NEW YORK – Nykode Therapeutics on Friday began a Phase II trial of its cancer vaccine, VB10.16, with or without Roche's checkpoint inhibitor Tecentriq (atezolizumab) for the treatment of HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer.
The two-arm trial will evaluate VB10.16 plus placebo or VB10.16 with Tecentriq in cervical cancer patients whose cancer is refractory to first-line treatment with Merck's Keytruda (pembrolizumab) plus chemotherapy and Genentech's Avastin (bevacizumab).
In the first part of the study, researchers will enroll about 30 patients in each trial arm for the double-blind study to determine whether VB10.16 or the VB10.16-Tecentriq combination is more effective. The second part of the study will select the best treatment from the first part and investigate its safety and efficacy in an additional 70 patients.
"The encouraging clinical profile and favorable tolerability exhibited by VB10.16 in combination with atezolizumab among patients with advanced HPV16-positive cervical cancer observed in [a previous open-label trial] supports our dedication to advancing VB10.16 as an innovative immunotherapy for HPV16-positive cancers," Klaus Edvardsen, chief development officer of Nykode Therapeutics, said in a statement.
Nykode, based in Oslo, Norway, is conducting the trial in collaboration with the nonprofit Gynecologic Oncology Group Foundation. The firm has several ongoing trials of VB10.16, its lead pipeline candidate, in HPV16-positive cervical cancer, high-grade squamous intraepithelial lesion of the cervix, and head and neck cancer.
The firm's pipeline also includes an individualized therapeutic cancer vaccine, VB10.NEO, being developed with Genentech. Nykode is currently evaluating that candidate in advanced cancers.