FDA Puts Ultimovac’s Cancer Vaccine Support Therapy on Fast Track

Norwegian pharmaceutical company Ultimovacs ASA announced Thursday that it has received Fast Track designation from the U.S. Food and Drug Administration for its most promising research product, UV1, as an add-on therapy to either pembrolizumab or ipilimumab in the treatment of unresectable or metastatic melanoma.

Ultimovacs, which is partnered with the Oslo Cancer Cluster, a non-profit organization comprised of hospitals, start-ups, patient organizations, and global pharmacy and technology companies, is headquartered in the Oslo Cancer Cluster’s Innovation Park.

Founded on proprietary technology developed from immunotherapy research conducted at the Oslo University Hospital, Ultimovacs is dedicated to becoming a leader in the development of broad-target, immune-stimulatory cancer vaccines.

“We are delighted UV1 has received the Fast Track designation and look forward to working more closely with the FDA to bring UV1 to melanoma patients as soon as possible,” said Ultimovacs Chief Executive Officer Carlos de Sousa. “The FDA’s decision recognizes the potential synergy of UV1 and checkpoint inhibitors and will greatly encourage physicians and patients involved in our Phase II clinical trial INITIUM. We remain committed to progressing UV1 in our four ongoing Phase II clinical studies and assessing development of UV1 with pembrolizumab in advanced melanoma.”

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