Nykode Therapeutics ASA announced the initiation of the Phase 1/2a clinical trial. The trial evaluates VB10.16, the Company?s wholly owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination with MSD?s (Merck & Co., Rahway, NJ, USA) PD-1 inhibitor KEYTRUDA (pembrolizumab) in first line (1L) setting in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VB-C-03 is a Phase 1/2a open-label, dose-finding trial investigating safety, tolerability, and efficacy.

It consists of two consecutive phases, a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a), testing VB10.16 in doses up to 9 mg, in combination with pembrolizumab in a 1L setting in patients with HPV16-positive, PD-L1-positive HNSCC. The trial will take place in Europe. Merck will supply KEYTRUDA, while Nykode retains all commercial rights to VB10.16 worldwide.