CAMBRIDGE, Mass., July 02, 2024 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Human Immunology Biosciences, a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs).
“We are very excited about the addition of felzartamab into our pipeline, further strengthening our presence in immunology with a promising late-stage therapeutic candidate being studied in multiple indications,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “With the transaction now complete, we will begin working together with our colleagues from HI-Bio on plans to advance felzartamab to phase 3 and ultimately deliver innovative treatments to patients with unmet needs across a range of rare diseases.”
“I’m looking forward to the important progress HI-Bio will make as part of Biogen, and the power of combining our talented HI-Bio team with Biogen’s global infrastructure to support the development of felzartamab and accelerate Biogen’s expanding immunology portfolio,” said Travis Murdoch, M.D., CEO of HI-Bio. “It’s clear from our engagement over many months – as we considered how HI-Bio programs could progress in the best possible way – that our teams share many of the same values, including being science-led and execution-focused, and a core mission to positively impact patients with severe diseases.”
Felzartamab demonstrated positive interim results from the Phase 2 IgA nephropathy (IgAN) study and from the completed Phase 2 antibody-mediated rejection (AMR) study. These data were presented at the recent European Renal Association Congress in Stockholm. The AMR study data were also published in the New England Journal of Medicine. Felzartamab has also demonstrated proof-of-concept in a Phase 2 study in primary membranous nephropathy (PMN) and there are plans to advance felzartamab to Phase 3 in AMR, IgAN, and PMN.
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. Felzartamab was originally developed by MorphoSys AG for multiple myeloma. HI-Bio exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan).
Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established.
About Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients
Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure, with chronic AMR affecting ~12% of patients that receive kidney transplants annually in the U.S.1 AMR has emerged as the leading cause of late graft loss in kidney transplant recipients. Effective treatment options for chronic AMR are currently limited.2
About Primary Membranous Nephropathy (PMN)
Primary membranous nephropathy (PMN) is a rare IMD affecting the kidneys, with an estimated incidence rate of ~1/100K per year in the United States.3 There are currently no therapies specifically approved for PMN. Standard of care comprises off-label use of a variety of agents, including immunosuppressive therapies like cyclophosphamide, and CD20-targeted B-cell depleting agents such as rituximab.4 Even with these strategies, approximately one third of patients do not achieve remission.4
About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis worldwide. It is a leading cause of chronic kidney disease with up to 40% of IgAN patients progressing to end stage kidney disease about 20 years after diagnosis. IgAN accounts for about 40% of all native-kidney biopsies in Japan, 25% in Europe, 12% in the United States, but less than 5% in central Africa.5
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
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