Kyverna Therapeutics Announces Achievement of 28-Day Post- Infusion Milestone for First U.S. Patient Dosed in Phase 1 Clinical Trial of CD19 CAR T-Cell Therapy for Lupus Nephritis.

28-day post-infusion data support KYV-101 safety profile.

KYV-101 is a novel, fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases.

The open-label, Phase 1 clinical trial in the U.S. is actively recruiting patients with LN at multiple sites, with additional patients being treated with KYV-101 for multiple indications in Europe.

EMERYVILLE, Calif., Sept. 13, 2023 — Kyverna Therapeutics (“Kyverna”), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced that KYV-101 was generally well tolerated with no report of immune effector cell-associated neurotoxicity syndrome (ICANS) after the standard 28-day post infusion observation period of the first U.S. patient enrolled in its Phase 1 clinical trial in subjects with relapsed or refractory lupus nephritis (LN). The KYV-101 infusion occurred earlier in July at the University of Colorado Anschutz Medical Campus.

KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for use in B cell-driven autoimmune diseases such as LN and represents an innovative approach to fighting autoimmune diseases by harnessing the power of the body’s immune system.

“There is a growing need for therapies that can drive greater and more rapid reduction of disease activity in patients with lupus nephritis. Cell-based therapies offer a potential new approach to very complex, and often challenging to treat, severe medical conditions,” said Amber Podoll, M.D., FASN, Associate Professor, University of Colorado Anschutz Medical Campus, and one of the principal investigators of the study.

“We are proud of our collaboration with Dr. Podoll and her team in providing potentially life-changing therapeutic options to patients suffering from autoimmune diseases. We expect to present data from more patients in the coming months and at our symposium at the ACR Convergence Meeting this November in San Diego.” said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics. “Our ability to consistently deliver on our promise of a seamless patient experience is a testament to our commitment to become best-in-class in the treatment of B-cell-driven autoimmune diseases.”

The open label, dose escalation, multi-center clinical trial is designed to assess the safety of KYV-101 in patients with refractory LN. The study is targeted to enroll approximately 9-to-12 patients with LN across the U.S. Additional patients are currently under treatment with KYV-101 in Europe for multiple indications.

CAR T-cell therapy involves modifying a patient’s immune T cells to recognize and remove B cells in the patient’s body. Kyverna’s anti-CD19 CAR T-cell therapy, KYV-101, specifically targets CD19, a protein expressed on the surface of B cells, which are involved in various types of malignancies, including autoimmune diseases. This experimental treatment may offer new hope to patients who have exhausted conventional treatment options. As more patients commence their journey with KYV-101, Kyverna continues to explore additional indications for this therapy, as well as develop a robust pipeline of promising immunotherapies aimed at addressing unmet medical needs.
 

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 (CAR) T-cell 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 cell-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.
 

Kyverna Therapeutics is a clinical-stage 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 (CAR) T-cell 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.
 

Christian Pflaumer
+1 (917) 841-4525
christian.pflaumer@ruderfinn.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.