Transcenta Holding Limited, a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announced that the first subject has been dosed successfully on August 28 in China phase I clinical trial of TST001, a humanized Claudin18.2 (CLDN18.2) monoclonal antibody developed by Transcenta's subsidiary Mabspace Biosciences (Suzhou) Co., Ltd. Transcenta conducts clinical trials of TST001 simultaneously in both China and the US, and the first subject has been dosed in the US on June 29, 2020.
NCT04495296 is a phase I clinical study conducted in China to evaluate the safety, tolerability, Pharmacokinetics, initial clinical activity and recommended dose for phase 2 study of TST001 in Chinese patients with unresectable or metastatic solid tumours.
"CLDN18.2 is found to be overexpressed in many tumours including gastric cancer, which makes it a promising anti-cancer therapeutic target. Currently, there is no approved anti-CLDN18.2 targeted therapeutics globally," said Professor Lin Shen, the lead investigator from Beijing Cancer Hospital, "We have dosed the first subject in China successfully, and we look forward to having a positive result, and we hope TST001 can be an effective and safe agent to benefit more gastric cancer patients."
"We have made significant progress on TST001 since the beginning of this year. Within the last 6 months, we have obtained IND clearance and dosed first patient in US and in China, and we hope to initiate phase Ib for TST001 next year," said Dr XuemingQian, Transcenta's co-founder and chief executive officer.
TST001, developed by Transcenta's subsidiary Mabspace Biosciences (Suzhou) Co., Ltd., is a high affinity humanized monoclonal antibody targeting CLDN18.2 positive tumours by mechanisms such as complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC) through combining CLDN18.2 with high affinity. Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its activity against CLDN18.2-expressing tumours. In preclinical pharmacodynamics studies, TST001 shows better anti-cancer activity than similar molecules.