SUZHOU, China, May 2, 2023 /PRNewswire/ -- 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,
Transtar-102 (NCT04495296) is an ongoing Phase I/II, open-label, multi-cohort, multi-center clinical study in China to evaluate the safety, tolerability and efficacy of Osemitamab (TST001) as single agent or in combination in several different indications. Cohort G evaluates Osemitamab (TST001) at the dose of 3 or 6 mg/kg Q3W in combination with Nivolumab plus CAPOX in 1L non-resectable locally advanced or metastatic G/GEJ adenocarcinoma with various level of CLDN18.2 expression: a total of 82 patients have been enrolled. Preliminary data show the absence of unexpected safety findings; efficacy is immature. Full results from this cohort will be reported in future medical conferences.
Cohort C evaluates Osemitamab (TST001) in combination with CAPOX as 1L treatment of non-resectable locally advanced and metastatic G/GEJ cancer. Enrollment was completed by the end of 2022 and updated efficacy data including duration of response and median progression free survival will be presented in upcoming medical conferences.
These cohorts support the upcoming global Phase III pivotal trial to be initiated in the second half of 2023.
"The completion of enrollment of these cohorts marks an important milestone for Transcenta. These clinical data lay the foundation of our Phase III and comply with dose optimization requirements from Health Authorities. They also provide important information related to the predictive role of CLDN18.2 expression on Osemitamab (TST001) associated outcomes, particularly in the medium and low expressors. We look forward to releasing these data in the very near future." said Dr. Caroline Germa, Transcenta's Executive Vice President, Global Medicine Development and Chief Medical Officer.
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.
For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.
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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