The European Medicines Agency (EMA) has granted orphan drug designation to Ultimovacs for its universal cancer vaccine UV1 for the treatment of mesothelioma.
The positive opinion follows a similar move by the US Food and Drug Administration, which granted an orphan drug designation for UV1 in October 2023.
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The Norwegian biotech is now eligible for extra scientific advice on its drug, fee reductions, and the potential for ten years of market exclusivity, as per European orphan drug incentives.
The EMA based its decision on positive results from Ultimovacs’ Phase II NIPU trial evaluating the vaccine in malignant pleural mesothelioma patients, according to a 19 February press release.
UV1 works by inducing T cell response against telomerase reverse transcriptase (hTERT) – a protein that provides the limitless self-renewal hallmark in cancer progression. The antigen is present in around 85-90% of cancers, according to Ultimovacs. Mesothelioma is an aggressive cancer that develops in the lining of internal organs and is most commonly caused by exposure to asbestos.
The randomised, multi-centre, open-label, proof of concept Phase II study (NCT04300244) compared patients receiving UV1 in addition to the checkpoint inhibitors Yervoy (ipilimumab) and Opdivo (nivolumab)—both marketed by Bristol Myers Squibb (BMS)— to patients receiving Yervoy and Opdivo alone. All participants had already received platinum-based chemotherapy as first-line treatment. The trial has been conducted in collaboration with BMS.
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By GlobalDataUltimovacs has reported a clinically meaningful improvement in overall survival for the group receiving the cancer vaccine with a good safety and tolerability profile observed.
According to a ClinicalTrials.gov entry, 118 participants are estimated to enrol. The aim of the study, according to Ultimovacs, is to evaluate adding a therapeutic cancer vaccine to an immune checkpoint inhibitor regimen.
In addition to orphan designations in mesothelioma, UV1 also has FDA orphan drug status for the treatment of stage IIB-stage IV melanoma. The candidate has been granted two fast track designations by the FDA – one for unresectable malignant pleural mesothelioma to improve overall survival and the other for the treatment of unresectable or metastatic melanoma. The company says it has Phase II trials in five cancer indications in total.
Ultimovacs will face competition from big pharma as cancer vaccines gain traction across the industry. mRNA-based vaccines being developed by Pfizer/BioNTech and Moderna/MSD’s have gained the most attention, showcasing high efficacy in reducing cancer spreading and death. Whilst mRNA vaccines are tailored to specific cancers, Ultimovacs says its off-the-shelf has the potential to treat a broad range of cancers.
