Ultimovacs - FDA Fast Track boosts confidence in UV1

Ultimovacs has received FDA Fast Track designation for its lead cancer vaccine, UV1, as a potential treatment for mesothelioma and builds on the Orphan Drug designation (ODD) already received in this indication. The designation offers a potentially accelerated route to market (if the clinical data continue to be supportive) as Ultimovacs progresses its universal vaccine in combination with checkpoint inhibitors across five indications. This regulatory decision was based on the positive results of the Phase II NIPU trial (reported October 2023), which showed a 27% reduction in risk of death with UV1 treatment compared to control. While management carefully evaluates an optimal path forward (Phase III programme) in mesothelioma, the most significant near-term catalyst remains the Phase II INITIUM results in malignant melanoma (expected March 2024). The company is scheduled to release FY23 earnings on 14 February and will likely provide an update then.

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