Ultimovacs Updates UV1 Phase II NIPU Mesothelioma Trial Data at ESMO 2024

On September 9, 2024, Ultimovacs ASA, a clinical-stage biotechnology company focused on creating innovative cancer immunotherapies, announced the findings from the UV1 Phase II NIPU trial at the 2024 ESMO Congress. This trial examined the efficacy of the UV1 telomerase vaccine in combination with immunotherapy drugs ipilimumab and nivolumab, as a second-line treatment for patients suffering from inoperable malignant pleural mesothelioma. The results were previously mentioned at ESMO 2023, revealing that the trial did not achieve its primary goal of improving progression-free survival (PFS) according to a blinded, independent central review. However, the study did indicate significant improvements in key secondary outcomes, such as a doubling of the objective response rate (ORR) and a 27% reduction in the risk of death.

At the 2024 ESMO Congress, updated data highlighted enhanced clinical benefits particularly in the epithelioid subgroup of mesothelioma patients. This group, which constitutes around 70% of mesothelioma cases, showed a median PFS of 5.5 months when treated with UV1 in combination with ipilimumab and nivolumab, compared to 2.9 months for those receiving only the immunotherapy drugs. Additionally, the updated data indicated a positive trend in overall survival (OS) for patients treated with UV1, although the advantage was somewhat less than earlier reports suggested.

The detailed findings will be showcased in a poster at the ESMO Congress in Barcelona, Spain, from September 13-17, 2024, with a presentation scheduled for September 14. The details are available on Ultimovacs' website, where the poster will also be uploaded post-presentation.

The NIPU trial, a randomized, open-label Phase II study, was led by Oslo University Hospital and supported by Bristol-Myers Squibb and Ultimovacs. Conducted across six university hospitals in Australia, Denmark, Norway, Spain, and Sweden, the study involved 118 patients randomized between June 2020 and January 2023. The patients were divided into two groups: one group received nivolumab and ipilimumab, while the other received the same drugs along with the UV1 vaccine. The primary goal was to observe a clinically significant benefit in patients whose disease had progressed despite first-line platinum doublet chemotherapy. The study continues to monitor the patients for subsequent events.

UV1, developed by Ultimovacs, is a universal cancer vaccine designed to provoke a specific T cell response against telomerase, an enzyme prevalent in 85-90% of cancer types. The vaccine comprises synthetic peptides that activate CD4+ T cells, which are instrumental in initiating a robust anti-tumor immune response. This activation happens through intradermal injections, where antigen-presenting cells (APCs) process the peptides and present them to naïve T cells in the lymph nodes. These activated T cells then circulate to identify and attack tumor cells.

Ultimovacs, dedicated to pushing the boundaries of cancer treatment, is currently evaluating the safety and efficacy of UV1 in various Phase II trials covering melanoma, mesothelioma, head and neck cancer, ovarian cancer, and non-small cell lung cancer. These studies span across the U.S., Europe, and Australia, involving over 750 patients. Additionally, Ultimovacs is working on novel conjugation technology aimed at broadening its vaccine pipeline and creating new therapeutic modalities across multiple disease areas.

Ultimovacs continues to strive towards providing new treatment options for cancer patients who do not benefit from the existing standards of care, and the latest data from the NIPU trial bolsters the rationale for further exploration of UV1, particularly for patients with epithelioid mesothelioma.