Ultimovacs has concluded the recruitment of 154 subjects in the Phase II INITIUM clinical trial of its universal cancer vaccine candidate, UV1, plus ipilimumab and nivolumab to treat metastatic malignant melanoma. 

UV1 acts on the human telomerase (hTERT), which is seen in 85%-90% of malignancies in all stages of tumour development. 

Nivolumab is a PD-1 checkpoint inhibitor while ipilimumab is a CTLA-4 checkpoint inhibitor. 

Sponsored by the company, the randomised, comparative trial will analyse the combination therapy as first-line treatment in advanced or metastatic malignant melanoma patients. 

In the trial, 50% of the recruited subjects were dosed with UV1 plus nivolumab and ipilimumab while the other 50% were given only nivolumab and ipilimumab. 

In line with the event-driven design of INITIUM, topline progression-free survival (PFS) data will be reported in the first half of next year following tumour progression or mortality seen in a total of 70 subjects.

Subsequent to the PFS readout, the company will progress to analyse other efficacy endpoints such as tumour response, duration of response and overall survival.

Ultimovacs CEO Carlos de Sousa said: “INITIUM has been designed as a robust comparative study to demonstrate that UV1 substantially enhances outcomes for patients over and above those that can be achieved with checkpoint inhibitors alone. 

“The results will provide a rational basis for the design and implementation of future pivotal clinical studies, together with the positive data that we have seen from our Phase I studies in malignant melanoma.”

In June this year, the company reported positive findings from a Phase I trial of UV1 plus PD-1 checkpoint inhibitor, pembrolizumab, to treat malignant melanoma. 

The 24-month overall survival rate was reported to be 73% for 30 subjects.