UV1

present findings from the phase 2 FOCUS trial evaluating UV1 vaccine combined with pembrolizumab in PD-L1-positive recurrent/metastatic head and neck squamous cell carcinoma. While UV1 elicited human telomerase reverse transcriptase-specific T cell responses in 86% of patients, clinical outcomes showed no improvement over pembrolizumab monotherapy.1 This discordance between immune activation and therapeutic efficacy underscores the necessity for further disease understanding and vaccine design in the future.

The addition of UV1 to pembrolizumab was safe but did not show an efficacy signal in this study population.

P2, N=184, Recruiting, Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Trial completion date: Dec 2026 --> Dec 2030 | Trial primary completion date: Dec 2024 --> Dec 2026

While DNA vaccines demonstrate promising immunogenicity, peptide vaccines, such as UV1, UCPVax, and Vx-001, have shown clinical efficacy in certain cancer types. Accordingly, we discuss the mechanisms of action, preclinical and clinical data, and the potential of these vaccines to elicit robust and durable anti-tumor immune responses. This review highlights the potential of telomerase-based vaccines as a promising strategy for cancer treatment and identifies areas for future research.

Patients with pleural mesothelioma treated with nivolumab and ipilimumab with or without UV1 vaccine in the NIPU study were included. Elevated levels of certain cytokines, both before and after onset of treatment, correlate with specific irAEs in PM patients receiving ICIs. These cytokines may be used as biomarkers to predict and detect irAES.

P1/2, N=18, Completed, Ultimovacs ASA | Active, not recruiting --> Completed

P1/2, N=22, Completed, Ultimovacs ASA | Active, not recruiting --> Completed

P1/2, N=12, Completed, Ultimovacs ASA | Active, not recruiting --> Completed

P1, N=30, Completed, Ultimovacs ASA | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jun 2024

P2, N=156, Completed, Ultimovacs ASA | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Apr 2024 | Trial primary completion date: Apr 2024 --> Jan 2024

P2, N=118, Active, not recruiting, Åslaug Helland | Trial primary completion date: Mar 2024 --> Mar 2025

The FOCUS study aims to optimize treatment of R/M HNSCC patients with this promising new treatment approach. https://clinicaltrials.gov/study/NCT05075122, identifier NCT05075122.