Xenopax (daclizumab biosimilar) / 3SBio - LARVOL DELTA

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