Kyverna Therapeutics Highlights Potential of KYV-101 in Rheumatoid Arthritis with Phase 1 Data from Investigator-Initiated Trial Presented at ACR Convergence 2025

Core Insights - KYV-101 shows significant reduction in disease-associated autoantibodies and improvement in disease activity for patients with difficult-to-treat rheumatoid arthritis (RA) [1][5] - The treatment has a well-tolerated profile, consistent with previous observations from 100 patients [1][2] - Emerging data from investigator-initiated trials (IIT) in RA suggest broad potential for KYV-101 in rheumatology indications [1][2] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases [10] - The lead candidate, KYV-101, is advancing through late-stage clinical development with ongoing trials for various autoimmune conditions [10] Clinical Trial Details - The COMPARE trial is a Phase 1/2 study comparing KYV-101 to rituximab in ACPA-positive, treatment-refractory RA patients [3] - Six patients in the Phase 1 portion had a mean of 5.8 prior failed biologic therapies before receiving KYV-101 [4] - The primary endpoint of the Phase 1 study was safety and tolerability, with additional evaluations for efficacy and biomarkers [4] Safety and Efficacy Results - KYV-101 was well-tolerated with no high-grade Cytokine Release Syndrome (CRS) or Immune Cell Associated Neurotoxicity Syndrome (ICANS) reported [7] - CAR T-cells expanded rapidly, with B-cell depletion observed in all patients, and significant reductions in pathogenic autoantibodies [7] - Four out of six patients met the ACR20 response criteria, with two achieving ACR50 response [7] Future Directions - The results support the initiation of the randomized Phase 2 portion of the study, which is currently ongoing with completed patient enrollment [5]