{"id":7820,"date":"2024-03-15T22:46:55","date_gmt":"2024-03-15T14:46:55","guid":{"rendered":"https:\/\/flcube.com\/?p=7820"},"modified":"2024-10-18T22:49:42","modified_gmt":"2024-10-18T14:49:42","slug":"shanghai-henlius-initiates-phase-i-trial-for-hlx42-an-innovative-adc-targeting-egfr","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=7820","title":{"rendered":"Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR"},"content":{"rendered":"\n

Shanghai Henlius Biotech Inc. (HKG: 2696<\/a>) 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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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<\/a><\/p>\n\n\n\n

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Shanghai Henlius Biotech Inc. 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