TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Press Release

Transcenta Announces First Patient Dosed in Phase IIa Study of Claudin18.2 Monoclonal Antibody TST001 Combined with Cisplatin and Gemcitabine for the First Line Treatment of Biliary Tract Cancer

28 Feb, 2022

SUZHOU, China, Feb. 28, 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, announces 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. Globally Transcenta is the first company exploring the potential of Claudin 18.2 targeting agent in biliary tract cancer.

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).

About Transcenta Holding Limited

Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing.

Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Beijing, Shanghai and Guangzhou in China and in Princeton, US, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.

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Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta's competitive environment and political, economic, legal and social conditions.

Transcenta, the Directors and the employees of Transcenta assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.


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