China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a Phase Ib/II clinical study in China for its SHR-A1811 combined with SHR-1701 in patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). This approval marks a significant step forward in the development of innovative treatments for these challenging cancers.
SHR-A1811: HER2-Targeted Antibody Drug Conjugate (ADC)
SHR-A1811 is an HER2-targeted antibody drug conjugate (ADC) designed to bind to the target antigen on the tumor surface and release small-molecule toxins to kill tumor cells through endocytosis. The product is currently undergoing multiple Phase I-III clinical trials, covering a range of HER2-expressed or mutant solid tumors. Similar commercially available products outside China include Kadcyla (trastuzumab emtansine) and Enhertu (trastuzumab deruxtecan).
SHR-1701: Dual-Target Fusion Protein
SHR-1701 is a fusion protein targeting both programmed-death ligand (PD-L1) and TGF-βRII. It is designed to promote the activation of effector T cells, improve immune regulation in the tumor microenvironment, and enhance the immune system’s ability to kill tumor cells. The drug is currently undergoing multiple clinical studies in solid tumors in China and a Phase I study in Australia. Notably, there are no similar products currently marketed anywhere in the world.
Future Outlook
The initiation of the Phase Ib/II clinical study for the SHR-A1811 and SHR-1701 combination underscores Hengrui Medicine’s commitment to advancing innovative cancer therapies. This trial aims to explore the potential synergistic effects of combining an HER2-targeted ADC with a dual-target fusion protein, offering new hope for patients with HER2-positive gastric cancer and gastroesophageal junction adenocarcinoma.-Fineline Info & Tech
