Oslo, 15 June 2020: Ultimovacs ASA (“Ultimovacs” or “Company”, ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, announced today that the first patient has been enrolled in the Phase II NIPU trial evaluating its lead product, UV1, as part of a combination treatment regimen against advanced malignant pleural mesothelioma (MPM), a rare lung cancer. The current clinical development timeline for UV1 in this indication remains in line with past guidance.
The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, will be investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in 118 patients with advanced malignant pleural mesothelioma. Oslo University Hospital (OUS) is the trial sponsor and first site to open. OUS is partnered with Ultimovacs and the global pharmaceutical leader, Bristol-Myers Squibb, which will provide ipilimumab and nivolumab for this study. OUS is in the process of activating the remaining sites in this trial.
Jens Bjørheim, Chief Medical Officer at Ultimovacs ASA commented:
“Advanced malignant pleural mesothelioma is an indication that still has a high unmet medical need. As such, the collaboration group with OUS and Bristol-Myers Squibb enables Ultimovacs to evaluate UV1 in a difficult-to-treat type of cancer in which we believe it could add benefit and work synergistically with checkpoint inhibitors. The continued enrollment in the NIPU trial remains an important part of our extensive Phase II clinical program in which we are planning to include more than 400 patients in three studies. Our hope is to provide an improved therapeutic option to patients suffering from a disease in which median overall survival is one year.”
Carlos de Sousa, Chief Executive Officer at Ultimovacs ASA added:
“The initiation of the NIPU trial follows the recent announcement of the entry into a collaboration with a big pharma and a leading European oncology clinical trial group as well as the successful completion of an oversubscribed private placement which fully finances the current UV1 clinical development program. The dosing of the first patient in our Phase II INITIUM trial in metastatic malignant melanoma is also expected soon. We are grateful for the support from our collaborator group that provides significant value to the program and enables the testing of UV1 in an underserved indication. Our goal is to continue to apply this type of collaboration model to the ongoing evaluation of UV1 in the future and ideally, deliver the full value of immunotherapy to patients in need.”
About NIPU
The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in mesothelioma. Oslo University Hospital (OUS) is the sponsor of the NIPU study. Bristol-Myers Squibb 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 NIPU study. Half of the patients will be treated with the combination of UV1, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at six national hospital centers specialized in treating mesothelioma in four countries (Norway, Sweden, Denmark and Australia). The study sites are planned to be Oslo University Hospital in Norway, Karolinska University Hospital and Skåne University Hospital Lund in Sweden, Copenhagen University Hospital and Aalborg University Hospital in Denmark and University of Western Australia in Perth, Australia.
The objective of the study is to induce a clinically meaningful progression-free survival benefit in patients with advanced malignant pleural mesothelioma after progression on first-line standard platinum doublet chemotherapy. The primary endpoint of the trial is progression-free survival. Planned readout of topline results is expected in the second half of 2022.
Advanced malignant pleural mesothelioma is a rare malignant tumor originating from the cells lining the mesothelial surface in the lungs. It 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. It is a serious form of thoracic cancer that is diagnosed in more than 30,000 and kills over 25,000 people per year.
About UV1 and the Phase II Clinical Trials
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 immuno-oncology drugs which require an ongoing T cell response for their mode of action. To date, UV1 has been tested in four clinical trials in a total of 78 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.
In addition to the NIPU trial described above, UV1 will be tested in two other randomized Phase II trials:
• The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma. Patients will be given UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor). The trial will be run in the US and Europe (including Norway). A total of 154 patients will be enrolled in the INITIUM study. 77 of the patients will be treated with nivolumab and ipilimumab, whereas the other 77 patients will receive nivolumab, ipilimumab and UV1. The primary endpoint of the study is progression-free survival. Planned readout of topline results is expected in the second half of 2022.
• A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.
The Phase II clinical program builds on three completed studies and one ongoing Phase I clinical trial. The Phase II trials will evaluate UV1 in three different indications in more than 400 patients and in collaboration with two big pharma companies. These trials are all fully financed. The ongoing and planned clinical trials represent a strong platform for Ultimovacs to advance towards a potential registration of the universal cancer vaccine, UV1.
For further information, please visit www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632