Abstract
Background: Anti-A/B is a bispecific monoclonal antibody thatblocks activities of soluble targets A and B. Robust immune responses were observed in a multiple-dose cynomolgus monkey toxicology study, negatively impacting the toxicokinetics/pharmacodynamics profile of anti-A/B in some animals. This was unexpected as similar findings were not observed in the two previously studied parental molecules. Methodology & Results: This paper discusses our characterization strategy for evaluating the immunogenic domain(s) of anti-A/B and our mitigation plan to monitor immunogenicity in the first-in-human clinical study. The characterization results from the cynomolgus monkey and Phase I studies are discussed. Conclusion: The characterization strategy discussed informed understanding of immunogenicity results and clinical impact, which can be broadly applied to other molecules with multiple-binding domains.
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