On August 28, 2023 Harbour BioMed (the"Company", HKEX: 02142) reported 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 (Press release, Harbour BioMed, AUG 28, 2023, View Source [SID1234634726]).
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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.
"HBM9033 is our first ADC asset that enters into clinical stage and it has the potential to be the best-in-class MSLN targeted therapeutics," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. " Building on the extensive applications of the HCAb PLUSTM platform in the ADC field, we have established an ecosystem of ADC that synergizes our in-house development with external collaborations. As evidenced by the rapid progress made by our partners and us, we will continuously strengthen our active presence in the ADC field globally."