Transcenta, Agilent To Develop CLDN18.2 Companion Diagnostic To Support Osemitamab Phase III Trial

(RTTNews) - Transcenta Holding Limited and Agilent Technologies, said that they have collaborated to develop a Claudin18.2 (CLDN18.2) companion diagnostic to support TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal adenocarcinoma.

Transcenta has developed a mouse anti-CLDN18.2 monoclonal antibody, clone 14G11 which specifically binds to CLDN18.2 but not CLDN18.1. This antibody, generated against a linear epitope located on the extracellular domain of loop 1, has a binding site that overlaps with the binding site of therapeutic antibody Osemitamab (TST001).

Agilent is developing Claudin18.2 IHC 14G11 pharmDx, an immunohistochemistry (IHC) assay for the detection of CLDN18.2 protein in gastric and gastroesophageal junction (GEJ) adenocarcinoma with the potential for other indications. Agilent and Transcenta presented the early results of the Claudin18.2 IHC 14G11 pharmDx assay at AACR Annual Meeting. Claudin18.2 IHC 14G11 pharmDx for Investigational Use Only/for Performance Evaluation Only will be used for patient selection in the phase III trial of gastric/GEJ adenocarcinoma where applicable ethics committee and regulatory approvals have been granted.