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Ultimovacs granted FDA Orphan Drug Designation for UV1 cancer vaccine in mesothelioma.

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NORDIC BUSINESS REPORT-October 9, 2023-Ultimovacs granted FDA Orphan Drug Designation for UV1 cancer vaccine in mesothelioma

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Norway-based clinical-stage biotechnology company Ultimovacs (OSE:ULTI) has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its therapeutic cancer vaccine UV1 for the treatment of patients with mesothelioma, the company announced on Monday.

This designation is based on preliminary data from the Phase II clinical trial, NIPU.

Mesothelioma, a rare and aggressive cancer, often linked to asbestos exposure, currently lacks effective treatment options.

The Phase II NIPU trial was designed to evaluate the impact of UV1 vaccination in combination with checkpoint inhibitors ipilimumab and nivolumab compared to ipilimumab and nivolumab alone as a second-line treatment after platinum-based chemotherapy. The multi-centre trial included 118 patients across several countries.

FDA Orphan Drug Designation aims to support the development of treatments for rare disorders affecting fewer than 200,000 individuals in the US, offering potential market exclusivity for up to seven years upon...

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