HPV 16 Immunotherapy Study Completes Patient Enrollment

A Pennsylvania pharmaceutical firm announced the DNA-immunotherapy product VGX-3100 had completed its enrollment with 24 patients for a Phase 2 clinical trial.  

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 open-label, multi-center Phase 2 study is designed to evaluate the safety and efficacy of VGX-3100 administered in adult men and women with Anal Dysplasia caused by HPV-16 and/or HPV-18.

This is important news since the current treatment is surgery.

Inovio Pharmaceutical is already evaluating VGX-3100 in two Phase 3 registration trials to treat cervical dysplasia caused by HPV.

Dr. J. Joseph Kim, Inovio's President, and CEO said in a press release, "We are very excited to expand the target indication for VGX-3100 to treat rare and difficult to treat diseases like anal HSIL, which have a high recurrence rate that requires multiple, repeat surgeries.”

“A new immunotherapy that could effectively eliminate or delay surgery could be transformative for patients with this high unmet medical condition.”

“Inovio plans to report preliminary efficacy and safety data from this Phase 2 study in the fourth quarter."

Anal Dysplasia or high-grade squamous intraepithelial lesions (HSIL) is an orphan disease and the precursor to anal cancer.  

Anal Dysplasia is estimated to have more than 20,000 new cases diagnosed and 1,280 anal cancer deaths in the United States in 2019. 

However, that is very likely an underestimate given that no validated screening test exists for the condition and no national registry or reporting exists, said the company.

Currently, the only treatments for anal dysplasia consist of surgical excision, electro-cautery or laser therapy, but up to 50 percent of those treated with these current treatments experience recurrence of the disease within one year of treatment and up to nearly 70 percent within 3 years of treatment.

Therefore, many patients with this condition need multiple treatments. 

Anal HSIL can lead to HPV-associated squamous cell carcinoma of the anus (SCCA).

Anal cancer is uncommon in the general population, but its incidence is increasing considerably– 64 percent higher since 1992. Anal cancer is estimated to have 8,300 new cases diagnosed in the United States in 2019.

And is higher among women than in men overall and higher in HIV-positive men and women than in HIV-negative persons. The risk of SCCA among HIV-positive men has continued to increase even after the introduction of highly active antiretroviral therapy.   

About Inovio Pharmaceuticals, Inc.- is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic DNA technology targeted against cancers and infectious diseases. For more information, visit Inovio.