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Clinical Trials

High Grade Intraepithelial Neoplasia (CIN)

VB10.16 Immunotherapy

The company’s lead product, VB10.16, is a therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies.

Study Title

An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With High Grade Intraepithelial Neoplasia (HSIL; CIN 2/3)

Phase

I/IIa

ClinicalTrials.gov Identifier

NCT02529930

Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer

 

Per year approximately 530,000 women are diagnosed with cervical cancer worldwide and over 275,000 women die of the disease annually. Invasive cervical cancer is preceded by a long phase of pre-invasive disease called Cervical Intraepithelial Neoplasia (CIN). Globally the number of high grade lesions (CIN 2/3) the immediate precursors to malignancy, is estimated to be in the range of 10 million.

 

Virtually all cervical cancers are caused by high risk HPV types. Among the different high risk HPV types known, HPV16 has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It can be detected in up to 60 % of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers).

 

Current standard therapy for CIN 2/3 varies between countries and regions and often involves surgical removal of the affected tissue. These invasive procedures are associated with bleeding, infection, cervical stenosis, scarring and most importantly pre-term deliveries in subsequent pregnancies. As a result, there is a significant need for an effective therapeutic vaccine to treat existing HPV infection and associated pre-malignancies and malignancies of the cervix and thereby prevent the development of cervical cancer caused by human papillomavirus.