Clinical Pharmacology – Biomolecular
2019 PharmSci 360
Bispecific antibodies are engineered to bind to two different antigens or two different epitopes on the same antigen, allowing the construction of a wide range of diverse formats. They represent a fast-growing area of immunotherapy, with over 100 different bispecific antibody formats, and new avenues for construction are constantly emerging. Bispecific antibodies may be used to link target cells with effector cells, or bind two epitopes on the same cell to block more than one signaling pathway. Of the above approaches, redirecting the cytotoxic potential of immune effector cells in the destruction of tumor cells has been an important driver in the development of bispecific antibodies. This session focuses on the various designs of bispecific molecules with a particular focus on clinical pharmacology considerations such drivers of efficacy, regulatory guidance on starting dose, bioanalytical challenges, selecting recommended phase 2 dose, as well as applications of various modeling and simulation approaches used for drug development.