Norwegian vaccine company Vaccibody has vaccinated the first patient in its exploratory, open-label, multicenter Phase I / IIa trial (VB C-01) of VB10.16 immunotherapy to treat high-grade Cervical Intraepithelial Neoplasia (CIN 2 / 3) caused by human papillomavirus 16 (HPV 16).
In the trial, patients will receive intramuscular vaccinations of VB10.16 at three different time points.
During the first phase of the trial in patients diagnosed with CIN 2 two different dosing schedules will be evaluated, while the best vaccination schedule will then be evaluated in the second phase in both CIN 2 and CIN 3 patients.
The primary objective of the trial is to evaluate the safety and tolerability of three doses of 3mg VB10.16.
The secondary objectives of the trial are to evaluate T cell mediated immune responses in the peripheral blood, as well as in the pre-malignant tissue of the CIN 2 / 3 lesions and to evaluate early signs of efficacy by means of HPV clearance and CIN regression.
Vaccibody CEO Martin Bonde said: "We are pleased to announce commencement of patient treatment in this first clinical trial with Vaccibody’s lead product VB10.16.
"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."
The first dosing of a patient has been carried out at successfully at Klinikum Wolfsburg.
Klinikum Wolfsburg Department of Obstetrics & Gynaecology principal investigator Dr Karl Ulrich Petry said: "The scientific approach of this well designed clinical study offers the chance to get a thorough understanding on how patients respond to VB10.16 immunotherapy.
"We are convinced that patients with CIN 2 and CIN 3 will be very motivated to participate in the study to test this therapeutic vaccination as it might offer a non-invasive treatment option avoiding the side effects associated with surgical excision of the affected tissue and potentially also cure the underlying HPV infection and prevent recurrence.
"Furthermore, VB10.16 could also protect from other HPV16 induced cancers."