China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced a strategic agreement with Agilent Technologies to co-develop Claudin18.2 companion diagnostic reagents, marking a significant step in the global development of osemitamab combined with nivolumab plus chemotherapy for first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with CLDN18.2 expression.
The companion diagnostic will support the pivotal Phase III TranStar301 study, highlighting the importance of precision medicine in oncology. Transcenta’s proprietary mouse anti-CLDN18.2 monoclonal antibody, clone 14G11, which specifically binds to CLDN18.2 and not CLDN18.1, is expected to enhance the targeting of osemitamab (TST001), a high-affinity humanized anti-CLDN18.2 mAb with enhanced antibody-dependent cellular cytotoxicity (ADCC). Osemitamab has demonstrated potent anti-tumor activities in tumor xenograft models and is currently in multiple clinical trials in the US and China, having received orphan drug designations (ODDs) from the US FDA for use in G/GEJ adenocarcinoma and pancreatic cancer .
Agilent Technologies is actively developing an immunohistochemical (IHC) reagent, CLDN18.2 IHC 14G11 pharmDx, for the detection of CLDN18.2 protein in G/GEJ adenocarcinoma, which could also be applied to other indications. This collaboration aims to enhance the precision and effectiveness of cancer treatments by identifying patients who are most likely to respond to osemitamab-based therapies.- Flcube.com
