Greenwich LifeSciences Inc. (GLSI), a clinical-stage biopharmaceutical company, on Monday released positive Phase 3 FLAMINGO-01 data for GLSI-100 in preventing breast cancer recurrences. The data was presented at the annual meeting of the American Association of Clinical Oncology (ASCO).
GLSI-100 is an investigational cancer vaccine containing a combination of GP2 peptide and Granulocyte Macrophage-cytokine stimulating factor (GM-CSF) for a concerted immunotherapy targeting HER2+ breast cancer and preventing metastasis. The vaccine was previously granted Fast Track designation by the FDA.
Data from the prospective, randomized, multi-center Phase 3 trial dosing over 1300 patients suggests that non-HLA-A*02 subjects showed a 70%-80% reduction in recurrence, and a statistically significant injection site reaction (ISR), indicating an increased immune response.
A new testing arm of about 250 non-HLA-A*02 patients has completed enrollment and will evaluate GLSI-100 administered by 6 intradermal injections over 6 months, and 5 subsequent boosters over 2.5 years. Immune responses to the drug will be measured using delayed-type hypersensitivity (DTH) skin tests and ISRs. Preliminary results demonstrated that 20.2% of patients experienced an ISR after the first vaccination.
GLSI is currently trading at $27.73, up 5.94%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.