NON-REGULATORY PRESS RELEASE
The NIPU trial is investigating the effect of adding UV1 vaccine to immunotherapy as second-line treatment of pleural mesothelioma. The results were initially presented at the ESMO Conference in October 2023 The publication outlines the full trial results, including observations on UV1’s positive impact on objective response rate, overall survival, and additional data on increased efficacy in defined histological subtypes Oslo, March 2, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that the results from the randomized controlled Phase II clinical trial, NIPU, are published in the European Journal of Cancer. The trial investigates the effect of adding Ultimovacs’ cancer vaccine UV1 to second-line treatment with ipilimumab and nivolumab for patients with pleural mesothelioma (NCT04300244). NIPU is an investigator-initiated, open-label, multi-center Phase II trial sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. Six university hospitals in Australia, Denmark, Norway, Spain, and Sweden participated in the trial. 118 patients were randomized between June 2020 and January 2023. The study did not meet its primary endpoint of improved progression-free survival (PFS) based on blinded independent central review (BICR). Analyses on the secondary endpoints, objective response rate (ORR) by BICR and overall survival (OS), showed a significant benefit of adding the UV1 vaccine to ipilimumab and nivolumab. Local assessment demonstrated an improved PFS among patients in the vaccine arm for all histological subtypes combined, and new subgroup analysis demonstrates further improvement for the epithelioid subtype. The epithelioid subtype represents approximately 70% of all patients with mesothelioma. Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate UV1 is 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 demonstrate UV1’s impact in combination with other immunotherapies in multiple cancer types expressing telomerase and where patients have unmet medical needs. UV1 is universal, off-the-shelf, and easy to use. UV1 is a patented technology owned by Ultimovacs. In addition, Ultimovacs holds all rights to the proprietary TET technology platform for any possible future formulations for the treatment of solid tumor indications. The Company is listed on the Euronext Oslo Stock Exchange (OSE: ULTI). 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, are at risk. This cancer usually takes several decades to develop after a person’s first exposure to asbestos. Most patients are diagnosed 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 illness. 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 a relevant target for therapeutic vaccination. 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. 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 with eight intradermal injections and the immune-modulator GM-CSF. For further information, please see www.ultimovacs.com or contact:
Email: carlos.desousa@ultimovacs.com
Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com
This stock exchange announcement was published by Anne Worsøe, Head at Investor Relations at Ultimovacs ASA, on March 2, 2024 at 18:40 CET.