HPV Treatment Demonstrates Positive Phase 2 Efficacy When Treating Precancerous Vulvar Dysplasia

A Pennsylvania based biotechnology company 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 percent or more reduction in HPV-16/18-associated vulvar HSIL (high-grade squamous intraepithelial lesion) was observed for 63 percent of trial participants (12 of 19) treated with VGX-3100 at six months post-treatment, stated INOVIO Pharmacuticals, Inc.’s press release issued on January 6, 2021.

Additionally, 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 percent. The trial also showed VGX-3100 to be safe and well-tolerated.

VGX-3100 is designed to utilize the patient's immune system for clearing HPV-16/18-associated high-grade precancerous lesions to reduce the risk of cancer.

Dr. Robert Edwards, M.D., with the University of Pittsburgh and Principal Coordinating Investigator for the Phase 2 clinical trial stated, "These Phase 2 efficacy results are a very promising non-surgical advance for a recalcitrant disease that normally requires repetitive ablation and excision procedures to achieve disease and risk reduction, and may offer a more safe, tolerable and efficacious treatment option for patients."

VGX-3100 Phase 2 Vulvar Dysplasia Trial Highlights included, but are not limited to the following: 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. No cases of vulvar cancer have been observed in the trial.

Click here for more information about the Phase 2 clinical trial.

Based upon these results, INOVIO stated it is planning to pursue Phase 3 development.

Vulvar dysplasia is a rare disease that affects women in immunocompetent and immunocompromised populations. Fewer than 2% of women with HPV-16/18-associated precancerous vulvar dysplasia exhibit spontaneous resolution. HPV-16/18-associated precancerous vulvar lesions (vulvar HSIL) are challenging to treat and typically require repeat ablation and excision procedures to achieve disease and risk reduction. 

Without adequate treatment, vulvar HSIL can progress to vulvar cancer. In 2017, vulvar cancer was diagnosed in 1354 women in the USA, and 411 died from vaginal cancer, says the U.S. CDC.

VGX-3100 is a DNA medicine in clinical trials for treating three HPV-16/18 related disease states – anal dysplasia, vulvar dysplasia, and cervical dysplasia. The cervical dysplasia program is in late Phase 3 clinical trials (REVEAL1 and REVEAL2). 

INOVIO is a biotechnology company based in Plymouth Meeting, PA, focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases.

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