On February 11, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported the completion of patient enrollment in the Phase 2 study of VB10.16, Nykode’s lead cancer vaccine candidate, in combination with Roche’s checkpoint inhibitor atezolizumab for the treatment of advanced cervical cancer (Press release, Nykode Therapeutics, FEB 11, 2022, View Source [SID1234608011]). VB10.16 is a potentially first-in-class off-the-shelf therapeutic HPV16 cancer vaccine designed to induce strong HPV16 specific T cell responses for the treatment of HPV16-positive cancers.
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"We are pleased to report the completion of patient enrollment in our ongoing Phase 2 trial of VB10.16, our wholly owned product candidate for the treatment of cervical cancer," said Michael Engsig, CEO of Nykode Therapeutics. "This is an important inflection point for Nykode as we advance our lead candidate through the clinic. After successfully enrolling 50 patients across trial sites in six countries, we look forward to reporting interim efficacy and safety data from the first patients in the first half of 2022. In parallel, we are exploring the possibility of evaluating VB10.16 in other HPV-driven cancers, including head and neck cancer."
VB C-02 is a multi-center, open-label Phase 2 trial of patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. Almost 20 European sites in six European countries were engaged in enrolling patients in the trial. Nykode has previously reported positive interim safety data from the trial.
Siri Torhaug, Chief Medical Officer of Nykode Therapeutics, commented: "Cervical cancer is a leading cause of death for women. It is an indication which continues to have a high unmet medical need with limited response to standard of care treatment in an advanced setting. We are very happy to have reached this important milestone for our lead cancer vaccine VB10.16 and look forward to continuing the development program. We are thankful for the patients, their families, the investigators and the trial site personnel who have made this trial possible."
Additional information about the Phase 2 trial is available at clinicaltrials.gov (NCT04405349).