Osemitamab (TST001)

Osemitamab (TST001) is the second most advanced Claudin18.2 targeting antibody therapeutic candidate being developed globally. It is generated by using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform.

Osemitamab (TST001) has high affinity, and enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

Since August 2020, clinical trials for Osemitamab (TST001) are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

Claudin18.2 is a transmembrane protein highly expressed in multiple solid tumor cells. In normal tissues, the expression of Claudin18.2 is restricted to the differentiated epithelial cells of the stomach. The high tissue specificity and tumor specificity makes Claudin18.2 an extremely promising target for next-generation targeted therapy.

Osemitamab (TST001) kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). 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 (TST001).

♦ Osemitamab (TST001) Has Promising Anti-tumor Activities and BIC/FIC Potentials

1）One Confirmed PR Achieved in Dose Escalation Studyin Late Line GC Patient at 6mg/kg

2）Confirmed PR in Pre-treated Pancreatic Cancer Patient with Medium-low CLDN18.2 Expression

Transcenta owns the global rights of Osemitamab (TST001) and has filed multiple patent applications for therapeutic and diagnostic antibodies targeting Claudin18.2 .

1）Clinical Development Collaboration

Global clinical collaboration with BMS to evaluate Osemitamab (TST001) in combination with Opdivo for 1L GC/GEJ cancer.

2）Academic Collaboration

Several translational studies with Peking University Cancer Hospital, Dana-Farber Cancer Institute, and Shanghai Zhongshan Hospital.