Transcenta

Transcenta Holding Limited is a global clinical-stage biopharmaceutical company with fully integrated capabilities in the discovery, research, development, and manufacturing of antibody-based therapeutics. Its lead product candidate is Osemitamab (TST001), a high-affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC). Osemitamab has shown potent anti-tumor activities in preclinical tumor xenograft models and is the second most advanced CLDN18.2 targeting antibody being developed globally.

Osemitamab was generated using Transcenta's proprietary Immune Tolerance Breaking Technology (IMTB) platform. It kills CLDN18.2 expressing tumor cells through ADCC mechanisms. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab was significantly reduced during production, further enhancing its ADCC activity mediated by NK cells. Osemitamab is being investigated as a potential treatment for various solid tumors, including gastric/gastroesophageal junction (G/GEJ) cancer, pancreatic cancer, and biliary tract cancer.

In a Phase I/IIa study (TranStar102), Osemitamab in combination with CAPOX chemotherapy demonstrated encouraging efficacy as a first-line treatment for advanced G/GEJ cancer. Among patients with CLDN18.2 expression, the confirmed overall response rate was 55%, with a median duration of response of 12.7 months and an estimated median progression-free survival of 14 months as of October 2023. preclinical data also supported the synergistic anti-tumor activity of Osemitamab combined with nivolumab and chemotherapy, including in PD-L1 negative tumors.

Transcenta has received clearance from regulatory authorities in the US, China, and South Korea to initiate a global Phase III pivotal trial (TranStar301) evaluating Osemitamab in combination with nivolumab and chemotherapy as a first-line treatment for patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic G/GEJ adenocarcinoma.

The company is operating as a publicly listed company, and is traded on the Hong Kong Stock Exchange under the ticker symbol 6628.