Kyverna Therapeutics Announces Regulatory Approval of Phase 1/2 Clinical Trial for KYV-101 in Germany
Approval of the Phase 1/2 open-label clinical trial in lupus nephritis by the Paul Ehrlich Institute in Germany follows KYV-101 Fast Track Designation by the U.S. Food and Drug Administration earlier this year
KYV-101 is a novel, fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases
EMERYVILLE, Calif., July 6, 2023 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the approval of its first Clinical Trial Application (CTA) by the Paul-Ehrlich-Institut (PEI) in Germany for KYV101, a novel therapy for the treatment of lupus nephritis (LN). KYV–101 is a novel, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for use in B cell-driven autoimmune diseases such as LN and represents an innovative approach to fighting autoimmune diseases by harnessing the power of the body's immune system.
"This approval recognizes the potential impact novel CD19 CAR T-cell therapies may bring to patients living with aggressive autoimmune diseases and reflects the global potential for KYV–101. We believe in changing the treatment paradigm by generating rigorous clinical data, and the PEI's approval paves the way to generate additional insights." said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics.
CAR T-cell therapy involves modifying a patient's immune T cells to recognize and remove B cells in the patient's body. Kyverna's anti-CD19 CAR T-cell therapy, KYV–101, specifically targets CD19, a protein expressed on the surface of B cells, which are involved in various types of autoimmune diseases. This experimental treatment may offer new hope to patients who have exhausted conventional treatment options. As more patients commence their journey with KYV–101, Kyverna continues to explore additional indications for this therapy, as well as develop a robust pipeline of promising immunotherapies aimed at addressing unmet medical needs.
About Lupus Nephritis (LN)
About Kyverna Therapeutics
1E. Carter et al., Nature Reviews Rheumatology, 12, Oct. 2016, 605-620.
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SOURCE Kyverna Therapeutics