HPV

The Problem

“High-risk HPVs are associated with approximately five percent of human cancers, including virtually all cervical cancers, as well as anal, vaginal, vulvar, penile, and oropharyngeal cancers. Although prophylactic vaccines are highly efficacious and appear promising for preventing a large fraction of HPV-associated cancers, they do not protect from pre-existing infections or prevent malignant progression and are not expected to impact the frequency of these cancers for decades. In the meantime, millions will develop HPV-associated cancers, and many will die of these cancers worldwide. It is imperative that we identify novel therapeutic targets to control and, ideally, eradicate HPV-associated cancers.”

David Soto, Christine Song and Margaret E. McLaughlin-Drubin

Division of Infectious Disease, Department of Medicine, Brigham & Women’s Hospital, Harvard Medical School

In Viruses 2017, 9(9), 248; https://doi.org/10.3390/v9090248

Standard of Care for HPV Cervical Precancers

In the United States, the standard treatment for cervical precancers is excision or destruction of the affected tissue. One common method is the Loop Electrosurgical Excision Procedure (LEEP), which uses an electric wire to remove the tip of the cervix.  https://youtu.be/sBu11XZJ7jA?si=Nphl7t2QEyPmjmKS

Recurrence rates for LEEP can range from 5% to 25%, and repeat procedures are common. Patients may face complications such as bleeding, pain, and psychological or emotional distress. Recovery after the procedure can take up to six months, during which quality of life may be negatively affected, and some may experience sexual dysfunction.  Additionally, there are potential future obstetric risks associated with multiple LEEPs. These risks can include mid-trimester loss, spontaneous abortion, premature rupture of membranes, preterm delivery, and cervical stenosis due to scarring. There may also be issues with subfertility and prolonged time to conception.

Our Approach

HPV infects the cervix and then transforms cervical cells into dysplastic, cancer prone cells.  The HPV proteins produced by the infecting virus in the cells both cause the cells to be cancerous but also leave their footprint on the cell surface that can readily be recognized by T-cells programmed to kill HPV infected cells by mRNA immunization.  In many cases, natural immunity clears the infection and stops the progression to cervical cancer.  In those whose disease persists, and progress, we propose to use mRNA immunization to boost the T-cell immunity to clear the disease and virus. Pinion’s proprietary vaccine induces very high levels HPV-specific T-cell immunity that can be boosted.  Robust and effective T-cell immunity is the hallmark of mRNA immunization.  Replacing LEEP and the costly, logistically, emotionally and entails medically complex follow-up, with a simple, effective and safe immunization, is our goal.