Ultimovacs, a clinical-stage biotechnology company, has announced data from the Phase II NIPU trial results of the UV1 cancer vaccine. 

The investigator-initiated, open-label, multi-center Phase II trial NIPU assessed the effect of adding the cancer vaccine to second-line treatment with ipilimumab and nivolumab for pleural mesothelioma patients. 

Malignant pleural mesothelioma is an aggressive type of cancer. It occurs in the thin layer of tissue that surrounds the lungs and inside part of the chest. 

Sponsored by Oslo University Hospital and supported by Bristol-Myers Squibb and Ultimovacs, the NIPU trial involved six university hospitals across Denmark, Australia, Norway, Spain, and Sweden.  

From June 2020 to January 2023, a total of 118 patients were randomised as part of the trial. 

The NIPU trial's objective was to achieve a clinically meaningful PFS benefit in patients with malignant pleural mesothelioma (MPM) after first-line chemotherapy. The combination of ipilimumab and nivolumab has been approved as a first-line treatment in the US and Europe. 

While the primary endpoint of improved progression-free survival (PFS) was not met, secondary endpoints showed a significant benefit, the company said. 

The objective response rate (ORR) and overall survival (OS) were positively impacted by adding UV1 to the treatment regimen.  

Notably, patients with the epithelioid subtype of mesothelioma, which accounts for about 70% of cases, demonstrated further improvement. 

In a press statement, Ultimovacs said: “The safety profile of the combination of UV1 plus ipilimumab and nivolumab observed in the trial was consistent with that of ipilimumab and nivolumab alone, confirming the good safety profile for the UV1 vaccine.”