Corning Jerry Pharmaceutical-B (09966) announced that JSKN016 (a human epidermal growth factor independently developed by the company...
According to the Zhitong Finance App, Corning Jerry Pharmaceutical-B (09966) announced that JSKN016 (a human epidermal growth factor receptor 3 (HER3) and human trophic cell surface glycoprotein antigen 2 (TROP2) bispecific antibody conjugate drug (ADC) independently developed by the company) successfully completed the first patient administration in China. This clinical trial is an open-label, multicenter, first-ever human trial, dose escalation, and dose expansion phase I clinical trial. This clinical trial aims to evaluate the safety, tolerability, antitumor activity, pharmacokinetics (PK), and immunogenicity of JSKN016 in patients with advanced solid tumors, and to determine the maximum tolerable dose (MTD) and/or phase II recommended dose (RP2D) of JSKN016 in patients with advanced malignant solid tumors. This clinical trial plan is to recruit a total of about 80 to 140 patients.
According to reports, JSKN016 is a self-developed bispecific ADC that can simultaneously target HER3 and TROP2 on tumor cells. JSKN016 is designed based on the company's unique sugar fixed-point coupling platform. After JSKN016 binds to TROP2 or HER3 on the tumor cell surface, it enters the lysosome through target-mediated endocytosis, releasing a cytotoxic topoisomerase I inhibitor (TOP1i), which in turn induces tumor cell death. Furthermore, the inhibitor can penetrate cell membranes and exert a bystander effect into antigen-negative tumor cells. The combined effect of the two can effectively inhibit the growth of tumor cells. On March 18, 2024, China's State Drug Administration approved JSKN016's Phase I clinical trial application for the treatment of advanced malignant solid tumors.