Xenopax (daclizumab biosimilar) / 3SBio - LARVOL DELTA

Second-line and salvage therapies for steroid-refractory acute graft-versus-host disease: an integrated synthesis of current evidence and clinical sequencing. (PubMed, Curr Opin Hematol) - "We propose an evidence-based clinical sequencing algorithm that integrates ruxolitinib, MSCs, extracorporeal photopheresis (ECP), mTOR-targeted salvage, ATG, and clinical trial enrollment and supportive-care priorities, including infectious prophylaxis and organ-specific management."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Oncology • Transplantation • JAK1 • JAK2 • REG3A • ST2

Efficacy and Safety of a Novel Two-Dose Regimen of Xenopax for Acute Rejection Prophylaxis in Kidney Transplantation (ATC 2026) - "This Xenopax regimen showed favorable efficacy and tolerability for AR prevention in kidney transplant recipients."

Clinical • Infectious Disease • Transplant Rejection • Transplantation • IL2RA

Xenopax from a real-world and economic perspective: The future of second-line treatment and prophylaxis for SR-aGVHD. (PubMed, Cell Transplant) - "Although ruxolitinib and basiliximab are widely used, their limitations highlight the need for safer, more effective, and scalable biologic strategies...Beyond salvage therapy, xenopax is gaining momentum in prophylactic settings, including as a potential replacement for methotrexate in haploidentical transplantation. Looking ahead, integration with autonomous decision-support systems-most notably daGOAT, the first AI platform validated to prescribe risk-adapted GVHD prophylaxis-may further strengthen CD25-targeted approaches. Together, these developments position xenopax as a versatile biologic with the potential to reshape both treatment and prevention paradigms in GVHD management."

Journal • Real-world evidence • Review • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Infectious Disease • Transplantation

Comparison of chimeric mouse-human and humanized anti-CD25 monoclonal antibodies for steroid-refractory acute graft-versus-host disease. (PubMed, Front Immunol) - "This study aimed toassess the effectiveness and safety of basiliximab compared with those of a humanized anti-CD25 monoclonal antibody (xenopax) in the treatment of SR-aGVHD in patients who underwent allo-HSCT...In conclusion, no significant differences were observed in efficacy or adverse events between chimeric mouse-human and humanized anti-CD25 monoclonal antibodies for the treatment of SR-aGVHD. Further studies with larger cohorts are necessary to validate these findings."

Clinical • Journal • Preclinical • Retrospective data • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation

The Comparison between Chimeric Mouse-Human and Humanized Anti-CD25 Monoclonal Antibody for Steroid-Refractory Acute Graft-Versus-Host Disease (ASH 2024) - "There were 27 (84%) and 36 (80%) patients (p=0.85) who used combined therapy for SR-aGVHD in the xenopax and basiliximab cohorts (mesenchymal stem cells, 63% vs 78%, ruxolitinib, 41% vs 20%, remicade, 6% vs 13%)...While the 1-year overall survival (OS) and relapse-free survival (RFS) from anti-CD25 monoclonal antibody were 63% vs 49% (p=0.13) and 51% vs 49% (p=0.42) in the xenopax and basiliximab cohorts. Conclusions According to this study, the efficacy and adverse events did not differ between the chimeric mouse-human and humanized anti-CD25 monoclonal antibody for SR-aGVHD, and larger study cohorts are needed to confirm our observations."

Preclinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Humanized Anti-CD25 Monoclonal Antibody Replacing MTX for Graft-Versus-Host Disease Prophylaxis in Haploidentical Hematopoietic Stem Cell Transplantation (ASH 2023) - P3 | "Introduction Currently, a short course of methotrexate (MTX) remains the classical regimen for the prevention of graft-versus-host disease (GVHD) in haploidentical hematopoietic stem cell transplantation (haplo-HSCT)...A total of 82 patients were administrated with a combination of cyclosporine (CsA) or tacrolimus, mycophenolate mofetil (MMF), anti-human thymocyte immunoglobulin (ATG), MTX (15mg, +1d, 10mg, +3d, 10mg, +6d), and humanized anti-CD25 monoclonal antibody (Xenopax, 25mg, +0d, +4d) (single-dose anti-CD25 with MTX group)...No significant difference occurred in two groups of the overall CIs of CMV viremia, EBV viremia, overall survival, disease-free survival, relapse and treatment-related mortality. Conclusions Based on the efficacy and safety of the clinical trial results at our transplant center, replacing MTX with a single dose of humanized anti-CD25 monoclonal antibody is a promising GVHD prophylaxis for haplo-HSCT."

Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Mucositis • Oncology • Stomatitis • Transplantation

Humanized Anti-CD25 Monoclonal Antibody for Graft-Versus-Host Disease Prophylaxis in Older Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation (ASH 2024) - P2 | "The enrolled patients were administrated with a combination of cyclosporine (CsA) or tacrolimus, mycophenolate mofetil (MMF), anti-human thymocyte immunoglobulin (ATG), MTX (15mg, +1d, 10mg, +3d, +6d,+11d), and humanized anti-CD25 monoclonal antibody (Xenopax, 1mg/kg, +1d, +4d)...No severe bacterial/fungus occurred. At a median follow-up of 271 days (range, 73 - 359), only one patient died of RSV pneumonia.ConclusionsThe humanized anti-CD25 monoclonal antibody is a promising GVHD prophylaxis for older patients receiving haplo-HSCT."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

Xenopax is effective for the treatment and prophylaxis of acute graft-versus-host disease. (PubMed, Blood Sci) - No abstract available

Journal • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Xenopax for the treatment of steroid-refractory acute graft-versus-host disease: the RELAX study. (PubMed, Mil Med Res) - "Our real-world findings suggest that xenopax is an effective and safe treatment for SR-aGVHD."

Journal • Retrospective data • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Transplantation • IL2

ANTI-CD25 MONOCLONAL ANTIBODY AS GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS IN HAPLOIDENTICAL HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR SEVERE APLASTIC ANEMIA (EBMT 2025) - "Nine patients received a combination of cyclosporine (CsA), mycophenolate mofetil (MMF), short-course methotrexate (MTX), and humanized anti-CD25 monoclonal antibody (Xenopax, 25 mg for patients ≤ 50 kg, 50 mg for patients > 50 kg, +3d), and one patient received a combination of CsA, MMF, ruxolitinib, and humanized anti-CD25 monoclonal antibody (Xenopax, 25 mg, +3d) for GVHD prophylaxis... Our preliminary findings showed that using humanized anti-CD25 monoclonal antibody is effective in preventing severe GVHD in haplo-HSCT for the treatment of SAA without compromising engraftment or increase of severe infection."

Acute Graft versus Host Disease • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Respiratory Diseases • Transplantation

ANTI-CD25 MONOCLONAL ANTIBODY AS GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS IN HAPLOIDENTICAL HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR SEVERE APLASTIC ANEMIA (EBMT 2025) - "Nine patients received a combination of cyclosporine (CsA), mycophenolate mofetil (MMF), short-course methotrexate (MTX), and humanized anti-CD25 monoclonal antibody (Xenopax, 25 mg for patients ≤ 50 kg, 50 mg for patients > 50 kg, +3d), and one patient received a combination of CsA, MMF, ruxolitinib, and humanized anti-CD25 monoclonal antibody (Xenopax, 25 mg, +3d) for GVHD prophylaxis... Our preliminary findings showed that using humanized anti-CD25 monoclonal antibody is effective in preventing severe GVHD in haplo-HSCT for the treatment of SAA without compromising engraftment or increase of severe infection."

Acute Graft versus Host Disease • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Respiratory Diseases • Transplantation

XENOPAX FOR STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE: A REAL-WORLD RELAX STUDY (EBMT 2025) - "Our real-world study indicates that xenopax is a safe and effective therapy for patients with SR-aGVHD. Thus far, this is the first study to confirm the clinical value of a humanized IL-2R antagonist for SR-aGVHD in a real-world setting."

Clinical • Real-world • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Infectious Disease

XENOPAX FOR STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE: A REAL-WORLD RELAX STUDY (EBMT 2025) - "Our real-world study indicates that xenopax is a safe and effective therapy for patients with SR-aGVHD. Thus far, this is the first study to confirm the clinical value of a humanized IL-2R antagonist for SR-aGVHD in a real-world setting."

Clinical • Real-world • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Infectious Disease