Kyverna Therapeutics to host KOL event on neuroimmunology CAR T franchise

Kyverna Therapeutics (KYTX) will host a virtual KOL event today to highlight its neuroimmunology CAR T franchise in stiff person syndrome and myasthenia gravis. As part of this event, the Company will share details of its Phase 3 clinical trial design in MG; positive longer-term follow-up data from MG and SPS compassionate use patients1 treated with KYV-101; key insights from leading KOLs highlighting the potential of CD19 CAR T-cell therapy in autoimmune diseases; and the initial framework of its neuroimmunology commercial strategy. Following alignment with the FDA, Kyverna has amended KYSA-6, its Phase 2 trial in MG, into a Phase 2/3 registrational study. The Company expects to initiate patient enrollment in the Phase 3 portion by year-end 2025. The KYSA-6 Phase 2/3 trial is an open-label, randomized, controlled study in adults with generalized myasthenia gravis seeking to demonstrate the superiority of KYV-101, a fully human autologous CD19-directed CAR T-cell therapy, compared to standard-of-care, which could include traditional agents or complement pathway inhibitors. The Phase 3 portion of the trial will include approximately 60 patients randomized 1:1 to receive either a single infusion of KYV-101 or continue SOC therapy. Highlights of the trial design include: The co-primary endpoints are a change from baseline in Myasthenia Gravis-Activities of Daily Living and Quantitative Myasthenia Gravis scores at 24 weeks compared to the SOC treatment arm. A key secondary endpoint is the change from baseline in Myasthenia Gravis Composite score at 24 weeks compared to the SOC treatment arm. Other endpoints will further seek to measure the magnitude of the anticipated clinical impact, reporting the proportion of patients demonstrating a greater than or equal to3-point reduction in MG-ADL score, achieving Minimum Symptom Expression, and remaining off immunosuppressant therapy following treatment. Patients initially randomized to the SOC treatment arm will ultimately have the option to crossover and receive KYV-101. Based on the substantial clinical effect size that has been observed in MG patients treated with KYV-1012, the Company believes the Phase 3 portion of the study is efficient and well-powered, enabling a clear and rapid path to BLA. In addition, distinct from most MG trials, KYSA-6 is designed to assess the impact of KYV-101 as a standalone treatment in the absence of concurrently maintained background immunosuppressive therapy, thereby enabling evaluation of its potential to deliver durable drug-free, disease-free remission after a single dose. Kyverna has completed enrollment of the Phase 2 portion of the KYSA-6 study and expects to report interim data in the fourth quarter of 2025.