ITI-5000 self-amplifying RNA vaccine enters human dosing in triple-negative breast cancer
Company / institutional announcement · Immunomic Therapeutics
Source published: · Event / reporting date: 2026-07-20
Site published: 2026-11-03 · Updated: 2026-11-03
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What changed
Immunomic announced first-patient dosing in VITALITI, the first-in-human Phase 1 trial of ITI-5000, a self-amplifying RNA cancer vaccine. The open-label study evaluates safety, tolerability, and preliminary immune activity in stage II–III triple-negative breast cancer, alone or alongside standard adjuvant therapy. Initial monitoring of the first participant identified no significant safety concerns, but this milestone provides no efficacy evidence.
Why it may matter
The study brings self-amplifying RNA into another oncology setting, with early safety and immune activity rather than recurrence prevention established at this stage.
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