Report

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.
Underlying
Ultimovacs

Ultimovacs ASA Formerly known as Ultimovacs AS. Ultimovacs ASA, formerly Ultimovacs AS, is a Norway-based pharmaceutical company developing immunotherapies against cancer. The Company's lead product candidate is UV1, a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immuno-oncology drugs which require an ongoing T cell response for their mode of action. The Company is performing a broad clinical development program with clinical trials in Europe and the USA.

Provider
Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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