Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, R&D and manufacturing of antibody-based therapeutics, announces today that an investigational new drug (IND) application of its humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (also known as TST001 internally) for the treatment of solid tumors submitted by its Suzhou subsidiary Mabspace Biosciences has been accepted by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China. The IND enabling CMC work was done in its Hangzhou subsidiary HJB. TST001 is the first program developed by Transcenta since merger and it took less than 12 months from the identification of preclinical candidate to IND filing.

TST001 is a humanized mAb targeting CLDN18.2, which is strictly expressed by the differentiated epithelial cells of the gastric mucosa in normal tissues and typically overexpressed in gastroesophageal cancer, pancreatic cancer, and other solid tumors. TST001 mainly kills tumor cells 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.

"We are very glad to be able to file the first IND at the anniversary of our merger. The advantage with an integrated platform is fully reflected in this program. TST001 provides us an important opportunity to target not only first line gastric cancer with Claudin18.2 expression, which are highly prevalent in Asia, but also several other globally prevalent tumor types with CLDN18.2 expression. These tumors, usually neither PDL1 positive nor responsive to checkpoint inhibitors, are an area of significant unmet medical needs. The development of TST001 will be guided by a novel companion diagnostic antibody developed by Transcenta which only binds CLDN18.2 but not CLDN18.1, a closely related isoform expressed in normal lung tissue. The US IND filing will be followed shortly. We look forward to expediting the development of TST001 to bring more effective treatment to a large number of cancer patients," said Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.