CHENGDU, China, June 9, 2022 – Keymed Biosciences (HKEX: 02162) announced today that the first patient has been dosed in the Phase I trial of CM350. CM350 is a GPC3xCD3 bispecific antibody developed by the Company for the treatment of solid tumors. The phase I trial is being conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of CM350 in patients with solid tumors.
Developed on Keymed's proprietary Novel T cell engager (nTCE) bispecific antibody platform, CM350 is the first GPC3xCD3 bispecific antibody to enter clinical development in China and the second in the world. GPC3 expression is rarely found in normal human adult tissues, but highly upregulated in a variety of solid tumors including hepatocellular carcinoma, lung cancer, gastric cancer and esophageal cancer, suggesting that GPC3 is an ideal target for the therapeutics of multiple solid tumors, especially hepatocellular carcinoma.
Preclinical studies have shown that CM350 could effectively kill GPC3-positive tumor cells by T cell-dependent cellular cytotoxicity (TDCC) and exert highly potent antitumor activity in mouse tumor models. Based on the advantages of the nTCE bispecific antibody platform, CM350 is optimized with highly effective tumor cell killing with favorable safety profile by minimizing non-specific effect on normal cells and cytokine release. Therefore, CM350 may provide a promising treatment option for cancer patients with better efficacy and manageable safety.
About nTCE bispecific antibody platform
Novel T cell engager (nTCE) is a CD3 bispecific antibody technology platform developed by Keymed with proprietary rights. Antibodies developed by the nTCE platform can effectively kill tumor cells by TDCC with minimized non-specific effect on normal cells and cytokine release, thereby reducing the occurrence of potential cytokine release syndrome in clinical treatment.
Antibodies developed by our nTCE platform have similar structures to native antibodies with favorite pharmacokinetic profiles. Through the sophisticated protein engineering technology, nTCE platform enables efficient pairing of cognate heavy/light chains of the bispecific antibody with high yield and low aggregation. Using our advanced nTCE platform, Keymed has developed a series of bispecific antibodies currently in the stages of preclinical and clinical development.