Greenwich LifeSciences, Inc. (NASDAQ:GLSI) saw its stock gain 7.7% on Thursday following an announcement that the European Medicines Agency (EMA) has approved the use of commercially manufactured GP2 in the company's FLAMINGO-01 clinical trial.
The EMA decision allows all participating clinical sites in both the United States and Europe to use the same commercially produced lot of GP2 in the ongoing Phase III study evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrence. Greenwich reported that the number of active clinical sites has risen from 160 to approximately 170-180, and that shipments of GP2 to European pharmacies are already underway.
Earlier in the year, Greenwich received U.S. Food and Drug Administration approval for the first commercial lot of GP2 vials for use in the United States in early 2026. All of the company's roughly 40-50 U.S. sites have started treating patients with those vials. The company is pursuing separate regulatory approvals to permit use of that same lot in the United Kingdom and Canada.
On the manufacturing side, Greenwich noted that the first three commercial lots of GP2 active ingredient were produced in 2023 at an approved commercial facility. Those lots, the company said, could be used to prepare about 200,000 doses. The first commercial lot filling GP2 into vials was manufactured in 2024.
The FLAMINGO-01 trial continues to advance enrollment and screening. More than 1,300 patients have been screened to date, with a current screening rate of approximately 800 patients per year. The trial's 250-patient non-HLA-A02 arm is now fully enrolled. Greenwich characterized this as representing five times the number of treated patients versus the roughly 50 patients treated in the earlier Phase IIb trial.
Greenwich also provided an early look at recurrence outcomes in the non-HLA-A02 cohort after completion of the Primary Immunization Series. A preliminary analysis indicates an approximate 70-80% reduction in recurrence rate in that arm. The company said this observation is trending similarly to results from the Phase IIb trial, where breast cancer recurrences were reduced by as much as 80% in HLA-A02 patients.
The EMA clearance to use commercially manufactured GP2 across U.S. and European sites aligns regulatory logistics with the company’s manufacturing capacity, while shipments to European pharmacies and ongoing U.S. dosing reflect an operational ramp. The company’s pursuit of additional regulatory permissions in the U.K. and Canada remains an outstanding procedural step.
Note: The data points and procedural details in this report are drawn from the company’s statements on EMA approval, manufacturing lots, trial enrollment, and preliminary recurrence analyses.