On April 20, 2020 Transcenta Holding Limited. ("Transcenta"), a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and manufacturing, reported that its subsidiary Mabspace Biosciences (Suzhou) Co., Limited has received clearance of its IND from FDA for its novel humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (internal project number TST001) (Press release, Transcenta, APR 20, 2020, View Source;301043268.html [SID1234556442]). It is developed jointly by Mabspace Biosciences and HJB, another Transcenta’s subsidiary focusing on CMC and manufacturing.
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The unique expression profile of Claudin 18.2 in normal tissue and its aberrant expression in multiple tumor types make Claudin 18.2 an attractive anti-cancer therapeutic target. TST001 is a humanized high affinity anti-Claudin 18.2 antibody and kills tumor cells via antibody-dependent cellular cytotoxicity (ADCC). Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its ADCC inducing activity against Claudin 18.2 expressing tumors. In preclinical studies, TST001 is efficacious in multiple tumor animal models, and well tolerated in GLP toxicology studies. As of today, TST001 has received clearance from both FDA and China National Medical Products Administration (NMPA) to initiate clinical trials in patients with metastatic solid tumors.
"The FDA’s clearance of our IND is an important milestone for TST001 project transition into clinical-stage. Our team is very excited to have the opportunity to test this differentiated Claudin 18.2 antibody in cancer patients. Our ongoing development of companion diagnostic antibody will help us to identify patients with Claudin 18.2 expression. We hope to expedite the development of this agent to bring potentially more efficacious treatment options to cancer patients around the world," said Dr. Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.