Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in Lupus Nephritis

Phase 1 open-label clinical trial in LN in U.S. is actively recruiting patients at multiple sites

KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor T-cell therapy designed to deplete B cells, including autoreactive B cells in autoimmune disease patients

Lupus nephritis (LN) is a serious complication of lupus; nearly half of adults diagnosed with lupus develop LN

EMERYVILLE, Calif., June 1, 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 U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KYV-101 for the treatment of patients with refractory lupus nephritis (LN). KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients.

“The FDA granting us Fast Track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus,” said Peter Maag, Ph.D., chief executive officer (CEO) of Kyverna. “We believe KYV-101 has the potential to drive greater and more rapid reduction of disease activity in patients with LN, and we look forward to sharing clinical data on patients in the second half of 2023.”

Kyverna’s Phase 1 open label, multi-center clinical trial of KYV-101 in the US is actively recruiting patients at multiple sites in the US. Kyverna also filed its first European Union (EU) Clinical Trial Application (CTA) to the Paul Ehrlich Institut (PEI) in Germany for a parallel Phase 1/2 clinical trial of KYV-101 in LN.

Fast Track designation is designed to facilitate the development and expedite the review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, thus enabling drugs to reach patients sooner. Therapies granted Fast Track designation are given the opportunity for more frequent interactions with the FDA and may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About Lupus Nephritis (LN)

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. 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 Contacts:

Kathy Vincent
Greig Communications, Inc.
kathy@greigcommunications.com

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