Drug Granted Fast Track Approval to Treat Refractory Lupus Nephritis

The US Food and Drug Administration (FDA) has granted fast track designation for Kyverna Therapeutics’ KYV-101 to treat 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.

In a 20-patient Phase I/II study in oncology, expected anti-lymphoma activity was associated with a significant reduction of cytokines released that translated into a strong reduction of cytokine-driven side effects such as the rate of immune effector cell-associated neurotoxicity syndrome 3. The fully human anti-CD19 CAR also translated into reduced immunogenicity that favorably impacted cell persistence. Kyverna recognized that these properties singled out KYV-101 as a product ideally poised for use in autoimmune disease patients, and the company obtained exclusive, worldwide licenses from the National Institutes of Health to use this CD19 construct in both autologous and allogeneic CAR T-cell therapies.

Kyverna’s Phase I open label, multicenter clinical trial of KYV-101 is actively recruiting patients at multiple sites in the U.S.

“The FDA granting us fast-track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and lifesaving medicine to patients with lupus,” said Peter Maag, PhD, chief executive officer 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.”