OSLO, Norway, June 01, 2021 (GLOBE NEWSWIRE) — Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today 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) has been published. The article in The Journal of Translational Medicine outlines the mechanistic rationale for the use of the combination of UV1 with two checkpoint inhibitors, ipilimumab and nivolumab.
The dual use of ipilimumab and nivolumab was recently approved as a first-line therapy in MPM where few therapeutic options are currently available. However, as Haakensen et al explain 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.
“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. “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-centre, 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 (NCT04300244).
Haakensen, V.D., Nowak, A.K., Ellingsen, E.B. et al. NIPU: a randomised, 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)
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.
About UV1 Clinical Programs
As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. The DOVACC study is sponsored by the Nordic Society of Gynaecological Oncology. In total, 184 patients with high-grade ovarian cancer will be enrolled to evaluate UV1 in combination with durvalumab and olaparib, both provided by AstraZeneca. FOCUS is an investigator-sponsored, randomized clinical trial enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, and will evaluate the impact of adding UV1 to this regimen. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and for the DOVACC and FOCUS studies in 2023.
Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor’s growth and its microenvironment. By directing the immune system to hTERT antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s impact in many cancer types and in combination with other immunotherapies. The Company will expand its pipeline using its novel TET-platform, which is an innovative vaccine technology that can generate multiple vaccine candidates designed to achieve increased T cell responses to a broad range of target antigens.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, Chief Executive Officer
Phone: +47 908 92507
Hans Vassgård Eid, Chief Financial Officer
Phone: +47 482 48632