UV1 Earns Orphan Drug Status for Metastatic Melanoma


On December 2, 2021, Ultimovacs ASA (“Ultimovacs”) announced via news release that its universal cancer vaccine, UV1, received Orphan Drug designation from the FDA. UV1 is designed for those with stage 2B melanoma to stage 4 melanoma, also known as metastatic melanoma. While it can be used in conjunction with ipilimumab and nivolumab, researchers are also evaluating UV1 as a potential monotherapy.

According to Precision Vaccinations, UV1 is:

a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. Unlike algorithm-selected vaccine peptides, the UV1 peptides contain epitopes documented by cancer patients’ immune systems [and] leverages the high prevalence of the human telomerase.

Previously, UV1 received Fast Track designation as an adjunctive therapy. Now, the treatment has received Orphan Drug designation. This status is granted to products designed to treat, diagnose, or prevent rare diseases, defined as affecting under 200,000 Americans. As a result, Ultimovacs also receives a variety of benefits. These include fee waivers, tax credits, increased regulatory assistance, and 7 years market exclusivity upon approval.

Metastatic Melanoma

Melanoma is a severe form of skin cancer which forms in melanocytes, or melanin-producing cells. While melanoma can occur in children, it most often occurs in adults. Melanoma is often found on the head, neck, or shoulders to hips for men, or on the arms and legs in women. Most often, melanoma forms on areas with high sun exposure. Other risk factors include having fair skin, having a family history of melanoma, or being older. Symptoms include skin color changes, as well as the appearance of new moles that change in color or diameter, have an irregular border and/or asymmetrical shape, and are evolving over time.

Metastatic melanoma, or stage 4 melanoma, occurs when the cancer spreads (metastasizes) throughout the body. Unfortunately, the prognosis is not great, with a 5-year survival rate of around 20-30%. Symptoms of metastatic melanoma depend on where the cancer has spread. Potential symptoms include:

  • Unintended weight loss
  • Swollen or painful lymph nodes
  • Enlarged liver
  • Headache
  • Weakness or numbness that affects the extremities
  • Appetite loss
  • Difficulty breathing
  • Hard lumps under the skin
  • Fatigue
  • Bone pain and/or broken bones
  • Seizures

Learn more about metastatic melanoma here.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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