Ultimovacs cancer vaccine fails to meet endpoints in Phase II trial for head and neck cancer

Following a recent trial failure, the future of Ultimovacs’ UV1 cancer vaccine now hinges on the Phase II DOVACC trial, with results expected in the first half of 2025. The UV1 vaccine, combined with MSD’s Keytruda (pembrolizumab), did not demonstrate efficacy in the Phase II FOCUS trial for metastatic or recurrent head and neck squamous cell carcinoma (HNSCC), failing to meet both primary and secondary endpoints, including progression-free survival and overall survival.

This setback follows cost-saving measures by Ultimovacs, including a 40% workforce reduction. The Norwegian biotech has faced challenges with UV1, as two other Phase II trials—NIPU and INITIUM—also failed to meet primary endpoints in different cancer indications.

Currently, hopes are pinned on the DOVACC trial, which tests UV1 in combination with AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) in BRCA-negative advanced ovarian cancer patients. Additionally, the Phase II LUNGVAC trial is assessing UV1 with Libtayo (cemiplimab) for advanced non-small cell lung cancer, with data expected in 2026.