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Inovio Receives European Medicines Agency Certification For Quality and Non-Clinical Data for Its Phase 3 Product, VGX-3100
PLYMOUTH MEETING, Pennsylvania, May 6, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that its lead Phase 3 product
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"PLYMOUTH MEETING, Pennsylvania, May 6, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that its lead Phase 3 product candidate, VGX-3100, has been granted an Advanced Therapy Medicinal Product Certificate for quality and non-clinical data. The procedure of certification of quality and non-clinical data involves an assessment of the available data in view of future registration and the related European Scientific Data Requirements, not including any clinical data or benefit-risk assessment. The granted EMA's certificate confirms that Inovio's chemistry, manufacturing and controls (CMC) data and nonclinical results available to date overall comply with the scientific and technical standards for evaluating an EU Marketing Authorization.\nDr. Ami Shah Brown, Inovio's Senior Vice President of Regulatory Affairs, said, \"We are extremely pleased that the current CMC, coupled with the nonclinical data supporting our lead product, VGX-3100, meets stringent EMA requirements. This certification is a testament to Inovio's technical excellence, cross-functional development expertise, and high quality standards as applied for VGX-3100 and indirectly for Inovio's technology.\"\nVGX-3100 is currently being tested in a pivotal, global Phase 3 program, which is assessing the efficacy of VGX-3100 to regress cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and to eliminate the HPV infection that causes these lesions. In parallel, the final commercial manufacturing process will be validated yielding additional quality data by time of the EU filing.\nAbout VGX-3100\nVGX-3100 is a DNA-based immunotherapy under investigation for the treatment of HPV 16 and HPV 18 infection and precancerous lesions of the cervix (Phase 3) and vulva and anus (Phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of precancerous cells. In a randomized, double-blind, placebo-controlled Phase 2b study in 167 adult women with histologically documented HPV 16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significa...