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2020-06-15 17:00:00
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 dosed in the global, randomized Phase II INITIUM clinical trial testing Ultimovacs’ lead candidate, UV1, in combination with ipilimumab and nivolumab in 154 patients with metastatic malignant melanoma. The first patient was dosed at the Oslo University Hospital (OUS) which is the first site to open in this trial. Topline results are anticipated to be announced in the second half of 2022. Jens Bjørheim, Chief Medical Officer at Ultimovacs ASA commented: “As our Company-sponsored Phase II trial, INITIUM represents an important focus for our UV1 clinical development program. The first patient dosed marks the achievement of an important milestone for the Company in our lead indication, metastatic malignant melanoma, in which patients often do not have a long-lasting response to current treatments. As a Phase II proof of concept study, the INITIUM trial has the potential for regulatory submission based on supportive trial results. We look forward to the continued enrollment in the INITIUM trial as it is an important part of our extensive Phase II clinical program in which we are planning to include more than 400 patients in three studies.” Carlos de Sousa, Chief Executive Officer at Ultimovacs ASA added: “The dosing of the first patient in the INITIUM trial today coincides with the dosing of the first patient in the other Phase II clinical trial, NIPU, which will test UV1 in patients with advanced malignant pleural mesothelioma. These important milestones follow our recent announcement of entry into a collaboration with a big pharma company and European oncology clinical trial group to evaluate UV1 in another oncological indication. Subsequently, the Company also successfully completed an oversubscribed private placement, which fully finances the current UV1 clinical development program. It is exciting to join Ultimovacs at this particularly dynamic time and I look forward to supporting the Company as it explores the potential of its universal cancer vaccine in patients with difficult to treat cancers.” Ultimovacs is in the process of activating more than 35 sites globally for the INITIUM trial. Additional hospitals in Norway, other European countries as well as the United States will be opened for patient inclusion throughout the second and third quarters of 2020. About INITIUM 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. 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 INITIUM trial described above, UV1 will be tested in two other randomized Phase II trials: • 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). Planned readout of the primary endpoint progression-free survival is H2-2022. • 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