HI-Bio’s lead asset, felzartamab, is a fully human anti-CD38 monoclonal antibody (mAb) 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.

“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, 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, Chief Executive Officer 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 diseases and its strong scientific expertise in immunology to support the advancement of felzartamab and the HI-Bio pipeline. Biogen seeks to retain talent from HI-Bio and establish a San Francisco Bay Area team focused on expanding its efforts in immune-mediated diseases.

The HI-Bio pipeline also includes an anti-C5aR1 antibody currently in a Phase 1 trial and with the potential for continued development in a range of complement-mediated diseases. HI-Bio also has discovery-stage mast cell programs with potential in a range of immune-mediated diseases.

The acquisition of HI-Bio is not expected to impact Biogen’s previously issued 2024 guidance. Biogen expects to finance the acquisition with cash and may also draw on its revolving credit agreement. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close in the third quarter of 2024.