Ultimovacs announces updated data analysis of UV1 Phase II NIPU study in mesothelioma at ESMO 2024 Page 1

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

The full results will be presented in a poster at the Congress, which will be held in Barcelona, ​​Spain, from 13 to 17 September 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 14 September.

Title: Updated survival and vaccination response from the NIPU study; a randomized phase II trial evaluating nivolumab and ipilimumab with or without UV1 vaccination in patients with pleural mesothelioma
Presentation number: 1917P
Speakers: Vilde D. Haakensen, MD, PhD, Project Group Leader at Oslo University Hospital
Date: Saturday, September 14, 2024

NIPU is an investigator-initiated, randomized, open-label, multicenter Phase II study 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 study. A total of 118 patients were randomized between June 2020 and January 2023.