Nykode Therapeutics ASA announced FDA approval of its investigational new drug (IND) application for the Phase 2 clinical trial. The trial is designed to evaluate VB10.16, the company's wholly owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination with Roche's PD-L1 inhibitor atezolizumab (Tecentriq®1) in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer. Nykode is on track to initiate the trial in the fourth quarter of 2023.

Atezolizumab is supplied by Roche. Nykode retains all commercial rights to VB10.16 worldwide.