Intramuscular vaccinations of VB10.16 will be offered to patients at three different time points. Vaccibody will assess two different dosing schedules in the first phase of the study in patients diagnosed with CIN 2.
The company will then evaluate best vaccination schedule in the second phase in both CIN 2 and CIN 3 patients.
The study aims to identify the safety and tolerability of three doses of 3 mg VB10.16. T cell mediated immune responses will be assessed in the peripheral blood as well as in the pre-malignant tissue of the CIN 2/3 lesions.
Vaccibody will also evaluate early indications of efficacy by HPV clearance and CIN regression.
Vaccibody CEO Martin Bonde said: "Surgery is currently the only available therapy to remove abnormal cervical lesions caused by human papillomavirus and thereby stop the progression to cervical cancer.
"We are hopeful that VB10.16 immunotherapy can help change this treatment paradigm by offering a safe and efficacious alternative in the form of a therapeutic HPV vaccine."
Vaccibody’s VB10.16 therapeutic DNA vaccine will treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies.
Earlier this year, Vaccibody submitted a clinical trial application to start the first in man clinical study of VB10.16.
About 530,000 women globally are diagnosed with cervical cancer per year and more than 275,000 people die of the disease.
The number of high grade lesions (CIN 2/3) the immediate precursors to malignancy, is expected to be in the range of 10 million.