On October 13, 2022 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 two scientific posters at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting in Boston, MA, November 8-12, 2022 (Press release, Transcenta, OCT 13, 2022, View Source [SID1234622011]): one related to Claudin18.2 and PD-L1 expression in gastric/gastro-esophageal adenocarcinoma, relevant for TST001 (Osemitamab) clinical development and the other on TST005 (PD-L1/TGF-β bifunctional antibody) trial in progress.
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Details of the poster presentations are as follows:
Title: Prevalence of Claudin18.2 and PD-L1 Expression in Chinese Gastric/Gastroesophageal Junction Adenocarcinoma
Abstract#: 105
Date & Time: Nov. 10, 2022, 9 a.m.–9 p.m. (EST)
Presenter: Dr. Caroline Germa, MD
First Author: Linlin Mao, PhD
Title: A phase 1, first in human, open-label, dose escalation and dose expansion study of TST005 in patients with locally advanced or metastatic solid tumors
Abstract#: 771
Date & Time: Nov. 10, 2022, 9 a.m.–9 p.m. (EST)
First Author: Anthony Tolcher, MD
Full text of the abstracts will be released on the SITC (Free SITC Whitepaper) website at 8:00 a.m. EST, November 7, 2022, and the posters will be available on Transcenta’s website (View Source) on November 12, 2022.
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 TST005
TST005 is the second bi-functional anti-PD-L1 and TGF-β trap fusion protein entering the global clinical stage. It simultaneously targets two immuno-suppressive pathways, transforming growth factor -β (TGF-β) and programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. TST005 consists of a high affinity PD-L1 antibody fused with an engineered TGF-β Receptor Type II protein in its C-terminal. TST005 lacks FcR binding activity and thus has reduced FcR mediated killing of PD-L1 expressing effector T cells. TST005’s high PD-L1 binding activity and enhanced TGF-β trap stability enables the targeted delivery of TGF-β trap into PD-L1 expressing tumors, thereby minimizing off-target toxicities of systemic inhibition of TGF-β signaling. TST005 displayed potent activity in vitro in reversing TGF-β induced T-cell suppression. In multiple syngeneic tumor models, TST005 induced significant increase of CD8+ T-cell infiltration into PD-L1 expressing tumors and displayed dose-dependent tumor growth inhibition in tumor model not sensitive to PD-(L)1 treatment due to high level TGF-β. TST005 is well tolerated in non-human primates and displayed a linear PK profile. TST005 is a potentially differentiated bi-functional immunotherapy candidate with improved therapeutic window. TST005 is being investigated in a FIH trial in the US and China (NCT04958434/CTR20221397).