For a second time this year, Ultimovacs saw its stock crash after reporting its cancer vaccine failed in a Phase 2 study in head and neck squamous cell carcinoma.
Topline data from the Phase 2 FOCUS study show that its vaccine, dubbed UV1, did not contribute to Keytruda’s efficacy in the progression-free survival primary endpoint and overall survival secondary endpoint, according to a Monday release.
The investigator-sponsored, open-label trial recruited 75 HNSCC patients, 50 of whom received UV1 and Keytruda while the rest were given standard-of-care Keytruda. Study participants either needed first-line care in metastatic disease or second-line therapy in the recurrent PD-L1 positive setting. They were all monitored for nearly a year or more.
Ultimovacs’ stock dropped 50% on the Oslo Stock Exchange Tuesday morning.
In March, the same cancer vaccine failed in a separate Phase 2 study in melanoma, in combination with Bristol Myers Squibb’s Yervoy and Opdivo. Back then, the Norwegian biotech’s stock crashed by 92%. In June 2023, the vaccine also missed the primary endpoint of a Phase 2 test in second-line mesothelioma, the company said.
Carlos de Sousa“Earlier this year we implemented a cash preservation program, enabling us to extend our runway to the fourth quarter of 2025, beyond the anticipated DOVACC Phase 2 topline readout in the first half of next year,” CEO Carlos de Sousa said in the Monday release.
The DOVACC trial is studying the vaccine with AstraZeneca’s Lynparza and Imfinzi as a second-line maintenance therapy in BRCA-negative ovarian cancer patients.
At the end of March, the company had 220 million Norwegian krone (almost $20 million) in cash and cash equivalents. In April, the biotech said it will cut 40% of its staffers to extend its cash runway.
The fifth UV1 study, the Phase 2 LUNGVAC trial investigating the cancer vaccine with Keytruda in non-small cell lung cancer, is expected to have data in the first half of 2026.