GLSI-100

Development notes

FLAMINGO-01 trial. 2/10/25- Provided update on open label HLA data. 4/3/25- Provided preliminary HLA prevalence, safety, and immune response data. 12/3/25– Screened over 1K patients. 12/08/25:- Non-HLA-A*02 open-label arm completed enrollment; company analyzing data and seeking randomized non-HLA-A*02 expansion. 12/15/25:- Preliminary ~80% recurrence reduction in non-HLA-A*02 open-label arm; first patient completed full vaccination series. 12/22/25:- DSMB twice in 2025 recommended study continue; steering committee backed protocol changes to accelerate interim analysis. 01/22/26:- FDA approved first commercial GP2 vial lot for FLAMINGO-01; non-HLA-A*02 arm fully enrolled. 03/03/26:- FLAMINGO-01 screen rate ~800/yr; non-HLA-A*02 arm fully enrolled; preliminary ~80% recurrence reduction after PIS. 03/16/26:- Commercial GP2 vials supplied to ~40 US sites; preliminary ~80% recurrence reduction reiterated. 03/17/26:- Non-HLA-A*02 arm recurrence <1%/year over 1.2 years; ~83% reduction vs Katherine. 03/18/26:- AACR 2026 posters Apr 20-21; immune response data statistically significant; preliminary PIS recurrence reduction ~70-80%. 03/19/26:- FLAMINGO-01 activated at City of Hope sites; total sites may rise to 190-200. 04/20/26:- AACR 2026 poster reported significant DTH immune response; screened >1,300; non-HLA-A*02 arm fully enrolled. 04/23/26:- ASCO poster/abstract on June 1, 2026 will present preliminary non-HLA-A*02 immune response data. 06/01/26:- ASCO LBA538 poster showed significant ISR increases in non-HLA-A*02 arm; Phase 3 FLAMINGO-01 ongoing. 07/09/26:- EMA allowed commercial GP2 in FLAMINGO-01 Europe. Preliminary PIS recurrence reduction ~70-80% in non-HLA-A*02 arm. 07/16/26:- EMA aligned Europe protocol; all sites enroll both HLA types. 07/20/26:- May 2026 DSMB recommended continue. Screened >1,500; combined HLA types to speed enrollment. 07/22/26:- UK approval expands FLAMINGO-01 to 5-10 UK sites; non-HLA arm fully enrolled.