Inovio Pharmaceuticals Inc. (NASDAQ: INO) shares posted a solid gain on Thursday after the company announced that it was beginning its late-stage trial of its treatment for cervical dysplasia caused by human papillomavirus (HPV). Specifically, the trial will deal with Inovio’s DNA-based immunotherapy, VGX-3100, and its efficacy in regressing cervical high-grade squamous intraepithelial lesions (HSIL), a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions.
Ultimately, the pivotal data from this program will support the potential licensure of VGX-3100 as the first immunotherapy for this disease. VGX-3100 stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and destroying pre-cancerous cells. There are no treatments available for HPV infection and surgery is the only approved treatment for cervical HSIL.
While surgery is effective at removing dysplastic lesions, it does not treat the underlying HPV infection and carries increased risk of cervical incompetence and preterm birth, which can result in fetal morbidity and mortality.
The primary endpoint for this Phase 3 trial is regression of cervical HSIL and virologic clearance of HPV-16 and/or HPV-18 in the cervix. The studies will evaluate cervical tissue changes at roughly 9 months after beginning a three dose regimen of VGX-3100.
Dr. Mark Bagarazzi, Inovio’s chief medical officer, commented:
Despite the availability of preventive HPV vaccines for over a decade, HPV-related cervical HSIL and cancers remain a widely prevalent problem. Unfortunately, current treatments are invasive and do not address the underlying HPV infection. VGX-3100 has the potential to be a first-in-class HPV-specific immunotherapy offering women the prospect of preventing cervical cancer without undergoing an invasive surgical procedure that may compromise their reproductive health. We are pleased to be able to immediately begin recruiting patients at the first 15 sites by the end of this month.
Shares of Inovio were last seen up 10.5% at $8.17 on Thursday, with a consensus analyst price target of $11.80 and a 52-week range of $5.83 to $11.62.