US FDA grants fast track designation to Kyverna Therapeutics’ KYV─101 to treat lupus nephritis

US FDA grants fast track designation to Kyverna Therapeutics’ KYV─101 to treat lupus nephritis

Kyverna Therapeutics (Kyverna), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, announced the US Food and Drug Administration (FDA) has granted Fast Track designation for KYV-101 for the treatment of patients with refractory lupus nephritis (LN). KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients.

“The FDA granting us Fast Track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus,” said Peter Maag, Ph.D., chief executive officer (CEO) of Kyverna. “We believe KYV-101 has the potential to drive greater and more rapid reduction of disease activity in patients with LN, and we look forward to sharing clinical data on patients in the second half of 2023.”