2022-11-16| Trials & Approvals

Kyverna’s Lupus Nephritis Cell Therapy Received FDA Clearance, Aiming for Phase 1 Trial in 2023

by Richard Chau
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Based in Emeryville, California, Kyverna Therapeutics is a cell therapy company dedicated to developing novel therapies for severe autoimmune and inflammatory diseases. The company recently 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 CAR T-cell therapy for the treatment of lupus nephritis (LN).

Related Article: Eli Lilly and BI Notch Clinical Win for Kidney Disease Drug 

Devastating Nature of Lupus Nephritis

Lupus nephritis (LN) is a severe complication of systemic lupus erythematosus (SLE). It occurs when the immune system mistakenly attacks the kidneys, leading to kidney inflammation, impaired kidney function or even kidney failure. Studies have shown that up to 40% of adults diagnosed with lupus eventually develop LN. Medications available for controlling inflammation and reducing kidney damage include corticosteroids and immunosuppressive drugs, which only show modest efficacy and they may lead to detrimental side effects following long-term usage. 

KYV-101 as a Potential Treatment for LN

KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 CAR T cell therapy with properties well suited for use in B cell-driven autoimmune diseases including LN. In a Phase 1/2 study in oncology involving 20 patients with B-cell lymphoma, expected anti-lymphoma activity in patients treated with this new anti-CD19 CAR T construct was associated with a significant reduction of cytokines released. Kyverna 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 (NIH) to use this CD19 construct in both autologous and allogeneic CAR T-cell therapies.

Kyverna filed its first IND application to the FDA for KYV-101 in October and received clearance last week. “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.”

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