Ultimovacs has announced that the first patient has been enrolled in FOCUS.
FOCUS is an investigator-led Phase II randomized clinical trial in head-and-neck cancer of the company’s telomerase cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab.
“Initiation of recruitment in FOCUS adds further momentum to the expanding clinical program of our lead cancer vaccine UV1,” says Jens Bjørheim, Chief Medical Officer at Ultimovacs. “There is a growing body of evidence to support the synergistic potential of UV1 in combination with immunotherapies. We believe the combination of UV1 with pembrolizumab can help address the clear unmet need in treating head and neck cancer.”
One of four Phase II trials
FOCUS is one of Ultimovacs’ four Phase II trials of UV1 in combination with various immunotherapy agents across four different cancer indications. The primary endpoint of FOCUS is progression-free survival rate at 6 months, with readout of topline results expected in 2023.
The FOCUS Phase II trial will be conducted at 10 sites across Germany.
FOCUS will enroll a total of 75 patients indicated for treatment with pembrolizumab, randomizing them 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone.
Photo of Jens Bjørheim: Ultimovacs