Ultimovacs ASA announced the completed recruitment of 118 patients with pleural mesothelioma in the NIPU trial. NIPU is a randomized, multi-center phase II trial initiated and sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. UV1 is being evaluated in combination with the checkpoint inhibitors ipilimumab and nivolumab as second-line treatment for patients with malignant pleural mesothelioma.

The ipilimumab and nivolumab combination is standard-of-care treatment for patients with malignant pleural mesothelioma in Europe and the U.S. Happening most frequently to people with occupational asbestos exposure risks, malignant pleural mesothelioma is a cancer of the lining of the lungs and the internal thoracic wall. Time from exposure to asbestos to diagnosis of disease usually takes several decades. The life expectancy for most mesothelioma patients is approximately 12 months after diagnosis, indicating a high unmet medical need.

The treatment combination evaluated in the NIPU trial represents an innovative approach for treatment of patients with malignant pleural mesothelioma. Consistent with NIPU's event-driven design, topline progression-free survival results will be disclosed after progression of cancer or death has been observed in a total of 69 patients. Data readout from the trial is expected during the first half of 2023.

The topline results will be disclosed through a press release followed by a more in-depth presentation of the results in an article and at a medical conference. Ultimovacs' universal cancer vaccine, UV1, is being investigated in combination with checkpoint inhibitors in five comparative phase II clinical trials. NIPU is the second of these studies to complete recruitment of patients, following the INITIUM study in metastatic malignant melanoma.

Topline readout from both these studies during is expected during the first half of 2023.