China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the National Medical Products Administration (NMPA) has accepted a Phase I clinical trial filing for its investigational drug FZ-AD005 in advanced solid tumors. This marks a significant step forward in the development of novel cancer therapies in China.
FZ-AD005: Mechanism and Development
FZ-AD005 is an antibody drug conjugate (ADC) developed on Fudan-Zhangjiang’s proprietary Linker-Drug platform. The ADC is composed of a recombinant human mouse chimeric antibody (DLL3) monoclonal antibody and a topoisomerase inhibitor (TOPOi) BB05. This innovative combination allows FZ-AD005 to bind and internalize DLL3 positive tumor cells, releasing the TOPOi payload through protease cleavage in lysosomes, effectively killing tumor cells.
Clinical Development and Future Prospects
The acceptance of the Phase I clinical trial filing by the NMPA paves the way for Fudan-Zhangjiang to advance FZ-AD005 through the clinical development process. This ADC has the potential to offer a new treatment option for patients with advanced solid tumors, particularly those with DLL3 positive cancer cells.-Fineline Info & Tech
