On December 13, 2020 Ultimovacs reported that the universal cancer vaccine UV1 will be investigated in a randomized, multi-center phase II trial in mesothelioma. The trial, named NIPU, investigates UV1 in combination with the checkpoint inhibitors nivolumab and ipilimumab as second-line treatment in mesothelioma. Oslo University Hospital (‘OUS’) is the sponsor of the study (Press release, Ultimovacs, DEC 13, 2019, View Source;lang=en-GB&companycode=no-ulti&v= [SID1234598614]). Bristol-Myers Squibb (‘BMS’) and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. A total of 118 patients will be included in the study. Half of the patients will be treated with the combination of UV1, nivolumab and ipilimumab, whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at 6 hospitals in 5 countries (Norway, Sweden, Denmark, Finland, and Australia). The study is about to be initiated and patient inclusion is expected to start in Q1 2020. The primary endpoint of the trial is progression-free survival (PFS) and the PFS read-out is expected mid-2022. The necessary approvals from the Norwegian Medicinal Agency and the ethics committee in Norway are in place to initiate the trial. Ultimovacs will cover the costs associated with its participation in the study from existing funds. Dr. Åslaug Helland, Oslo University Hospital, principal investigator of the study, says: "We are enthusiastic about the initiation of this clinical trial which will be run with the support from BMS and Ultimovacs. Malignant pleural mesothelioma is the most common type of mesothelioma and is a disease with a high unmet medical need. The immunotherapy combination of nivolumab, ipilimumab and UV1 could represent a highly interesting treatment regime where the different mechanisms of action of the three drugs could provide synergistic effects that could be of clinical benefit to patients. " Øyvind Kongstun Arnesen, CEO of Ultimovacs, says: "We are pleased to take part in this exciting clinical trial with our universal therapeutic cancer vaccine, UV1. As we have previously seen, the combination of UV1 and ipilimumab provided rapid and durable immune responses in our phase I melanoma trial suggesting a synergistic immunological activity. The simultaneous administration of another checkpoint inhibitor, nivolumab, may further support the immune system’s ability to recognize and effectively kill the cancer cells. " The initiation of the NIPU trial brings UV1 in clinical investigation in its fourth cancer type to date. Previously, UV1 has been tested within prostate cancer, non-small cell lung cancer, and malignant melanoma. In Q1 2020, Ultimovacs expects to include the first of 154 patients in a randomized trial in malignant melanoma where UV1 is combined with nivolumab and ipilimumab. Øyvind Kongstun Arnesen, CEO of Ultimovacs, adds: "The fact that UV1 will be investigated in two large randomized clinical trials in different cancer types and with a total of 272 patients is a major step forward for Ultimovacs and the development of UV1. This will enhance the opportunities for successful clinical results in an additional cancer indication and support that UV1 may be broadly applicable across cancer types." About NIPU NIPU is an investigator-initiated, Oslo University Hospital sponsored, randomized, multi-center, open-label, proof of concept study comparing the efficacy and safety of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) with and without UV1 in patients with inoperable malignant pleural mesothelioma (MPM) who have progressed after first-line platinum-based chemotherapy. Biological material will be sampled, and there will be several explorative analyses aiming at identifying biomarkers and revealing mechanisms of action. In total, 118 patients will be randomized into two patient groups treated with ipilimumab and nivolumab with or without UV1 together with sargramostim (GM-CSF) as vaccine adjuvant. The objective of the study is to induce a meaningful progression-free survival (PFS) benefit in patients with MPM after progression on first-line standard platinum doublet chemotherapy. The study sites are planned to be Oslo University Hospital in Norway, Karolinska University Hospital and Skåne University Hospital Lund in Sweden, Rigshospitalet in Denmark, Helsinki University Hospital in Finland, and Sir Charles Gairdner Hospital in Perth, Australia. About Malignant Pleural Mesothelioma Malignant pleural mesothelioma (MPM) is a rare malignant tumor originating from the cells lining the mesothelial surface in the lungs. MPM is the most common type of mesothelioma and is a disease with a high unmet medical need with a median overall survival of approximately 1 year. Most patients are treated with palliative chemotherapy. Patients with disease progression after first-line therapy have few therapeutic options. Asbestos exposure is heavily linked to the development of the disease. It may take 10-50 years for symptoms of mesothelioma to manifest after initial asbestos exposure. Even though the use of asbestos to a large extent is banned today, new incidences of mesothelioma will continue to be a medical challenge for decades. About Ipilimumab Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. About Nivolumab Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, nivolumab has become an important treatment option across multiple cancers. About UV1 UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a 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. With its mechanism of action, UV1 is potentially a universal cancer vaccine that can be applied across most cancer types.

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