INOVIO's VGX-3100 Demonstrates Positive Phase 2 Efficacy in Treatment of Precancerous Vulvar Dysplasia Caused by HPV-16/18
January 06, 2021 at 08:00 am EST
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INOVIO announced positive efficacy results for an open-label Phase 2 trial of VGX-3100 to treat HPV-16 and HPV-18-associated vulvar dysplasia. A 25% or more reduction in HPV-16/18-associated vulvar HSIL (high-grade squamous intraepithelial lesion) was observed for 63% of trial participants (12 of 19) treated with VGX-3100 at six months post-treatment. Three out of the 20 participants with histology data (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area. By comparison, the spontaneous resolution of vulvar HSIL caused by HPV-16/18 is estimated to be only 2%. The trial also showed VGX-3100 to be safe and well-tolerated. Based upon these results INOVIO is planning to pursue Phase 3 development. VGX-3100 Phase 2 Vulvar Dysplasia Trial Highlights: Trial participants were 24 women between 22 and 70 years of age at entry and other than having HSIL were healthy; 80% (20/25) had VIN3 disease (the more severe form of VIN) and 88% (22/25) had a history of 1 or more recurrences; There were no discontinuations due to adverse events; five participants elected to withdraw for reasons unrelated to adverse events; 19 participants had digital photography data, and 12 (63%) had clinically significant lesion reduction as defined by a reduction of lesion area of more than 25%; 20 participants had histology and virology data and 3 (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area; Histology was assessed by up to two independent pathologists and non-detectability of HPV-16/18 from lesion tissue using PCR (polymerase chain reaction)-based testing, at six months following the administration of VGX-3100; Efficacy endpoints were measured six months post-treatment; Safety will continue to be assessed for 18 months following the last dose; The most observed adverse event was injection site pain, the majority of which were mild-to-moderate; No cases of vulvar cancer have been observed in the trial.
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.