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Kyverna Therapeutics Submits CTA for Phase 1/2 Clinical Study of KYV-101 in Germany

– 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[1]. 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[2].

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 KYV-101

KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis and other B-cell driven autoimmune diseases. In a 20-patient Phase 1/2 study in oncology, expected anti-lymphoma activity was associated with a significant reduction of cytokines released that translated into a strong reduction of cytokine-driven side effects such as the rate of immune effector cells-associated neurotoxicity syndrome (ICANS)[3]. The fully human anti-CD19 CAR also translated into reduced immunogenicity that favorably impacted cell persistence at one month. Kyverna recognized that these properties 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.

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.

Media Contact:

Kathy Vincent
Greig Communications
kathy@greigcommunications.com
  1. E. Carter et al., Nature Reviews Rheumatology, 12, Oct. 2016, 605-620.
  2. Adv Chronic Kidney Dis. 2019;26(5):313.
  3. Brudno et al., Nature Medicine 2020; 26:270-280.