SynCon® HPV immunotherapy for pre-cancers and cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. About 14 million Americans become newly infected each year and over half of all sexually active men and women become infected at some time in their lives. 90% of HPV infections regress spontaneously (meaning they are cleared by the body’s immune system) within two years, however, HPV infections that persist in the body can cause cell abnormalities that may lead to cancer.

HPV types can be classified into low-risk or high-risk. Low-risk HPV types do not cause cancer but can yield warts around the genitals or anus. High-risk HPV types can result in precancerous lesions or cancer. For most patients diagnosed with high-risk HPV types, the disease regresses within one to two years; however, some HPV infections can persist for many years and lead to cancers of the cervix, head and neck, and anogenital region. According to the Centers for Disease Control (CDC), during 2004–2008, an average of 33,369 HPV-associated cancers were diagnosed each year in the United States. Furthermore, HPV (high-risk types) caused cancer accounts for nearly 5% of cancers worldwide.

Although more than 150 related HPV viruses have been identified, HPV types 16 & 18 account for approximately 75-95% of all HPV caused cancers.

There are currently two approved vaccines (Gardasil® and Cervarix®) on the market for the prevention of HPV types 6, 11, 16, or 18-related infection. Both of these vaccines have shown a great deal of efficacy in preventing infection from the specific HPV types included in the respective vaccines and the majority of cases of pre-cancerous cervical lesions (CIN 1, 2, 3), cervical cancer, and genital warts in vaccinated individuals. In addition to their effectiveness in preventing the onset of genital warts, CIN, and cervical cancer, these two prophylactic vaccines could theoretically reduce the high incidence rate of HPV types 16 and 18-related head and neck or anogenital cancers. Despite the proven effectiveness of these vaccines in the prevention of disease, they do not have therapeutic capabilities. There are currently no treatment immunotherapy or drug options once an individual is infected with the virus.

Inovio is creating DNA immunotherapies designed to treat precancerous cervical lesions, cervical cancer, head and neck cancers, and anogenital cancers caused by HPV types 16 & 18. If proven effective in clinical trials, Inovio’s treatment could provide patients with an alternative treatment option to surgery, chemotherapy, and radiation, the current standard of care treatment options for those already diagnosed with HPV caused precancerous lesions and cancer.