Ultimovacs cancer vaccine fails in head and neck cancer's Phase II trial

Ultimovacs' UV1 cancer vaccine, combined with MSD’s Keytruda (pembrolizumab), failed to meet primary and secondary endpoints in the Phase II FOCUS trial (NCT05075122) for metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). The combination did not improve progression-free survival or overall survival.

This failure follows Ultimovacs' recent cost-saving measures, including a 40% workforce reduction. The trial, funded by Martin Luther University Halle-Wittenberg and Ultimovacs, was a major milestone for the company.

Previously, UV1 also failed to meet endpoints in the Phase II NIPU and INITIUM trials, testing it with Bristol Myers Squibb's Opdivo and Yervoy in mesothelioma and malignant melanoma, respectively.

Looking ahead, the Phase II DOVACC trial (NCT04742075) will evaluate UV1 with AstraZeneca’s Imfinzi and Lynparza in advanced ovarian cancer, with results expected in early 2025. The LUNGVAC trial (NCT05344209) is studying UV1 with Libtayo in non-small cell lung cancer, with data due in mid-2026.