Shanghai, China, October 14, 2022 - Genor Biopharma (Stock code: 6998.HK) announced today that the first patient has been successfully dosed in a Phase I/II clinical trial of GB263T, a novel EGFR/cMET/cMET trispecific therapeutic antibody, in China for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC) and other solid tumors.
Previously, the first patient has been successfully dosed in this GB263T FIH study in Australia.
GB263T is the world's first EGFR/cMET/cMET tri-specific antibody targeting EGFR and two different epitopes of cMET and has been designed with the goal of improving safety and efficacy. Thus, GB263T is a highly differentiated tri-specific antibody that exhibits multiple mechanisms of action to inhibit primary and secondary EGFR mutations and cMET signaling pathway simultaneously. The unique sequential binding feature whereby c-MET VHH2 binding depends on c-MET VHH1 binding expands the safety and efficacy window.
Preclinical studies showed that GB263T potently blocked ligand-induced phosphorylation of EGFR and cMET, and demonstrated better dual inhibition of EGFR and cMET signaling pathways compared to the JNJ-372 analogue. GB263T effectively induced enhanced internalization of EGFR and cMET, and downregulated the expression levels of both EGFR and cMET proteins. The in vivo anti-cancer efficacy of GB263T was demonstrated in several different tumor models, such as those with EGFR exon 20 insertion, EGFR exon 19 deletion, including C797S mutation, and various cMET alteration models. In all the models studied, GB263T demonstrated significant and dose-dependent tumor inhibition. In addition, GB263T did not show any major toxicities in monkeys, even at a high dose given for four weeks in a GLP tox study.