M&A

HI-Bio’s lead asset is felzartamab, a fully human anti-CD38 monoclonal antibody that has demonstrated its ability to selectively deplete CD38+ cells including plasma cells and natural killer (NK) cells through its clinical studies. The drug has many potential additional applications such as various immune-mediated diseases.

Felzartamab has already gained a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration for development for the treatment of primary membranous nephropathy (PMN) as well as gaining an ODD for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.

Biogen is intending to use its existing global development and commercialisation capabilities within the rare diseases space and its expertise in immunology in order to further the development of the drug as well as the rest of the HI-Bio pipeline.

Priya Singhal MD MPH, head of development at Biogen, commented: “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. 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.”

Travis Murdoch MD, chief executive officer of HI-Bio, added: “With its deep development and commercialisation capabilities, Biogen is in a position to accelerate the development of new medicines, including felzartamab, for patients with severe immune-mediated diseases. We are excited to combine the HI-Bio team’s expertise with Biogen’s global footprint.”