China – based biopharma Transcenta Holding Ltd (HKG: 6628) has announced that it has received clinical trial approval in China for TST003, its potential first – in – class monoclonal antibody (mAb) targeting Gremlin1. The drug candidate has already received IND clearance from the US FDA in September this year, highlighting its global development potential.
About TST003 and Gremlin1
TST003 is designed to target Gremlin1, a member of the TGF – β superfamily that promotes epithelial – mesenchymal transition and has been found to be highly upregulated in multiple solid tumor types. Transcenta published research in Nature Cancer in May 2022, demonstrating TST003’s potential for treating androgen receptor – negative/low prostate cancer. The drug has shown strong preclinical data, particularly in castration – resistant prostate cancer.
Clinical Promise and Future Development
TST003 has demonstrated promise in tumor models of multiple difficult – to – treat solid tumors, including castration – resistant prostate cancer and microsatellite – stable colorectal cancer. The drug has shown efficacy both as a single agent and in combination with checkpoint inhibitors. This dual – action potential positions TST003 as a promising candidate for addressing significant unmet medical needs in oncology.-Fineline Info & Tech
