Announcement • Jun 09
Artiva Biotherapeutics Highlights AlloNK Data Presented At EULAR 2026 And Receives FDA RMAT Designation In Refractory Rheumatoid Arthritis
Artiva Biotherapeutics, Inc. highlighted clinical, safety and translational data for AlloNK (also known as AB-101), an allogeneic, off-the-shelf, non-genetically modified natural killer (NK) cell therapy candidate, presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London. Across five accepted abstracts, Artiva Biotherapeutics, Inc. presented data evaluating AlloNK in combination with rituximab across B-cell driven autoimmune diseases, including rheumatoid arthritis (RA), Sjögren disease (SjD) and systemic sclerosis (SSc). The presentations included a late-breaking oral presentation highlighting clinical efficacy responses in 31 patients with rheumatologic diseases, an oral presentation describing the first SjD patient treated with AlloNK, a poster presentation of clinical responses in refractory RA, a poster tour presentation of deep B-cell depletion data and an additional publication-only abstract describing the safety profile observed across patients treated with AlloNK plus anti-CD20 antibodies. In addition, the FDA recently granted RMAT designation to AlloNK in combination with rituximab for the treatment of refractory RA, supporting Artiva Biotherapeutics, Inc.’s planned registrational strategy. Artiva Biotherapeutics, Inc. presented data in refractory RA from both the company-sponsored Phase 2a basket trial and an investigator-initiated basket trial. Patients enrolled in these studies had long-standing, highly active disease and had received multiple prior targeted therapies. In the company-sponsored Phase 2a basket trial, 71% of patients with six months of follow-up achieved an ACR50 response. Across the pooled RA dataset, which included 21 patients with at least 12 weeks of follow-up, clinical responses were observed as early as three months and deepened at six months. Among patients with six months of follow-up, five of six patients in the investigator-initiated trial achieved an ACR50 or modified ACR50 response, and five of seven patients in the company-sponsored Phase 2a basket trial achieved an ACR50 response. As of the April 3, 2026 data cutoff, no patient had loss of response, required high-dose steroids or started a new biologic or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) following treatment with AlloNK plus rituximab. In SjD, Artiva Biotherapeutics, Inc. presented an oral presentation describing the first treated patient, who demonstrated substantial improvement across disease activity, patient-reported and functional measures, including ClinESSDAI, ESSPRI, FACIT-Fatigue and stimulated salivary flow. In the broader SjD dataset, patients had high baseline disease activity, with mean ClinESSDAI of 16.1 and mean ESSPRI of 8.0. Patients demonstrated improvements across clinical measures and function, including normalization of mean stimulated salivary flow at six months, with mean stimulated salivary flow increasing from 0.65 mL/min at baseline to 1.23 mL/min at six months. In SSc, initial data demonstrated improvement in modified Rodnan skin score (mRSS) and composite clinical response measures. Among patients with six months of follow-up, mean mRSS improved by 9.5 points, all patients achieved rCRISS25 and 50% achieved rCRISS50. Artiva Biotherapeutics, Inc.’s safety presentation included data from 55 autoimmune patients treated with AlloNK plus rituximab and demonstrated a tolerability profile supportive of outpatient administration. As previously announced, no cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), AlloNK-related serious adverse events or treatment discontinuations due to adverse events were observed as of the April 3, 2026, data cutoff. The rate of Grade 3 or higher infections was 2%, and no patients were hospitalized for infection during the initial 28-day post-treatment period. Two of 55 patients were hospitalized for treatment-emergent adverse events during the initial 28-day period, neither of which was deemed related to AlloNK. In a poster tour presentation, Artiva Biotherapeutics, Inc. highlighted translational data demonstrating uniform and consistent B-cell depletion by Day 13 in all 51 evaluable autoimmune patients following treatment with cyclophosphamide/fludarabine, AlloNK and rituximab. Complete B-cell depletion was observed using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff. B-cell reconstitution was characterized by a predominance of naïve/transitional B cells, consistent with the proposed B-cell “reset” mechanism. Artiva Biotherapeutics, Inc.’s presentations at EULAR 2026 included: Late-Breaking Oral Presentation: AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy Combined with Rituximab, Generates Robust Clinical Efficacy Responses Comparable with Autologous CAR T in 31 Patients with Rheumatologic Diseases; Oral Presentation: AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated; Poster View Presentation: Robust and Durable Clinical Responses Observed Following Treatment with AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab in Patients with Severe Rheumatoid Arthritis and Inadequate Response to Multiple Prior Targeted Therapies; Poster Tour: AB-101, an Allogeneic NK Cell Therapy, in Combination with Anti-CD20 Monoclonal Antibodies, Consistently Achieves Deep B-cell Depletion Comparable with CAR T Cell Therapies in Patients with Rheumatologic Diseases; Publication-Only Abstract: Treatment with an Allogeneic NK Cell Therapy, AB-101, in Combination with Anti-CD20 Antibodies in Immune-mediated Diseases Demonstrates a Favorable Safety Profile and Comparable B-cell Depletion to CD19 CAR T Therapies.
