HPV-Attributed Head and Neck Cancer: A New Treatment on the Horizon

By Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech

Human papillomavirus (HPV) is a common viral infection of the skin, the lining of the mouth, throat, genitals, and anal area. Most people with HPV don’t have any symptoms and their immune system generally gets rid of the infection without any treatment. However, in some cases, infection with high-risk or cancer-causing HPV can lead to cancer. Most HPV-related head and neck cancers are caused by a type of HPV called HPV-16, which accounts for over 90% of HPV-positive head and neck cancers.

It often takes many years for HPV- infected cells to become cancerous. We can’t predict whose infection will disappear and who will develop cancer. Most head and neck cancers caused by HPV form in the oral cavity: the part of the throat that includes the base of the tongue and the tonsils. These cancers are called oropharyngeal cancers. The Centers for Disease Control and Prevention issued a press release in 2015 stating that for the first time, oropharyngeal cancers had surpassed cervical cancer as the main HPV-related malignancy in the U.S. population. In fact, the steep rise in the annual number of HPV-related oropharyngeal cancer cases has frequently been referred to as “the silent HPV epidemic.” By the year 2030, it is anticipated that the burden will increase from 20,000 to 30,000 new diagnoses of HPV-positive oropharyngeal cancer per year.

PDS Biotech is developing a new immuno-therapy designed to target HPV-16 called PDS0101. PDS0101 has been shown to stimulate high levels of HPV-16-specific killer T-cells that target and kill head and neck tumor cells that are caused by HPV-16 infection. We’re currently enrolling patients in VERSATILE-002, a clinical trial studying PDS0101 in combination with the checkpoint inhibitor KEYTRUDA (pembrolizumab). The study is for patients with HPV16-positive head and neck cancer that has returned or spread. While KEYTRUDA is an effective medication, it does not treat the HPV infection causing the cancer. Every patient who enrolls in VERSATILE-002 will be treated with both therapies.

Hearing from your doctor that the cancer you’ve been fighting has returned or spread, is a challenging situation for patients and their families. There are many questions, the most important being “what do we do now?” The treatment options you discuss with your doctor may include both traditional therapies and investigational therapies that are available through a clinical trial. Clinical trials use new medicines that are being studied to better control or eliminate cancer. Treatment options in a clinical trial may include chemotherapy, radiation therapy, surgery or immunotherapy or even some combination of them. If you’re interested in learning more about VERSATILE-002 and whether you might qualify, please visit our website at www.pdsbiotech.com or click this link. We look forward to hearing from you.


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HNCA provides me with the information and support I need. It also provides me with a medium to serve as a role model to others diagnosed with head and neck cancer.Jason Mendelsohn
Stage-4 HPV-related oral cancer survivor


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