OSLO, Norway–(BUSINESS WIRE)–Vaccibody AS announced today vaccination of the first patient in its
multicentre 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 3 mg 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, commented: 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.
Principal investigator, Prof. Dr. med. Karl Ulrich Petry, Department of
Obstetrics & Gynaecology Klinikum Wolfsburg commented: 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. The first dosing of a patient has just been
performed successfully in our hospital . 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.
Martin Bonde, CEO, +47 22958193