Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease

This is a single-arm, open-label, single-center phase 2 study evaluating RP2 as a therapy for participants with high-risk oral precancerous diseases (OPDs). RP2 is a herpes simplex virus (a viral infection commonly known as the "cold sore virus") that has been changed to grow in and destroy cancer cells and to activate (turn on) the human immune system to attack the cancer cells. RP2 is made using herpes simplex virus type-1 (HSV-1) viral carrier which has been changed such that it is unlikely to cause human disease The U.S. Food and Drug Administration (FDA) has not approved RP2 as a treatment for high-risk oral precancerous disease. The study procedures for this research study include a screening visit to determine eligibility, in-clinic visits, blood tests, urine tests, and mucosal punch biopsy, Participants will receive the study drug every 2 weeks and will be followed for up to 2 years. It is expected that up to 25 people will take part in this research study. Replimune, Inc. is supporting this study by supplying the drug, RP2, and providing funding.