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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
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the "Risk Factors" section of the final prospectus. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information, please visit https://kyvernatx.com.

Kyverna Media Contact:
Consort Partners for Kyverna
kyvernatx@consortpartners.com

^1. Müller et al., N Engl J Med 2024;390:687-700.

SOURCE Kyverna Therapeutics