Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines,  announced that the European Medicines Agency (EMA) has issued a positive opinion on the company’s application for Orphan Drug Designation (ODD) for its therapeutic cancer vaccine UV1 for the treatment of mesothelioma. This designation comes in light of compelling results from the Phase II clinical trial, NIPU, evaluating UV1 in combination with ipilimumab and nivolumab treatment for patients with malignant pleural mesothelioma.

Carlos de Sousa, CEO of Ultimovacs, expressed enthusiasm for the EMA's decision, stating, “The EMA’s Orphan Drug Designation for UV1 in mesothelioma is an important step forward in the development of our cancer vaccine in this indication. It allows for important regulatory and commercial benefits and provides us with the potential to rapidly advance UV1 for a patient population with poor prognosis and a high unmet medical need.”

Mesothelioma, a rare and aggressive cancer often associated with asbestos exposure, presents a significant challenge in treatment due to its limited therapeutic options and high mortality rate. UV1's promising performance in the NIPU trial, where it was combined with checkpoint inhibitors ipilimumab and nivolumab, showcased a notable improvement in overall survival compared to treatment with ipilimumab and nivolumab alone as a second-line treatment after platinum-based chemotherapy.

Orphan Drug Designation by the EMA signifies regulatory recognition of UV1's potential to address an unmet medical need in a condition affecting fewer than five in 10,000 people in the EU. This designation provides Ultimovacs with valuable benefits and incentives, including market exclusivity, clinical protocol assistance, and reduced regulatory fees.

UV1's journey towards regulatory approval has been marked by significant milestones, including the recent Fast Track designation granted by the U.S. Food and Drug Administration (FDA) for its use in combination with ipilimumab and nivolumab for the treatment of unresectable malignant pleural mesothelioma. Earlier, UV1 also received Orphan Drug Designation from the FDA for the treatment of mesothelioma and stage IIB-stage IV melanoma, underscoring its potential as a breakthrough therapy in oncology.

Ultimovacs remains committed to advancing UV1 as a promising cancer vaccine, with the aim of improving treatment outcomes and quality of life for patients battling mesothelioma and other challenging malignancies.