Kyverna and Stanford to Assess KYV-101's Impact on Progressive MS

Kyverna Therapeutics, a clinical-stage biopharmaceutical firm specializing in cell therapies for autoimmune diseases, has entered into a collaboration with Stanford University to conduct a phase 1 investigator-initiated trial (IIT) of KYV-101. This innovative treatment is a fully human anti-CD19 CAR T-cell therapy designed to target B cells, which play a role in autoimmune diseases. The trial will involve nine to twelve adults with non-relapsing and progressive forms of multiple sclerosis (MS), each receiving a single dose of KYV-101. The study will be complemented by advanced correlative studies to explore disease biology and potential immune system responses following KYV-101 infusion.

The trial is part of a broader initiative by Kyverna to assess KYV-101's therapeutic effects across various autoimmune conditions. Jeffrey Dunn, M.D., a leading expert in neuroimmunology at Stanford University, expressed optimism about the potential of CAR T-cell therapy for treating immune-mediated diseases of the nervous system, noting the significance of this first-in-human study.

Robert Lowsky, M.D., a professor at Stanford University, highlighted the importance of applying oncology expertise to B cell-driven autoimmunity to address medical needs and make transformative therapies accessible to patients beyond cancer.

Peter Maag, Ph.D., CEO of Kyverna, expressed enthusiasm for the collaboration with Stanford and the opportunity to expand knowledge on the impact of CAR T-cell therapy in treating MS. The company's CAR T-cell therapy, KYV-101, is being evaluated in lupus nephritis and has received FDA clearance for phase 2 trials in MS and myasthenia gravis, as well as a phase 1/2 trial in systemic sclerosis.

MS is a chronic condition that affects over 2.8 million people globally, with patients experiencing a wide range of symptoms and a gradual worsening of the disease despite current treatments. KYV-101, developed with the NIH, is an autologous CAR T-cell product candidate that has shown promise in improving tolerability in a phase 1 oncology trial.

Kyverna Therapeutics, listed on NASDAQ as KYTX, is advancing its pipeline of next-generation CAR T-cell therapies, aiming to transform the treatment of autoimmune diseases by targeting B cells with properties tailored for autoimmune conditions.

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