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KYV-101 by Kyverna Secures U.S. FDA Clearance for Progressive Multiple Sclerosis Treatment in KYSA-7 Phase 2 Trial

Thursday, January 04, 2024

Kyverna Therapeutics, Inc. (Kyverna) has obtained clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, allowing the progression of its autologous CD19 chimeric antigen receptor (CAR) T-cell product, KYV-101, for the treatment of multiple sclerosis (MS).

The IND approval is a significant step for Kyverna, opening the path for the KYSA-7 trial, specifically targeting patients with treatment-refractory progressive MS. The trial aims to provide a new option for patients with limited treatment choices, offering the potential for preventing disability progression and achieving lasting, treatment-free remission.

Dr. Bruce Cree, Clinical Research Director at the University of California, San Francisco, emphasized the study's importance for MS patients, suggesting it could reshape the treatment landscape by fundamentally reprogramming the immune system. Dr. Manuel Friese from the University Medical Center Hamburg-Eppendorf in Germany expressed optimism about the study's potential impact on MS treatment options.

Kyverna's CEO, Peter Maag, highlighted the patient-centered approach and the paradigm shift that KYV-101 represents for autoimmune diseases. He emphasized the company's commitment to extending therapeutic benefits to various indications, reflecting a broader vision for addressing unmet medical needs in autoimmune diseases.

CAR T-cell therapy involves modifying a patient's T cells to target and eliminate specific cells within the body. KYV-101, Kyverna's CD19 CAR T-cell therapy, focuses on CD19, a protein associated with B cells in autoimmune diseases. The company plans to explore additional indications for KYV-101, building a robust pipeline of immunotherapies to address diverse autoimmune conditions.

Multiple sclerosis, a chronic neurodegenerative autoimmune disease affecting millions worldwide, poses significant challenges to patients' quality of life. Current treatments aim to reduce relapses and delay disability progression, but there remains a need for more effective solutions.

KYV-101, designed as an autologous, fully human CD19 CAR T-cell product, has undergone Phase 1 trials in oncology, demonstrating promising results. Kyverna is actively exploring KYV-101's potential in other autoimmune conditions such as lupus nephritis, with additional trials in systemic sclerosis and myasthenia gravis in preparation. The unique properties of KYV-101 are seen as critical for the success of CAR T-cell therapies in treating autoimmune diseases.



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