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Metastatic Melanoma Vaccine Candidate Granted Orphan Drug Designation

December 2, 2021 • 5:23 pm CST
(Vax Before Cancer)

Norway-based Ultimovacs ASA today announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company’s universal cancer vaccine UV1 to treat stage IIB – IV melanoma.

UV1, as an add-on therapy to checkpoint inhibitors ipilimumab and nivolumab.

And UV1 is currently being studied as a first-line treatment for metastatic melanoma in a Phase II trial named INITIUM.

The FDA Orphan drug designation provides certain benefits, including seven-year market exclusivity upon regulatory approval if received, exemption from FDA application fees, and tax credits for qualified clinical trials.

“We are very pleased to have been granted this orphan drug designation for UV1 in treating metastatic melanoma. The designation underlines the promise of UV1 that has been shown in our clinical studies in metastatic melanoma to date,” said Carlos de Sousa, CEO of Ultimovacs, in a press statement issued on December 2, 2021.

“We remain committed to further investigating UV1 in our ongoing Phase II clinical studies and to continuing our constructive dialog with regulators to bring UV1 to patients as soon as possible.”

In October 2021, the FDA granted Fast Track designation to UV1 as an add-on therapy to ipilimumab or pembrolizumab to treat unresectable or metastatic melanoma.

Melanoma is the fifth most common cancer in both men and women in the U.S., with more than 100,000 new cases of melanoma diagnosed every year.

UV1 is being investigated in combination with checkpoint inhibitors in Phase II trials covering advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma, malignant pleural mesothelioma, and non-small cell lung cancer.

In total, the five Phase II trials will enroll more than 650 patients at nearly 100 clinical centers across 15 countries.

Ultimovacs, based in Oslo, Norway, is developing immune-stimulatory vaccines to treat a broad range of cancers.