Ultimovacs Announces Updated Data Analysis on UV1 Phase II NIPU Trial in Mesothelioma at ESMO 2024

Oslo, September 9, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing novel immunotherapies against cancer, announces the presentation of updated data analysis from the UV1 Phase II NIPU trial (NCT04300244), at the 2024 ESMO Congress. The NIPU trial evaluated the addition of UV1 telomerase vaccine to immunotherapy with ipilimumab and nivolumab compared with ipilimumab and nivolumab alone, as a second-line treatment for patients with inoperable malignant pleural mesothelioma. As presented at ESMO 2023, the trial did not meet the primary endpoint of improved progression-free survival (PFS) by blinded, independent central review (BICR), however the data showed a meaningful benefit on the key secondary endpoints including a doubling of objective response rate (ORR) and a 27% reduction in risk of death. The ESMO 2024 poster presentation highlights an increased clinical benefit observed for the epithelioid subgroup, demonstrating an improvement in median PFS of 5.5 months for UV1 in combination with ipilimumab and nivolumab, versus a median PFS of 2.9 months for immunotherapy alone. The epithelioid subtype represents approximately 70% of all patients with mesothelioma. In addition, the ESMO 2024 data presentation demonstrates a positive difference in overall survival (OS) for UV1 treatment at the latest patient follow-up, although the degree of benefit is less than previously reported.

The full results will be presented in a poster at the congress, held in Barcelona, Spain from September 13-17, 2024. The abstract is available on the Ultimovacs website (under the section 'Presentations and publications') and the poster will be available on the Ultimovacs website after the presentation on Saturday, September 14.

Title: 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
Presentation Number: 1917P
Speaker: Vilde D. Haakensen, MD, PhD, Project Group Leader at the Oslo University Hospital
Date: Saturday, September 14, 2024

NIPU is an investigator-initiated, randomized, 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. A total of 118 patients were randomized between June 2020 and January 2023.