Vaccibody AS Announces Vaccination of First Patient in Its Phase I/IIa Study with VB10.16 Immunotherapy for Patients with HPV16 Induced High Grade Lesions of the Cervix

OSLO, Norway--()--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.

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