UV1

Ultimovacs ASA announced Phase II FOCUS trial results showing UV1 + pembrolizumab did not improve PFS or OS in late-stage HNSCC patients, failing primary/secondary endpoints. UV1 maintained a positive safety profile.

Ultimovacs ASA's Phase II FOCUS trial results, published on medRxiv, showed no clinical benefits in PFS or OS when adding UV1 to pembrolizumab in late-stage HNSCC patients, missing primary and secondary endpoints. UV1 maintained a positive safety profile. The trial, led by Prof. Mascha Binder and sponsored by the University of Halle-Wittenberg, aimed to assess UV1's efficacy and tolerability as an add-on to pembrolizumab. Patients were randomized 2:1 to receive UV1+pembrolizumab or pembrolizumab alone, with primary endpoint PFS at 6 months. UV1, a universal cancer vaccine targeting telomerase, is administered via intradermal injections with GM-CSF over three months.

Ultimovacs ASA announced Phase II FOCUS trial results showing UV1 vaccine added to pembrolizumab did not improve progression-free or overall survival in late-stage HNSCC patients, failing primary and secondary endpoints. UV1 maintained a positive safety profile.

Ultimovacs ASA halts LUNGVAC trial recruitment due to slow enrollment, driven by new NSCLC treatments. 31 enrolled patients will continue treatment, with topline data expected in H1 2025. Ultimovacs also conducts Phase II DOVACC trial for ovarian cancer and pre-clinical research on a novel drug conjugation platform, with updates planned by end of 2024.

Ultimovacs ASA halts recruitment for LUNGVAC trial due to slow enrollment, driven by new NSCLC treatments. All 31 enrolled patients will continue treatment, with topline data expected in H1 2025. Ultimovacs also advances UV1 in ovarian cancer and explores a novel drug conjugation platform.

Ultimovacs ASA presented updated data from the UV1 Phase II NIPU trial at the 2024 ESMO Congress, showing increased clinical benefit for the epithelioid subgroup, with a median PFS improvement of 5.5 months for UV1 combined with ipilimumab and nivolumab versus 2.9 months for immunotherapy alone. The trial did not meet the primary endpoint of improved PFS but demonstrated a doubling of ORR and a 27% reduction in death risk.

Ultimovacs ASA presented updated data from the UV1 Phase II NIPU trial at the 2024 ESMO Congress, showing increased clinical benefit for the epithelioid subgroup with a median PFS improvement of 5.5 months for UV1 combined with ipilimumab and nivolumab versus 2.9 months for immunotherapy alone. The trial did not meet the primary endpoint of improved PFS but demonstrated a doubling of ORR and a 27% reduction in risk of death. The full results will be presented in a poster at the congress.