Kyverna Therapeutics announces data from Phase 2 from KYSA-6 clinical trial

Kyverna Therapeutics (KYTX) announced positive interim data from the Phase 2 portion of the registrational KYSA-6 clinical trial of KYV-101 in generalized myasthenia gravis, or gMG. The data will be shared in an oral presentation today by Srikanth Muppidi, Clinical Professor, Adult Neurology, Stanford Medicine, at the Myasthenia Gravis Foundation of America, or MGFA, Scientific Session during the American Association of Neuromuscular and Electrodiagnostic Medicine, or AANEM, Annual Meeting in San Francisco, CA. “With today’s results, we are setting a new standard across key clinical outcome measures for gMG, particularly in the depth and durability of response achieved with just a single dose of KYV-101,” said Warner Biddle, CEO of Kyverna Therapeutics. The Phase 2 portion of the registrational KYSA-6 clinical trial is a single-arm, open-label, multicenter study of KYV-101 in gMG. The primary endpoints were Myasthenia Gravis Activities of Daily Living, or MG-ADL, score at 24 weeks and the incidence and severity of adverse events, or AEs. Secondary endpoints included Quantitative Myasthenia Gravis, or QMG, and Myasthenia Gravis Composite, or MGC, scores. As of the October 3 data cut-off, six patients with moderate to severe gMG, and an average disease duration of 5.3 years were treated with a single dose of 1108 KYV-101 CAR+T cells. All patients had failed prior immunosuppressant therapies such as FcRns and complement inhibitors. At data cut-off, duration of follow-up after KYV-101 infusion was up to 36 weeks.