Ultimovacs granted Orphan Drug Designation by FDA

Ultimovacs has announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) for the company’s universal cancer vaccine UV1 for the treatment of stage IIB – IV melanoma.

UV1, as an add-on therapy to checkpoint inhibitors ipilimumab and nivolumab, is currently being studied as a first-line treatment for metastatic melanoma in a Phase II trial named INITIUM.

“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,” says Carlos de Sousa, CEO of Ultimovacs. “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.”

Fast Track designation in October

In October this year, the U.S. FDA granted Fast Track designation to UV1 as an add-on therapy to ipilimumab or to pembrolizumab for the treatment of unresectable or metastatic melanoma.

Five Phase II trials

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