TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

Transcenta, Biologics, Antibody, Claudin 18.2

TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

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Transcenta to Present Two Phase I Clinical Trials of TST001 at Upcoming ASCO GI and IGCC

2022 - 01 - 12

SUZHOU, China, Jan. 12, 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 that the TST001 US Phase I Trial has been selected as a Trial in Progress poster presentation at the 2022 ASCO GI conference from January 20 to 22,2022 in San Francisco, CA; and the TST001 China Phase I trial data as a poster presentation at the International Gastric Cancer Congress (IGCC), from March 6 to 9, 2022 in Houston, TX.


Poster Presentations


Abstract Title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Locally Advanced or Metastatic Solid Tumors

Abstract Number: TPS375

First Author: Nashat Y. Gabrail, MD



Abstract Title: A Phase I Study of TST001 (anti-Claudin18.2 monoclonal antibody) in Patients with Solid Tumors

Abstract Number: IGCC22-ABS-1152

Michael Shi, Ning Li, Jifang Gong, Weijian Guo, Jian Zhang, Nong Xu, Miao Zhang, Changsong Qi, Zhenzhong Xia, Yu Shen, Jianming Wang, Li Xu, Chuan Qi, Xueming Qian, Lin Shen

First Author: Michael Shi, MD., Ph.D.


TST001 is a high affinity humanized antibody developed by Transcenta. TST001 displayed potent ADCC activity in vitro against Claudin18.2 expressing tumor cells and anti-tumor activities in the tumor models with medium to high level of Claudin18.2 expression. Two phase I trials have been ongoing in both US and China since April 2020.

TST001 has completed dose escalation part of the China study and is currently being tested as monotherapy in a phase Ib/IIa trial in Claudin18.2 expressing patients of multiple tumor types including GC/GEJ, Pancreatic Cancer as well as several other tumor types. In addition, TST001 is also being tested in combination with chemotherapy or PD-1 in both first line and prior treated gastric /gastric esophageal junction cancer patients. The IGCC poster will present the data of the TST001 dose-escalation part from this ongoing trial.

The US study is completing the dose escalation part and will be expanded in Claudin18.2 expressing cancer patients, where TST001 will be used both as monotherapy in several cancer types and in combination with PD-1 inhibitor in gastric cancer. The ASCO GI poster TPS375 will present the design of the US trial as Trial in Progress.  

“The biological characteristics of Claudin18.2 suggest it is an ideal therapeutic target for cancer drug development.” said by Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta,“Data from patients treated with the current doses of either TST001 alone or in combination with chemotherapy supports that TST001 is safe. The U.S. Food and Drug Administration (FDA) also granted Orphan Drug Designation to TST001 previously, for the treatment of patients with gastric cancer or gastroesophageal junction. We also expect that the study of TST001 in combination with chemotherapy and/or PD-1 could offer new and more effective treatment options for gastric cancer patients.”


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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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.

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