China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study assessing the safety, pharmacokinetics, and preliminary efficacy of its antibody-drug conjugate (ADC) CPO301 in patients with advanced lung cancer characterized by EGFR gene mutations or EGFR overexpression.
Preclinical Efficacy of CPO301 in Targeting EGFR Mutations
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, showing a dose-dependent response. Notably, CPO301 exhibits strong antitumor effects in human-derived tissue xenotransplantation (PDX) models of non-small cell lung cancer (NSCLC) that contain EGFR triple mutations (Exon19Del, T790M, and C797S), which are known to confer resistance to third-generation EGFR TKIs like osimertinib.
Safety and Tolerability in Preclinical Studies
CPO301 has also demonstrated good safety and tolerability in preclinical toxicology and safety pharmacology studies, reinforcing its potential as a viable treatment option for patients with advanced lung cancer. The initiation of the Phase I clinical study marks a significant step forward in CSPC Pharmaceutical’s commitment to developing innovative therapies for challenging oncological conditions.-Fineline Info & Tech
