Biogens acquisition of HI-Bio includes lead investigational mAb, felzartamab, under development for treating a range of immune-mediated diseases.

Biogen announced on May 22, 2024 that it has entered into a definitive agreement to acquire Human Immunology Biosciences (HI-Bio), a privately-held US-based clinical-stage biotechnology company focused on targeted therapies for severe immune-mediated diseases (IMDs). 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 the acquisition, Biogen gains felzartamab, HI-Bios lead asset. Felzartamab is a fully human anti-CD38 monoclonal antibody (mAb) that has been shown to selectively deplete CD38+ cells in clinical studies. This selective depletion includes plasma cells and natural killer (NK) cells. This action may allow for additional applications that improve clinical outcomes in a broad range of immune-mediated diseases, Biogen stated in a company press release.

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, MD, head of Development at Biogen, in the press release. 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.

FDA has granted felzartamab breakthrough therapy designation and orphan drug designation for development in treating primary membranous nephropathy (PMN). The mAb has also received orphan drug designation for treating antibody-mediated rejection (AMR) in kidney transplant recipients. Felzartamab has completed Phase II studies in PMN and AMR and remains in ongoing Phase II studies in immunoglobulin A nephropathy (IgAN). HI-Bio plans to advance the mAb to Phase III studies in each indication; the company is presenting two abstracts at the European Renal Association Congress in Stockholm, which is occurring May 2326, 2024. HI-Bios presentation includes complete Phase II data from the AMR study in kidney transplant patients and interim data from the Phase II IgAN study, according to the press release. Studies have also generated clinical data for felzartamab in the AMR, PMN, and IgAN indications.

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, MD, chief executive officer of HI-Bio, in the release. We are excited to combine the HI-Bio teams expertise with Biogens global footprint.

In addition to the felzartamab lead program, HI-Bios pipeline consists of izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase I trial. This candidate has the potential for continued development in a range of complement-mediated diseases. HI-Bio also has discovery-stage mast cell programs with potential application in a range of immune-mediated diseases.

The treatment of IMDs has largely benefitted from the evolution of targeted biologic therapies. Targeted biologics have demonstrated efficacy, speed of onset, and tolerability. Whats more, research efforts have shown that clinically unrelated immune-mediated inflammatory conditions can share similar immune dysregulation. This discovery has since led to a shift in way IMDs and other inflammatory disorders are managed (1).

1. Kuek, A.; Hazleman, B. L.; Ostr A. J. Immune-Mediated Inflammatory Diseases (IMIDs) and Biologic Therapy: A Medical Revolution. Postgrad Med J. 2007, 83 (978), 251260. DOI: 10.1136/pgmj.2006.052688

Source: Biogen

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Biogen Boosts Immunology Portfolio with $1.8 Billion Acquisition of HI-Bio - BioPharm International