Transcenta, a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and manufacturing, today announced that its subsidiary Mabspace Biosciences (Suzhou) Co., Limited has received the clearance from the National Medical Products Administration (NMPA) to initiate Phase I clinical trials in China for its Claudin 18.2 (CLDN18.2) humanized monoclonal antibody, TST001. TST001 was developed jointly by scientists from Mabspace and HJB, Transcenta’s subsidiary focusing on CMC and manufacturing.

As a humanized monoclonal antibody against CLDN18.2, TST001 kills tumor cells mainly by antibody-dependent cellular cytotoxicity (ADCC). TST001 displayed significantly higher binding affinity to CLDN18.2 relative to a competitor molecule, lower fucose content, binds to a different binding epitope, which resulted in over 100-fold improved ADCC activity in tumor cells with varying CLDN18.2 expression, especially in CLDN18.2 low expressing tumors. TST001 can be applied to not only first line gastric cancer with Claudin18.2 expression, which are highly prevalent in Asia, but also several other globally prevalent tumor types expressing CLDN18.2. CLDN18.2 is strictly expressed by the differentiated epithelial cells of the gastric mucosa in normal tissues and aberrantly overexpressed in gastroesophageal cancer, pancreatic cancer and other solid tumors.

“We thank CDE for their effort in completing the review on time during this special time. We are very excited to have the opportunity to evaluate the safety and efficacy of TST001 in cancer patients whose tumor express high levels of Claudin 18.2, in particular the majority of gastric cancer patients who can only use chemotherapy, a tumor type highly prevalent in China. We will focus our resources to expedite the development of this program to bring cost effective anti-cancer therapeutics to cancer patients around the world”, said Dr. Xueming Qian, Co-Founder and Chief Executive Officer of Transcenta.