Our wholly owned lead product candidate, VB10.16, is an immunotherapy targeting malignancies caused by the cancer inducing Human Papillomavirus 16 (HPV16). HPV is the cause of 630,000 cases of cancers annually and HPV16 is the predominant cause.
We have completed our 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 is available. The VB C-02 trial has published positive interim safety and efficacy data.
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 Nykode’s first candidate VB10.16 may present opportunities in a number of cancer indications.
Nykode has a clinical collaboration agreement with Roche4 to study VB10.16 in combination with Roche’s checkpoint inhibitor atezolizumab (TECENTRIQ®) in advanced cervical cancer. See here for more information.
We have three studies under our VB10.16 clinical program:
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.
ClinicalTrials.gov Identifier: NCT04405349
Nykode is currently planning a dose escalation trial of VB10.16 in combination with CPI in patients with HPV16-positive HNSCC. Trial builds on the encouraging clinical efficacy and favorable safety profile that was observed with VB10.16 in combination with CPI in patients with HPV16-positive cervical cancer (C-02 trial). Safety, efficacy and immunogenicity of multiple VB10.16 dose levels will be assessed.