FDA lifts clinical hold on HPV vaccine trial

In October 2016, the US Food and Drug Administration placed a clinical hold on a proposed Phase III clinical program for VGX-3100, its investigation therapeutic vaccine for cervical dysplasia caused by the human papillomavirus (HPV).

However, yesterday, the FDA lifted that hold, allowing the drug’s maker, Inovio Pharmaceuticals (Nasdaq: INO), to resume its research program, and leading to the company’s shares rocketing 10.8% to $8.19.

Inovio’s Phase III study will assess the efficacy of VGX-3100 in regressing cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions. The pivotal data from this program will support the potential licensure of VGX-3100 as the first immunotherapy for this disease.