Greenwich LifeSciences Provides Global Update on FLAMINGO-01

Core Insights - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][26] - The trial has shown promising preliminary data regarding safety and immune response, leading to potential expansions in patient enrollment and trial design [2][12] Group 1: Trial Progress and Future Plans - The FLAMINGO-01 trial has confirmed that preliminary data for HLA prevalence, safety, and immune response is trending positively in both HLA-A02 and non-HLA-A02 patient arms [2] - The non-HLA-A*02 arm was expanded to 250 patients in 2024, with regulatory approval from both EU and US authorities, and further changes are being considered to enhance the trial's market potential [2] - In Q1 2025, the company achieved a screening rate of over 150 patients per quarter across 117 active sites, with plans to activate an additional 40 sites in the EU [3] Group 2: Clinical Sites and Networks - The trial includes approximately 40 US clinical sites, featuring prominent teaching hospitals such as Yale, Johns Hopkins, and Stanford, which are actively recruiting patients [4] - In Europe, the trial has expanded into five countries with 77 activated clinical sites, primarily in Spain, France, Germany, Italy, and Poland [5][6] - Major academic networks in Europe, such as GEICAM in Spain and GBG in Germany, are collaborating in the trial, enhancing its credibility and outreach [7][9] Group 3: Steering Committee and Expert Involvement - The Steering Committee consists of leading experts in breast cancer oncology from prominent hospitals and networks in the US and Europe, contributing to the trial's design and execution [12] - The company is focused on improving the trial's conduct and design to replicate Phase IIb results and prepare for commercialization of GLSI-100 [12] Group 4: About GLSI-100 and Breast Cancer - GLSI-100 is designed for HER2 positive breast cancer patients who have residual disease post-surgery and have completed neoadjuvant and postoperative adjuvant trastuzumab treatment [24] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [24]