Potential Treatment for Myasthenia Gravis Receives Fast Track Designation from the FDA

KYV-101 (Kyverna Therapeutics, Emeryville, CA) an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell therapeutic candidate, has been granted Fast Track Designation by the Food and Drug Administration (FDA) for investigation as a potential treatment for myasthenia gravis (MG). KYV-101 is designed to modify T cells to target CD19, which is a protein that is expressed on the surface of the B cells involved in autoimmune diseases, including MG.

In 2023, the investigational new drug (IND) application of KYV-101 was cleared by the FDA, enabling Kyverna Therapeutics to initiate a planned phase 2 open-label, multicenter clinical trial called KYSA-6, to investigate KYV-101 as a potential therapy for MG. KYSA-6 is part of a pipeline of clinical trials investigating KYV-101, including the ongoing phase 1 study KYSA-1 (NCT05938725) in the United States and the ongoing phase 1/2 clinical trial KYSA-3 in Germany assessing the medication’s use for refractory lupus nephritis.

"We are very happy to receive this important designation for KYV-101 in the KYSA-6 trial and remain committed to improving the lives of patients living with severe and debilitating neurological autoimmune diseases," said Peter Maag, PhD, CEO of Kyverna Therapeutics. "This is the second time KYV-101 has received such designation, after obtaining the first one for lupus nephritis earlier this year."