The Human Papillomavirus (HPV) is the most common viral infection of the reproductive system, and nearly all cases of cervical cancer can be attributable to HPV infection, according to the World Health Organization (WHO). A recent study estimated the prevalence of HPV in unvaccinated 16-25-year-olds is 53.5%, and these numbers are likely to increase (Wendland et al., 2020). There are more than 100 subtypes of HPV, types 16 and 18 causing over 70% of cervical cancer and precancerous lesions. 

Although around 90% of HPV infections clear up on their own within 2 years, 10% progress to cervical dysplasia (abnormal PAP smears) and sometimes to cancer, most commonly cervical, but also cancers of the vulva, vagina, and anus. Cervical cancer is the fourth most common cancer in women and more than half a million are estimated to be diagnosed in the world each year. Early-stage cervical cancers may be curable with surgery and radiation therapy, but for more advanced cases only palliative treatments, e.g., chemotherapy, are available. An estimated 265,000 women die from this disease each year worldwide. 

Gardasil®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) helps protect individuals ages 9 to 45 against the diseases caused by 9 types of HPV. However, for maximum effectiveness, Gardasil®9 must be given before exposure to HPV. Once women have been infected with the virus, the vaccine is ineffective. What is the solution for these women? 

What is needed is a drug or vaccine that cures HPV infection after it has been established but before it has caused cancer. In February of this year, Biovaxys Technology Corp. and ProCare Health announced a collaboration for cancer and viral vaccines, with Biovaxys' haptenization technology platform at the forefront of this joint effort. The two companies are planning a clinical study in Spain for stage III/stage IV ovarian cancer and joint development of vaccines for cervical cancer and HPV. 

BioVaxys' HPV viral vaccine platform itself involves taking viral antigens and modifying them with a 'hapten' molecule. In studies done with its SARS-CoV-2 vaccine candidate, the BioVaxys hapten-antigen conjugate vaccine stimulated both an antibody response and robust activation of T lymphocytes, which are critically important in fighting viruses. Biovaxys believes that the haptenized HPV vaccine will break immunological tolerance to the virus, even in women already

infected. If that strategy were to be effective, the vaccine could prevent or decrease the likelihood of those women developing cervical and the other HPV-associated cancers.