HER2/Neu GP2 vaccine - Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology
Alternative Names: GLSI-100; GP2 peptide + GM-CSF vaccine; GP2 peptide - Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology; HER2/Neu Peptide GP2; HER2/neu peptide vaccineLatest Information Update: 15 Sep 2025
At a glance
- Originator Uniformed Services University of the Health Sciences
- Developer Greenwich LifeSciences Inc; NuGenerex Immuno-Oncology
- Class Antineoplastics; Cancer vaccines; Immunotherapies; Peptide vaccines
- Mechanism of Action Immunostimulants
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase III HER2 positive breast cancer
Most Recent Events
- 10 Sep 2025 Greenwich LifeSciences announces intention to submit BLA to US FDA for HER2-positive-breast-cancer
- 10 Sep 2025 HER2/Neu GP2 vaccine receives Fast Track designation for HER2-positive-breast-cancer [Intradermal,Injection] (Second-line therapy or greater) in USA
- 02 Apr 2025 Efficacy data from phase-III FLAMINGO-01 trials in HER2-positive breast cancer released by Greenwich LifeSciences