On May 8, 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 two posters for clinical trials of its ADCC enhanced anti-CLDN18.2 monoclonal antibody Osemitamab (TST001) in combination with CAPOX or CAPOX plus Nivolumab for first-line G/GEJ cancer will be presented at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting (Press release, Transcenta, MAY 8, 2023, View Source [SID1234631191]).
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The first poster is an update of the clinical results (TranStar102) for the combination of Osemitamab (TST001) with CAPOX in first-line G/GEJ cancer patients with CLDN18.2 expression (membranous staining ≥1+ intensity in ≥10% of tumor cells) as assessed centrally using IHC 14G11 LDT assay: long term endpoints such as progression free survival ("PFS") and duration of response ("DOR") will be presented. The second one is a trial in progress (TranStar101), including the chemotherapy-free combination of Osemitamab (TST001) and Nivolumab, and the triple combination of Osemitamab (TST001), Nivolumab and mFOLFOX6 in G/GEJ caner. This year’s meeting will take place both online and in-person from June 2, 2023 to June 6, 2023, in Chicago, Illinois, USA.
The ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community.
A brief summary of the presentations is as follows:
Abstract#: 4046
Poster Bd#: 367
Title: Osemitamab (TST001) in Combination with Capecitabine and Oxaliplatin (CAPOX) as a First-line Treatment of Advanced G/GEJ Cancer: Updated Data of Cohort C from a Phase I/IIa, Multi-center Study (TranStar102/TST001-1002)
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Monday June 5, 2023 8:00 AM – 11:00 AM (EDT)
First Author: Prof. Lin Shen, Beijing Cancer Hospital
Abstract#: TPS4176
Poster Bd#: 494b
Title: A Multi-cohort Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Osemitamab (TST001) Administered as a Monotherapy, with Nivolumab or Standard of Care in Patients with Locally Advanced or Metastatic Solid Tumors (TransStar101/TST001-1001)
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Monday June 5, 2023 9:00 AM – 12:00 PM (EDT)
First Author: Dr. Yelena Janjigian, Memorial Sloan Kettering Cancer Center
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). Multiple 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.