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Transcenta, Biologics, Antibody, Claudin 18.2

TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

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Transcenta to Present Efficacy Data by CLDN18.2 Expression Level from Phase 1/2 Study of Osemitamab (TST001) plus CAPOX as the First-Line Treatment of Advanced G/GEJ Cancer at 2023 ESMO GI Annual Congress

2023 - 06 - 16

SUZHOU, China, June 16, 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 efficacy data by CLDN18.2 expression level from phase 1/2 study of Osemitamab (TST001) plus Capecitabine and Oxaliplatin (CAPOX) as the first-line treatment of advanced G/GEJ cancer will be presented as a poster at 2023 ESMO World GI.

The data showed that Osemitamab (TST001) has durable anti-tumor activity in all the study population including both high and low to median CLDN18.2-expressing gastric cancer.

The congress, organized by the European Society for Medical Oncology (ESMO), will be held in Barcelona, Spain, from June 28th to July 1st, 2023. As the largest global gathering in the field, ESMO World GI brings together leading gastroenterology, oncology, pathology, and hepatology experts, clinicians, and surgeons, as well as clinical researchers from across the globe to share pioneering research, approaches, and best practices in treating patients with cancers of the gastrointestinal tract.


A brief summary of the presentation is as follows:


Title: Osemitamab plus Capecitabine and Oxaliplatin (CAPOX) as the First-Line Treatment of Advanced G/GEJ Cancer-Updated Efficacy Data per Claudin 18.2 Expression Level from Study TranStar102/TST001-1002-Cohort

First Author & Presenting Author: Prof. Lin Shen, Beijing Cancer Hospital

Abstract Number: PD-7

Poster Discussion Time: Thursday, June 29, 2023 from 09:35 AM - 09:55 AM (CEST)

Poster Presentation Time: June 29, 2023 from 09:30 AM - 10:00 AM and June 29, 2023 from 05:10 PM to 05:40 PM (CEST)


Data presented at the congress will be available to view in the Scientific Publications section of the Transcenta website ( following the ESMO GI Congress.


About Osemitamab (TST001)

Osemitamab (TST001) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC") and complement-dependent cytotoxicity ("CDC") activities and potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) is generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC and CDC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic 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 Business Development 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 HiCB as its core technology in Suzhou Industrial Park. Transcenta is developing 13 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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