Press ReleasesMarch 29, 2024

HI-Bio to Present at the 61st European Renal Association (ERA) Congress

Oral and late-breaking oral presentations will highlight data from Phase 2 IGNAZ study in IgA nephropathy and Phase 2 data in antibody-mediated rejection

SOUTH SAN FRANCISCO, Calif. – March 29, 2024 – Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that two abstracts have been accepted for oral presentation at the 61st European Renal Association (ERA) Congress, taking place May 23-26, 2024, in Stockholm and in a virtual format. Presentations will include data from the Phase 2 IGNAZ trial of felzartamab in patients with IgA nephropathy (IgAN) and a late-breaking oral presentation of complete Phase 2 data from the investigator-sponsored study of felzartamab in antibody-mediated rejection (AMR) in kidney transplant recipients. The presentations reflect the first clinical data from felzartamab in these indications, and the first clinical data from HI-Bio development programs with felzartamab beyond primary membranous nephropathy (PMN).


Oral Presentations 


Abstract Title: Felzartamab (anti-CD38) in Patients with IgA Nephropathy - Interim Results from the IGNAZ Study

Session Topic: Glomerular, tubulo-Interstitial diseases & general nephrology

Subtopic: B4 - Prevention, Treatment and Clinical Trials

Date and Time:  May 24, 2024, 12:54 – 13:03 CEST (Moderated Orals 1.2, Room T5)

Presenter: Jürgen Floege, M.D., RWTH Aachen University


Abstract Title: Randomized Phase 2 Trial of Felzartamab in Humoral Transplant Rejection

Session Topic: Institutional

Subtopic: E3 - Treatment & Clinical Trials

Date and Time: May 25, 2024, 12:30 – 12:45 CEST (Late Breaking Clinical Trials II, Victoria Hall)

Presenter: Katharina A. Mayer, M.D., Medical University of Vienna

For more information, please visit the 61st ERA Congress website.


About Felzartamab

Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies.

HI-Bio is focused on developing felzartamab in a number of immune-mediated diseases, including antibody-mediated rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and primary membranous nephropathy (PMN). Felzartamab has received Breakthrough Therapy designation and Orphan Drug Designation from the FDA for development in the treatment of PMN, and Orphan Drug Designation in the treatment of AMR in kidney transplant recipients.

HI-Bio in-licensed felzartamab from MorphoSys in 2022 and holds exclusive worldwide rights for felzartamab with the exception of Greater China. 

Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority.

About HI-Bio 

Human Immunology Biosciences, Inc. (HI-Bio™) is a clinical-stage biotechnology company focused on discovering and developing precision medicines for people suffering from immune-mediated diseases (IMDs). HI-Bio is leading clinical immunology into its next chapter by targeting cellular drivers of disease. To learn more about HI-Bio, visit us at www.hibio.com or follow us on LinkedIn and X.