Genor Biopharma obtains IND approval from NMPA to commence the phase I/II clinical trial of GB263T, the world's first EGFR/cMET/cMET tri-specific antibody
Shanghai, China, June 6, 2022 - Genor Biopharma (Stock code: 6998.HK) announced today that the company has obtained the IND approval from the National Medical Products Administration (NMPA) on June 2, 2022 for the phase I/II clinical trials of GB263T, a novel EGFR/cMET/cMET trispecific therapeutic antibody.
This clinical trial was accepted by the Center for Drug Evaluation of the National Medical Products Administration (CDE) on March 28, 2022 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 a first-in-human (FIH) clinical trial (NCT05332574) of GB263T in Australia on May 18, 2022.
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.
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.