Shanghai, China I September 30, 2021 I Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for a Phase I/IIa, open-label, single-arm study for a Claudin 18.2 antibody-drug conjugate (ADC). This study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of this ADC in patients with Claudin 18.2-positive advanced solid tumors in the U.S. and Australia.
About the Novel Claudin 18.2 ADC
This novel ADC with an optimized drug-antibody ratio (DAR), consisting of an anti-Claudin 18.2 antibody attached to a lipophilicity-enhanced topoisomerase I inhibitor payload via a cleavable linker, is being developed by Hengrui. This molecular design enhances plasma stability and bystander effect with balanced safety. This ADC demonstrated a favorable efficacy, safety, and PK profile based on the data from preclinical studies.
About Claudin 18.2
Claudins are tetraspan transmembrane tight-junction proteins that regulate epithelial barriers.1 Claudin 18.2 has a restricted expression profile in normal tissues. It physiologically expresses in the tight junction supramolecular complex of gastric mucosa.2 However, prior studies demonstrate that frequent ectopic activation of Claudin 18.2 can be found in a diversity of malignant entities such as gastric, pancreatic, esophageal, ovarian, and lung tumors, which makes Claudin 18.2 a pan-cancer target.3
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.
1. Barbara Schlingmann, et al. Regulation of claudin/zonula occludens-1 complexes by hetero-claudin interactions. Nat. Commun., 2016, 7, 12276.
2. Bo Xu, et al. Highly expressed Claudin18.2 as a potential therapeutic target in advanced gastric signet-ring cell carcinoma (SRCC). J. Gastrointest. Oncol., 2020, 11, 1431.
3. Prabhsimranjot Singh, et al. Anti-claudin 18.2 antibody as new targeted therapy for advanced gastric cancer. J. Hematol. Oncol., 2017, 10, 105.
SOURCE: Jiangsu Hengrui Pharamceuticals
Post Views: 18
Shanghai, China I September 30, 2021 I Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for a Phase I/IIa, open-label, single-arm study for a Claudin 18.2 antibody-drug conjugate (ADC). This study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of this ADC in patients with Claudin 18.2-positive advanced solid tumors in the U.S. and Australia.
About the Novel Claudin 18.2 ADC
This novel ADC with an optimized drug-antibody ratio (DAR), consisting of an anti-Claudin 18.2 antibody attached to a lipophilicity-enhanced topoisomerase I inhibitor payload via a cleavable linker, is being developed by Hengrui. This molecular design enhances plasma stability and bystander effect with balanced safety. This ADC demonstrated a favorable efficacy, safety, and PK profile based on the data from preclinical studies.
About Claudin 18.2
Claudins are tetraspan transmembrane tight-junction proteins that regulate epithelial barriers.1 Claudin 18.2 has a restricted expression profile in normal tissues. It physiologically expresses in the tight junction supramolecular complex of gastric mucosa.2 However, prior studies demonstrate that frequent ectopic activation of Claudin 18.2 can be found in a diversity of malignant entities such as gastric, pancreatic, esophageal, ovarian, and lung tumors, which makes Claudin 18.2 a pan-cancer target.3
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.
1. Barbara Schlingmann, et al. Regulation of claudin/zonula occludens-1 complexes by hetero-claudin interactions. Nat. Commun., 2016, 7, 12276.
2. Bo Xu, et al. Highly expressed Claudin18.2 as a potential therapeutic target in advanced gastric signet-ring cell carcinoma (SRCC). J. Gastrointest. Oncol., 2020, 11, 1431.
3. Prabhsimranjot Singh, et al. Anti-claudin 18.2 antibody as new targeted therapy for advanced gastric cancer. J. Hematol. Oncol., 2017, 10, 105.
SOURCE: Jiangsu Hengrui Pharamceuticals
Post Views: 18
