- Company files its first Investigational New Drug application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis

- Kyverna's therapeutic platformcombines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate autoreactive immune cells at the root cause of inflammatory disease

EMERYVILLE, Calif., Oct. 18, 2022 /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 filing of its first Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) 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 treatments1. 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 alive2.

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 releasedthat 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. Pending results of the FDA review, Kyverna is actively working with clinical sites in the U.S. and Europe to support initiation of the Phase 1/2 study in LN.

"We are extremely proud to be leading a possible revolution in how we treat severe immune-related and inflammatory diseases. The filing of this IND for KYV-101 in lupus nephritis is an important milestone for Kyverna and we are excited by the prospect of KYV-101 opening a new era in the care of patients with LN. We strongly believe that KYV-101 may drastically change the course of this devastating disease," said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics. "We look forward to working with the FDA to initiate the KYV-101 clinical study."

"Patients with lupus nephritis too often experience serious complications from the medications used to control the disease process or from the disease itself. We applaud the team at Kyverna for developing novel treatment approaches for these patients that today have very limited treatment options," said Richard A. Furie, M.D., The Marilyn and Barry Rubenstein Chair in Rheumatology, professor, Institute of Molecular Medicine, Feinstein Institutes for Medical Research, chief of Division of Rheumatology, Northwell Health, and professor of medicine, Donald and Barbara Zucker School of Medicine at Hofstra University/Northwell Health.

About KYV-101KYV-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, systemic sclerosis, and inflammatory myopathies. Kyverna has 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 TherapeuticsKyverna 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. In addition to aiming to develop next-generationchimeric antigen receptor T-cell (CAR T) therapies in both autologous and allogeneic settings, Kyverna is creating synReg T cells, a synthetic version of Regulatory T cells (Tregs), powerful natural immune cells that control immune homeostasis through multiple immunosuppressive mechanisms. 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 visithttps://kyvernatx.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.

SOURCE Kyverna Therapeutics

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Kyverna Therapeutics Submits IND for Novel CAR T-Cell Therapy to Treat Lupus Nephritis - PR Newswire