Nykode Therapeutics initiated a Phase II trial for its cancer vaccine, VB10.16, aimed at treating HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer. The trial, conducted in collaboration with Roche’s checkpoint inhibitor Tecentriq (atezolizumab), focuses on patients whose cancer is resistant to first-line treatment with Merck’s Keytruda plus chemotherapy and Genentech’s Avastin.
The trial consists of two arms: one evaluating VB10.16 with a placebo, and the other studying VB10.16 combined with Tecentriq. Initially, each arm will enroll approximately 30 patients in a double-blind study to compare the efficacy of the treatments. Subsequently, the more effective treatment will be selected for further investigation in an additional 70 patients to assess safety and efficacy.
Klaus Edvardsen, Nykode’s chief development officer, expressed optimism based on previous trials’ positive outcomes, highlighting VB10.16’s promising clinical profile and tolerability when combined with atezolizumab. Nykode, headquartered in Oslo, Norway, is conducting the trial in collaboration with the nonprofit Gynecologic Oncology Group Foundation.
Nykode’s pipeline includes ongoing trials of VB10.16 in HPV16-positive cervical cancer, high-grade squamous intraepithelial lesion of the cervix, and head and neck cancer. Additionally, they are developing an individualized therapeutic cancer vaccine, VB10.NEO, in partnership with Genentech, currently undergoing evaluation in advanced cancers.
This Phase II trial underscores Nykode’s commitment to advancing innovative immunotherapy solutions for HPV16-positive cancers, leveraging strategic collaborations and a diversified pipeline to address unmet medical needs in oncology.