Melanoma Vaccine Candidate Granted FDA Fast-Track Designation

Norway-based Ultimovacs ASA announced today its universal cancer vaccine, UV1, in combination with checkpoint inhibitors, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) in treating unresectable or metastatic melanoma, either as an add-on therapy to pembrolizumab or as add-on therapy to ipilimumab.

Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.

Drugs with FDA Fast Track designation may also be considered for Accelerated Approval and Priority Review, provided certain criteria are met.

Carlos de Sousa, CEO of Ultimovacs, stated in a press release, "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 the development of UV1 with pembrolizumab in advanced melanoma."

The Fast Track designation is based on data from two separate Phase I trials of UV1 in combination with checkpoint inhibitors, either with pembrolizumab (anti-PD-1) or with ipilimumab (anti-CTLA-4).

Ultimovacs's UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. It is currently being investigated in combination with checkpoint inhibitors in four Phase II trials: unresectable or metastatic melanoma, ovarian cancer, head, and neck squamous cell carcinoma, and malignant pleural mesothelioma.

Ultimovacs (OSE ULTI) is developing immune-stimulatory vaccines to treat a broad range of cancers. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and increase anti-tumor responses. 

Ultimovacs is headquartered at the Oslo Cancer Cluster Innovation Park in Oslo, Norway, and also has an office in Uppsala, Sweden.