Ultimovac’s cancer vaccine UV1 triggers an immune response against malignant plural mesothelioma. Image Credit: Shutterstock/Sergey Nivens

Ultimovacs has received an orphan drug designation from the US Food and Drug Administration (FDA) for its lead therapeutic cancer vaccine UV1’s study in mesothelioma.

The vaccine is designed to induce an immune response against the cancer cell proliferation enzyme telomerase (hTERT), in patients with malignant pleural mesothelioma, which is the most common form of malignant mesothelioma.

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UV1 consists of three synthetic hTERT peptides selected based on epitope-spreading data. As per the company, these chains have demonstrated strong CD4+ T-cell responses across different cancer types. UV1 is currently being investigated in a broader, multi-center Phase II program across five different indications.

The orphan drug designation was based on initial data from Phase II NIPU study (NCT04300244), a randomised, open-label clinical trial sponsored by Oslo University Hospital and conducted in Norway, Spain, Australia, Denmark, and Sweden.

In the study, UV1 was given to 118 patients in conjunction with Bristol-Myers Squibb’s checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) as a second-line cancer treatment after platinum chemotherapy. The Opdivo/Yervoy combination is approved as a first-line treatment for malignant pleural mesothelioma in the US and Europe.

Patient enrollment began in June 2020 and ended in January 2023. The study did not meet its primary endpoint, but as per the company, there was a favourable trend in overall survival. Results from this trial will be presented at the upcoming ESMO Congress 2023 taking place 20-24 October in Madrid.

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The company is also evaluating UV1 in the Phase II INITIUM study (NCT04382664) as a treatment for first-line metastatic malignant melanoma—where the therapy also has an orphan drug designation. In this trial as well, UV1 is being studied in combination with Opdivo and Yervoy. In April, the company revised its estimates for when data from this trial would be available, from H1 to H2 2023, and then more recently to H1 2024, since disease progression in patients in the trial was occurring slower than anticipated.  

Following the news on the FDA designation, Ultimovacs chief executive officer Carlos de Sousa said, “Gaining FDA orphan drug designation for UV1 in mesothelioma highlights UV1’s potential and the significant need for new treatment options for this patient population.”

Mesothelioma is a rare form of cancer, which causes tumor growth along the thin tissue lining the lungs following exposure to environmental asbestos. It currently has a five-year survival rate of 12%.