An announcement has been made by CSPC Innovation Pharmaceutical Co.,Ltd. (ASX: 300765) regarding its majority-owned subsidiary, CSPC Group Jushi Bio-pharmaceutical Co., Ltd. (Jushi Bio). The subsidiary has recently commenced a Phase III clinical trial for SYS6043.
The trial is designed as a randomized, multi-center, open-label study. It will evaluate SYS6043 against a chemotherapy regimen chosen by the investigator. The study participants will be individuals with platinum-resistant advanced ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
SYS6043 is an antibody-drug conjugate (ADC) product developed by Jushi Bio that targets B7-H3. The antibody component of the drug is engineered to bind specifically to cells expressing B7-H3 on their surface, facilitating internalization into the cell.
The linker-drug component consists of a tetrapeptide linker conjugated to a topoisomerase I inhibitor. This structure is designed to be cleaved by specific proteases, which then releases the small-molecule toxin to destroy tumor cells. The drug also exhibits a bystander effect, allowing it to non-specifically eliminate surrounding tumor tissue cells.
A key feature of SYS6043 is its modified Fc region, which differs from the traditional wild-type Fc. This modification is intended to reduce uptake by lymphocytes, thereby lowering the risk of off-target toxicity and potentially enhancing the overall safety profile of the treatment.
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