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INOVIO Highlights Key Updates on Phase 3 Program for VGX-3100, its DNA-based Immunotherapy for the Treatment of Cervical HSIL Caused by HPV-16 and/or HPV-18
INOVIO completes enrollment of REVEAL2 Long-term data favorable from REVEAL1 PLYMOUTH MEETING, Pa., Dec. 14, 2021 /PRNewswire/ -- INOVIO (NASDAQ: INO), a
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"INOVIO completes enrollment of REVEAL2\n Long-term data favorable from REVEAL1\n\n\nPLYMOUTH MEETING, Pa., Dec. 14, 2021 /PRNewswire/ -- 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. \nKey Updates for VGX-3100: \n- 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.\nDr. 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-surg...