felzartamab (MOR202) / TJ Biopharma, Novartis, Biogen - LARVOL DELTA

Monitoring Anti-CD38 Treatment with Felzartamab in Antibody-Mediated Kidney Allograft Rejection (ERA 2025) - No abstract available

Antibody-mediated Rejection • Transplant Rejection

Felzartamab in humoral rejection: an update (ERA 2025) - No abstract available

Antibody-mediated Rejection

Effect of felzartamab anti-CD38 treatment on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies (ERA 2025) - No abstract available

Biopsy • Antibody-mediated Rejection • Transplantation

Microvascular inflammation in kidney allografts: New directions for patient management. (PubMed, Am J Transplant) - "Therapies targeting NK cells, particularly the anti-CD38 antibody felzartamab, have shown promising reductions in MVI and molecular injury. Notably, the U.S. Food and Drug Administration has approved an MVI-based primary endpoint for a phase 3 trial evaluating this approach, representing a critical step toward the development of new therapeutics. Recognizing MVI as a multifaceted histological phenotype -driven by diverse triggers- may signal a paradigm shift in transplant medicine."

Journal • Antibody-mediated Rejection • Cardiovascular • Infectious Disease • Inflammation • Reperfusion Injury • Transplantation

MONET: MOR202 for Refractory MN (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: Mario Negri Institute for Pharmacological Research | Active, not recruiting ➔ Completed

Trial completion • Glomerulonephritis • Renal Disease

Felzartamab Effective in Kidney Transplant Rejection (Medthority) - "'Antibody-mediated rejection remains a significant challenge in kidney transplantation, with limited safer and effective treatment options currently available. With the potential to be disease-modifying based on the encouraging results observed in the Phase II study, I believe felzartamab could be an important new therapeutic treatment option for patients with late AMR,' said Dr. Suphamai Bunnapradist..."

Media quote

Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients (GlobeNewswire) - "Biogen Inc...announced the initiation of dosing in the global clinical study, TRANSCEND. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients diagnosed with late antibody-mediated rejection (AMR). TRANSCEND is designed to enroll approximately 120 kidney transplant recipients with late AMR....In addition to beginning a Phase 3 study of felzartamab in AMR, as previously announced, Biogen plans to initiate Phase 3 trials of felzartamab in IgA nephropathy and primary membranous nephropathy in 2025.... As part of the initiation of the Phase 3 trial for felzartamab, MorphoSys will earn a one-time milestone payment of $35 million from Biogen."

Commercial • New P3 trial • Trial status • Antibody-mediated Rejection • IgA Nephropathy

A Study of Felzartamab in Participants With Lupus Nephritis (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: HI-Bio, A Biogen Company | Phase classification: P1 ➔ P1/2

Phase classification • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

CD38 monoclonal antibody felzartamab for late antibody-mediated rejection: a phase II drug evaluation. (PubMed, Expert Opin Investig Drugs) - "Felzartamab is also being investigated for the treatment of other antibody-mediated kidney diseases, such as lupus nephritis, primary membranous nephropathy and IgA nephropathy. If proven effective, it could expand the therapeutic options for kidney transplant rejection and primary kidney diseases."

Clinical • IO biomarker • Journal • P2 data • Review • Antibody-mediated Rejection • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Transplant Rejection • Transplantation

FELZARTAMAB REDUCES aPLA2R Ab BY SELECTIVELY DEPLETING CD38+ PLASMA CELLS AND PLASMABLASTS, THE MAIN PATHOGENIC CELLULAR DRIVERS OF DISEASE IN PRIMARY MEMBRANOUS NEPHROPATHY (PMN) (ISN-WCN 2025) - P1/2, P2 | "Table 1. Median baseline values and % change in key biomarkers in M-Place and NewPlace trials Download: Download high-res image (227KB) Download: Download full-size image"

IO biomarker • Glomerulonephritis • Infectious Disease • Renal Disease • Tetanus

FELZARTAMAB DURABLY REDUCES DISEASE RELEVANT BIOMARKERS THROUGH TARGETING OF CD38+ PLASMA CELLS AND PLASMABLASTS, THE UPSTREAM DRIVERS OF IgA NEPHROPATHY (IgAN) (ISN-WCN 2025) - P2 | "This abstract was also submitted for ASN Kidney Week 2024 congress. Download: Download high-res image (251KB) Download: Download full-size image"

Biomarker • IO biomarker • Glomerulonephritis • IgA Nephropathy • Immunology • Renal Disease

FELZARTAMAB FOR IgA NEPHROPATHY: FINAL RESULTS OF THE IGNAZ STUDY (ISN-WCN 2025) - "This abstract was also submitted for ASN Kidney Week 2024 congress. Download: Download high-res image (189KB) Download: Download full-size image"

Clinical • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease • Renal Disease

FELZARTAMAB SELECTIVELY AND POTENTLY TARGETS CD38+ ANTIBODY SECRETING CELLS FROM PATIENTS WITH IMMUNE-MEDIATED KIDNEY DISEASES (ISN-WCN 2025) - "This abstract was also submitted for ASN Kidney Week congress. Download: Download high-res image (119KB) Download: Download full-size image"

Clinical • Antibody-mediated Rejection • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • CD34

Estimating the efficacy of felzartamab to treat antibody-mediated rejection using the iBox prognostication system. (PubMed, Am J Transplant) - No abstract available

Journal • Antibody-mediated Rejection • Transplantation

TRANSCEND: A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR) (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: HI-Bio, A Biogen Company | Not yet recruiting ➔ Recruiting

Enrollment open • Antibody-mediated Rejection • Transplantation

Enhanced Prenatal and Postnatal Development Study in Marmoset Monkeys Following Administration of Felzartamab. (PubMed, Int J Toxicol) - "Among infants, there were no felzartamab-related malformations or variations in external anatomy or skeletal morphology and no felzartamab-related observations in histopathology, hematologic and immune cell development, or humoral immune response to vaccination. In conclusion, among pregnant marmoset monkeys dosed with felzartamab, the lack of reproductive toxicity and felzartamab-related effects on offspring supports the clinical evaluation of felzartamab in women of childbearing potential and further demonstrates the suitability of the marmoset monkey for ePPND studies."

IO biomarker • Journal • Hematological Disorders

TRANSCEND: A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR) (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: HI-Bio, A Biogen Company

New P3 trial • Antibody-mediated Rejection • Transplantation

Felzartamab Durably Reduces Disease-Relevant Biomarkers through Targeting of CD38+ Plasma Cells and Plasmablasts, the Upstream Drivers of IgAN (KIDNEY WEEK 2024) - P2 | "Felza targets and depletes the upstream cellular drivers of IgAN resulting in rapid reduction of major disease related biomarkers. Effects are maintained off-treatment while also preserving humoral immunity. These observations are consistent with other indications, supporting the disease modifying potential of felza in immune mediated diseases."

Biomarker • IO biomarker • Glomerulonephritis • IgA Nephropathy • Immunology

Felzartamab for IgA Nephropathy: Final Results of the IGNAZ Study (KIDNEY WEEK 2024) - "Felzartamab was generally well tolerated and led to sustained proteinuria reduction and reduced eGFR decline vs PBO, indicating potential disease modification in patients with IgAN. Investigation of felzartamab in patients at high risk for loss of kidney function is warranted."

Clinical • Late-breaking abstract • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease • Renal Disease

Felzartamab Selectively and Potently Targets CD38+ Antibody-Secreting Cells from Patients with Immune-Mediated Kidney Diseases (KIDNEY WEEK 2024) - "These in vitro and in vivo proof of concept studies highlight the capacity of felza to selectively deplete CD38+ ASC, suggesting the potential for clinical utility in antibody-driven IMD. Clinical trials assessing the safety and efficacy of felza in immune-mediated kidney diseases including MN, IgAN, antibody-mediated kidney rejection and lupus nephritis are currently ongoing."

Clinical • Antibody-mediated Rejection • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • CD34

Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients (GlobeNewswire) - "Biogen Inc...announced today that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients....Biogen plans to initiate Phase 3 trials for felzartamab across AMR, IgAN, and PMN in 2025."

Breakthrough therapy • New P3 trial • Antibody-mediated Rejection • IgA Nephropathy • Immunology • Nephrology • Transplant Rejection

Cancelled: Evaluation of Neutralizing Agent – DaraEx – to Combat Anti-CD38 Serologic Interference (AABB 2024) - "Another method of removing the anti-CD38 serologic interference is the imusyn DaraEx (For Research Use Only) neutralizing agent, which inhibits the agglutination effect of the anti-CD38 antibodies Daratumumab, Felzartamab, and Isatuximab in the IAT, and does not cause any red cell antigen destruction.Study Design/ Ten previously identified anti-CD38 patients referred to the IRL for antibody consultation were tested in parallel with the current procedure of DTT treatment of the red cells and with the new DaraEx neutralizing reagent. Both methods, 0.2M DTT and DaraEx, proved to be effective at removing the anti-CD38 serologic interference. DaraEx appears to be the more favorable option in situations when a patient phenotypes cellano or Kpb negative, or when using the Gel column technique to accommodate smaller sample volumes. Taking cost into consideration, the use of DaraEx over 0.2M DTT treatment as the primary method, to routinely remove the anti-CD38 interference in..."

Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Felzartamab in Antibody-Mediated Rejection. (PubMed, N Engl J Med) - No abstract available

Journal • Antibody-mediated Rejection

Felzartamab in Antibody-Mediated Rejection. (PubMed, N Engl J Med) - No abstract available

Journal • Antibody-mediated Rejection

Felzartamab in Antibody-Mediated Rejection. Reply. (PubMed, N Engl J Med) - No abstract available

Journal • Antibody-mediated Rejection