Kyverna and Stanford University Collaborate to Investigate Multiple Sclerosis Treatment

 Kyverna Therapeutics (Nasdaq: KYTX) will collaborate with Stanford University to allow the use of KYV-101, an investigational, anti-CD19 CAR T-cell therapy in an open label, Phase 1 investigator-initiated trial (IIT) in nine to 12 adult subjects with non-relapsing and progressive forms of multiple sclerosis. KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases.

Jeffrey Dunn, M.D., the Lily Sarafan director of Neuroimmunology and clinical professor and chief of Neuroimmunology, Department of Neurology and Neurological Sciences at Stanford University, said, “We foresee great therapeutic potential for CAR T-cell therapy for immune-mediated disease of the nervous system. This phase 1 trial is a first-in-human study that will assess safety, feasibility, and tolerance in patients with non-relapsing multiple sclerosis for which there is no proven treatment. We are grateful for the opportunity to join forces with Kyverna to explore what may prove to be paradigm-changing immunotherapy.”

CAR T-cell therapy involves modifying a patient’s T cells to recognize and remove B cells in the patient’s body. Kyverna’s 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 autoimmune diseases.

Multiple sclerosis is a chronic, progressive neurodegenerative autoimmune disease affecting over 2.8 million individuals worldwide. Symptoms include blurred vision, slurred speech, tremors, numbness, extreme fatigue, problems with memory and concentration, and, in severe cases, the inability to walk or stand.

KYV-101 is currently being evaluated in sponsored, open-label trials of KYV-101 in patients with lupus nephritis, an autoimmune disease, and IND clearance has been obtained from the FDA for Phase 2 trials of KYV-101 for multiple sclerosis and myasthenia gravis, and a Phase 1/2 trial for systemic sclerosis. 

About Kyverna Therapeutics

Kyverna Therapeutics (NASDAQ: KYTX) 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.