Kyverna Therapeutics, Inc. (Kyverna) announced today the publication in Proceedings of the National Academy of Sciences (PNAS)1 of a report describing the first use of KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, in a 69-year-old patient suffering from treatment-refractory stiff-person syndrome (SPS) as part of a named-patient use in Germany for critically ill individuals who fail conventional therapies.
Patient received KYV-101, a fully human anti-CD19 CAR T-cell product candidate, as part of a named-patient treatment option after failure to respond to conventional therapies Significant improvement in walking distance and 40% reduction in GABAergic medications were among the reported results Well-tolerated treatment with low-grade CRS and no ICANS supports continued exploration of KYV-101 in neuroimmunological disease EMERYVILLE, Calif., June 17, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today the publication in Proceedings of the National Academy of Sciences (PNAS)1 of a report describing the first use of KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, in a 69-year-old patient suffering from treatment-refractory stiff-person syndrome (SPS) as part of a named-patient use in Germany for critically ill individuals who fail conventional therapies. “It is extremely encouraging to see this patient improving the self-reported, uninterrupted walking distance from less than 50 meters to several kilometers within three months after treatment,” said Simon Faissner, M.D., professor for translational neuroimmunology at the Department of Neurology, Ruhr University Bochum, St. Josef Hospital, in Germany, and lead co-author. “These dramatic improvements – if confirmed by further studies – may eventually provide renewed hope for a much-needed paradigm shift in the treatment of debilitating autoimmune diseases.” “It is remarkable to observe the transformational effects in a patient deemed refractory to available standard treatments. With the disease progressing over several years despite the best medical treatment, I recommended the CAR T-cell therapy approach,” said Ralf Gold, M.D., professor of Medicine, chair of Neurology at Ruhr University Bochum, St. Josef Hospital, in Germany, and senior co-author. “The absence of observed neurotoxicity and the measured impact on the pathogenic anti-GAD65 autoantibodies pave the way for additional studies to confirm the initial, promising findings.” “On the heels of recent case reports of the use of KYV-101 in multiple sclerosis and myasthenia gravis, we are excited to see positive outcomes of KYV-101 in a patient suffering from SPS,” said Peter Maag, Ph.D., chief executive officer of Kyverna. “These data underscore the dedication of the Kyverna village to patient care and scientific advancement.” About Stiff Person Syndrome (SPS) About KYV-101 KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials of KYV-101 in the United States and Germany across two broad areas of autoimmune disease: rheumatology and neurology. With 50 patients treated so far with the CAR in KYV-101 in both oncological and autoimmune conditions at more than 15 locations in Europe and the U.S., we believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies. KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies. About Kyverna Therapeutics 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 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna’s pipeline includes next-generation 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. Forward-Looking Statements For more information, please visit https://kyvernatx.com. Kyverna Media Contact: 1 Faissner S, et al. PNAS. 2024;121: e2403227121. doi.org/10.1073/pnas.2403227121 View original content to download multimedia:https://www.prnewswire.com/news-releases/first-in-disease-use-of-kyverna-therapeutics-kyv-101-in-patient-with-severe-stiff-person-syndrome-published-in-proceedings-of-the-national-academy-of-sciences-pnas-302174562.html SOURCE Kyverna Therapeutics | ||
Company Codes: NASDAQ-NMS:KYTX |