Universal Cancer Vaccine Candidate Presents Positive Long-term Benefits

A clinical-stage leader in immune-stimulatory vaccines for cancer announced the publication of its favorable long-term Overall Survival (OS) data from a Phase I trial evaluating a universal cancer vaccine candidate, UV1, in combination with checkpoint inhibitor ipilimumab, in patients with metastatic malignant melanoma.

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. 

Published in the Frontiers in Immunology journal on May 11, 2021, Norway-based Ultimovacs ASA’s UV1 vaccine candidate achieved the primary endpoints of safety and tolerability.

Fifty percent of the study’s late-stage patients were still alive at the data cut-off, supporting the combination of the UV1 vaccine with ipilimumab, a CTLA-4 checkpoint inhibitor, and standard-of-care treatment.

Jens Bjørheim, Chief Medical Officer at Ultimovacs, commented in a related press statement, "Historical data on the use of ipilimumab as monotherapy in malignant melanoma have shown a 5-year survival rate below 20%. Therefore the results published today reinforce UV1's potential in this indication."

The data published in Frontiers in Immunology covers 4.8 years of follow-up on the total of 12 metastatic malignant melanoma patients that were enrolled in the Phase I trial. As reported, the OS was 50% at 4.8 years, confirmed by five years of follow-up announced by the Company in December 2020. 

Building on these promising Phase I results, Ultimovacs is currently enrolling its Phase II clinical trial (INITIUM) evaluating UV1 combined with ipilimumab and nivolumab in patients with metastatic malignant melanoma. The company expects to announce data on the trial's primary endpoint in 2H2022. 

In addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating UV1 in combination with pembrolizumab, a PD-1 checkpoint inhibitor, as a first line treatment in metastatic malignant melanoma patients. 

UV1 is being developed as an "off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. 

To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile and encouraging signals of efficacy. 

Ultimovacs anticipates announcing data on the primary endpoints for other studies in 2H2022 and 2023.

The trial was conducted under the ethical principles of the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice and approved by an independent ethics committee and the appropriate national and institutional review boards.

This work was supported by Ultimovacs ASA, the Norwegian Ministry of Health and Care Services, and the Norwegian Cancer Society [grant number 2220815]. Ultimovacs was involved in the study design of the trial.

Located in Osla, Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to treat various cancers.

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