Kyverna Gets Fast Track for Lupus Nephritis Drug

FDA has granted Kyverna Therapeutics a fast track designation for KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy for treating patients with refractory lupus nephritis. KYV-101 is designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients, the company says, adding that a Phase 1 open-label, multi-center clinical trial of KYV-101 in the U.S. is actively recruiting patients.       

Additionally, in an earlier 20-patient Phase 1/2 study of KYV-101 in oncology, the “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 cells-associated neurotoxicity syndrome,” the company says. Data also showed that therapy was associated with reduced immunogenicity that “favorably impacted cell persistence,” it says.