Following the recent trial failure, all hopes for Ultimovacs’ UV1 cancer vaccine development now rests on the Phase II DOVACC trial, the results from which are expected in H1 2025. Image Credit: Leremy / Shutterstock.

Ultimovacs’ cancer vaccine UV1 development has suffered another setback as the UV1 vaccine in combination with MSD’s Keytruda (pembrolizumab) failed to show efficacy in a Phase II trial.

The Phase II FOCUS trial (NCT05075122) evaluating UV1 and Keytruda combination therapy in patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) failed to meet primary and secondary endpoints. The combination therapy failed to elicit clinical benefits in progression-free survival or overall survival.

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The news comes months after Ultimovacs initiated cost-saving measures in April, including a 40% workforce reduction. The Phase II FOCUS trial was one of the key anticipated milestones for the company. The investigator-initiated study was funded by Martin Luther University Halle-Wittenberg and Ultimovacs.

The Norwegian biotech has had limited success with its UV1 cancer vaccine. Two other Phase II trials, NIPU and INITIUM, for the vaccine used in combination with Bristol Myers Squibb (BMS)’s PD 1checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) failed to meet primary endpoints in two cancer indications.

The Phase II NIPU trial (NCT04300244) evaluated UV1, Opdivo and Yervoy combination as a second-line treatment in mesothelioma patients. The study failed to meet its primary endpoint of progression-free survival (PFS). 

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The Phase II INITIUM trial (NCT02275416) evaluated the same combination but in patients with unresectable or metastatic malignant melanoma. The study also failed to meet primary endpoints, with the company deciding to stop pursuing the therapy in this indication.

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All hopes for Ultimovacs’ UV1 cancer vaccine development now rests on the Phase II DOVACC trial (NCT04742075). The study is evaluating UV1 in combination with AstraZeneca’s checkpoint inhibitor Imfinzi (durvalumab) and AstraZeneca and MSD’s PARP inhibitor Lynparza (olaparib) in patients with BRCA-negative (BRCA wild type) advanced ovarian cancer. The readout from the study is expected in the first half of 2025.

Another study evaluating UV1 is an investigator-led Phase II LUNGVAC trial (NCT05344209). The study investigates the combination therapy of UV1 and Sanofi and Regeneron’s Libtayo (cemiplimab) as a first-line therapy in patients with advanced or metastatic non-small cell lung cancer. The trial started recruitment in October 2022 and reached only 15% enrolment as of Q4 2023. The topline data from the trial is expected in H1 2026.