Biogen Finalizes Human Immunology Biosciences Acquisition

Biogen Inc., a leading biotechnology company based in Cambridge, Massachusetts, has recently finalized the acquisition of Human Immunology Biosciences (HI-Bio™), a private clinical-stage biotech firm specializing in targeted treatments for severe immune-mediated diseases (IMDs). This move aims to bolster Biogen's pipeline in the field of immunology, particularly with the addition of felzartamab, a promising late-stage therapeutic candidate.

Dr. Priya Singhal, Head of Development at Biogen, expressed enthusiasm about integrating felzartamab into their development programs. She highlighted the potential of this therapeutic candidate, which is currently being studied for multiple indications, to address significant unmet medical needs. Dr. Singhal emphasized Biogen's commitment to advancing felzartamab to Phase 3 clinical trials, with the goal of delivering innovative treatments to patients suffering from rare diseases.

Dr. Travis Murdoch, CEO of HI-Bio, also expressed optimism about the merger. He noted that the combination of HI-Bio’s skilled team and Biogen’s global resources would accelerate the development of felzartamab and enhance Biogen's expanding portfolio in immunology. Dr. Murdoch underscored the shared values and missions of both companies, particularly their science-led approaches and dedication to improving patient outcomes.

Felzartamab, the centerpiece of this acquisition, has shown promising interim results in Phase 2 studies for IgA nephropathy (IgAN) and antibody-mediated rejection (AMR). These results were shared at the European Renal Association Congress in Stockholm, with additional data from the AMR study published in the New England Journal of Medicine. The candidate has also demonstrated proof-of-concept in a Phase 2 study for primary membranous nephropathy (PMN). Biogen plans to advance felzartamab to Phase 3 trials in AMR, IgAN, and PMN.

Felzartamab is a human monoclonal antibody targeting CD38, a protein found on mature plasma cells. Clinical studies have shown that felzartamab can selectively deplete CD38+ plasma cells, potentially improving outcomes in diseases driven by harmful antibodies. Originally developed by MorphoSys AG for multiple myeloma, HI-Bio acquired exclusive rights to develop and commercialize felzartamab in all regions except China, including Macau, Hong Kong, and Taiwan. It remains an investigational therapeutic with no regulatory approval yet, and its safety and efficacy are still under evaluation.

Antibody-mediated rejection (AMR) is a leading cause of kidney transplant failure, affecting about 12% of kidney transplant recipients in the United States each year. AMR is the primary cause of late graft loss in these patients, and effective treatments are currently limited.

Primary membranous nephropathy (PMN) is a rare kidney disease with an incidence rate of approximately 1 in 100,000 annually in the United States. No specific therapies are approved for PMN, and the standard of care involves off-label use of various immunosuppressive agents. Even with treatment, about one-third of patients do not achieve remission.

Immunoglobulin A nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis globally. It is a major cause of chronic kidney disease, with up to 40% of patients progressing to end-stage kidney disease within 20 years of diagnosis. IgAN accounts for a significant proportion of native kidney biopsies in various parts of the world, though its prevalence is lower in central Africa.

Biogen, established in 1978, remains at the forefront of biotechnology, pioneering innovative treatments aimed at transforming patient lives and delivering value to shareholders and communities. The company leverages a deep understanding of human biology and various treatment modalities to advance first-in-class therapies, balancing bold risks with investment returns for sustainable growth.