Inovio Pharmaceuticals, Inc. INO announced that it has completed enrollment in the pivotal phase III study, REVEAL 1, which is currently evaluating VGX-3100 for the treatment of cervical dysplasia caused by human papillomavirus (HPV). The study successfully achieved the recruitment target of 198 subjects. Its investigation of the indication holds immense significance as the same can progress to cervical cancer when left untreated.
VGX-3100, an HPV immunotherapy, is the most advanced candidate in Inovio’s pipeline. If approved, it will be the first immunotherapy and a non-surgical treatment option for women with late-stage cervical dysplasia.
Shares of Inovio rallied 19.8% following this news on Wednesday. However, the stock has dropped 24.5% so far this year versus the industry’s increase of 3.9%.
The phase III study is evaluating the efficacy of VGX-3100 to regress cervical HSIL (high-grade squamous intraepithelial lesions) and eradicate the HPV infection that causes these lesions. The primary endpoint of the study is regression of cervical HSIL and virologic clearance of HPV 16 and/or HPV 18 in the cervix.
Notably, this March, Inovio started enrolling patients in the confirmatory REVEAL 2 study. The program is designed to assess the cervical tissue changes at nine months after being treated with three dose regimens of VGX-3100 at months zero, one and three each.
Based on data from the REVEAL 2 analysis, Inovio plans to submit a regulatory filing, seeking an approval for VGX-3100 in 2021. Two more phase II probes are examining the efficacy of VGX-3100 on patients with vulvar dysplasia and anal dysplasia.
We would like to remind investors that last August, Inovio entered into a partnership agreement with the AIDS Malignancy Consortium to evaluate VGX-3100 for treating HPV-associated precancerous conditions in patients, who have tested positive for HIV.
Moreover, last month, Inovio formed a companion diagnostic partnership with the Dutch pharmaceutical company, Qiagen N.V. QGEN. This collaboration is aimed at creating a liquid biopsy companion diagnostic test to guide the selection of patients, who would benefit from Inovio’s VGX-3100.