Ultimovacs Announces Topline Results from INITIUM Study Evaluating UV1 Vaccination Added to Ipilimumab and Nivolumab in Patients with Unresectable or Metastatic Malignant Melanoma

• With the 18-month minimum follow-up of the patients in the INITIUM trial, the trial did not meet the primary endpoint of prolonging progression-free survival (PFS). Median PFS was not reached in either arm. Evaluation of secondary endpoints did not show a difference in overall survival and objective response rate between the treatment and control arms
• UV1 maintained its positive safety profile with similar safety and tolerability as observed in the control arm
• Ultimovacs remains confident in the potential of the UV1 vaccine and its promise in specific therapeutic combinations and indications 
• Upcoming data from the FOCUS Phase II trial and overall survival updates from the NIPU Phase II trial will be the next important data points for the further assessment of UV1
• Cash preservation initiatives will be implemented to ensure that the available financial resources will sustain the company into 2025, enabling the achievement of upcoming key inflection points.
  

Oslo, March 7 2024: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced topline results from the Phase II clinical trial, INITIUM (NCT04382664), evaluating the company’s therapeutic cancer vaccine candidate UV1 as first-line treatment in unresectable or metastatic malignant melanoma.

The study’s primary endpoint was to investigate progression-free survival (PFS) in the experimental arm (UV1 plus treatment with checkpoint inhibitors (CPIs) ipilimumab and nivolumab) as compared to the control arm (ipilimumab and nivolumab alone). Secondary endpoints included overall survival (OS), objective response rate (ORR) as well as duration of response (DOR) and safety. Topline data demonstrated that the combined treatment of UV1 with ipilimumab and nivolumab showed similar clinical benefits as treatment with ipilimumab and nivolumab alone, meaning the primary and secondary endpoints of the study were not met.

With the 18-month minimum follow-up of the patients in the trial, the median PFS was not reached in either arm, and the Hazard Ratio (HR) between the arms for PFS was 0.95. Evaluation of secondary endpoints did not show a difference in overall survival and objective response rate between the arms. UV1 maintained a positive safety and tolerability profile.

Ultimovacs will further analyze the full data set while continuing to advance its ongoing Phase II trials for UV1.

“Ultimovacs had set a very high bar for UV1 by comparing it to the ipilimumab and nivolumab combination, currently considered the most effective treatment for this patient population. Nevertheless, we are disappointed that UV1 did not add further clinical benefit for these late-stage melanoma patients in the INITIUM trial. Looking forward, our first objective is to complete the analysis of the full data set in depth to gain further insights on UV1’s effects,” said Jens Bjørheim, Chief Medical Officer, Ultimovacs. “We wish to thank the patients for their trust and the investigators for their collaboration with us.”