Biogen has completed the acquisition of Human Immunology Biosciences (HI-Bio), a clinical-stage biotechnology company specializing in the development of therapies for severe immune-mediated diseases (IMDs). This strategic move will advance felzartamab, a therapeutic human monoclonal antibody, to Phase 3 trials. Felzartamab targets CD38, a protein found on mature plasma cells, and has demonstrated the potential in depleting CD38+ plasma cells, thereby enhancing clinical outcomes in diseases caused by pathogenic antibodies. The acquisition accelerates the development of felzartamab for conditions including antibody-mediated rejection (AMR), immunoglobulin A nephropathy (IgAN), and primary membranous nephropathy (PMN).
In Phase 2 studies for these conditions, felzartamab has shown promising results, with positive interim data for IgAN and AMR presented at the European Renal Association Congress and published in the New England Journal of Medicine. About 12% of kidney transplant recipients in the United States are annually affected by AMR, which is a substantial cause of kidney transplant failure. While IgAN is the most prevalent primary glomerulonephritis worldwide, PMN is a rare kidney disorder with an incidence rate of approximately 1 in 100,000 per year in the United States. Biogen, established in 1978, is renowned for its innovative biotechnology initiatives, which are designed to generate value for patients, shareholders, and communities by providing transformative medicines.