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HI-Bio to Present at the American Society of Nephrology Kidney Week 2023 Annual Meeting

2023-10-13

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临床2期引进/卖出孤儿药临床1期

Oral presentation will highlight final data from Phase 2 M-PLACE study of felzartamab in patients with Primary Membranous Nephropathy

SOUTH SAN FRANCISCO, Calif., Oct. 13, 2023 /PRNewswire/ -- Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that three abstracts will be presented at the upcoming American Society of Nephrology's (ASN) Kidney Week 2023 Annual Meeting, taking place November 2-5, 2023 in Philadelphia, Pennsylvania. This will include an oral presentation of final data from the Phase 2 M-PLACE trial of felzartamab in patients with primary membranous nephropathy (PMN).

Oral Presentation

Abstract Title: Safety and Efficacy of Felzartamab in Primary Membranous Nephropathy (PMN): Final Analysis of the M-PLACE Study [#TH-OR27]

Session Title: Glomerular Diseases: Clinical and Translational Studies [OR1402]

Date and Time: November 2, 2023, 5:24 PM – 5:33 PM ET

Presenter: Brad Rovin, M.D., Ohio State University

Poster Presentations

Abstract Title: Felzartamab (anti-CD38 antibody) for the treatment of Lupus Nephritis – An Open Label Phase 1b Study (NCT06064929) [#INFO13-TH]

Session Title: Informational Posters - I

Date and Time: November 2, 2023, 10 AM – 12 PM ET

Presenter: Brad Rovin, M.D., Ohio State University

Abstract Title: Felzartamab reduces aPLA2R Ab by selectively depleting CD38+ plasma cells and plasmablasts, the main pathogenic cellular drivers of disease in Primary Membranous Nephropathy (PMN) [#SA-PO910]

Session Title: Glomerular Diseases: Therapeutics [PO1402-1]

Date and Time: November 4, 2023, 10 AM – 12 PM ET

Presenter: Donna Flesher, Ph.D., HI-Bio

For more information on these and other abstracts, please visit the ASN Kidney Week 2023 website.

About Primary Membranous Nephropathy (PMN)

PMN is a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome (NS) in adults worldwide. Disease onset and diagnosis typically occurs between 40 and 50 years of age, with 80% of patients presenting with Nephrotic Syndrome (i.e., edema, >3.5 g/day proteinuria, hypoalbuminemia). PMN is characterized by a thickening of the glomerular basement membrane (GBM) due to the formation and deposition of immune complexes in this space between podocytes and the glomerular endothelium of the kidney.

Approximately 80% of PMN cases arise due to autoantibodies that recognize the phospholipase A2 receptor (PLA2R) antigen expressed on podocytes. Anti-PLA2R is both a diagnostic and prognostic biomarker, and total aPLA2R antibody level has been shown to be a biomarker for prognosis of outcome in patients with PMN. Other autoantibodies have been identified in patients with PMN including anti-THSD7A, NELL-1 and Sema3B, further supporting the role of antibody-secreting plasma cells in the pathophysiology of PMN. CD38+ long-lived plasma cells and plasmablasts are a main source of autoantibodies.

There are no approved therapies for PMN. The current standard of care comprises off-label use of supportive care measures (e.g., angiotensin-converting enzyme inhibitors angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, statins, and diuretics), conventional immunosuppressive treatments (ISTs) (e.g. cyclophosphamide combined with steroids and calcineurin inhibitors) or B-cell depleting agents (e.g. anti-CD20 antibodies). However, these treatments are not effective in all patients, with a significant proportion of patients not achieving remission or relapsing. In addition, conventional immunosuppressive treatments are associated with a high risk of toxicity.

About Lupus Nephritis

Lupus nephritis (LN) is an organ-threatening manifestation of systemic lupus erythematosus (SLE) affecting nearly 135,000 U.S. patients, with only 30 to 40 percent of all patients achieving a complete renal response with current standard of care. Approximately 35 percent of those who do respond may relapse. A hallmark of lupus, including LN, is the production of high-titer, high affinity, isotype-switched autoantibodies produced by CD38+ plasma cells. In patients with LN, autoantibodies form immune complexes that directly induce disease pathogenesis in the kidney through activation of the complement cascade and initiate a feed-forward loop to further drive inflammation through the production of Type I interferons (IFN) and other pro-inflammatory cytokines. Plasmablasts and plasma cells express very high levels of CD38, making CD38 a compelling target for depletion of pathogenic autoantibody-producing cells in patients with SLE, including LN. In patients with SLE, CD38 expression is also induced on plasmacytoid Dendritic Cells (pDCs), the primary cellular source of Type I IFN production that perpetuates SLE pathogenesis.

About Felzartamab

Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. By targeting CD38, felzartamab has the potential to deplete CD38+ plasma cells while leaving other functionally important plasma cells intact, which may ultimately improve clinical outcomes in a broad range of autoantibody driven diseases.

HI-Bio is focused on developing felzartamab in a number of autoantibody-driven immune-mediated diseases, including primary membranous nephropathy (PMN), IgA nephropathy (IgAN) and antibody mediated rejection (AMR). In May, felzartamab received Orphan Drug Designation from the FDA for treatment of PMN. ODD was achieved following data from two Phase 2 studies of felzartamab in PMN showing dose-dependent reductions in pathogenic antibody levels.

HI-Bio in-licensed felzartamab from MorphoSys in June 2022, and holds exclusive worldwide rights for felzartamab with the exception of Greater China. In 2017, MorphoSys entered into an exclusive regional licensing agreement with I-Mab Biopharma to develop and commercialize felzartamab in Greater China which encompasses Mainland China, Hong Kong, Macau and Taiwan. I-Mab is evaluating felzartamab in relapsed/refractory multiple myeloma relapsed/refractory multiple myeloma.

Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities.

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 Twitter.

SOURCE HI-Bio