Transcenta doses first patient in advanced solid tumor drug trial

Transcenta Holding Limited, a biotherapeutics firm based in Shanghai that focuses on discovering, developing and commercializing antibody-based therapeutics, has recently revealed dosing its first candidate in the US Phase I clinical study of TST001, a novel humanized Claudin18.2 (CLDN18.2) monoclonal antibody created by Mabspace Biosciences, a unit of Transcenta.

According to reliable sources, the Phase I clinical trial in the US focuses on evaluating the effects of TST001 in patients suffering from metastatic or advanced solid tumors. The primary goal of this study is to determine TST001's tolerability and safety while assessing the recommended dose for the Phase II trial.

CLDN18.2 is considered as one of the most promising therapeutic targets for gastric cancer. Evidently, its overexpression in multiple tumors positions it as an attractive target for anti-cancer therapeutic.

Speaking on the trial, Dr. Xueming Qian, Chief Executive Officer and Co-Founder, Transcenta, said that anti-cancer therapeutics act as one of the vital parts of the company's pipeline. With this being the first project to enter into the clinical study since the merger, TST001 has managed to record positive anti-cancer activities in pre-clinical trials.

Transcenta is planning to commence its clinical trial in China as well. The company would continue to utilize the benefits of its fully integrated abilities to fast-track TST001’s clinical evaluation, either in combination with other therapeutics or as monotherapy, added Dr. Qian.

Prior to this news, Transcenta had made headlines when it had announced that it had attained clearance from the FDA for the CLDN18.2 monoclonal antibody. As per Dr. Qian, gaining the FDA approval of its IND comes as a crucial milestone for the TST001 project, helping it to transition into clinical-stage. Transcenta‘s team is thrilled to receive the opportunity to evaluate Claudin 18.2 antibody in cancer patients.

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