Vaccibody’s lead product cancidate VB10.16 is a DNA based immunotherapy targeting malignancies caused by Human Papilloma Virus 16 (HPV16). HPV16 is a major contributor to several cancers, including Cervical, Vulvar, Anal and Head and Neck Cancer.
Vaccibody has completed its VB C-01 trial, testing VB10.16 in a first-in human study with the title “An exploratory, safety and immunogenicity study of the human papillomavirus (HPV16) immunotherapy VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3)” and positive 12 months data are available. See here for more information.
Earlier stages of HPV16 infection as well as other cancers induced by HPV may be treated with the same vaccine. A clinical proof of concept with Vaccibody’s first candidate VB10.16 may therefore open up for opportunities in a number of cancer indications.
Vaccibody has a clinical collaboration agreement with Roche to study VB10.16, Vaccibody’s vaccine directed towards HPV positive cancers in combination with Roche’s checkpoint inhibitor atezolizumab (TECENTRIQ®) in advanced cervical cancer. See here for more information.
Vaccibody’s two studies under its VB10.16 clinical program are:
An open-label Phase I/IIa study to evaluate the safety and immunogenicity of VB10.16 in HPV16-positive patients with HSIL (CIN 2/3). The study was completed January 31, 2019, and the final report is available with positive 12-month data.
ClinicalTrials.gov Identifier: NCT02529930
An open-label Phase II study to evaluate the safety and efficacy of multiple dosing with VB10.16 in combination with atezoluzimab (Tecentriq®) in HPV16-positive patients with advanced, non-resectable cervical cancer.