By Fineline Cube China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced the first patient dosing in a Phase I/II clinical study for its pipeline candidate GB263T in advanced non-small cell lung cancer (NSCLC) and other solid tumors in China. The drug was first administered in a first-in-human trial in Australia in May this year. This marks a significant step forward in the development of innovative treatments for advanced solid tumors.
GB263T: Mechanism and Pre-Clinical Results
GB263T is a potential global first-in-class EGFR/cMET/cMET tri-specific antibody. Pre-clinical studies have shown that, compared with JNJ-372 analogues, GB263T effectively blocked ligand-induced phosphorylation of EGFR and c-Met, demonstrating improved dual inhibition of the EGFR and cMET signaling pathways. The in vivo anticancer efficacy of GB263T has been confirmed in several different tumor models, including EGFR exon 20 insertion, EGFR exon 19 deletion (including c797s mutation), and various abnormal cMET expressions. In all models studied, the drug showed significant dose-dependent tumor inhibition.
Safety Profile
In the GLP toxicological study, GB263T was administered at a high dose for four weeks, with no significant toxic or side effects observed in cynomolgus monkeys. This suggests a favorable safety profile for the drug, which is crucial for its further clinical development.
Future Outlook
The initiation of the Phase I/II clinical study for GB263T underscores Genor Biopharma’s commitment to advancing innovative cancer therapies. By targeting the EGFR and cMET pathways, GB263T aims to provide new treatment options for patients with advanced non-small cell lung cancer and other solid tumors.-Fineline Info & Tech