Kyverna Therapeutics Announces Positive Interim Phase 2 Data from KYSA-6 Study of KYV-101 in Generalized Myasthenia Gravis at AANEM 2025

Core Insights - Kyverna Therapeutics announced positive interim data from the Phase 2 portion of the KYSA-6 clinical trial for KYV-101 in generalized myasthenia gravis (gMG), achieving 100% clinically meaningful responses in primary endpoints [1][2][5] - The results indicate that KYV-101 can provide rapid and durable symptom improvement with a single dose, potentially leading to drug-free, disease-free remission [2][5][10] Efficacy - 100% of patients (6 out of 6) achieved clinically meaningful reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, with mean reductions of -8.0 points and -7.7 points at 24 weeks, respectively [6][12] - Deep responses were observed as early as two weeks post-treatment, indicating rapid efficacy [6][12] Safety - KYV-101 was well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [12] - One patient experienced a serious adverse event of Grade 4 neutropenia, which improved with standard supportive care [12] Clinical Trial Design - The Phase 2 portion of the KYSA-6 trial is a single-arm, open-label, multicenter study focusing on the efficacy and safety of KYV-101 in gMG [3][8] - The trial was amended to a registrational Phase 2/3 study following discussions with the FDA [8] Future Plans - The company plans to initiate enrollment for the Phase 3 portion of the trial by the end of the year and will share updated data from the Phase 2 portion next year [5][12] - Kyverna aims to establish a first-in-class neuroimmunology franchise and expand growth opportunities across multiple autoimmune indications [2][13]