Ultimovacs’ cancer vaccine UV1 has failed yet another midphase clinical trial. The third flop, this time in head and neck cancer, leaves UV1 with one shot at salvation before the Norwegian biotech reaches the end of its cash runway.
UV1 is designed to induce a T-cell response against an enzyme that is active in most cancer cells. In the latest study, FOCUS, investigators assessed the effect of adding UV1 to Merck & Co.’s major blockbuster oncology med Keytruda in people with metastatic or recurrent head and neck cancer. Used as a first-line treatment, UV1 failed to improve progression-free survival, causing the study to miss its primary endpoint.
The study also missed the key secondary endpoint of overall survival (OS). Ultimovacs is yet to share data from the investigator-initiated study but gave no indication there’s a sign of a silver lining in the details. A line about UV1’s positive safety profile is the only upbeat takeaway from the top-line data.
Attention now turns to DOVACC, a phase 2 trial that is scheduled to read out in the first half of 2025. The trial is testing UV1 as a second-line treatment in women with BRCA-negative ovarian cancer who have had a partial or complete response to chemotherapy. Patients in the investigational arm are receiving UV1 in combination with the PARP inhibitor Lynparza and the checkpoint inhibitor Imfinzi.
Ultimovacs is on a losing streak heading into the key DOVACC readout. A mesothelioma study missed its primary endpoint last year, although the biotech later reported a hit on the secondary OS endpoint. This year, Ultimovacs has chalked up failures in melanoma and ovarian cancer.
A fifth study, LUNGVAC, sits alongside DOVACC on the list of UV1 studies that are yet to report data, but the biotech doesn’t expect to report top-line results until the first half of 2026. Ultimovacs cut costs after the melanoma flop to extend its cash runway into the fourth quarter of 2025, ensuring it can keep going to the DOVACC data but putting the LUNGVAC readout beyond the reach of its current resources.
Beyond UV1, Ultimovacs has a TET platform that combines tumor-specific antigens and an adjuvant in the same molecule. The biotech finished a 12-person phase 1 study of a TET candidate last year and shared an update alongside news of the latest UV1 fail. Ultimovacs said it is “actively developing a novel technology platform identified during the TET development” and will provide an update this year.