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Mechanistic Rationale of Cancer Vaccine Supporting Phase 2 Study in Malignant Mesothelioma Treatment

June 1, 2021 • 1:17 pm CDT
(Vax Before Cancer)

Norway-based Ultimovacs ASA announced that a peer-reviewed article on the ongoing NIPU Phase II trial of the Company’s universal cancer vaccine, UV1, in malignant pleural mesothelioma (MPM) was published. Journal of Translational Medicine.

This article outlines the mechanistic rationale for using the combination of UV1 with two checkpoint inhibitors, ipilimumab and nivolumab.

The dual-use of ipilimumab and nivolumab was recently approved as first-line therapy in MPM, where few therapeutic options are currently available.

However, as Haakensen et al. explains in the article, observed response rates with checkpoint inhibitors have been moderate in MPM compared to documented performance for the combination of checkpoint inhibitors in other cancers, suggesting that checkpoint inhibitors alone may be insufficient to trigger an immune response.

Earlier phase I/II studies have shown that UV1 is safe on its own and when used in combination with checkpoint inhibitors and that it induces vaccine-specific immune response associated with survival.

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. 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 as well as encouraging signals of efficacy.

“The NIPU trial is important in understanding the potentially synergistic activities of checkpoint inhibitors and our universal cancer vaccine, UV1,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs, in a press release. 

“Malignant pleural mesothelioma is a challenging disease to treat even with checkpoint inhibitors that have been effective in other types of cancer. The article published today explains how we think UV1 may help in meeting that challenge.”

NIPU is a randomized, multi-center, open-label, proof of concept study comparing the efficacy and safety of nivolumab and ipilimumab with or without UV1 in patients with inoperable malignant pleural mesothelioma after first-line platinum-based chemotherapy.

Article details:  Haakensen, V.D., Nowak, A.K., Ellingsen, E.B. et al. NIPU: a randomized, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second-line treatment in patients with malignant mesothelioma. J Transl Med 19, 232 (2021).

About Ultimovacs: Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to treat a broad range of cancers. For further information, please see