Biogen bets $1.15bn on immunology drug developer HI-Bio

Biogen has expanded its specialty immunology pipeline with an agreement to buy Human Immunology Biosciences (HI-Bio) and its lead drug felzartamab, in trials for a range of diseases, including IgA nephropathy (IgAN).

The $1.8 billion deal – which comes just weeks after Biogen chief executive Chris Viehbacher said the company wasn’t expecting to sign any large deals this year in its first-quarter results update – breaks down to an upfront payment of $1.15 billion, with another $650 million in milestones tied to felzartamab’s development.

Felzartamab is an anti-CD38 antibody that HI-Bio licensed in 2022 from German biotech MorphoSys, which is in the process of being acquired by Swiss pharma group Novartis and holds a 15% stake in the South San Francisco-based biotech. The drug is in mid-stage clinical trials for IgAN, as well as primary membranous nephropathy (PMN) and antibody-mediated transplant rejection, and is in phase 1 for lupus nephritis.

CD38 is found on plasma cells – B-lymphocytes whose main function is to generate antibodies – so, felzartamab could have broad utility in immune-mediated diseases (IMDs) driven by antibody responses against normal human tissues.

Biogen’s clinical-stage immunology pipeline is fairly small, consisting of UCB-partnered anti-CD40L antibody dapirolizumab pegol in phase 3 for systemic lupus erythematosus (SLE) and anti-BDCA2 antibody litifilimab in phase 3 for SLE and phase 2 for cutaneous lupus erythematosus (CLE).

Priya Singhal, head of development at Biogen, said in a statement that felzartamab would be a “strategic addition” to the company’s portfolio “as we continue to augment our pipeline and build on our expertise in immunology.”

Aside from felzartamab, HI-Bio’s pipeline also includes anti-C5aR1 antibody izastobart, which is in early-stage clinical testing and has potential in complement-mediated diseases, and an undisclosed programme targeting mast cells, which are a key component of inflammation and allergic reactions.

The addition of felzartamab – which has completed phase 2 testing in IgAN and PMN and is being prepared for phase 3 – comes at a time when Biogen has been ringing the changes in its R&D pipeline.

Last week, the company discontinued the development of antisense drugs BIIB121 for Angelman syndrome and BIIB105 for amyotrophic lateral sclerosis (ALS), both developed in partnership with Ionis, while in September it closed the $7.3 billion acquisition of Reata Pharma, adding an FDA-approved therapy for Friedreich’s ataxia.

It has been adding to its late-stage pipeline to help offset a slow rollout of Eisai-partnered Alzheimer’s disease therapy Leqembi (lecanemab) – although, that may now be starting to gather momentum – as well as a multiple sclerosis franchise that is being hit hard by generic competition, declining sales of spinal muscular atrophy (SMA) therapy Spinraza (nusinersen), due to competition from newer therapies and the recent failure of oral MS drug orelabrutinib.