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

WHOLE BLOOD RNASEQ PROFILING IDENTIFIED FUNCTIONALLY ENRICHED GENE EXPRESSION PATTERNS IN FELZARTAMAB-TREATED PATIENTS WITH IGA NEPHROPATHY: DATA FROM THE PHASE 2 IGNAZ STUDY (ISN-WCN 2026) - P2 | "Jonathan Barratt reports consulting and speaker fees from Alnylam, Argenx, Astellas, BioCryst, Calliditas, Chinook, Dimerix, Galapagos, Novartis, Omeros, Travere Therapeutics, Vera Therapeutics, Visterra, and HI-Bio Inc, a Biogen company; grant support from Argenx, Calliditas, Chinook, Galapagos, GSK, Novartis, Omeros, Travere Therapeutics, and Visterra; clinical trials with Chinook (ADU-CL-19 and ALIGN), Novartis (APPLAUSE), Omeros (ARTEMIS-IGAN), Visterra (ENVISION), Calliditas (NefIgARD), Vera Therapeutics (ORIGIN), and HI-Bio Inc, a Biogen company (IGNAZ); and research projects with Argenx, Calliditas, Chinook, Galapagos, GSK, Novartis, Omeros, Travere Therapeutics, and Visterra. Krzysztof Kiryluk reports consulting fees from HI-Bio Inc, a Biogen company, and research grants from the National Institutes of Health, Visterra, Wanda, AstraZeneca, and IgA Foundation of America.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • IO biomarker • P2 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

PRESERVATION OF HUMORAL IMMUNITY AND RESPONSE TO VACCINATION AND INFECTION IN FELZARTAMAB-TREATED PATIENTS WITH IGA NEPHROPATHY: DATA FROM THE PHASE 2 IGNAZ STUDY (ISN-WCN 2026) - P2 | "Tabea Kräft was an employee of MorphoSys GmbH, a Novartis company, and may have had stock or stock options at the time the study was conducted. Jonathan Barratt reports consulting and speaker fees from Alnylam, Argenx, Astellas, BioCryst, Calliditas, Chinook, Dimerix, Galapagos, Novartis, Omeros, Travere Therapeutics, Vera Therapeutics, Visterra, and HI-Bio Inc, a Biogen company; grant support from Argenx, Calliditas, Chinook, Galapagos, GSK, Novartis, Omeros, Travere Therapeutics, and Visterra; clinical trials with Chinook (ADU-CL-19 and ALIGN), Novartis (APPLAUSE), Omeros (ARTEMIS-IGAN), Visterra (ENVISION), Calliditas (NefIgARD), Vera Therapeutics (ORIGIN), and HI-Bio Inc, a Biogen company (IGNAZ); and research projects with Argenx, Calliditas, Chinook, Galapagos, GSK, Novartis, Omeros, Travere Therapeutics, and Visterra.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • P2 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases • Tetanus

TRANSCEND LTE: A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Biogen

New P3 trial • Antibody-mediated Rejection • Transplantation

299IG301: A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) ( PREVAIL ) (clinicaltrialsregister.eu) - P2/3 | N=201 | Recruiting | Sponsor: Biogen Idec Research Limited

New P2/3 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

299AR201: A Trial of Felzartamab in Recipients of Kidney Transplants with Late Isolated Microvascular Inflammation (MVI) - (TRANSPIRE) (clinicaltrialsregister.eu) - P1/2 | N=31 | Not yet recruiting | Sponsor: Biogen Idec Research Limited

New P1/2 trial • Inflammation • Transplantation

Emerging Therapies in IgA Nephropathy: From A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) Inhibitors to Precision Medicine. (PubMed, Cureus) - "This review synthesizes current evidence on evolving treatments, with a focus on A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) (e.g., sibeprenlimab, atacicept, povetacicept, telitacicept), complement pathway modulators (e.g., iptacopan, cemdisiran, ravulizumab), and novel agents such as felzartamab and sparsentan. It also explores precision medicine strategies, including biomarker-guided therapy, individualized risk stratification, and combination regimens. Supported by high-quality recent clinical trial data and the latest kidney disease outcome guidelines, these innovations represent a paradigm shift toward personalized, disease-modifying treatment in IgAN, offering a new horizon for improved renal outcomes and long-term disease control."

Journal • Review • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Updates on Kidney Transplantation From the World Transplant Congress 2025. (PubMed, Transplantation) - "For highly sensitized patients, novel desensitization regimens incorporating new proteasome inhibitors and anti-CD38 antibodies (daratumumab, felzartamab) effectively reduced donor-specific antibodies, enabling transplantation in previously ineligible candidates. Artificial intelligence tools that integrate multiomics data are emerging as powerful predictors of graft outcomes. Collectively, these innovations address critical challenges of organ shortage, rejection, and individualized care, charting the next era in transplantation."

IO biomarker • Journal • Antibody-mediated Rejection • Nephrology • Transplantation

TRANSPIRE: A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation (clinicaltrials.gov) - P2 | N=81 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Inflammation • Transplantation

Microvascular inflammation in the kidney transplant, beyond acute antibody-mediated rejection. (PubMed, Curr Opin Nephrol Hypertens) - "MVI represents a heterogeneous spectrum of alloimmune injuries that extends beyond the traditional AMR framework. Combining histology with emerging artificial intelligence tools, molecular diagnostics, and noninvasive biomarkers, will offer a more integrated approach to diagnosis, risk stratification, and development of novel therapies."

IO biomarker • Journal • Antibody-mediated Rejection • Inflammation • Transplant Rejection • Transplantation

Resolving the Interference of Anti-CD38 Antibodies on Blood Compatibility Assays Using CD38 "Baitbodies" Approach. (PubMed, J Immunol Res) - "The CD38-mFc baitbody successfully prevented agglutination reactions induced by three clinically relevant anti-CD38 monoclonal antibodies-daratumumab, felzartamab and isatuximab-in spiked samples. The CD38-mFc construct also demonstrated potential in a head-to-head comparison with commercial mitigation reagents, DaraEx and Grifols sCD38. Finally, the CD38-mFc baitbody effectively neutralized daratumumab in patient samples, preventing false positive test outcomes."

Journal • Oncology

A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: HI-Bio, A Biogen Company | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1 | N=20 ➔ 14

Enrollment change • Enrollment closed • Phase classification • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

One tool, multiple gains: anti-CD38 therapy in antibody-mediated rejection. (PubMed, Clin Kidney J) - "These include anti-CD38 monoclonal antibodies such as daratumumab, felzartamab and isatuximab. This review synthesizes the current understanding of AMR, presents the Banff 2022 diagnostic frameworks updates and critically appraises the exciting potential and limitations of anti-CD38 therapies in AMR. As the transplant community shifts toward precision immunotherapy, anti-CD38 agents may help reshape future treatment paradigms in kidney transplantation-provided their use is guided by mechanistic insights and rigorous clinical evaluation."

Journal • Antibody-mediated Rejection • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation

Whole-Blood RNA Sequencing (RNAseq) Profiling Identifies Functionally Enriched Gene Expression Patterns in Felzartamab-Treated Patients with IgAN: Data from the Phase 2 IGNAZ Study (KIDNEY WEEK 2025) - P2 | "Conclusion Felzartamab treatment-related gene expression changes detected by whole blood RNAseq are functionally enriched for CD38 + cell types, including immunoglobulin and IgA-related genes, supporting targeting and reduction of plasma cells in IgAN. These results validate the use of this dataset for further analyses to understand the mechanism of action of felzartamab and to further characterize felzartamab treatment response in patients with IgAN."

Clinical • IO biomarker • P2 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

PROMINENT: An Open-Label, Randomized Phase 3 Trial of Felzartamab in Primary Membranous Nephropathy (KIDNEY WEEK 2025) - P3 | "PROMINENT (NCT06962800) is an open-label, multicenter, randomized Phase 3 study in which 180 adults with newly diagnosed or relapsed biopsy-confirmed PMN in need of immunosuppressive therapy will be randomized to IV felzartamab or oral tacrolimus in protocol-specified dosing regimens. Participants who experience worsening kidney function or proteinuria, relapse, or do not improve on assigned treatment can receive rescue treatment. PROMINENT is the first Phase 3 trial evaluating the targeting of CD38 + plasma cells and plasmablasts in PMN to reduce proteinuria and preserve kidney function, which may address an unmet need in a disease with no approved therapies."

Clinical • P3 data • Glomerulonephritis • Immunology • Nephrology • Renal Disease

PREVAIL: A Phase 3 Trial of Felzartamab in Adults with IgAN (KIDNEY WEEK 2025) - P3 | "PREVAIL is the first Phase 3 trial investigating CD38 + targeting in IgAN. The results will further inform on the safety and efficacy of this novel therapy with the potential to specifically target the pathogenic cellular drivers of IgAN and disease relevant antibody production."

Clinical • P3 data • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Preservation of Humoral Immunity and Response to Vaccination and Infection in Felzartamab-Treated Patients with IgAN: Data from the Phase 2 IGNAZ Study (KIDNEY WEEK 2025) - P2 | "Conclusion Patients with IgAN receiving felzartamab demonstrated preservation of humoral immunity, which may contribute to a favorable safety profile versus other B-cell targeting therapies. These findings are consistent with those previously observed in PMN."

Clinical • P2 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases • Tetanus

TRANSPIRE: A Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients with Late Isolated Microvascular Inflammation (KIDNEY WEEK 2025) - "Safety will be assessed throughout the study. TRANSPIRE is the first clinical trial designed to investigate a targeted therapy in kidney transplant recipients with late isolated MVI."

Clinical • P2 data • Antibody-mediated Rejection • Inflammation • Transplantation

TRANSCEND: A Phase 3 Trial of the Anti-CD38 Antibody Felzartamab in Kidney Transplant Recipients with Late Antibody-Mediated Rejection (KIDNEY WEEK 2025) - P3 | "TRANSCEND is the first Phase 3 trial evaluating the concept of CD38 targeting in AMR after kidney transplant. Results from this study may provide a novel treatment option and potentially transformative therapy for this challenging condition of high unmet medical need."

Clinical • P3 data • Antibody-mediated Rejection • Inflammation • Transplantation

IMMUNOLOGICAL AND HISTOLOGICAL REVERSAL OF REFRACTORY ABMR WITH DARATUMUMAB IN PEDIATRIC KIDNEY TRANSPLANTATION (ESPN 2025) - " Two pediatric patients were included in a non-randomized pilot study assessing the safety and efficacy of daratumumab as rescue therapy for refractory ABMR to conventional therapy (SOC: immunoadsorption, IGIV and rituximab). Our preliminary data suggest that daratumumab is a safe treatment with a promising response for refractory ABMR and chronic active ABMR, associated with a significant recovery of active microvascular inflammatory lesions and downregulating circulating DSA. Further studies may help to determine whether maintenance therapy or repeated courses are required, and to assess the long-term impact on graft function and survival. References 1 Mayer KA, Schrezenmeier E, Diebold M, et al, A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection."

Clinical • Antibody-mediated Rejection • Inflammation • Pediatrics • Transplantation • NCOA4

TRANSPIRE: A Study to Learn About the Effects of Felzartamab Infusions on Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation (clinicaltrials.gov) - P2 | N=81 | Not yet recruiting | Sponsor: Biogen

New P2 trial • Inflammation • Transplantation

Treatment of Plasma Cell Disorders Post Solid Organ Transplant – A Positive Single Center Experience using Immunomodulatory Drugs (IMS 2025) - "Data collected included transplant type, treatment details & patient & allograft outcomes. 7 patients met the inclusion criteria: 4 received IMiD, lenalidomide 5mg, 1 patient also received pomalidomide & 3 patients received no IMiDs, serving as a comparison group...There was no rejection documented in all patients.CaseAgeSexHLA Mismatch (DSA)Haematological DiagnosisTransplant to IMiD (Years)Time on IMiD (Years)Haematological response to IMiD IS161F3LCDD--VGPRPred 5, Tac (6-8), MPA 360mg BD264M3AL Amyloidosis--VGPRPred 5, Tac (6-7), MMF 1g BD372FUnknownMM--VGPRTac (5-6), MMF 500mg BD467M0SM54VGPRTac (1-3)569M6 (A2)MM53VGPRPred 5, Tac (6-7), MMF 1g BD682M1MM153VGPRPred 5, Tac (4-6), MMF 250mg BD757F6 (Moderate A2, A24)MM70.5No responsePred 5/25, TacTable 1: Patient characteristics, hematologic response & allograft outcomes (MMF: mycophenolate mofetil, MPA: mycophenolic acid, Pred: prednisone, SM: Smouldering myeloma, Tac: Tacrolimus (target level), VGPR:..."

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

Histological Reversal of Refractory ABMR with Daratumumab in Kidney Transplant Patients (WTC 2025) - "Anti-CD38 therapies, targeting plasma cells, some mature B-cell subsets, and NK cells, may have a beneficial therapeutic effect in ABMR, as recently shown with Felzartamab. * We designed a non-randomized pilot study assessing the safety and efficacy of daratumumab as rescue therapy for refractory ABMR to conventional therapy (PE, IVIG and/or rituximab)... Our preliminary data strongly suggest that daratumumab treatment for refractory ABMR is associated with a significant recovery of active microvascular inflammatory lesions of ABMR and a reduction of circulating DSA. Mechanistic studies will bring deeper insight on the mechanisms of action of the drug."

Clinical • Antibody-mediated Rejection • Glomerulonephritis • Infectious Disease • Inflammation • Nephrology • Pneumonia • Respiratory Diseases • Septic Shock • Transplantation

Felzartamab: a magic bullet to treat microvascular rejection? (PubMed, Kidney Int) - No abstract available

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

TRANSCEND: A Phase 3 Trial of the Anti-CD38 Antibody Felzartamab in Kidney Transplant Recipients with Late Antibody-Mediated Rejection (WTC 2025) - P3 | "TRANSCEND is the first Phase 3 trial evaluating the concept of CD38 targeting in AMR after kidney transplantation. Results from this study may provide a novel treatment option and potentially transformative therapy for this challenging condition of high unmet medical need."

Clinical • P3 data • Antibody-mediated Rejection • Inflammation • Transplantation

Phase 2 study of felzartamab, an investigational anti-CD38 monoclonal antibody, in AMR (WTC 2025) - "Sponsored by Biogen"

P2 data