Ultimovacs - UV1 hits transitory roadblock with INITIUM top-line

Ultimovacs has announced top-line results for the Phase II INITIUM trial evaluating its cancer vaccine for the treatment of malignant melanoma. While UV1 maintained its desirable safety and tolerability profile, the study did not meet its primary endpoint of progression-free survival (PFS), or the secondary endpoints of overall survival (OS) and objective response rate (ORR). The UV1 arm showed similar performance to the control arm, ipilimumab and nivolumab (the current standard of care). Despite these top-line results, the company will continue to explore UV1 in the other four Phase II indications in combination with various checkpoint inhibitors. Upcoming milestones include top-line results for FOCUS in Q324 (in head and neck squamous cell carcinoma), an update on the OS data from NIPU in H224 (in malignant pleural mesothelioma) and top-line results for DOVACC in H125 (in ovarian cancer). Management's cash preservation initiatives are intended to sustain the company into 2025.

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