Cambridge, MA, Rotterdam, NL, Suzhou, CN— August 28, 2023

Harbour BioMed (the“Company”, HKEX: 02142) 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.

"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 PLUS^TM 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."

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions.
 
The Company’s proprietary antibody technology platforms Harbour Mice^® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) are capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^®, HBICE^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies.  

Forward-Looking Statements

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