Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first subject dosing in a Phase I clinical trial for HLX42, an antibody-drug conjugate (ADC) co-developed with Suzhou-based Medilink Therapeutics. The study will initially evaluate HLX42 in patients with advanced or metastatic solid tumors in China.
HLX42 is an innovative ADC targeting the epidermal growth factor receptor (EGFR). This candidate is conjugated with highly specific humanized IgG1 EGFR antibody molecules, cleavable novel ligands, and a unique DNA topoisomerase I (TOPO I) small molecule payload. Upon intravenous infusion, the linker toxin of HLX42 is designed to be selectively cleaved and released within the tumor microenvironment, exhibiting a robust bystander killing effect. This distinct mechanism of action provides HLX42 with a broader therapeutic window compared to similar ADCs, potentially enhancing its efficacy in treating solid tumors.
The development of HLX42 has progressed rapidly; it received approval for Phase I trials in advanced/metastatic solid tumors in both China and the US last October and November. Furthermore, in December, HLX42 was granted fast-track designation by the US FDA for treating advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations in patients who have experienced progression after third-generation EGFR tyrosine kinase inhibitor (TKI) therapy.- Flcube.com
