Inovio: VGX-3100 Showed Positive Phase 2 Efficacy In Treatment Of Precancerous Anal Dysplasia

(RTTNews) - Biotechnology company Inovio Pharmaceuticals Inc. (INO) said Wednesday that positive Phase 2 efficacy results showed that VGX-3100, the company's lead immunotherapy asset, showed resolution of HPV-16/18-associated precancerous anal lesions or HSIL in 50 percent, or 11 of the 22 subjects, six months following the start of treatment.

The open label, single arm trial also showed VGX-3100 to be safe and well-tolerated in treating men and women with HPV-16-/18-associated anal dysplasia, the company noted.

Anal dysplasia is a rare disease that affects men and women in both immunocompetent and immunocompromised populations.

Less than 1 in 5 people with HPV-16- or HPV-18-associated precancerous dysplasia exhibit spontaneous resolution at one year. Without adequate treatment, anal dysplasia can progress to anal cancer.

Inovio said it plans to pursue a registrational Phase 3 clinical trial for HPV-16-/18-associated anal dysplasia, and also apply for rare and orphan disease designation for this indication in 2021.

Inovio also has an ongoing partnership with the AIDS Malignancy Consortium or AMC to evaluate VGX-3100 in HIV-positive adult men and women.

This ongoing open-label, multi-center Phase 2 study is designed to evaluate the safety and efficacy of VGX-3100 administered by intramuscular injection with Cellectra delivery system in adult men and women who are HIV-positive with anal HSIL associated with HPV-16 and/or HPV-18.