The paper reports on a series of 15 patients with severe rheumatological autoimmune diseases that were treated with a single infusion of CD19 CAR T-cell therapy by the European team with up to 29 months post-treatment follow up
The Authors report the treatment appears to be feasible, safe, and efficacious in the conditions treated, paving the way for further controlled trials
EMERYVILLE, Calif., Feb. 22, 2024 /PRNewswire/ — Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, congratulates Prof. Georg Schett, a member of Kyverna’s Scientific Advisory Board, and his team of European collaborators on the publication in the New England Journal of Medicine1 of a landmark paper reporting on a median 15-month follow up of a series of 15 patients suffering from severe systemic lupus erythematosus, idiopathic inflammatory myositis, or systemic sclerosis who received a single infusion of autologous CD19 chimeric antigen receptor (CAR) T cells. After treatment, immunosuppressive therapy was discontinued in all patients. The treatment was well tolerated with the patients experiencing primarily mild CAR T cell therapy associated side effects.
The investigational medicinal product consisted of an autologous CD19 CAR T-cell therapy that was locally manufactured in the certified GMP laboratory of the Universitätsklinikum Erlangen (Department of Medicine 5, Hematology and Oncology) in Erlangen, Germany.
“The work of Prof. Schett and his collaborators is instrumental in delivering renewed hope for patients living with severe rheumatological autoimmune diseases and paves the way for multi-center clinical studies to ultimately define the safety and efficacy of CAR T-cell therapies in B cell-driven autoimmune diseases,” said Peter Maag, Ph.D., chief executive officer of Kyverna.
CAR T-cell therapy involves modifying a patient’s T cells to recognize and remove B cells in the patient’s body. CD19 CAR T-cell therapy specifically targets CD19, a protein expressed on the surface of B cells, which are involved in various types of autoimmune diseases.
About Kyverna Therapeutics
Kyverna is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.
Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1 trials in the United States and Germany for patients with lupus nephritis.
Kyverna’s pipeline includes next-generation chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases.
By advancing more than one mechanism for taming autoimmunity, Kyverna is positioned to act on its mission of transforming how autoimmune diseases are treated.
Forward-Looking Statements
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1. Müller et al., N Engl J Med 2024;390:687-700.
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