On July 1, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that the first subject has been dosed successfully in the US Phase I clinical trial of TST001, a humanized Claudin18.2 (CLDN18.2) monoclonal antibody developed by Transcenta’s subsidiary Mabspace Biosciences (Suzhou) Co., Ltd (Press release, Transcenta, JUL 1, 2020, View Source [SID1234561633]).

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NCT04396821 is a Phase I clinical study conducted in the US to evaluate TST001 in the treatment of patients with advanced or metastatic solid tumors. The primary objectives of the study are to evaluate TST001’s safety, tolerability and recommended dose for Phase II study.

CLDN18.2, found widely expressed in gastric cancer patients, has been regarded as one of the most promising therapeutic target for gastric cancer. It is a tight junction protein with expression strictly confined to differentiated epithelial cells of the normal gastric mucosa, and its overexpression in many tumors makes it an attractive anti-cancer therapeutic target.

"Anti-cancer therapeutics is one of the key parts of Transcenta’s pipeline. As the first project entered clinical trial since merger, TST001 has shown encouraging anti-cancer activities in pre-clinical studies. Soon we’ll initiate its clinical study in China. We will continue to leverage the advantages of our fully integrated capabilities to accelerate the clinical evaluation of TST001, either as monotherapy or in combination with other drugs, bringing potentially more efficacious treatment options to cancer patients around the world," said Dr. Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.

About TST001

TST001, developed by Transcenta’s subsidiary Mabspace Biosciences (Suzhou) Co., Ltd., is a high affinity humanized monoclonal antibody targeting CLDN18.2 positive tumors 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 tumors. In preclinical pharmacodynamics studies, TST001 shows better anti-cancer activity than similar molecules.