Ultimovacs - Another ODD boosts the off-the-shelf, universal UV1

Ultimovacs has been granted Orphan Drug designation (ODD) from the European Medicines Agency (EMA) for UV1 in mesothelioma, marking another step forward for the clinical development of its lead universal, off-the-shelf cancer vaccine. This encouraging regulatory designation follows on the heels of the FDA ODD (October 2023) and Fast Track designation (February 2024) for UV1 in this same indication, which helps set the foundation for a potential Phase III programme. A key benefit of EU ODD is the potential for 10-year market exclusivity, provided UV1 achieves regulatory approval. The EMA decision was based on the recent positive data from the Phase II NIPU trial (reported October 2023) demonstrating a 27% reduction in risk of death with UV1 treatment compared to the standard of care in patients with malignant pleural mesothelioma (MPM). We await the results from the Phase II INITIUM trial in malignant melanoma (MM), the company's lead indication, in March 2024, which is likely the next catalyst for the company.

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