While all eyes are on various attempts to get a Covid-19 vaccine, behind the scenes there has been progress on new immune therapy for non-surgical treatment of precancerous disease of the cervix called dysplasia and vaccination for HPV disease prevention as well. Reported on the Bloomberg site June 26, 2019 Inovio Pharmaceuticals, announced the completion enrollment VGX-3100, a novel DNA-based immunotherapy vaccine being tested to treat cervical dysplasia caused by human papillomavirus (HPV).
We know that if left undetected and untreated, cervical dysplasia can progress to cervical cancer. If approved, VGX-3100 would be the first immunotherapy and non-surgical alternative for women with late-stage cervical dysplasia. If the vaccine results of the next phase of study are positive they could get an FDA submission as early as 2021.
On the Bloomberg site it was reported that Inovio's Phase 3 program consisting of three injections given at months 0,1 and 3,is assessing the efficacy of VGX-3100 to regress cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and to eliminate the HPV infection that causes these lesions. The REVEAL studies are prospective, randomized,double-blind, placebo-controlled trials evaluating adult women with HPV 16/18 cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3.
Earlier trials worked to eliminate the high grade dysplasia in about half of the women tested. It works by having the patient’s own immune system clear the HPV infection at the route of the problem. Currently there are no known treatments to clear HPV infection.