![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Friday, October 29, 2021 2:43:36 PM
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.
https://inf-news.translate.goog/science/7efffc00133461570d149c793b68bb15.html?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=nui
Recent INO News
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/13/2024 10:22:02 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 10:06:54 AM
- INOVIO Reports Second Quarter 2024 Financial Results and Recent Business Highlights • PR Newswire (US) • 08/08/2024 08:05:00 PM
- INOVIO Reports Inducement Grant Under Inducement Plan • PR Newswire (US) • 08/01/2024 08:05:00 PM
- Inovio Receives Advanced Therapy Medicinal Product Certificate from European Medicines Agency for Quality and Non-Clinical Data for Lead Candidate INO-3107 • PR Newswire (US) • 07/25/2024 08:05:00 PM
- INOVIO to Report Second Quarter 2024 Financial Results on August 8, 2024 • PR Newswire (US) • 07/25/2024 12:00:00 PM
- INO-3107 Awarded the Innovation Passport Designation Under U.K. Government's Innovative Licensing and Access Pathway • PR Newswire (US) • 07/11/2024 12:00:00 PM
- INOVIO Announces Appointment of Steven Egge as Chief Commercial Officer • PR Newswire (US) • 07/02/2024 08:05:00 PM
- INOVIO Reports Inducement Grant Under Inducement Plan • PR Newswire (US) • 07/01/2024 08:00:00 PM
- INOVIO Added to Russell 2000® Index Effective July 1, 2024 • PR Newswire (US) • 07/01/2024 12:00:00 PM
- INOVIO to Participate in Virtual Fireside Chat Hosted by Stephens Inc. • PR Newswire (US) • 06/04/2024 12:00:00 PM
- INOVIO Reports Inducement Grants Under Inducement Plan • PR Newswire (US) • 05/31/2024 08:48:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/28/2024 08:01:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:50:34 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:50:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:49:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:13:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:12:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:11:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:10:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:08:13 PM
ELEMENT79 ANNOUNCES UPLISTING TO OTCQB VENTURE MARKET • ELMGF • Aug 26, 2024 10:03 AM
North Bay Resources Announces Gold Assays up to 2.2 Ounces per Ton, Fran Gold Project, British Columbia • NBRI • Aug 26, 2024 10:00 AM
PickleJar Unveils Latest Venue Managed Services Innovations in Upcoming Webinar • PKLE • Aug 23, 2024 1:11 PM
Element79 Gold Corp Provides Update on Nevada Portfolio • ELMGF • Aug 23, 2024 8:00 AM
Maybacks Adds Award Winning Show to Its Lineup Discusses Maybacks Opportunity • AHRO • Aug 22, 2024 11:30 AM
North Bay Resources Announces First Gold Concentrate at Mt. Vernon Gold Mine, Assays 12 oz/ton Gold, 17.5 oz/ton Platinum, and 8 oz./ton Silver, Sierra County, California • NBRI • Aug 22, 2024 10:28 AM