The first DNA HPV vaccine officially launched Phase III clinical trials in China

On March 26th, according to a report from Oriental Gaosheng, its subsidiary company Oriental Strategy’s VGX-3100 project has been approved by the Office of Genetics, officially launching the combination of VGX-3100 and the device CELLECTRATM 5PSP in the country for the treatment of HPV-16/18-related high cervical squamous Phase III clinical study of intraepithelial lesions (HSIL).

VGX-3100 is a DNA immunotherapy developed by Inovio.

Inovio's DNA therapy mechanism of action

Once VGX-3100 is approved for marketing, it will be the world's first non-surgical treatment developed for the treatment of HPV-related precancerous lesions (cervical precancerous lesions, anal precancerous lesions, vulvar precancerous lesions, etc.

In January 2018, Orient Strategy and Inovio reached a cooperation, and owns the exclusive development, production and commercialization rights of VGX-3100 in Greater China (Mainland China, Hong Kong, Macau, Taiwan).

VGX-3100 is currently undergoing two key international multi-center phase III clinical trials, including REVEAL 1 and REVEA L2.

The REVEAL 1 study enrolled 201 patients with HPV-16/18-related high-grade cervical squamous intraepithelial lesions.

The safety of VGX-3100 is consistent with the results of early clinical trials.

Inovio will continue to follow up REVEAL1 subjects for safety and durable response rates for 18 months after the last dose.