Biogen bulking out mAb pipeline through $1.15bn HI-Bio buy

Biogen agreed to acquire Human Immunology Biosciences (HI-Bio) for $1.15 billion cash, with a further $650 million in potential milestone payments.

The deal, anticipated to close in the third quarter, will add lead asset felzartamab, a fully human anti-CD38 monoclonal antibody (mAb) that last month demonstrated its ability to deplete CD38+ plasma cells –believed to drive Primary Membranous Nephropathy (PMN) through the production of anti-PLA2R (aPLA2R) autoantibodies – in Phase II clinical trials.

Beyond PMN, the candidate is being investigated immunoglobulin A nephropathy and, through a partnership with I-Mab, in relapsed/refractory multiple myeloma, thus has been described by Biogen as “a pipeline-in-a-product across a range of immune-mediated diseases.”

Priya Singhal, head of Development at Biogen, said: “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.”

South San Francisco, California-based HI-Bio came out of stealth in 2022, armed with $120 million in funding, two drugs from Morphosys, and its own drug discovery technology. Earlier this year, the firm announced it had raised $95 million in a Series B funding round for clinical support of felzartamab. HI-Bio’s second candidate is izastobart/HIB210, an anti-C5aR1 antibody in Phase I for a range of complement-mediated diseases, while its discovery stage mast cell programs has the potential in a range of immune-mediated diseases.

“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, CEO of HI-Bio. “We are excited to combine the HI-Bio team’s expertise with Biogen’s global footprint.”

Biogen has a large mAb commercial presence, with some of its products including Tysabri (natalizumab) for multiple sclerosis and Crohn's disease, Ocrevus (Ocrelizumab) for multiple sclerosis, and Leqembi (lecanemab) for Alzheimer's disease. Aduhelm (aducanumab), which won US approval in 2021 for Alzheimer’s, was dropped earlier this year because of limited sales due to questions surrounding its efficacy, along with access barriers imposed by the US government’s Centers for Medicare & Medicaid Services (CMS) program.