Ultimovacs ASA announced that the analysis of the INITIUM data will be initiated in mid-January 2024, following an amendment of the clinical trial protocol. The INITIUM protocol has been amended to allow data readout based on a minimum of 18-month follow-up of all evaluable patients, at which time the patients have a mean follow-up time of 24 months. The amendment will maintain the integrity of the study statistics.

The protocol amendment was submitted to the regulatory authorities in the countries where the INITIUM trial is conducted: The U.S. Food and Drug Administration (FDA) and regulatory bodies in Belgium, Norway, and the U.K. The FDA has not issued any objections to the amendment and the Regulatory Authorities in two European countries have approved the amendment with one pending. The INITIUM study (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.

The first patient was enrolled in June 2020, and the trial completed enrollment of 156 patients in July 2022. Per the original trial protocol, data analysis would be conducted after cancer progression or death has been verified in 70 patients. Based on published historical references, progression was estimated to occur in 70 patients by the first half of 2023.

With the current development in patient progression, reaching these 70 events could take many months or even years, justifying the decision to implement the protocol amendment. Based on the recent acceptance from the regulators, the data can now be analyzed in early 2024, enabling Ultimovacs to maintain its guidance on reporting the outcome of the study two to three months later in the first half of 2024. The primary endpoint of the Phase II study INITIUM 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 ipilimumab.

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 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.

UV1 is a therapeutic cancer vaccine used to generate an immune response against the enzyme human telomerase (hTERT).  The enzyme is essential for the ability of cancer cells to proliferate. Telomerase is present in 85-90% of all cancers, across the stages of the disease. The vaccine is manufactured as an off-the-shelf product with a long shelf life.

UV1 is easy to use and does not require sophisticated hospital infrastructure, enabling patient access to therapy also in community centers, and rural and underserved communities. Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical development program across various cancer indications with different biology and disease stages, combined with different checkpoint inhibitors. The topline data from INITIUM will be the second readout among the five randomized trials in the UV1 Phase II clinical program.

In October 2023, the UV1 Phase II trial NIPU in malignant mesothelioma reported a clinically meaningful overall survival benefit in the patients receiving UV1 vaccination, with no added toxicities. Per protocol, the overall survival results were statistically significant. In addition to the studies in malignant melanoma and malignant mesothelioma, Phase II studies are ongoing in patients with head and neck cancer (FOCUS), ovarian cancer (DOVACC), and non-small cell lung cancer (LUNGVAC).

The data from the FOCUS trial is expected in the second half of 2024.