Inovio Pharmaceuticals Inc (INO)

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The first DNA HPV vaccine officially launched Phase III clinical trials in China
October 30, 2021 01:02 HKT

Today, according to a report by Dongfang Gaosheng, the VGX-3100 project of its subsidiary Dongfang Lue has been approved by the Genetics Office, and the combination of VGX-3100 and the device CELLECTRATM 5PSP in the treatment of HPV-16/18-related cervical high-grade squamous intraepithelial lesions has been officially launched in China (HSIL) Phase III clinical study.

VGX-3100 is a DNA immunotherapy developed by Inovio. It is the world's first therapeutic vaccine for human papillomavirus (HPV)-related precancerous lesions. This DNA vaccine is developed by Inovio's SynCon platform, which uses specially designed computer algorithms to identify and optimize the DNA sequence of the target antigen (virus or tumor), and then generate an optimized DNA plasmid. Then the optimized DNA plasmid is directly delivered to the cells of muscle or skin through its proprietary smart device CELLECTRA. The CELLECTRA device uses a short electrical pulse to reversibly open small holes in the cell membrane, allowing plasmids to enter . Once in the cell, the DNA plasmid can induce the cell to naturally produce the target antigen, and the antigen can trigger the required T cell and antibody-mediated immune response, so that the body can obtain specific immune protection.

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.), and also the world's first DNA drugs. Globally, these three indications currently have no treatment other than surgery, and drug treatment is temporarily blank.

In January 2018, Oriental Strategy and Inovio reached a cooperation, which has the exclusive development, production and commercialization rights of VGX-3100 in Greater China (Mainland China, Hong Kong, Macau, Taiwan). The indications include cervical, vulvar and anal precancerous Treatment and prevention of precancerous lesions caused by HPV infection.

VGX-3100 is currently undergoing two international multi-center pivotal phase III clinical trials, including REVEAL 1 and REVEA L2. On March 1 this year, INOVIO announced that the REVEAL 1 study has reached the primary and secondary clinical endpoints. This study is the first DNA therapy to achieve clinical endpoints.

The REVEAL 1 study enrolled 201 patients with HPV-16/18-related high-grade cervical squamous intraepithelial lesions. The results of the study showed that among the 193 patients with evaluable efficacy, 23.7% (31/131) of the patients in the treatment group reached the common primary endpoint of achieving HSIL lesion histological outcome and HPV16/18 virus clearance, while the placebo group was 11.3% (7/62), a statistically significant difference (p=0.022; 95%CI: 0.4, 22.5). The study also reached all secondary endpoints.

The safety of VGX-3100 is consistent with the results of early clinical trials. There are no treatment-related adverse events. Most of the adverse reactions are mild to moderate, and patients can alleviate spontaneously.

Inovio will continue to follow up REVEAL1 subjects for safety and durable response rates for 18 months after the last dose. At the same time, the REVEAL2 study has also started enrolling subjects.
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