Harbour BioMed announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its first antibody drug conjugate (ADC) program HBM9033. HBM9033 is an ADC drug candidate that specifically targets human mesothelin (MSLN), an upregulated tumor associated antigen in various solid tumors, including mesothelioma, ovary cancer, lung cancer, breast cancer, and pancreatic cancers. The fully human monoclonal antibody (mAb) in HBM9033, generated from the Harbour Mice® platform, binds preferably to membrane bond MSLN over soluble MSLN, which minimizes the interference of the shedding MSLN on the binding and internalization of the membrane bond MSLN.

HBM9033 utilizes a tumor specific cleavable linker with a novel topoisomerase inhibitor for improved stability and activity. The unique design for both mAb and linker-payload together has demonstrated superior potency and safety of HBM9033 in pre-clinical studies. This product was developed by the Company, in collaboration with MediLink Therapeutics.

This phase I study is to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9033 in subjects with advanced solid tumors.