VGX-3100 is an investigational immunotherapy vaccine that includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18.
VGX-3100 is designed to treat pre-cancers and cancers caused by human papillomavirus (HPV).
VGX-3100 is delivered intramuscularly followed by electroporation with CELLECTRA-5PSP delivery device.
March 26, 2020: Inovio announced positive interim results from an open-label, Phase 2 study showing its lead DNA medicine candidate VGX-3100 to be safe and effective in treating men and women with anal dysplasia, also known as high grade squamous intraepithelial lesion (HSIL), a precancerous condition caused by high-risk human papillomavirus (HPV) types 16/18. Of the 20 subjects who had results at the time of data review, 50% (10 of 20 subjects) showed clearance of HPV-16/18 associated precancerous lesions and 75% (15 of 20 subjects) demonstrated an overall decrease in the number of lesions 6 months after the start of treatment. No cases of anal cancer have been observed in the trial. The results support the ability of VGX-3100 to effectively treat multiple HPV associated diseases.
July 8, 2019: Inovio announced that it has completed enrollment in its Phase 2 trial with VGX-3100 in patients with precancerous lesions of the vulva or vulvar intraepithelial neoplasia (VIN). VGX-3100 is an immunotherapy that targets human papillomavirus (HPV) 16 and 18 and is being studied for the treatment of HPV-related precancerous lesions and the HPV infection that causes these lesions.
June 26, 2019: Inovio has announced the completion of the target enrollment of 198 participants for its pivotal Phase 3 REVEAL 1 registration trial of VGX-3100, a novel DNA-based immunotherapy being tested to treat cervical dysplasia caused by human papillomavirus (HPV).
Clinical Trial NCT03185013: Phase 3 Clinical Trial REVEAL 1 Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL
- REVEAL 1 is designed to provide a one-year safety data for a minimum of 198 patients on VGX-3100.
Clinical Trial NCT03721978: Phase 3 Clinical Trial REVEAL 2 Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL
- A confirmatory Phase 3 trial (REVEAL 2) is currently enrolling and is designed to provide a one-month safety data for a minimum of 198 patients.
- A persistent HPV infection can lead to high-grade squamous intraepithelial lesions (HSIL) in cervical cells. HPV types 16 and 18 cause 70% of cervical cancer cases.
- In the US and EU5 countries, there are approximately 3.4 million incidences of low-grade and high-grade cervical precancers.
- VGX-3100 was the first therapeutic vaccine to demonstrate efficacy against cervical HSIL associated with HPV-16 and HPV-18.
Clinical Trial NCT03180684: Phase 2 Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL
- A persistent infection with HPV can lead to the development of high-grade squamous intraepithelial lesions (HSIL) in vulvar cells.
- Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with vulvar HSIL in an ongoing Phase 2 trial.
- This is a randomized, open-label study of VGX-3100 alone or in combination with imiquimod in patients with HPV-16 and/or HPV-18 related vulvar HSIL.
Clinical Trial NCT03499795: Phase 2 VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High-Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2
- A persistent infection with HPV can lead to the development of high-grade squamous intraepithelial lesions (HSIL) in anal and/or peri-anal cells. These lesions can lead to anal cancer.
- Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with anal HSIL in an ongoing Phase 2 trial.
- This is an open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are HIV negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papillomavirus (HPV)-16 and/or HPV-18.