Kyverna Therapeutics (KYTX) announced positive one-year clinical trial data for its CAR T-cell therapy, miv-cel, in patients with stiff person syndrome (SPS) and longer-term data in generalized myasthenia gravis (gMG). The results from both trials demonstrated durable clinical responses and a favorable safety profile, supporting the drug's potential as a single-dose treatment for neurologic autoimmune diseases.
Key Details
- Stiff Person Syndrome (SPS): One-year data from the KYSA-8 registrational trial showed a sustained 49% median improvement in mobility (T25FW), with 92% of patients remaining free of chronic immunotherapies.
- Generalized Myasthenia Gravis (gMG): Longer-term data from the KYSA-6 Phase 2 trial showed durable responses for up to 1.5 years, with 86% (6 of 7) of patients remaining off immunosuppressants at last follow-up.
- Regulatory Timeline: The company plans to complete its rolling Biologics License Application (BLA) submission for miv-cel in SPS in Q4 2026.
- Safety Profile: Miv-cel was reported to be well-tolerated in both studies, with no high-grade cytokine release syndrome (CRS) or neurotoxicity (ICANS).