The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
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.”
Drugs such as Merck’s Pembrolizumab (Keytruda) and Bristol Myers Squibb’s nivolumab (Opdivo) and ipilimumab (Yervoy) are monoclonal antibody medications designed to prevent cancers from stimulating certain immune-suppressant checkpoints, thereby increasing the activity of the immune system.
Ultimovacs UV1 takes advantage of this increased activity by stimulating the immune system to target human telomerase (hTERT) antigens that are present in over 80% of all types of cancer. Ideally, this leads CD4 helper T cells toward tumor cells in order to trigger an immune system cascade. When used in conjunction with checkpoint inhibitors such as ipilimumab and pembrolizumab, Phase I trials showed significantly high percentages of melanoma patients surviving one to two years after the study.
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy. Patients treated with UV1, in combination with either partner therapy, achieved an objective response rate of 57%, with 30% of these patients enjoying a complete response or complete tumor remission. At the 24-month follow-up, 80% of these patients were still alive.
Currently, similar Phase II trials are underway to test UV1 and friends against three other cancers: ovarian cancer, head and neck squamous cell carcinoma and malignant pleural mesothelioma. Meanwhile, a fourth Phase II study is further addressing the treatment of unresectable or metastatic melanoma with UV1 in combination with ipilimumab and nivolumab.
Fast Track status is reserved for research programs focused on the development of drugs that address serious medical conditions and fill an unmet medical need, with the goal of accelerating particularly promising treatments to patients with high unmet needs.
These programs are entitled to a closer relationship with the FDA that ensures expeditious drug development and approval, including resources such as more frequent opportunities for feedback, eligibility for accelerated approval and priority review and additional meetings to discuss the drug’s development plan.
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