Inovio Pharmaceuticals Kicks Off Late-Stage HPV Clinical Trial

By Chris Lange Updated Jan 12, 11:14AM EST · Published Jun 8, 12:25PM EDT

Follow 24/7 Wall St. on Google

This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

Inovio Pharmaceuticals Kicks Off Late-Stage HPV Clinical Trial — © Thinkstock

Inovio Pharmaceuticals Inc. (NASDAQ: INO) shares posted a solid gain on Thursday after the company announced that it was beginning its late-stage trial of its treatment for cervical dysplasia caused by human papillomavirus (HPV). Specifically, the trial will deal with Inovio’s DNA-based immunotherapy, VGX-3100, and its efficacy in regressing cervical high-grade squamous intraepithelial lesions (HSIL), a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions.

Ultimately, the pivotal data from this program will support the potential licensure of VGX-3100 as the first immunotherapy for this disease. VGX-3100 stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and destroying pre-cancerous cells. There are no treatments available for HPV infection and surgery is the only approved treatment for cervical HSIL.

While surgery is effective at removing dysplastic lesions, it does not treat the underlying HPV infection and carries increased risk of cervical incompetence and preterm birth, which can result in fetal morbidity and mortality.

The primary endpoint for this Phase 3 trial is regression of cervical HSIL and virologic clearance of HPV-16 and/or HPV-18 in the cervix. The studies will evaluate cervical tissue changes at roughly 9 months after beginning a three dose regimen of VGX-3100.

[nativounit]

Dr. Mark Bagarazzi, Inovio’s chief medical officer, commented:

Despite the availability of preventive HPV vaccines for over a decade, HPV-related cervical HSIL and cancers remain a widely prevalent problem. Unfortunately, current treatments are invasive and do not address the underlying HPV infection. VGX-3100 has the potential to be a first-in-class HPV-specific immunotherapy offering women the prospect of preventing cervical cancer without undergoing an invasive surgical procedure that may compromise their reproductive health. We are pleased to be able to immediately begin recruiting patients at the first 15 sites by the end of this month.

Shares of Inovio were last seen up 10.5% at $8.17 on Thursday, with a consensus analyst price target of $11.80 and a 52-week range of $5.83 to $11.62.

[wallst_email_signup]

About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.