Research & Development
Ultimovacs gains EMA Orphan Drug status for UV1 cancer vaccine in mesothelioma
19 February 2024 -

Norway-based clinical-stage biotechnology company Ultimovacs (OSE:ULTI) announced on Monday that it has secured Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its UV1 cancer vaccine in mesothelioma, supported by positive results from the NIPU Phase II trial.

UV1 has also received ODD from the US Food and Drug Administration (FDA) for treating mesothelioma and malignant melanoma stages IIB to IV.

In the EU, ODD provides exclusive market rights for 10 years, clinical protocol assistance, centralised marketing authorisation and reduced regulatory fees.

Mesothelioma, often linked to asbestos exposure, lacks effective treatments, making UV1's approval significant. The NIPU trial demonstrated UV1's efficacy in combination with ipilimumab and nivolumab, showing improved overall survival without added toxicities.

Recently approved Fast Track designation from the FDA further accelerates UV1's path to approval, marking potentially significant progress in mesothelioma treatment.