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BioWorld - Saturday, March 28, 2026
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Home » Harbour Biomed’s ADC HBM-9033 receives FDA clearance to enter clinic for advanced solid tumors
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Immuno-oncology

Harbour Biomed’s ADC HBM-9033 receives FDA clearance to enter clinic for advanced solid tumors

Aug. 28, 2023
Harbour Biomed Ltd. has received FDA clearance of its IND application to commence a phase I trial of HBM-9033 in advanced solid tumors. Developed in collaboration with Medilink Therapeutics (Suzhou) Co. Ltd., HBM-9033 is an antibody-drug conjugate that specifically targets human mesothelin (MSLN), an upregulated tumor-associated antigen in various solid tumors, including mesothelioma, ovarian cancer, lung cancer, breast cancer and pancreatic cancers. The fully human monoclonal antibody in HBM-9033, 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.
BioWorld Science Regulatory Cancer Antibody-drug conjugate Immuno-oncology FDA IND

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