NEW YORK – Nykode Therapeutics said on Friday that it has finished enrolling a Phase II study evaluating its cancer vaccine candidate VB10.16 combined with PD-1 checkpoint inhibitors for advanced HPV16-positive cervical cancer.
Specifically, the Oslo, Norway-based firm has enrolled the target 50 patients in its VB C-02 trial, all of whom have advanced or recurrent, non-resectable HPV16-positive cervical cancer. The trial is designed to evaluate the safety and preliminary efficacy of VB10.16, an off-the-shelf therapeutic which, when combined with Genentech's Tecentriq (atezolizumab), is meant to induce strong HPV16-specific T-cell responses in HPV16-positive cancers. According to Nykode, previously reported interim safety data from the trial has been positive.
In addition to the treatment's safety and efficacy, Nykode will assess in the trial predictive biomarkers of response, such as expression of PD-L1 and other genes as well as changes in the tumor microenvironment using immunohistochemistry. Investigators will also analyze correlations between clinical response by RECIST and HPV16 circulating tumor DNA in patients' plasma.
The company is conducting the Phase II trial in roughly 20 sites across Europe, and expects to report interim data during the first half of 2022.
According to Nykode CEO Michael Engsig, the firm is also exploring VB10.16 in other HPV-driven cancers, including head and neck cancers.