The board of directors of Transcenta Holding Limited announced that the Company has presented progression free survival data by CLDN18.2 expression level from Phase I/II study of Osemitamab (TST001) plus Capecitabine and Oxaliplatin (CAPOX) as the first-line treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer at ESMO World Congress on Gastrointestinal Cancer 2023. These data will support the upcoming global Phase III pivotal trial to be initiated in the second half of 2023. Title.

Osemitamab plus CAPOX as the first-line treatment for patients with advanced G/GEJ cancer was explored in a dose escalation and expansion Phase I/II study in China (Cohort C of TranStar102, NCT04495296). In the expansion phase (except 8 patients from a safety run-in), CLDN18.2 positive was required, which is defined as IHC membrane staining =10% tumor cells with =1+ intensity per LDT assay, selecting approximately 55% of the screened patients. Osemitamab (TST001) is a high affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity.

It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab is generated using the Company's Immune Tolerance Breaking Technology (IMTB) platform.

Osemitamab(TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab(TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab. Clinical trials for Osemitamab (tST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296).

Osemitamab (tST001) were granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal intersection (G/GEJ) and pancreatic cancer.