VGX-3100 Cancer Immunotherapy Ready to Launch HPV Phase 2 Study

A Pennsylvania biotechnology company announced the VGX-3100 vaccine Phase 2 clinical trial has completed enrollment of 33 patients with precancerous lesions of the vulva or vulvar intraepithelial neoplasia (VIN).   

Inovio Pharmaceuticals’s 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. 

This study is important since there are no FDA-approved non-surgical treatments for precancerous lesions of the vulva. 

VIN has a very low rate of spontaneous, or natural, regression − below 5 percent, said Inovio in a press release. 

Surgery, the most common treatment, is associated with high rates of disease recurrence and can cause disfigurement, long-term pain, and psychological distress for the women who undergo the procedure.   

VIN recurs in approximately one of every two patients who undergo surgical treatment.

Approximately 27,000 cases of HPV-related vulvar pre-cancers occur in the U.S. each year with a similar number of estimated cases in Europe each year.   

The primary endpoint of the phase 2 study is a histologic clearance of high-grade lesions and virologic clearance of the HPV virus in vulvar tissue samples. The study will also evaluate the safety and tolerability of VGX-3100.

The company intends to report interim clinical data from this study before year's end. 

Dr. Prakash Bhuyan, M.D., Ph.D., VP, Clinical Development and the lead for the VGX-3100 Program, said, "Inovio is developing VGX-3100 to be the first, comprehensive non-surgical treatment option for HPV-related precancer.  Surgical treatment of VIN is often disfiguring, and recurrence occurs in approximately one-third of women.” 

Inovio is already evaluating VGX-3100 in two Phase 3 registration trials, REVEAL 1 and REVEAL 2, to treat cervical dysplasia caused by HPV. 

In a previously conducted Phase 2b randomized, placebo-controlled study of 167 women with HPV-associated cervical pre-cancer, VGX-3100 led to a significantly higher rate of lesion regression and clearance of the underlying HPV viral infection.

HPV vaccine news

• HPV Vaccine Now Recommended For ‘GenX’
• REVEAL 1 Cervical Cancer Study Ready to Launch

The Centers for Disease Control and Prevention (CDC) says HPV is a common virus that can lead to certain types of cancer later in life. 

Additionally, the CDC recommends HPV vaccination begins at ages 11-12 to protect against cervical, vaginal, vulvar, and anal cancers and genital warts caused by HPV viruses.

The Gardasil 9 vaccine is the only HPV vaccine approved in the USA. Gardasil 9 may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. 

Inovio is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic nucleic technology targeted against cancers and infectious diseases.