SOUTH SAN FRANCISCO, Calif., March 29, 2024 /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 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).
SOUTH SAN FRANCISCO, Calif., March 21, 2024 /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 the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for felzartamab for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.
HI-Bio Announces $95 Million Series B Financing
Human Immunology Biosciences, known as HI-Bio for short, has raised $95 million as it awaits data from a series of studies on its lead compound, an antibody that targets a white blood cell surface protein called CD38.
HI-Bio Announces Felzartamab Granted Breakthrough Therapy Designation
SOUTH SAN FRANCISCO, Calif., July 11, 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 the first participants have been dosed in a Phase 1 healthy volunteer study of HIB210, an investigational monoclonal antibody targeting C5aR1.
SOUTH SAN FRANCISCO, Calif., May 25, 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 the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for felzartamab, the company's investigational agent that is in development for the treatment of primary membranous nephropathy (PMN). Felzartamab is an investigational monoclonal antibody designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies. The company intends to advance felzartamab into late-stage studies.
SOUTH SAN FRANCISCO, Calif., April 11, 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 positive data from two Phase 2 studies of felzartamab, M-PLACE and NewPLACE. Felzartamab is an investigational monoclonal antibody designed to deplete CD38+ plasma cells, which are believed to drive Primary Membranous Nephropathy (PMN) through the production of anti-PLA2R (aPLA2R) autoantibodies. The company intends to advance felzartamab into late-stage studies.