Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VGX 3100 · 1 trial · 1 indication
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less at the 36 week visit.
| Arm | Type | Description |
|---|---|---|
| VGX 3100 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VGX 3100 | BIOLOGICAL | 1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12. |
| Placebo | BIOLOGICAL | 1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12. |
| CELLECTRA™-5P | DEVICE | CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12. |
Inclusion Criteria: * Female subjects age 18-55 years; * Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with no evidence of invasive cancer in any specimen; * Colposcopy is satisfactory based on visualization...
VGX 3100 is an investigational immunotherapy being developed for the treatment of cervical dysplasia, cervical intraepithelial neoplasia, and high grade squamous intraepithelial lesions (HSIL) caused by human papillomavirus (HPV). It is also being studied for vulvar HSIL and anal neoplasms related to HPV-16 and HPV-18.
VGX 3100 is a DNA vaccine that targets HPV-16 and HPV-18, the two high-risk strains responsible for most cervical and anal cancers. It is designed to generate an immune response against these viral proteins, potentially clearing the infection and preventing progression to cancer.
VGX 3100 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INO. Inovio specializes in DNA-based immunotherapies and vaccines.
VGX 3100 has completed Phase 2 and Phase 3 clinical trials. It is not FDA approved and remains an investigational drug. The most advanced trials, REVEAL 1 and REVEAL 2, were Phase 3 studies evaluating the drug for the treatment of cervical HSIL.
VGX 3100 has been studied in several completed trials, including NCT01304524 (Phase 2 for cervical intraepithelial neoplasia), NCT03185013 (REVEAL 1, Phase 3 for cervical HSIL), NCT03499795 (Phase 2 for anal HSIL), and NCT03721978 (REVEAL 2, Phase 3 for cervical HSIL).
Yes, VGX 3100 and VGX-3100 refer to the same investigational drug. The hyphenated version is used in clinical trial registrations and scientific literature, while the non-hyphenated form is commonly used in company communications.