UV1

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.

A high baseline SLD and a high relative increase from nadir were identified as main predictors for a reduced OS in NSCLC and MM patients, respectively. Our model predictions highlighted that additional maintenance doses, i.e. UV1 administration for longer periods, may result in more sustained tumor size shrinkage.

P2, N=154, Active, not recruiting, Ultimovacs ASA | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jan 2026 | Trial primary completion date: Jun 2023 --> Apr 2024

P2; Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2024

Encouraging safety and preliminary efficacy were observed. Randomized phase II trials are currently ongoing.

Supportive analyses indicate an increased ORR and clinically meaningful prolonged survival in the intervention arm. The results warrant confirmation in a larger clinical trial.

Twenty-two men with ISUP 4 to 5 and lymph node and/or bone metastases were treated with androgen deprivation therapy (ADT), radiotherapy and the hTERT vaccine UV1 between January 2013 and July 2014...The long-term monitoring showed that some patients had unanticipated subsequent high immune responses without developing recurrence. This association indicates that there might be a clinical benefit of hTERT vaccination in a subgroup of men with primary metastatic hormone-sensitive prostate cancer treated with ADT and radiotherapy.

P1, N=30, Active, not recruiting, Ultimovacs ASA | Trial completion date: Oct 2022 --> Oct 2025

Clinical responses were observed irrespective of established predictive biomarkers for checkpoint inhibitor efficacy, indicating an added benefit of the vaccine-induced T cells. The clinical and immunological read-out warrants further investigation of UV1 in combination with checkpoint inhibitors. Trial registration Clinicaltrials.gov identifier: NCT02275416. Registered October 27, 2014. https://clinicaltrials.gov/ct2/show/NCT02275416?term=uv1&draw=2&rank=6.

Long-term immunomonitoring of patients showed highly dynamic and persistent telomerase peptide-specific immune responses lasting up to 7.5 years after the initial vaccination, suggesting a plausible functional role of these T cells in long-term survivors. The superior immune response kinetics observed in the melanoma study substantiate the rationale for future combinatorial treatment strategies with UV1 vaccination and checkpoint inhibition for rapid and frequent induction of anti-telomerase immune responses in patients with cancer.

P2, N=75, Recruiting, Martin-Luther-Universität Halle-Wittenberg

Conclusions UV1 in combination with ipilimumab leads to robust and long-lasting CD4+ Th1 anti-hTERT immune responses sculpting the local tumor microenvironment. Trial Registration NCT02275416

The rapid expansion of UV1-specific Th1 cells in the majority of patients indicates synergy between UV1 vaccine and CTLA-4 blockade. This may have translated into clinical benefit, encouraging the combination of UV1 vaccination with standard of care treatment regimes containing ipilimumab/CTLA-4 blocking antibodies.

P1, N=30, Active, not recruiting, Ultimovacs ASA | Recruiting --> Active, not recruiting | N=20 --> 30 | Trial completion date: May 2021 --> Oct 2022 | Trial primary completion date: May 2020 --> Oct 2022

Combining UV1 and ipilimumab is safe and induces clinical responses in melanoma. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism. OS compares favorably to historical controls.

Combining UV1 and ipilimumab is safe and induces clinical responses in melanoma. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism. OS compares favorably to historical controls.