Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the initiation and opening of sites to enroll the second portion of the company’s Phase 3 program for VGX-3100, Inovio’s DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus (HPV). The study, named REVEAL 2, is the company’s confirmatory stage Phase 3 clinical study and is designed to evaluate the efficacy and safety of VGX-3100. If approved after completion of the Phase 3 clinical trials, VGX-3100 will stand as the first immunotherapy for women with cervical dysplasia. The company made the announcement in concert with the celebration marking the 2019 International HPV Awareness Day. The annual campaign encourages everyone to take action to learn about HPV, and how to manage the risk of HPV related cancers and precancers. (For more information on HPV Day visit: https://www.askabouthpv.org/)
Dr. J. Joseph Kim, Inovio’s President & CEO, said, “The early initiation of our REVEAL 2, our second Phase 3 study, marks another milestone for our lead product VGX-3100. I am confident in our team’s experience and expertise to advance the REVEAL program forward to deliver on our goal to file a BLA for VGX-3100 in 2021. And most importantly, we remember that patients are waiting and our efforts are bringing an innovative, impactful therapy to people where surgery is their only option.
Dr. Kim added, “Inovio is also investigating VGX-3100 in Phase 2 clinical trials for treating anal and vulvar dysplasia with interim results expected later this year.”
Inovio’s Phase 3 program 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 (2:1), double-blind, placebo-controlled trials evaluating adult women with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3.
The primary endpoint 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 approximately 9 months after beginning a three dose regimen of VGX-3100 administered at months 0, 1, and 3. Secondary endpoints include safety; tolerability; regression of CIN 2/3 to CIN 1 or normal; virologic clearance of HPV; efficacy measured by non-progression to cancer; and clearance of HPV from non-cervical anatomic locations. For more information on these studies, please visit clinicaltrials.gov (search identifier NCT03185013 and NCT03721978 for REVEAL 1 and REVEAL 2, respectively).
Inovio previously reported that VGX-3100 eliminated high grade dysplasia in almost 50% of women in its Phase 2b randomized, placebo-controlled trial. In 80% of the women whose high grade dysplasia was eliminated, the HPV infection was also cleared by VGX-3100. Further data analysis revealed that the combination of HPV detection and cervical cytology (Pap smear) following dosing was predictive for both elimination of the high grade dysplasia and clearance of HPV.
In addition to advancing its HPV program trial enrollment, Inovio continues to pursue research into biomarkers with the intent of attaining the ability to predict clinical response to VGX-3100 that may ultimately aid in patient selection and physician guidance of patient care. These pre-treatment biomarkers could identify patients most likely to respond to treatment with VGX-3100, increasing absolute efficacy of the product.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.