– Company files its second clinical trial application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis
– Application to initiate a clinical study in the EU follows acceptance of Kyverna’s US Investigational New Drug (IND) application
EMERYVILLE, Calif., January 6, 2023 – Kyverna Therapeutics (“Kyverna”), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the filing of its first European Union (EU) Clinical Trial Application (CTA) to the Paul Ehrlich Institut (PEI) in Germany for KYV-101, a novel therapy for the treatment of lupus nephritis.
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.
This application follows acceptance of Kyverna’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) and reflects the global potential for KYV-101. Pending results of the PEI review, Kyverna is actively working with clinical sites in Europe to support initiation of the Phase 1/2 study in LN.
About Kyverna Therapeutics
Kyverna Therapeutics is a cell therapy company with the mission of engineering a new class of therapies for autoimmune and inflammatory diseases. The Kyverna therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Kyverna’s pipeline includes next-generation chimeric antigen receptor T-cell (CAR T) therapies in both autologous and allogeneic formats with properties well suited for use in B cell-driven autoimmune diseases. By offering more than one mechanism for taming autoimmunity, Kyverna is positioned to act on its mission of transforming how autoimmune diseases are treated. For more information, please visit https://kyvernatx.com.
- E. Carter et al., Nature Reviews Rheumatology, 12, Oct. 2016, 605-620.
- Adv Chronic Kidney Dis. 2019;26(5):313.
- Brudno et al., Nature Medicine 2020; 26:270-280.