Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in Lupus Nephritis

Kyverna Therapeutics, a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the U.S. 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.”

Kyverna’s Phase 1 open-label, multi-center clinical trial of KYV-101 in the US is actively recruiting patients at multiple sites in the US. Kyverna also filed its first European Union (EU) Clinical Trial Application (CTA) to the Paul Ehrlich Institut (PEI) in Germany for a parallel Phase 1/2 clinical trial of KYV-101 in LN.

Fast Track designation is designed to facilitate the development and expedite the review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, thus enabling drugs to reach patients sooner. Therapies granted Fast Track designation are given the opportunity for more frequent interactions with the FDA and may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.