Ultimovacs’ cancer vaccine UV1 has encountered another setback, failing in its third midphase clinical trial, this time targeting head and neck cancer. The trial, known as FOCUS, tested UV1 alongside Merck & Co.’s Keytruda in patients with metastatic or recurrent head and neck cancer. Unfortunately, UV1 did not improve progression-free survival or overall survival, missing both primary and secondary endpoints. The study’s only positive note was UV1’s favorable safety profile.
With this latest failure, Ultimovacs faces a critical juncture, as the company is nearing the end of its financial runway. The next major test for UV1 will be the DOVACC phase 2 trial, expected to report results in early 2025. This trial is evaluating UV1 as a second-line treatment for BRCA-negative ovarian cancer patients who have responded partially or completely to chemotherapy. UV1 is being tested in combination with the PARP inhibitor Lynparza and the checkpoint inhibitor Imfinzi.
Ultimovacs is struggling with a string of clinical trial disappointments. Last year, a mesothelioma study missed its primary endpoint, though it later showed some success on the overall survival endpoint. This year, the company has faced setbacks in melanoma and ovarian cancer trials. To conserve resources, Ultimovacs laid off 40% of its staff after the melanoma trial failure and extended its cash runway into the fourth quarter of 2025.
Alongside the DOVACC trial, Ultimovacs is awaiting results from another study, LUNGVAC, but does not expect to have data until early 2026. The company’s financial constraints are pushing this readout beyond their current budget.
In addition to UV1, Ultimovacs is developing a TET platform, which combines tumor-specific antigens with an adjuvant in one molecule. After completing a small phase 1 study of a TET candidate last year, Ultimovacs is exploring advancements in this technology and plans to provide updates later this year.
In summary, Ultimovacs faces a critical period as it awaits results from upcoming trials while grappling with recent failures and financial constraints. The company is focused on leveraging its TET platform and other assets to navigate these challenges and pursue future opportunities.