Ultimovacs ASA announced the completion of enrollment of 75 patients and that the last patient has received the first dose in the FOCUS study (NCT05075122). FOCUS is an investigator-initiated Phase II randomized clinical trial sponsored by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. The study investigates Ultimovacs?

therapeutic cancer vaccine, UV1, in combination with pembrolizumab versus pembrolizumab alone, as first-line treatment for patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). For these patients, pembrolizumab is a standard of care treatment. The FOCUS trial is being conducted at ten sites across Germany and is led by Principal Investigator Mascha Binder, M.D., Professor of Medical Oncology at the Faculty of Medicine, University Hospital of Basel.

Professor Binder is a renowned oncology clinician and researcher specializing in the analysis of immune-oncology treatments and their interaction with tumor tissues. The topline results will include overall survival (OS) with minimum 12 months of follow-up in addition to progression-free survival (PFS), enabling a full assessment of the study outcomes. These data will be analyzed 12 months after the last patient was enrolled and is expected to be disclosed in the second half of 2024.

The results will be announced through a press release followed by an in-depth presentation of the data at a medical conference and in a peer-reviewed journal. Head and neck cancer is the seventh most common type of cancer worldwide, and squamous cell carcinoma (HNSCC) represents about 90% of these patients. HNSCC occurs in the head and neck region, including the throat, mouth, sinuses and nose.

Despite advances in treatment strategies, the prognosis for these patients is poor. 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. UV1 is a patented, proprietary technology owned by Ultimovacs. Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical development program across various cancer indications with different biologies and disease stages, in combination with different checkpoint inhibitors.

In addition to head and neck cancer, Phase II studies are ongoing in patients with malignant melanoma, pleural mesothelioma, ovarian cancer, and non-small cell lung cancer. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council.