Ultimovacs ASA announced that the U.S. Food and Drug Administration (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. The designation was granted based on results from the Phase II clinical trial, NIPU, evaluating UV1 in patients with unresectable malignant pleural mesothelioma, which were presented at the ESMO Congress 2023. As defined by the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions with the goal of bringing important new drugs earlier to patients.

The Fast Track designation enables Ultimovacs to have more frequent interactions with the FDA to discuss the UV1 development path for the treatment of mesothelioma. For more information on the Fast Track process, please visit the FDA?s official website. The impact of UV1 vaccination in patients with unresectable malignant pleural mesothelioma has been evaluated in a randomized Phase II clinical trial, NIPU.

In the study, UV1 was combined with checkpoint inhibitors ipilimumab and nivolumab and compared to ipilimumab and nivolumab alone as a second-line treatment, after first-line treatment with platinum-based chemotherapy. The results from the study demonstrated a clinically meaningful improvement in overall survival for UV1 with no added toxicities. The NIPU study is sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs.

Mesothelioma is a rare and aggressive form of cancer with a high mortality rate and few therapeutic options. Patients with mesothelioma commonly have a history of occupational or environmental exposure to asbestos, and it typically takes decades for this specific form of cancer to develop. In October 2023, UV1 received Orphan Drug Designation by the FDA for the treatment of mesothelioma.

In December 2021, the FDA granted Orphan Drug Designation for UV1 for the treatment of stage IIB-stage IV melanoma. In October 2021, the FDA granted Fast Track designation for UV1 as an add-on therapy to ipilimumab or pembrolizumab for the treatment of unresectable or metastatic melanoma.