SUZHOU, China, Jan. 18, 2023, 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 it will present the design of 2 cohorts from a Phase I/IIa study of TST001, its high affinity humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, in combination with Nivolumab plus Capecitabine and Oxaliplatin as first-line or with Nivolumab as late-line treatment in locally advanced and metastatic gastric/gastroesophageal junction (G/GEJ) cancer (TranStar102/TST001-1002). 

The 2023 ASCO GI Cancers Symposium has a strong focus on the latest innovative science, solution-focused strategies and multidisciplinary approaches in GI cancer research and development, treatment and care. 

Details of the poster are as follows:

Title: TST001 (a High Affinity Humanized Anti-Claudin18.2 Monoclonal Antibody) in Combination with Nivolumab plus Capecitabine and Oxaliplatin as First-line or with Nivolumab as Late-line Treatment in Locally Advanced and Metastatic Gastric/Gastroesophageal Junction (G/GEJ) Cancer: Design of Cohorts from a Phase I/IIa Study (TranStar102/TST001-1002)

Abstract Number: TPS476

Session Title: Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

First Author: Professor Weijian Guo, Fudan University Shanghai Cancer Center

Presentation Time: Thursday, January 19, 2023,  12:00 PM - 1:30 PM（PST）

Presenter: Professor Weijian Guo, Fudan University Shanghai Cancer Center

“We are committed to developing our best-in-class CLDN18.2 antibody, Osemitamab to the best of its potential. There is a strong scientific rationale to combine it with the standard of care nivolumab and chemotherapy, including in PD-L1 CPS less than 5.” said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

About TST001 (Osemitamab)

TST001 (Osemitamab) 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 (Osemitamab) is the second most advanced Claudin18.2 targeting antibody being developed globally. TST001 (Osemitamab) is generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. TST001 (Osemitamab) kills Claudin18.2 expressing tumor cells by mechanisms of ADCC and CDC. Leveraging advanced bioprocessing technology, the fucose content of TST001 (Osemitamab) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001 (Osemitamab). Clinical trials for TST001 (Osemitamab) are ongoing in the U.S. and China (NCT04396821, NCT04495296/CTR20201281). TST001 (Osemitamab) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) cancer.

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 Princeton, US and in Beijing, Shanghai and Guangzhou of China, 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.

For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.

CONTACT: Public Relations: pr@transcenta.com, Investor Relations: ir@transcenta.com, Business Development: bd@transcenta.com