Biogen expands immunology portfolio with $1.8 billion acquisition of HI-Bio

On May 22, 2024, Biogen announced that it has entered into a definitive agreement to acquire Human Immunology Biosciences (HI-Bio), a privately held U.S. clinical-stage biotechnology company focused on targeted therapies for severe immune-related diseases ( IMD). ). Under the agreement, Biogen will pay $1.15 billion upfront and up to $650 million in potential milestone payments. The transaction is expected to close in the third quarter of 2024, pending necessary regulatory approvals and customary closing conditions.

With this acquisition, Biogen gains felzartamab, a major asset of HI-Bio. Felzartamab is a fully human anti-CD38 monoclonal antibody (mAb) that has been shown in clinical trials to selectively deplete CD38+ cells. This selective depletion involves plasma cells and natural killer (NK) cells. This action may enable additional applications that improve clinical outcomes in a broad range of immune-related diseases, Biogen said in a company news release.

“We believe this late-stage asset, which has demonstrated impact on key biomarkers and clinical endpoints in three kidney diseases with significant unmet needs, is a strategic addition to Biogen’s portfolio as we continue to improve our pipeline and build on our expertise in immunology,” Priya Singhal, Biogen’s chief development officer, said in a press release. “We look forward to welcoming HI-Bio employees to Biogen and working together to advance potential therapies for patients with rare immune diseases where the need is high and unmet.”

The FDA has granted breakthrough drug and orphan drug designation to felzartamab for the treatment of primary membranous nephropathy (PMN). The mAb has also received orphan drug designation for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients. Felzartamab has completed Phase II trials in PMN and antimicrobial resistance and remains in Phase II trials in immunoglobulin A nephropathy (IgAN). HI-Bio plans to submit mAbs to phase III trials in each indication; the company is presenting two abstracts at the European Society of Nephrology Congress in Stockholm, May 23-26, 2024. HI-Bio’s presentation includes full Phase II data from the AMR trial in kidney transplant patients and interim data from the Phase II IgAN trial – according to the press release. The studies also provided clinical data on felzartamab in the indications of AMR, PMN and IgAN.

“With its deep development and commercialization capabilities, Biogen is positioned to accelerate the development of new medicines, including felzartamab, for patients with severe immune-related diseases,” said Travis Murdoch, MD, CEO of HI-Bio, in the release. “We are excited to combine the expertise of the HI-Bio team with Biogen’s global reach.”

In addition to its core felzartamab program, HI-Bio’s pipeline includes isostobart/HIB210, an anti-C5aR1 antibody currently in Phase I trial. This candidate has the potential for further development in a number of complement-dependent diseases. HI-Bio also has discovery-stage mast cell programs that have potential applications in the treatment of a number of immune-related diseases.

The evolution of targeted biologic therapies has greatly benefited from the treatment of IMD. Targeted biologics have demonstrated efficacy, rapidity of action, and tolerability. Furthermore, studies have shown that clinically unrelated immune-mediated inflammatory conditions may be characterized by similar immune dysregulation. This discovery led to a change in the treatment of IMD and other inflammatory diseases (1).

Reference

1. Kuek, A.; Hazleman, B.L.; Ostör AJ Immune-mediated inflammatory diseases (IMID) and biological therapy: a medical revolution. Postgraduate Medicine J. 2007, 83 (978), 251–260. DOI: 10.1136/pgmj.2006.052688

source: Biogen