INOVIO (NASDAQ: INO) has announced updates on the third phase program for VGX—3100 for HPV-associated cervical high grade squamous intraepithelial lesions, that include a one-year follow up of safety and efficacy findings in subjects from REVEAL1, finalizing REVEAL2 enrolment, and advancing the pre-treatment biomarker candidate for VGX-3100 for further development with QIAGEN. Additionally, the company’s development partner in Greater China, ApolloBio Corp, does the first subject in a separated Phase 3 study in China.
INOVIO is making progress in developing HPV immunotherapies
CEO and President of the company J. Joseph Kim, said, “We are making strong progress in developing INOVIO’s immunotherapies treating HPV-associated cervical HSIL. Left untreated, cervical HSIL may progress to cancer. VGX-3100 has the potential to be the first approved immunotherapy and non-surgical alternative for women with cervical HSIL and we look forward to advancing our efforts from our Phase 3 studies through commercialization.”
“Completing enrollment for REVEAL2, and reporting on our long-term data from REVEAL1, are important milestones for VGX-3100 and an opportunity to advance women’s health, given the lack of a non-surgical therapeutic for cervical HSIL. With our two Phase 3 studies now fully enrolled, INOVIO remains on target for the topline efficacy readout from this study in the second half of 2022,” Commented SVP Clinical Development and Program Lead for VGX-3100.
Third phase program evaluating the efficacy of VGX-3100
The company’s third phase program in cervical HSIL evaluates VGX-3100’s efficacy to regress cervical HSIL, which is a direct cervical cancer precursor, and do away with HPV-16 and HPV 18 infections that cause the lesions. The REVEAL trials are double-blind, randomized, prospective, placebo-controlled studies assessing adult women with HPV-18 and HPV-16 positive cervical HSIL. Notably, REVEAL 1 offered one-year post-endpoint safety data for at least 198 subjects, and REVEAL 2 provided one-month safety and efficacy data for around 198 participants.
INOVIO is also working with QIAGEN to co-develop a liquid biopsy-based diagnostic test based on next-generation sequencing (NGS) technology to aid clinical decision-making for VGX-3100 usage in cervical HSIL.
