– Phase 1 clinical trial expected to launch early 2023 and will evaluate safety and preliminary impact on disease activity of KYV-101

EMERYVILLE, Calif., November 11, 2022 – Kyverna Therapeutics (“Kyverna”), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the clearance of its first Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of KYV-101, a novel therapy for the treatment of lupus nephritis.

“We are pleased with the FDA’s clearance of our IND application for our lead candidate KY-101 in lupus nephritis. This is a huge achievement for Kyverna and a significant moment in the field of cell therapies targeting autoimmune disease,” said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics. “We look forward to working with investigators to initiate our Phase 1 clinical trial in early 2023 and to continue our commitment to bringing novel treatment options to this vulnerable patient population living with this devastating disease.”

“There is a clear need for additional therapies for lupus nephritis, as current interventions are limited in their rates of response,” said Peter A. Merkel, M.D., MPH, chief of rheumatology and professor of medicine and epidemiology at the University of Pennsylvania. “Given recent publications showing the potential of cell-based therapy for patients with lupus nephritis, it is exciting to see that a clinical trial is commencing in this indication. This work also holds promise for other B-cell-driven autoimmune diseases.”

Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE), more commonly known as lupus. Approximately 40 percent of adults diagnosed with lupus eventually develop LN and 60 percent of LN patients will fail standard of care and approved treatments. Aside from modest efficacy, current treatments expose these young adults to the well-demonstrated detrimental consequences of chronic treatment with corticosteroids and other powerful immunosuppressants. Up to 10 percent of patients with LN and 40 percent with diffuse LN (class IV) will ultimately develop kidney failure, requiring dialysis or a kidney transplant to stay alive.

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