Greenwich LifeSciences announced that it has finished enrolling the 250 patients who lack the HLA‑A*02 allele in the open‑label arm of its Phase III FLAMINGO‑01 study, bringing the total number of participants receiving the GLSI‑100 vaccine to 750 across all trial arms.
The open‑label cohort now represents roughly 55% of the overall FLAMINGO‑01 population, a proportion that reflects the prevalence of the non‑HLA‑A*02 genotype in the target population. Completing enrollment in this arm allows the company to collect safety and efficacy data from a larger, more diverse group of participants, a critical step toward generating the interim data needed for planned futility and superiority analyses.
With the arm fully enrolled, Greenwich can accelerate the overall trial timeline. The company expects to begin interim safety and efficacy readouts in the first quarter of 2026, and the data will inform discussions with the FDA and EMA as the company seeks to expand the non‑HLA‑A*02 cohort into a randomized, controlled design. The milestone also positions GLSI‑100 for a potential regulatory review as a preventive therapy for HER2‑positive breast cancer survivors.
Financially, Greenwich remains a small, early‑stage biopharma company with a market capitalization of about $124 million and a current ratio of 2.35. The company is not yet profitable, but the enrollment milestone strengthens its clinical pipeline and supports its ongoing Fast Track designation, which the FDA granted in September 2025 for GLSI‑100’s indication in preventing breast cancer recurrence.
GLSI‑100 is an immunotherapy that combines a HER2‑derived peptide (GP2) with GM‑CSF to train the immune system to target residual HER2‑expressing cells. Phase IIb data showed an 80% or greater reduction in breast‑cancer recurrences with no metastatic recurrences reported, underscoring the potential impact of the Phase III program. The FLAMINGO‑01 trial is expanding globally, with sites in the United States and Europe and plans to open up to 150 sites worldwide, including new locations in Austria, Belgium, Portugal, and Ireland.
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