China-based Harbour BioMed (HKG: 2142) has announced receiving Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HBM9033. This ADC specifically targets human mesothelin (MSLN), a tumor-associated antigen that is upregulated in various solid tumors, including mesothelioma, ovarian, lung, breast, and pancreatic cancers.
HBM9033’s Design and Pre-Clinical Performance
The fully human monoclonal antibody (mAb) in HBM9033 was generated via Harbour’s proprietary platform and demonstrates a preference for binding to membrane-bound MSLN over soluble MSLN. This feature minimizes the interference of shedding MSLN on the binding and internalization of the membrane-bound MSLN. HBM9033 utilizes a tumor-specific cleavable linker with a novel topoisomerase inhibitor, which enhances the stability and activity of the ADC. The unique design of both the mAb and linker-payload has demonstrated superior potency and safety in pre-clinical studies.
Collaboration and Phase I Study Objectives
The development of HBM9033 was a collaborative effort with MediLink Therapeutics. The Phase I study aims to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9033 in subjects with advanced solid tumors. This clinical trial marks a significant step towards bringing a potentially effective treatment option for patients with MSLN-expressing cancers.-Fineline Info & Tech
