ON January 17, 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, reported 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) (Press release, Transcenta, JAN 17, 2023, View Source [SID1234626309]).
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The 2023 ASCO (Free ASCO Whitepaper) 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.