Molecule X is a bispecific antibody agonist to receptor A and receptor B in a phase 1b clinical study. Anti-drug antibody (ADA) was assessed in human serum samples using a tiered strategy and bridging assay format. The post-baseline ADA incidence was 22.7 % in Molecule X-treated patients, and the majority of patients did not have detectable ADA until Day 127. To understand the high incidence and late onset of ADA, many efforts including in-study cut-point implementation and confirmatory assay investigations have been explored.
Identify bioanalytical challenges in drug development of bispecific antibody agonist
Gain valuable experience in clinical immunogenicity assay development and troubleshooting
Learn strategies how to understand the high incidence and late onset of ADA in clinical studies