Harbour BioMed announced that the company has been granted the clearance of Investigational New Drug (IND) from the Food and Drug Administration (FDA) of the United States to initiate the first-in-human (FIH) clinical trial in the U.S. for bispecific antibody HBM9027. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9027 in subjects with advanced solid tumors. HBM9027 is generated from Harbour BioMed's proprietary fully human HBICE® platform.

It is a novel PD-L1xCD40 bispecific antibody, which is designed to activate CD40 relied on PD-L1 crosslinking for a promising safety profile. PD-L1 is overexpressed on a variety of solid malignancies, and with its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM9027 has shown excellent and promising safety profile with strong anti-tumor efficacy in its pre-clinical studies.