Significant and Clinically Meaningful Improvement in Overall Survival for Patients with Malignant Mesothelioma Receiving UV1 Cancer Vaccine

• UV1, in combination with the checkpoint inhibitors ipilimumab and nivolumab from Bristol-Myers Squibb, met the study protocol’s predefined threshold for statistical significance and demonstrated a 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
  
  
• First demonstration of universal cancer vaccine efficacy in randomized Phase II clinical trial; Proof of Concept supporting further clinical development
  
  
• Webcast presentation by Principal Investigator Professor Åslaug Helland, MD, PhD, and Ultimovacs management will take place today, Mon, Oct 23, 2023, at 14:30 am (CET). The slide presentation is attached to this announcement. The webcast can be accessed live or as a replay (link). Company presentation, incl. NIPU data is available on the Ultimovacs website.  

Oslo, October 23, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced the full dataset from the NIPU clinical trial (NCT04300244) presented at the ESMO Congress 2023 in Madrid. NIPU is an investigator-initiated, randomized, multi-center, open-label Phase II clinical trial for second-line treatment in patients with malignant mesothelioma (MPM).

The data from the study was published initially in a late-breaking abstract at ESMO. Further details have now been provided in an oral presentation by the Principal Investigator at the ESMO Congress. The results showed that Ultimovacs’ cancer vaccine UV1, in combination with ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement in overall survival versus ipilimumab and nivolumab alone, a key secondary endpoint. No additional safety concerns were reported from the UV1 treatment.

UV1 plus ipilimumab and nivolumab improved overall survival (OS), reducing the risk of death by 27% (hazard ratio (HR)=0.73 [80% CI, 0.53-1.00], 1-sided p value = 0.0985, 2-sided p value = 0.197). The median OS was 15.4 months (95% CI, 11.1-22.6) for UV1 plus ipilimumab and nivolumab (treatment arm) versus 11.1 months (95% CI, 8.8-18.1) for ipilimumab and nivolumab alone (control arm), with a median observation time of 17.3 months. This degree of improvement met the protocol's predefined threshold for statistical significance.