Transcenta and Agilent Collaborate on CLDN18.2 Diagnostic for Osemitamab Phase III Trial

Transcenta, a biopharmaceutical firm specializing in antibody-based therapeutics, has entered into a partnership with Agilent Technologies, a leader in companion diagnostic (CDx) development, to create a diagnostic tool for Osemitamab (TST001). Osemitamab is a monoclonal antibody designed to target Claudin18.2 (CLDN18.2), a protein overexpressed in certain gastric and gastroesophageal junction adenocarcinomas. The collaboration aims to support the global Phase III clinical trial of Osemitamab in combination with Nivolumab and chemotherapy for patients with advanced forms of these cancers.
The diagnostic tool under development is an immunohistochemistry (IHC) assay known as Claudin18.2 IHC 14G11 pharmDx, which will detect the presence of CLDN18.2 protein in tumor samples. This will aid in identifying patients who are most likely to benefit from Osemitamab treatment. The assay's early results were showcased at the AACR Annual Meeting, and it is intended for patient selection in the Phase III trial once ethical and regulatory approvals are secured.
Transcenta's contribution to the project includes a mouse monoclonal antibody, clone 14G11, which binds specifically to CLDN18.2, sharing a binding site with Osemitamab. This antibody was developed using Transcenta's proprietary Immune Tolerance Breaking Technology (IMTB) platform and has demonstrated significant anti-tumor activity in preclinical models. The production process for Osemitamab has been optimized to reduce fucose content, enhancing its antibody-dependent cellular cytotoxicity (ADCC) against tumor cells expressing CLDN18.2.
Dr. Caroline Germa, Transcenta's Executive Vice President and Chief Medical Officer, praised Agilent's expertise in CDx development and expressed enthusiasm for the potential impact on patient health outcomes. Dr. Paul Beresford, VP/GM of CDx at Agilent, echoed the sentiment, highlighting the importance of precision medicine in improving diagnostics and treatments for adenocarcinoma patients.
Osemitamab is currently undergoing clinical trials in the U.S. and China, with several trial identifiers provided for reference. It has also received Orphan Drug Designation from the FDA for the treatment of gastric or gastroesophageal junction and pancreatic cancers.
Transcenta, listed on the Hong Kong Stock Exchange (HKEX: 06628), operates globally with a strong presence in Suzhou, Hangzhou, Princeton, Beijing, Shanghai, Guangzhou, Boston, and Los Angeles. The company is advancing a pipeline of 13 therapeutic antibody molecules for oncology and other diseases, such as bone and kidney disorders.