Greenwich LifeSciences Earns EMA Nod for GP2 in 170-180 Trial Sites with 70-80% Recurrence Drop
GLSI•EMA approved the use of a commercial GP2 lot for FLAMINGO-01 in Europe, enabling all ~170-180 US and European sites to use the same lot with shipments underway and capacity for about 200,000 doses. Preliminary data from 250 non-HLA-A*02 patients show a 70-80% recurrence reduction after the primary immunization series.
1. European Approval of Commercial GP2 Use
The European Medicines Agency has completed its review and approved the use of the existing commercially manufactured GP2 lot in FLAMINGO-01 in Europe. This aligns EU trial sites with US sites, allowing all ~170-180 clinical locations to use the same lot and streamlining supply logistics.
2. Distribution to US and EU Sites
Three active GP2 ingredient lots manufactured in 2023 provided enough material for about 200,000 doses, with the first vial-filled commercial lot produced in 2024. After FDA approval of that lot for FLAMINGO-01 in early 2026, all 40-50 US sites began treating patients, and European pharmacy shipments are now underway.
3. Trial Expansion and Enrollment
FLAMINGO-01 has expanded from 160 to approximately 170-180 sites across the US and Europe, screening over 1,300 patients at a current rate of ~800 per year. The non-HLA-A*02 arm is fully enrolled with 250 patients, all undergoing a six-month primary immunization series followed by five boosters.
4. Preliminary Efficacy Data
Open-label analysis of the non-HLA-A02 arm indicates a 70-80% reduction in breast cancer recurrence after the primary immunization series, mirroring Phase IIb hazard ratios. Immune response and safety profiles in these patients are tracking similarly to HLA-A02 arms, although all data remain preliminary.
