FDA Grants Fast Track Designation to HP518 for AR+ TNBC

[God_Loves_Me]

The FDA has granted fast track designation to HP518 as a potential therapeutic option for patients with androgen receptor (AR)–positive triple-negative breast cancer (TNBC).1

HP518 is a potent AR PROTAC degrader designed to degrade wild-type AR and AR ligand-binding domain mutations such as L702H. In preclinical studies using AR-positive TNBC animal models, the agent showed antitumor activity, including significant tumor reduction, and favorable safety.

“We are thrilled to receive fast track designation from the FDA for HP518,” Yuanwei Chen, PhD, chief executive officer of Hinova Pharmaceuticals, stated in a news release. "This designation underscores the significant need for new treatment options for patients with TNBC and highlights the potential of our investigational therapy to make a meaningful impact on this devastating disease. The discovery of HP518’s novel mechanism of action provides new hope for effective treatment. We look forward to working closely with the FDA to advance HP518 through the clinical development process as efficiently as possible.”

Source : onclive.com/view/fda-grants...