The topline data readout from the Phase II FOCUS trial demonstrated that adding UV1 to the standard of care pembrolizumab did not lead to clinical benefits in progression free survival or overall survival in those late-stage HNSCC patients, therefore, the study did not meet its primary and secondary endpoints.
“We have implemented a broad Phase II clinical development program testing our cancer vaccine in a range of different indications. Unfortunately, the FOCUS study did not provide us with the results we had hoped for, and we are disappointed that UV1 was not able to provide added clinical benefit for these HNSCC patients,” says Carlos de Sousa, Chief Executive Officer at Ultimovacs.
Further, the Ultimovacs team is actively developing a novel technology platform identified during the TET development and we look forward to providing more details before year-end.”
“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 II topline readout in the first half of next year. Further, the Ultimovacs team is actively developing a novel technology platform identified during the TET development and we look forward to providing more details before year-end,” he adds.
FOCUS
FOCUS is an investigator-initiated randomized Phase II clinical trial sponsored by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. It investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination with pembrolizumab versus pembrolizumab alone, as a first-line treatment in metastatic patients or a second-line treatment in patients with recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC). In this indication, pembrolizumab is currently considered the standard of care treatment for patients. The primary endpoint of the study is progression free survival at 6 months. All patients have been followed up for close to 12 months or longer for PFS, overall survival (OS) and safety.
“We are disappointed that the FOCUS trial did not achieve the desired outcome for patients, which underscores the complexities of treating metastatic and recurrent head and neck cancer. This cancer type is particularly aggressive with limited treatment options and high rates of recurrence. Our broad clinical development program was designed to identify the best patient populations for UV1 and we are now focusing our efforts on the upcoming DOVACC data readout in the first half of next year,” says Jens Bjørheim, Chief Medical Officer at Ultimovacs.
Ultimovacs is also investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment for patients with high-grade BRCA negative ovarian cancer.”
Ultimovacs is also investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment for patients with high-grade BRCA negative ovarian cancer. Topline results are expected in the first half of 2025 well within the current financial runway which reaches to the fourth quarter of 2025.
Photo of Carlos de Sousa: Ultimovacs
