell therapy offers a new treatment option for patients living with MS. This therapy holds the promise to alter the treatment paradigm of MS by fundamentally readjusting the immune system,” said Manuel Friese, Professor of Neurology and Director of the Institute of Neuroimmunology and Multiple Sclerosis at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Kyverna is also currently conducting trials of KYV-101 in patients with lupus nephritis, while additional trials in systemic sclerosis and myasthenia gravis are in preparation.