Ultimovacs ASA announced that the last patient enrolled in the INITIUM trial has now been followed for 18 months, thereby enabling readout of the primary endpoint. The Company expects to announce topline results from the randomized Phase II clinical trial in March this year. The first patient was enrolled in INITIUM in June 2020, and the trial completed enrollment of 156 patients in July 2022.

The amendment was agreed to by the relevant regulatory authorities in the countries where the trial has been conducted. The protocol amendment will maintain the integrity of the study statistics without materially affecting the scientific value of the clinical trial. The patients in the INITIUM trial have been followed for a range of 18 to 42 months with an expected median observation time of approximately 24 months.

The INITIUM clinical trial (NCT04382664) evaluates Ultimovacs' universal cancer vaccine, UV1, as first-line treatment in unresectable or metastatic malignant melanoma in combination with PD-1 checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab. Nivolumab and ipilimumab are considered the "gold standard" treatment for patients with unresectable or metastatic melanoma who can tolerate the potential toxicity. The randomized Phase II clinical trial results will provide comparative data on the efficacy and safety of UV1 vaccination added to the standard-of-care immunotherapy.

The primary endpoint of the INITIUM trial is progression-free survival (PFS) as per RECIST 1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety of UV1 vaccination in combination with nivolumab and nivolumab. Ultimovacs has received a dual Fast Track designation from the FDA, granted in October 2021, for UV1 in combination with checkpoint inhibitors in the treatment of unresectable or metastatic metastatic melanoma - either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. In December 2021, UV1 was granted Orphan Drug designation from the FDA for treatment of stage IIB-IV melanoma.

INITIUM is an Ultimovacs-sponsored randomized, comparative, multicenter Phase II clinical trial in which the universal cancer vaccine UV1 will be evaluated in combination with the checkpoint inhibitors ipilimumab and nivolumib for first-line treatment of patients with unresectable or prostate malignant melanoma. The first patient received treatment in the INITIUM trial in June 2020, and the last patient was enrolled in July 2022.