Chengdu-based biotech Hinova Pharmaceuticals Inc., (SHA: 688302) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, HP568. The Chinese firm plans to test HP568 in patients with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced breast cancer, an indication that was approved for study in China in October this year.
HP568: An Innovative ERα-Targeted PROTAC Drug
HP568 is a novel ERα-targeted PROteolysis TArgeting Chimera (PROTAC) drug, which is composed of a target protein ligand, an E3 ligase ligand, and a linker between the two ligands. Preclinical study results have demonstrated that HP568 exerts its anti-proliferative activity by specifically catalyzing proteasome-dependent rapid degradation of ER α in vitro.
Strong Degradation Activity and In Vivo Efficacy
HP568 has shown strong degradation activity against both wild-type ER α protein and clinically common ER α mutant proteins. In an in vivo mouse model, the drug has been able to dose-dependently inhibit the growth of in situ transplanted tumors in mice, while also exhibiting good safety. This places HP568 as a potentially groundbreaking therapy, as there is no similar product approved anywhere around the world.-Fineline Info & Tech
