China-based biopharma Hinova Pharmaceuticals has announced that a clinical trial filing for its androgen receptor (AR) targeted proteolysis-targeting chimeric (PROTAC) drug HP518 in metastatic castration-resistant prostate cancer (mCRPC) has been accepted for review by the US FDA. The study in question is an open-label study assessing the safety, pharmacokinetics, and anti-tumor activity of the drug in mCRPC.
Preclinical Data and Drug Profile
Preclinical studies found that HP518 exhibited high degradation activity against wild-type AR and some AR mutants resistant to enzalutamide. The drug had high AR selectivity and exhibited excellent antiproliferative activity in AR-dependent prostate cancer cell lines. It also demonstrated excellent efficacy in animal models of prostate cancer. There is no similar product approved for marketing anywhere in the world.
Clinical Development and Future Prospects
A Phase I study for HP518, approved in October 2021 in Australia, enrolled the first patient in January 2022. The acceptance of the clinical trial filing by the FDA marks a significant milestone for Hinova Pharmaceuticals in advancing its innovative PROTAC drug HP518. By leveraging its expertise in drug development, Hinova aims to address significant unmet medical needs in the treatment of metastatic castration-resistant prostate cancer, improving patient outcomes and quality of life.-Fineline Info & Tech
