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 (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / 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) and pancreatic cancer
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).
Link: A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors
Link: A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 - Claudin18.2 Monoclonal Antibody in the Treatment of Locally Advanced or Metastatic Solid Tumors