Pharma Focus Asia

Biogen Strengthens Late-Stage Pipeline and Expands Immunology Portfolio with Acquisition of Human Immunology Biosciences

Thursday, May 23, 2024

Biogen Inc. (Nasdaq: BIIB) has revealed its acquisition of Human Immunology Biosciences (HI-Bio™), a privately-held biotech firm specializing in targeted therapies for severe immune-mediated diseases (IMDs). The deal involves an upfront payment of $1.15 billion with potential milestone payments of up to $650 million, totaling a maximum of $1.8 billion.

HI-Bio's primary asset, felzartamab, is a fully human anti-CD38 monoclonal antibody showing promise in clinical studies for selectively depleting CD38+ cells, including plasma cells and natural killer cells. This mechanism holds the potential for improving outcomes across various IMDs.

Felzartamab has received Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) from the FDA for treating primary membranous nephropathy (PMN) and antibody-mediated rejection (AMR) in kidney transplant recipients. Phase 2 studies have concluded for PMN and AMR, with ongoing trials for IgA nephropathy (IgAN). HI-Bio aims to present comprehensive Phase 2 data at the upcoming European Renal Association (ERA) Congress.

Biogen sees this acquisition as a strategic enhancement to its immunology pipeline, especially in addressing rare immune diseases with significant unmet needs. They plan to leverage their global development and commercialization capabilities to advance felzartamab and HI-Bio's pipeline.

Apart from felzartamab, HI-Bio's pipeline includes izastobart/HIB210, an anti-C5aR1 antibody in Phase 1 trials, and mast cell programs at the discovery stage, with potential applications in various immune-mediated diseases.

The financial details involve an upfront payment of $1.15 billion to HI-Bio, with potential additional payments contingent on felzartamab program milestones. The transaction is expected to close in the third quarter of 2024, pending regulatory approvals.

Felzartamab, an investigational therapeutic monoclonal antibody targeting CD38, shows promise in depleting plasma cells and is being developed for multiple indications. AMR, PMN, and IgAN are among the primary focus areas, addressing significant unmet medical needs in immune-mediated diseases affecting the kidneys.

AMR is a leading cause of kidney transplant failure, with limited effective treatment options currently available. PMN, a rare IMD, lacks approved therapies, relying on off-label treatments like immunosuppressive therapies and B-cell depleting agents. IgAN, a common cause of chronic kidney disease worldwide, presents a substantial medical challenge, with a significant portion of patients progressing to end-stage kidney disease.

In summary, Biogen's acquisition of HI-Bio underscores its commitment to advancing therapies for severe immune-mediated diseases, with felzartamab positioned as a potential breakthrough in addressing unmet medical needs in kidney-related conditions.



Cytiva - Supor Prime filtersMFA + MMA 2024CPHI China || PMEC China 2024Asia Healthcare Week 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference3rd World ADC Asia 2024