Ultimovacs ASA announced encouraging overall survival (OS) data from the cohort 2 in the UV1-103 Phase I clinical trial in malignant melanoma. All patients in cohort 2 who were alive at the 2-year follow-up, remain alive at the 3-year follow-up. The UV1-103 study evaluates Ultimovacs' universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in patients with advanced non-resectable or metastatic malignant melanoma.

The study enrolled 30 patients in the U.S. in two cohorts that differ only in the concentration of GM-CSF used as vaccine adjuvant. Ultimovacs further investigates UV1 in malignant melanoma in its randomized Phase II INITIUM trial of UV1 in combination with ipilimumab and nivolumab. The trial completed enrollment of 156 patients with advanced non-re intersectable or metastatic malignant metastatic malignant melanoma in July 2022.

The top-line results will be disclosed after cancer progression has been verified in 70 patients, which was anticipated in the first half of 2023. As announced in April 2023, the readout is now expected in the second half of 2023. This is due to patients taking longer than estimated to experience cancer progression, which is very encouraging and positive for patients.

This US-based Phase I clinical trial is evaluating the Company's lead candidate, UV1, in combination With the anti-PD- 1 checkpoint inhibitor, pembrolizumab. The trial evaluates safety, tolerability, and initial signs of clinical response. Thirty patients in the U.S., were treated in the study in two cohorts that differ only In the concentration of GM-CS F used as vaccine adjuvant; The 20 patients in the first cohort received a 37.5 mcg GM-CSF adjuvant dose per UV1 vaccination.

Three patients in cohort 1 chose not to be followed up further after 24 months. The trial had previously reached its primary endpoint of safety and tolerability, and no unexpected safety issues related to UV1 have been observed in this trial.