5 February 2024 - The designation was granted by the US FDA based on results from the randomised Phase II clinical trial NIPU, which showed improved overall survival with UV1 vaccination as an add-on to ipilimumab and nivolumab immunotherapy.
Ultimovacs today announced that the US FDA had granted fast track designation to the company’s therapeutic cancer vaccine UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival, including first-line patients.