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

Targeting CD38 in Antibody-Mediated Rejection. (PubMed, Transpl Int) - "This review focuses on recent results from CD38-targeted therapies, with felzartamab emerging as a promising option. Previous case reports and series suggested that off-label daratumumab treatment could effectively reverse AMR...The potential benefits of prolonged therapy are currently being investigated in a recently launched phase III trial. Future studies may expand the applications of CD38 targeting to early AMR or broader indications, such as DSA-negative microvascular inflammation."

Journal • Review • Antibody-mediated Rejection • Inflammation • Transplantation

Antibody-mediated Rejection - Treatment Standard. (PubMed, Nephrol Dial Transplant) - "We conclude that steroids, rituximab, bortezomib, and interleukin-6 (IL-6) antagonists lack sufficiently robust evidence to support their use in AMR. Along these lines, in severe early AMR, complement inhibition may also be an option. Ongoing phase 2 trials evaluating prolonged courses of high dose IVIG, the neonatal Fc receptor blocker efgartigimod, the tyrosine kinase inhibitor fostamatinib, and the complement inhibitor BIVV020, along with phase 3 trials of the anti-IL-6 receptor antibody tocilizumab and the CD38 antibody felzartamab, offer hope for effective, approved therapies targeting different aspects of AMR pathobiology."

Journal • Antibody-mediated Rejection • Inflammation • Transplantation

Monitoring Anti-CD38 Treatment with Felzartamab in Antibody-Mediated Kidney Allograft Rejection (ERA 2025) - "These results suggest that dd-cfDNA, may serve as a useful biomarker for monitoring early response to felzartamab treatment. More importantly, dd-cfDNA could indicate the recurrence of rejection after treatment cessation in a timely none-invasive manner, which is subject to ongoing investigations"

IO biomarker • Antibody-mediated Rejection • Inflammation • Transplant Rejection • CXCL10 • CXCL9

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) - "Felzartamab selectively suppressed IFNG-inducible and NK cell transcripts, offering parenchymal benefits and potentially slowing progression to kidney failure despite near-universal molecular recurrence by week 52."

Biopsy • Antibody-mediated Rejection • Renal Disease • Transplantation • IFNG

PREVAIL: A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) (clinicaltrials.gov) - P3 | N=454 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Renal Disease

TREATMENT OF PLASMA CELL DISORDERS POST SOLID ORGAN TRANSPLANT - A POSITIVE SINGLE CENTER EXPERIENCE USING IMMUNOMODULATORY DRUGS (EHA 2025) - "Seven patients met the inclusion criteria, of which four patients were treated with IMiD, low dose lenalidomide 5mg; one patient also received pomalidomide for two months...Most patients had a very good partial response (VGPR); a complete response was suspected in 5 patients but could not be confirmed due lack of confirmatory bone marrow biopsy.(Table 1: Patient characteristics, hematologic response and allograft outcomes (MMF: mycophenolate mofetil, MPA: mycophenolic acid, Pred: prednisone, SM: Smouldering myeloma, Tac: Tacrolimus (target level), VGPR: Very Good Partial Response) Summary/ In this limited case series with long-term follow up, IMiD use in SOT recipients was not associated with SOTr and resulted in hematologic VGPR in three out of four patients.This contrasts with the majority of existing literature, which suggests a plausible risk of SOTr as IMIDs induce T-cell proliferation, enhance interleukin-2 and interferon-gamma production and inhibit regulatory..."

Clinical • Immunomodulating • Amyloidosis • Antibody-mediated Rejection • Hematological Disorders • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • Solid Organ Transplantation • Transplant Rejection • Transplantation • IFNG • IL2

PROMINENT: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN) (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Biogen

New P3 trial • Glomerulonephritis • Renal Disease

Effect of felzartamab on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies. (PubMed, Nat Med) - "However, we also found that felzartamab had parenchymal benefits at week 52, slowing the trajectories of molecular injury scores beyond the treatment period, suggesting that suppression of ABMR activity could potentially slow future progression to kidney failure. These data provide preliminary molecular insights into the effects of CD38-directed treatment for ABMR, which have the potential to inform future therapeutic strategies."

Journal • Antibody-mediated Rejection • Renal Disease • Transplantation • IFNG

TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=113 | Completed | Sponsor: TJ Biopharma Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

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

PREVAIL: A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) (clinicaltrials.gov) - P3 | N=454 | Not yet recruiting | Sponsor: Biogen

New P3 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

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