NEW YORK – Biotherapeutics company Transcenta said on Monday that the US Food and Drug Administration has accepted its investigational new drug application for the Claudin 18.2 monoclonal antibody TST001, allowing for the start of clinical trials.
The drug has also received permission from China's National Medical Products Administration to initiate trials for TST001 in patients with Claudin 18.2-expressing metastatic solid tumors.
Claudin 18.2 is expressed abnormally in various tumor types, and TST001 is an anti-Claudin 18.2 antibody that uses antibody-dependent cellular cytotoxicity to kill tumor cells. In preclinical studies, the investigational drug showed activity in animal models and was well-tolerated.
Transcenta CEO Xueming Qian said in a statement that the team is also developing an antibody for use within a companion diagnostic that will identify patients with Claudin 18.2 expression.
Previously, anti-Claudin 18.2 agents have shown some efficacy in gastric cancer patients. Currently, Astellas Pharma is running multiple trials for its anti-Claudin 18.2 antibody zolbetuximab (IMAB362) in Claudin 18.2-positive gastrointestinal cancers.