Ultimovacs Implements Operational Adjustments to Support Continuous Advancement of the UV1 Vaccine Phase II Program - Seite 2

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About the UV1 Phase II program

The immunotherapeutic cancer vaccine UV1 is investigated in combination with checkpoint inhibitors in patients with various cancer indications with diverse tumor biology. The clinical strategy behind the UV1 Phase II program’s diversity is to evaluate the potential broad applicability of the cancer vaccine when combined with other immunotherapies:

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as first-line treatment for patients with malignant melanoma. Enrollment of 156 patients completed in July 2022. Sponsored by Ultimovacs. With the 18-month minimum follow-up of the patients in the INITIUM trial, the trial did not meet the primary or secondary endpoints. Median PFS was not reached in either arm. UV1 maintained its beneficial safety profile.

• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-line treatment for patients with malignant pleural mesothelioma. Enrollment of 118 patients completed in January 2023. Data presented at the ESMO Congress in October 2023 showed that UV1, as an add-on to ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement in overall survival versus ipilimumab and nivolumab alone. 31% of the patients receiving the UV1 vaccine experienced an objective response, compared to 16% in the control arm. The investigator-initiated study is led by Oslo University Hospital and supported by Bristol-Myers Squibb and Ultimovacs.
  

• FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line treatment for patients with head and neck cancer. Enrollment of 75 patients completed in August 2023, expected readout Q3 2024. The investigator-initiated study is led by Halle University in Germany, supported by Ultimovacs.
  
  

• DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as maintenance therapy in non-BRCA mutated patients with advanced ovarian cancer. 75 of 184 patients enrolled as of Q4 2023 reporting, expected readout H1 2025. The investigator-initiated study is led by NSGO-CTU and supported by ENGOT, AstraZeneca, and Ultimovacs.
• LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of non-small cell lung cancer patients. 23 of 138 patients enrolled as of Q4 2023 reporting, expected readout H1 2026. The investigator-initiated study is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.

About UV1