Bioanalytics – Biomolecular
Yanqiu (Emma) Liu, PhD
Senior Principal Scientist
Genentech
South San Francisco, California
William Hallet, PhD (he/him/his)
Associate Scientific Director
Janssen R&D / J&J
Spring House, Pennsylvania
Molecule X is a bispecific antibody agonist to receptor A and receptor B in a phase 1b clinical study. Anti-drug antibody (ADA) of Molecule X was assessed in human serum samples using a tiered strategy and bridging assay format. The post-baseline ADA incidence was 22.7 % (27 out of 119 patients) in Molecule X-treated patients. The majority of patients did not have detectable ADA until Day 127 (follow-up time point), although the PK drop was observed as early as Day 50 in some patients. To understand the high incidence and late onset of ADA, intensive investigation has been done to solve the mystery of the discrepancy between ADA onset and PK impact. The presentation focuses on discussing the results from the investigation.