GLSI-100

GLSI-100 is a cancer vaccine developed by Greenwich LifeSciences. Its target is HER2 (the sponsor names HER2/neu). The sponsor states: Combines GP2, a nine-amino-acid HER2/neu-derived transmembrane peptide, with the immunoadjuvant GM-CSF to prime and expand HER2/neu-specific CD8+ cytotoxic T lymphocytes that recognise and destroy HER2/neu-expressing cancer cells, aiming to prevent breast cancer recurrence. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT05232916 (Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects), in HR-positive / HER2-negative breast cancer. The largest, NCT05232916, plans to enrol 2250 participants with primary completion expected 2031-12. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.