INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer and HPV-associated diseases, today announced
INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer and HPV-associated diseases, today announced updates on the Phase 3 program for VGX-3100 for HPV-associated cervical high-grade squamous intraepithelial lesions (HSIL), including a one-year follow-up of efficacy and safety data in participants from REVEAL1, completing enrollment in REVEAL2, and advancing its pre-treatment biomarker candidate for VGX-3100 to be further developed with QIAGEN. In addition, INOVIO's development partner within Greater China (mainland China, Hong Kong, Macao, Taiwan), ApolloBio Corp. ("ApolloBio"), dosed the first participant in a separate Phase 3 trial in China.
Key Updates for VGX-3100:
– REVEAL2 – INOVIO's second global Phase 3 clinical trial of VGX-3100 for cervical HSIL is fully enrolled and top-line efficacy and safety data are expected to be available in 2H22.
– REVEAL1 – INOVIO completed the 52-week safety follow-up of participants in REVEAL1, INOVIO's first global Phase 3 trial of VGX-3100, and the safety profile of VGX-3100 observed at Week 36 remained well-tolerated through Week 88. In addition, participants treated with VGX-3100 who met the primary endpoint at Week 36 remained clear of HPV-16 and/or HPV-18 at Week 88.
– Pre-treatment Biomarker – INOVIO and QIAGEN have made progress in biomarker development by identifying candidate biomarker signatures for VGX-3100 with the intent of selecting a final signature in a pre-treatment in vitro diagnostic to improve the primary clinical outcome for biomarker-positive patients with cervical HSIL.
– Phase 3 Trial in China – The first participant has been dosed in the Phase 3 trial of VGX-3100 for cervical HSIL in China. This trial is being run by ApolloBio and is similar in design to REVEAL2. The trial is expected to enroll up to 84 participants.
Dr. J. Joseph Kim, President and CEO of INOVIO, 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."
Dr. Jeffrey Skolnik, Senior Vice President of Clinical Development and Program Lead for VGX-3100, added, "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."
INOVIO's Phase 3 program in cervical HSIL is assessing the efficacy of VGX-3100 to regress cervical HSIL, a direct precursor to cervical cancer, and to eliminate the HPV-16 and/or HPV-18 infection that causes these lesions. The REVEAL studies are prospective, randomized, double-blind, placebo-controlled trials evaluating adult women with HPV-16 and/or HPV-18 positive biopsy-proven cervical HSIL. REVEAL1 provided one-year post-endpoint safety data for a minimum of 198 participants randomized, while REVEAL2 will provide efficacy and one-month safety data for a minimum of 198 participants. For more information on the REVEAL1 and REVEAL2 studies, please visit clinicaltrials.gov (search identifier NCT03185013 and NCT03721978, respectively).
INOVIO completed the 52-week safety follow-up of participants in REVEAL1 and showed that the safety profile of VGX-3100 at Week 36 remained well-tolerated through Week 88. In addition, participants treated with VGX-3100 who met the primary endpoint at Week 36 remained clear of HPV-16 and/or HPV-18 at Week 88. There was no substantial change in the per-protocol assessment of primary efficacy from the mITT analysis that was previously reported for REVEAL1 (link).
Additionally, INOVIO is advancing its partnership with QIAGEN to co-develop a liquid biopsy-based diagnostic product based on next-generation sequencing (NGS) technology to guide clinical decision-making for the use of VGX-3100 in cervical HSIL. This biomarker, if validated, has the potential to increase the probability of clinical response in biomarker-positive women with cervical HSIL. QIAGEN offers an extensive expertise in technologies from polymerase chain reaction (PCR) to NGS for diagnostic development. INOVIO anticipates having additional information on its biomarker development in 2022.
Separately, INOVIO's partner ApolloBio dosed the first participant in the Phase 3 clinical trial of VGX-3100 in China. The Phase 3 trial in China is similar in design to REVEAL1 and REVEAL2 – randomized, double-blinded, placebo-controlled. The trial is expected to enroll 84 participants. In 2018, the companies signed an agreement providing ApolloBio with the exclusive right to develop, manufacture and commercialize VGX-3100 within Greater China (link).
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