INOVIO Updates on Phase 3 Program for VGX-3100 for HPV-Associated Cervical High-Grade Squamous Intraepithelial Lesions
December 14, 2021 at 08:00 am EST
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INOVIO 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 the company completed the 52-week safety follow-up of participants in REVEAL1, company'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.
Inovio Pharmaceuticals, Inc. is a clinical-stage biotechnology company. The Company is focused on developing and commercializing deoxyribonucleic acid (DNA) medicines to help treat and protect people from diseases associated with human papillomavirus (HPV), cancer, and infectious diseases. Its DNA medicines pipeline include INO-3107 for HPV-related recurrent respiratory papillomatosis (RRP); INO-3112 for the treatment of HPV-related Oropharyngeal Squamous Cell Carcinoma, or OPSCC; VGX-3100 for the treatment of Anal or Perianal HSIL; INO-5401 for the treatment of Glioblastoma Multiforme (GBM), and INO-5401 for the Treatment of Glioblastoma Multiforme (GBM). Its lead candidate is INO-3107 for the treatment of RRP, a rare and debilitating disease of the respiratory tract caused by HPV infection. Its DNA medicines platform consists of DNA plasmids and its CELLECTRA devices, which are used to deliver the DNA plasmids into the cell. Its CELLECTRA device portfolio consists of two models.