Vaccibody, a Norway-based vaccine company, has announced vaccination of the first patient in its multicenter trial VB C-01—an exploratory, open-label, multicenter phase I/IIa study VB10.16 immunotherapy for the treatment of high-grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).
Patients will receive intramuscular vaccinations of VB10.16 at three different time points. Two different dosing schedules will be evaluated during the first phase of the study in patients diagnosed with CIN 2, 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 study is to evaluate the safety and tolerability of three doses of 3mg VB10.16. The secondary objectives are to assess 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.
Martin Bonde, CEO of Vaccibody, 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.”