Ultimovacs To Present Update of NIPU Phase II Trial in Patients with Malignant Mesothelioma

Ultimovacs to present update of NIPU phase II trial in patients with malignant mesothelioma at ESMO Congress 2024 from Sept 13-17 at Barcelona

Overview

Ultimovacs ASA, a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, has announced that an update from the phase II NIPU trial (NCT04300244) in patients with malignant mesothelioma will be presented in a poster presentation at the 2024 ESMO Congress. The conference will be held at Barcelona in Spain from September 13 to 17, 2024.

Updated survival and vaccine response from the NIPU trial -  A randomised, phase II study evaluating nivolumab and ipilimumab with or without UV1 vaccination in patients with pleural mesothelioma.

Previous Presentation of Data

• The first comprehensive data from the NIPU phase II trial was presented at the ESMO Congress 2023. 
• While the study did not meet its primary endpoint, UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab demonstrated clinically meaningful overall survival benefit with no added toxicities, compared to ipilimumab and nivolumab alone, in the second-line treatment of patients with malignant mesothelioma. 
• The results were also published in the European Journal of Cancer in March 2024.

About NIPU

• NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized, multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1, is evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors, nivolumab and ipilimumab, as second-line treatment of malignant mesothelioma. 
• The trial sponsor is Oslo University Hospital, supported in the preparation and execution of the trial by Ultimovacs and Bristol-Myers Squibb.

Trial Process

• 118 patients were 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 received 8 intradermal injections of UV1 vaccine during the first three months of treatment. 
• The objective of the study is to achieve a clinically meaningful benefit in patients with malignant mesothelioma (MPM) after progression on first-line standard platinum doublet chemotherapy. 
• Subsequent events emerging in patients in both arms of the NIPU study will continue to be monitored beyond read-out of the primary endpoint. 
• The ipilimumab and nivolumab combination has recently been approved as first-line treatment for patients with malignant pleural mesothelioma in Europe and the US.

The trial was sized to detect a target PFS HR of 0.6, with 80% power and a 1-sided alpha of 0.1. Overall survival was calculated using the same method as for PFS.

UV1 Vaccine

• UV1 is a universal cancer vaccine designed to induce a specific T-cell response against telomerase.
• UV1 consists of long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T-cells. 
• These CD4+ T-cells have the potential to provide inflammatory signals, and T-cell support is believed to be critical for triggering a strong anti-tumor immune response. 
• Following intradermal injection, antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides. 
• These APCs will process the peptides and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. 
• Activated vaccine-specific T-cells will then enter the circulation and search for cells displaying their cognate antigen in the context of HLA molecules.

About UV1 Peptides

• The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. 
• It is, therefore not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. 
• UV1 is administered over three months as eight intradermal injections together with the immune-modulator GM-CSF.

About Ultimovacs

• Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines. 
• The lead cancer vaccine candidate UV1 is an off-the-shelf vaccine directed against human telomerase (hTERT), an antigen present in 85-90% of cancers in all stages of tumor growth. 
• A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, aims to investigate UV1’s impact in combination with other immunotherapies in multiple cancer types. 
• UV1 is a patented technology owned by Ultimovacs. In addition, Ultimovacs holds all rights of the proprietary TET technology platform for any possible future use of formulations in various solid tumor indications.

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