Kyverna Therapeutics Announces FDA Clearance of IND for KYV-101, a Novel Fully Human CD19 CAR T-Cell Therapy to Treat Lupus Nephritis

Phase 1 clinical trial expected to launch early 2023 and will evaluate safety and preliminary impact on disease activity of KYV-101

EMERYVILLE, CA, USA I November 11, 2022 I Kyverna Therapeutics ("Kyverna"), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the clearance of its first Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of KYV-101, a novel therapy for the treatment of lupus nephritis.

"We are pleased with the FDA's clearance of our IND application for our lead candidate KY-101 in lupus nephritis. This is a huge achievement for Kyverna and a significant moment in the field of cell therapies targeting autoimmune disease," said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics. "We look forward to working with investigators to initiate our Phase 1 clinical trial in early 2023 and to continue our commitment to bringing novel treatment options to this vulnerable patient population living with this devastating disease."

"There is a clear need for additional therapies for lupus nephritis, as current interventions are limited in their rates of response," said Peter A. Merkel, M.D., MPH, chief of rheumatology and professor of medicine and epidemiology at the University of Pennsylvania. "Given recent publications showing the potential of cell-based therapy for patients with lupus nephritis, it is exciting to see that a clinical trial is commencing in this indication. This work also holds promise for other B-cell-driven autoimmune diseases."

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.

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. In addition to aiming to develop next-generation chimeric 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 visit https://kyvernatx.com.

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

SOURCE: Kyverna Therapeutics

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