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Inovio Completes Enrollment of its VGX-3100 Open-label Phase 2 Trial for Treatment of HPV-Related High-Grade Anal Dysplasia
PLYMOUTH MEETING, Pa., Aug. 19, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that it has completed enrollment in the
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":" PLYMOUTH MEETING, Pa., Aug. 19, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today that it has completed enrollment in the company's open-label, 24 patient, Phase 2 trial with its lead immunotherapy product VGX-3100 in patients with precancerous lesions of the anus, i.e. anal high-grade squamous intraepithelial lesions (anal HSIL, aka anal intraepithelial neoplasia). VGX-3100 is an immunotherapy that targets human papillomavirus (HPV) 16 and 18 and is being studied for the treatment of HPV-related precancerous lesions and the HPV infection that causes these lesions. Inovio is already evaluating VGX-3100 in two Phase 3 registration trials to treat cervical dysplasia caused by HPV, for which the company has previously announced the completion of enrollment for the first of those pivotal trials, REVEAL 1.\nThis open-label, multi-center Phase 2 study is designed to evaluate the safety and efficacy of VGX-3100 administered Inovio's CELLECTRA® delivery system in adult men and women with anal HSIL caused by HPV-16 and/or HPV-18 and builds on significant clinical benefits demonstrated with Inovio's HPV immunotherapies in multiple clinical trials. VGX-3100 in a Phase 2 proof-of-concept trial for cervical dysplasia demonstrated a complete response in 43 out of 107 patients in regression of high grade cervical lesions and elimination of the underlying HPV infection. Additional 2 out of 4 metastatic head and neck cancer patients treated with MEDI0457 and a PD-1 check point inhibitors in a Phase 1 study experienced a long-term complete response for more two years and counting. The other 18 out 22 head and neck patients treated with MEDI0457 have not progressed for over 4 years post-treatment. Lastly, a pilot study of Inovio's immunotherapy in recurrent respiratory papillomatosis (RRP) resulted in 2 out of 2 patients delaying surgery due to lack of tumor recurrence.\nDr. J. Joseph Kim, Inovio's President and CEO, said, \"We are very excited to expand the target indication for VGX-3100 to treat rare and difficult to treat diseases like anal HSIL, which have a high recurrence rate that requires multiple, repeat surgeries. A new immunotherapy that could effectively eliminate or delay surgery could be transformative for patients with this high unmet medical condition, Inovio plans to report preliminary efficacy and s...