Ultimovacs Announces Completed Patient Recruitment in NIPU Phase II Clinical Trial of UV1 in Mesothelioma
- Full recruitment of 118 patients with mesothelioma in Scandinavia, Spain and Australia
- The study provides randomized data on impact of UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab
- Topline progression-free survival data expected H1 2023
Oslo, 23 January2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces the completed recruitment of 118 patients with pleural mesothelioma in the NIPU trial.
NIPU is a randomized, multi-center phase II trial initiated and sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. UV1 is being evaluated in combination with the checkpoint inhibitors ipilimumab and nivolumab as second-line treatment for patients with malignant pleural mesothelioma. The ipilimumab and nivolumab combination is standard-of-care treatment for patients with malignant pleural mesothelioma in Europe and the U.S.
“We are pleased to see the NIPU trial fully enrolled. We are dedicated to advancing the care of patients suffering from mesothelioma, for which current treatment options are limited,” said Åslaug Helland, Principal Investigator in the NIPU trial and Professor at Oslo University Hospital.
Happening most frequently to people with occupational asbestos exposure risks, malignant pleural mesothelioma is a cancer of the lining of the lungs and the internal thoracic wall. Time from exposure to asbestos to diagnosis of disease usually takes several decades. The life expectancy for most mesothelioma patients is approximately 12 months after diagnosis, indicating a high unmet medical need. The treatment combination evaluated in the NIPU trial represents an innovative approach for treatment of patients with malignant pleural mesothelioma.
Consistent with NIPU’s event-driven design, topline progression-free survival results will be disclosed after progression of cancer or death has been observed in a total of 69 patients. Data readout from the trial is expected during the first half of 2023. The topline results will be disclosed through a press release followed by a more in-depth presentation of the results in an article and at a medical conference.
Ultimovacs' universal cancer vaccine, UV1, is being investigated in combination with checkpoint inhibitors in five comparative phase II clinical trials. NIPU is the second of these studies to complete recruitment of patients, following the INITIUM study in metastatic malignant melanoma. Topline readout from both these studies during is expected during the first half of 2023.
“We are entering a very exciting period for Ultimovacs as we are approaching topline readouts from the first two of the company’s five randomized phase II clinical studies investigating UV1,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “If positive, these results have the potential to be transformative for the treatment of cancer patients with a severe unmet need, and for Ultimovacs on our mission to support these patients.”
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized, multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1, will be evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors, nivolumab and ipilimumab, as second-line treatment in malignant pleural mesothelioma. The trial sponsor is Oslo University Hospital, supported in the preparation and execution of the trial by Ultimovacs and Bristol-Myers Squibb. The 118 patients are randomized 1:1 into two treatment arms. All participants receive treatment with nivolumab (240 mg every 2 weeks) and ipilimumab (1 mg/kg every 6 weeks) until disease progression, unacceptable toxicity or for a maximum of 2 years. Patients randomized to the experimental arm receive 8 intradermal injections of UV1 vaccine during the first three months of treatment. The objective of the study is to achieve a clinically meaningful progression-free survival (PFS) benefit in patients with malignant pleural mesothelioma (MPM) after progression on first-line standard platinum doublet chemotherapy.
Malignant pleural mesothelioma is a rare and aggressive type of cancer that occurs in the thin layer of tissue that surrounds the lungs and inside of the chest. Mesothelioma accounted for 30 870 new cancer cases and 26 278 cancer deaths worldwide in 2020, according to International Agency for Research on Cancer (Globocan 2020). Pleural mesothelioma is a disease with a high unmet medical need, especially in industrialized countries. The median overall survival is approximately 1 year. Occupational asbestos exposure is the No. 1 cause of the disease, and several occupations like firefighters, military veterans, construction, and industry workers, pose a high risk. This cancer usually takes several decades to develop after a person’s first exposure to asbestos. Most people receive a diagnosis after age 70 because of the long latency period. Even though the use of asbestos to a large extent is banned in many countries today, new incidences of mesothelioma will continue to be a medical and public health challenge because of the long latency period typical of the illnesses. For patients with inoperable disease, few treatment options are available after first line chemotherapy. The combination of ipilimumab and nivolumab has recently shown increased survival compared to standard chemotherapy, but most patients do not respond, and improvements are called for. Telomerase is expressed in mesothelioma cells and is therefore an attractive target for therapeutic vaccination.
Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in 85-90% of cancers in all stages of tumor growth. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor and the draining lymph nodes to activate an immune system cascade and increase anti-tumor responses. With a broad Phase II program in five cancer indications enrolling more than 650 patients, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types, in combination with other immunotherapies, for patients with unmet needs. Ultimovacs’ second technology approach, based on the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the same molecule and entered Phase I studies in 2021.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Anne Worsøe, Head of IR & Communication
Phone: +47 90686815
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on 23 January, 2023 at 08:00 CET.
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