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

Oslo, September 9, 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 trial (NCT04300244), at the ESMO Congress 2024. The NIPU study evaluated the addition of UV1 telomerase vaccine to immunotherapy with ipilimumab and nivolumab compared with ipilimumab and nivolumab alone, as second-line treatment for patients with unresectable malignant pleural mesothelioma. presented At ESMO 2023, the trial did not meet its primary endpoint of improved progression-free survival (PFS) by blinded independent central review (BICR), but the data demonstrated meaningful benefit on key secondary endpoints, including a doubling of the objective response rate (ORR) and a 27% reduction in the 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. Furthermore, the ESMO 2024 data presentation shows a positive difference in overall survival (OS) for UV1 treatment at last patient follow-up, although the magnitude of benefit is less than previously reported.

The full results will be published presented in a poster at the congress 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 vaccine 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
Speaker: 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 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 study. A total of 118 patients were randomized between June 2020 and January 2023.