On February 27, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported the successful dosing of first patient in China Phase IIa Study of TST001, a Claudin18.2 monoclonal antibody, combined with Cisplatin and Gemcitabine for the first line treatment of systemic treatment-naïve locally advanced or metastatic biliary tract cancer patients (Press release, Transcenta, FEB 27, 2022, View Source [SID1234609084]). Globally Transcenta is the first company exploring the potential of Claudin 18.2 targeting agent in biliary tract cancer.

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Biliary tract cancer is a relatively rare malignancy, which includes cholangiocarcinoma and gallbladder carcinoma. Cholangiocarcinoma is further classified into extrahepatic and intrahepatic cholangiocarcinoma. In the treatment of biliary tract cancer, radical resection is the standard and only approach for patients at the early stage. However, most of the patients cannot receive surgical resection, as the cancer has stepped into the metastatic stage by the time of diagnosis. For biliary tract cancer, few effective therapies are available for these patients, which leaves significant unmet clinical needs.

This Phase IIa clinical trial is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and anti-tumor efficacy of TST001 in patients with systemic treatment-naïve locally advanced or metastatic biliary tract cancer. These patients will be screened using an immunohistochemistry assay developed by Transcenta and validated by central lab that specifically detects Claudin18.2 but not Claudin 18.1.

"Biliary tract cancer has poor prognosis and the combination of Cisplatin and Gemcitabine is the standard of care for first line treatment." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta." Using our proprietary IHC antibody, Transcenta has shown that Claudin18.2 is over-expressed in the tumor of a subset of biliary tract cancer patients. As the combination of Claudin18.2 targeting agent with chemo backbone has shown promising activity in first line gastric cancer, the addition of TST001 to the first line chemotherapy regimen may also provide better treatment benefit to biliary tract cancer patients with Claudin18.2-expressing tumor."

About TST001
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. 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 TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).