The US Patent and Trademark Office (USPTO) has issued US Patent #8,685,897 to AnaptysBio for broadly covering a novel approach to antibody humanisation using somatic hypermutation.

Leveraging key advantages of AnaptysBio’s SHM-XEL platform, this approach rapidly generates high potency humanised therapeutic antibodies using minimal non-human sequence content. The newly issued US patent is assigned to AnaptysBio and constitutes the 18th patent issuance in AnaptysBio’s intellectual property portfolio.

The majority of therapeutic antibodies licensed by the FDA for human use to date have been developed via humanisation of murine antibodies. However, historical technologies utilised for humanisation have required large non-human segments to be incorporated, resulting in therapeutic antibodies with only 65-90 per cent human content. In addition, historical approaches have been hampered by labour-intensive framework engineering processes required to restore binding potency lost during humanisation.

In contrast, AnaptysBio’s proprietary humanisation methodology is designed to rapidly generate therapeutic antibodies using a single heavy chain complementary determining region of murine origin. Relevant sequence information is directly isolated from murine B cells without the need to generate hybridomas.1 By concurrently optimising potency and biophysical properties using its SHM-XEL platform, AnaptysBio has routinely generated humanised therapeutic-grade antibodies with greater than 97 per cent human content in less than 6 months.2“This patent issuance provides AnaptysBio with exclusive ownership to an entirely new paradigm in antibody humanisation using somatic hypermutation. We have overcome prior limitations by reducing both the murine content and time required to generate humanised antibody lead candidates,” said Hamza Suria, AnaptysBio’s president and chief executive officer. “In addition to our fully-human libraries, SHM-XEL based humanisation provides a robust avenue for AnaptysBio to develop first-in-class therapeutic antibodies for emerging targets in oncology, inflammation, muscle-wasting disorders and fibrosis.”

AnaptysBio is a privately-held company focused on the generation of antibody therapeutics and is the leader in the use of somatic hypermutation (SHM) for antibody discovery and optimization.