MD Anderson Launches Phase 2 HPV Vaccine Study

Inovio Pharmaceuticals announced the first patient dosing in a Phase 2 combination study targeting a broad array of cancers associated with the human papillomavirus (HPV), which is a group of more than 200 related viruses. 

This open-label study is sponsored by Dr. Michael Frumovitz, MD, MPH, of the MD Anderson Cancer Center in Houston, Texas,  where the trial will be conducted as part of MD Anderson’s “Moon Shot” cancer initiative.   

Dr. Frumovitz said in a press release, “This is the first Phase 2 clinical trial at MD Anderson that is focused not on the site of disease origin, but instead on the cause of a cancer, in this case, exposure to HPV 16 or 18.” 

HPV types 16 and 18, are responsible for most HPV-caused cancers, says Cancer.gov. 

“This study will be “site agnostic”, meaning any patient with an HPV 16/18 associated cancer, regardless of primary site, will be eligible.” 

“Another truly unique aspect of this study is a separate cohort for patients who are HIV positive with an HPV 16/18 associated cancer,” said Dr. Frumovitz.  

This clinical trial of 77 people is evaluating MEDI0457 in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with HPV-associated cervical, anal, penile, and vulvar cancers. 

A recent article highlights a recent Phase 1 study of MEDI0457 as a monotherapy in 22 HPV-positive patients with HPV-associated head and neck cancer that demonstrated MEDI0457 generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue. 

MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which MedImmune in-licensed from Inovio) is under evaluation by MedImmune to treat HPV-associated cancers. 

Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (Phase 3) and vulva (Phase 2) and anal (Phase 2). 

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease. 

VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes the destruction of pre-cancerous cells. 

In a randomized, double-blind, placebo-controlled Phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. 

Recently, during October 2018, the HPV preventive vaccine Gardasil 9 was approved for people between the ages of 9 and 45 years old. 

This expanded Gardasil 9 approval is based on new data from a long-term follow-up study. 

“Preventing cancer with a vaccine is a dream come true as a healthcare provider. And now even more people can benefit from this life-saving therapy,” said Michelle Beall, Pharm.D., Clinical Pharmacist, Brookshire Grocery Company.   

“I highly encourage anyone from 9 to 45 years of age to ask their pharmacist about receiving this vaccine.” 

To schedule an HPV vaccination appointment at a local pharmacy, please visit this website.