Shanghai, China, May 18, 2022 - Genor Biopharma (Stock code: 6998.HK) announced today that the first patient has been successfully dosed in a first-in-human (FIH) clinical trial of GB263T, a novel EGFR/cMET/cMET trispecific therapeutic antibody.
The GB263T clinical trial (NCT05332574) for the treatment of advanced Non-Small Cell Lung Cancer (NSCLC) and other solid tumors was formally submitted to Bellberry HREC Australia on December 20, 2021, and was approved by the Australian Ethics Committee on March 28, 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.
Benefiting from the powerful strength and fast-moving execution ability of Genor Biopharma’s CMC, the process technology development, toxicology study & clinical study drug manufacturing and clinical trial application of GB263T were completed within only twelve months and in compliance with international standards. This was much faster than the industry average. Moreover, the excellent process performance and product quality were ensured with a high expression level of 5-6g/L and high purity of 99.5%.
Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, Genor Biopharma said: “We are pleased to see the rapid advancement of this highly innovative and differentiated clinical candidate. It is testimony to Genor Biopharma’s cross-functional team capabilities and close collaboration with globally renowned KOLs. We expect to see excellent potential of GB263T in combination with 3rd generation EGFR TKIs as a first line treatment in patients with EGFR mutated locally advanced or metastatic NSCLC”
The China IND application of GB263T was officially accepted by the NMPA on March 28, 2022.