Mim8

Overview

Novo Nordisk bispecific antibody bridging factor IX and factor X — analogous to emicizumab but far more potent — projected at 20-50 mg once-monthly pen-injector dosing for hemophilia A; manufactured from two CHO cell lines using controlled Fc-hinge disulfide exchange; BLA submitted within 5 years of Phase 1 start in 2020. Mim8 is a bispecific antibody from Novo Nordisk that bridges factor IX and factor X in the same manner as emicizumab but is far more potent, with projected doses of approximately 20-50 mg given once monthly via a pen injector; it works only in hemophilia A patients because it requires factor IX. Mim8 is manufactured using two separate CHO cell lines each expressing one antibody arm with Fc charge-repulsion mutations; the two are purified separately, mixed, hinge disulfides reduced to allow heterodimerization by partner preference, then hinge is re-oxidized and the heterodimer purified. (Mim8 Overview (35:00-40:00))