China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from Health Canada to initiate a Phase I clinical study. The study will assess the safety, pharmacokinetics, and preliminary efficacy of its in-house developed antibody-drug conjugate (ADC), CPO301, in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC). This development follows the clinical trial approval received in the US in April this year.
Preclinical Success of CPO301
Preclinical studies have demonstrated that CPO301 effectively inhibits the growth of human tumors with various EGFR-activated mutations or wild-type EGFR overexpression models in immunocompromised mice, in a dose-dependent manner. Notably, CPO301 has shown particularly strong antitumor effects in human-derived tissue xenotransplantation (PDX) models of humanized non-small cell lung cancer containing EGFR triple mutations (Exon19Del, T790M, and C797S), which are known to confer resistance to third-generation EGFR tyrosine kinase inhibitor (TKI) osimertinib.
Safety and Tolerability Profile of CPO301
CPO301 has also demonstrated good safety and tolerability in preclinical toxicology and safety pharmacology studies. These promising results have paved the way for the transition from preclinical to clinical studies, with the aim of evaluating the potential therapeutic benefits of CPO301 in treating advanced solid tumors.-Fineline Info & Tech
