Abstract: INFO13-TH
Felzartamab (Anti-CD38 Antibody) for the Treatment of Lupus Nephritis: An Open-Label Phase 1b Study
Session Information
- Informational Posters - I
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Rovin, Brad H., The Ohio State University, Columbus, Ohio, United States
- Pineda, Lilia D., Human Immunology Biosciences Inc, South San Francisco, California, United States
- Patel, Uptal D., Human Immunology Biosciences Inc, South San Francisco, California, United States
- Tersini, Karen, Human Immunology Biosciences Inc, South San Francisco, California, United States
- Mysler, Eduardo, Reumatologo en Organization Medica de Investigation (OMI), Buenos Aires, Argentina
- Dall'Era, Maria, UCSF Medical Center, San Francisco, California, United States
Description
Background: Lupus Nephritis (LN) is an organ-threatening manifestation of SLE with only 30-40% of patients achieving complete renal response with current standard of care. A hallmark of LN is high-titer autoantibodies which are predominantly produced by CD38+ plasma cells. Autoantibodies form immune complexes that deposit in the glomerulus and incite kidney damage via production of inflammatory mediators including Type I interferons (IFN). CD38 expression is also induced on plasmacytoid Dendritic Cells (pDCs), the primary source of Type I IFN. CD38 is thus a compelling target for depletion of pathogenic cells in LN, supported by emerging clinical data that anti-CD38 therapy in LN is well tolerated with evidence of disease improvement or resolution.
Felzartamab (felza) is a fully human, anti-CD38 investigational agent in development for several immune-mediated kidney diseases, including primary membranous nephropathy (PMN), IgA nephropathy, and antibody-mediated kidney transplant rejection. Felza is well tolerated with encouraging evidence of CD38+ cell depletion and lowering autoantibodies. In studies of high-risk PMN pts, felza resulted in rapid, deep, and durable aPLA2R autoantibody responses with associated improvements in proteinuria and serum albumin. A global, open-label Ph1b study testing the safety and efficacy felza in LN is ongoing.
Objective: To generate safety, tolerability, and proof-of-concept data of felza in LN
Methods: ~20 pts in US, Canada, Australia, Argentina, Chile, and Mexico with SLE and Class III or IV +/- V LN will receive 9 IV doses of felza over 5 months with 7 months of follow-up. Key inclusion criteria: (1) UPCR > 1.0 g/g, (2) eGFR ≥ 45 mL/min/1.73 m2, (3) positive anti-dsDNA and/or low complement 3, and (4) history of inadequate response to a minimum 3-month course of standard LN treatment. Primary endpoint is safety and tolerability of felza, and key secondary and exploratory endpoints include pharmacokinetics, efficacy of felza (proteinuria, eGFR, SLEDAI-2K), serologic markers (change in C3 and anti-dsDNA), and other blood and urinary biomarkers (e.g., immune cells,Type I IFN, etc).
Funding
- Human Immunology Biosciences Inc