Core Insights - Artiva Biotherapeutics announced positive initial safety and translational data from clinical trials of AlloNK in combination with anti-CD20 monoclonal antibodies for autoimmune diseases, indicating that AlloNK is well tolerated and effective in B-cell depletion [2][3] Group 1: Treatment Efficacy and Safety - AlloNK, an allogeneic NK cell therapy, demonstrated consistent and complete B-cell depletion in all patients treated by Day 13, comparable to results seen in B-cell driven lymphoma [1][3] - No cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was reported, and the treatment was generally well tolerated with most adverse events being Grade 1 or 2 [1][10] - Among 32 patients treated, all demonstrated non-quantifiable peripheral CD19+ B-cell levels by Day 13, supporting the intended mechanism of action for AlloNK [10] Group 2: Clinical Trials and Future Plans - Artiva is conducting three ongoing Phase 1 and 2 clinical trials for refractory rheumatoid arthritis (RA), Sjögren's disease, and other autoimmune conditions, with plans to share initial clinical response data in the first half of 2026 [3][10] - The company aims to align with the U.S. Food and Drug Administration (FDA) on pivotal trial design for AlloNK in refractory RA in the first half of 2026 [1][10] Group 3: Market Opportunity - There is a significant unmet need for patients with refractory RA who have failed at least two biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/ts DMARDs), representing over 150,000 patients in the U.S. [10] - Current real-world data shows only a 10-20% ACR50 response in patients who have failed two or more b/ts DMARDs, indicating room for improvement with AlloNK [10]
Artiva Biotherapeutics Announces Positive Initial Safety and Translational Data Supporting Deep B-Cell Depletion with AlloNK® in Autoimmune Disease