Biogen Inc. and Human Immunology Biosciences (HI-Bio), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), have entered into a definitive agreement under which Biogen will acquire HI-Bio for $1.15 billion upfront and up to $650 million in potential milestone payments.

About HI-Bio’s Lead Asset

HI-Bio’s lead asset, felzartamab, is a fully human anti-CD38 monoclonal antibody that has been shown in clinical studies to selectively deplete CD38+ cells including plasma cells and natural killer, or NK, cells which may allow for additional applications that improve clinical outcomes in a broad range of immune-mediated diseases.
 
Felzartamab has received Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for development in the treatment of primary membranous nephropathy (PMN) and has received ODD in the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.
 
Phase 2 studies have been completed in PMN and AMR and remain ongoing in IgA nephropathy (IgAN), and HI-Bio has plans to advance each indication to Phase 3.
 
“We believe this late-stage asset, which has demonstrated impact on key biomarkers and clinical endpoints in three renal diseases with serious unmet needs, is a strategic addition to the Biogen portfolio as we continue to augment our pipeline and build on our expertise in immunology,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We look forward to welcoming HI-Bio employees into Biogen and, together, working to advance potential therapies for patients with rare immune diseases with high unmet need.”
 
“With its deep development and commercialization capabilities, Biogen is in a position to accelerate the development of new medicines, including felzartamab, for patients with severe immune-mediated diseases,” said Travis Murdoch, M.D., CEO of HI-Bio. “We are excited to combine the HI-Bio team’s expertise with Biogen’s global footprint.”
 
Biogen plans to leverage its existing global development and commercialization capabilities in rare disease and its scientific expertise in immunology to support the advancement of felzartamab and the HI-Bio pipeline. Biogen also seeks to retain expertise and talent from HI-Bio and establish a San Francisco Bay Area team focused on expanding its efforts in immune-mediated diseases.
 
In addition to lead program felzartamab, the HI-Bio pipeline also includes izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase 1 trial and with potential for continued development in a range of complement-mediated diseases. Furthermore, HI-Bio has discovery stage mast cell programs with potential in a range of immune-mediated diseases.

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