Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01

Core Viewpoint Greenwich LifeSciences, Inc. has made significant progress in its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with the FDA approving the first commercial lot of GP2 for use in the trial, which is a crucial step towards filing a Biological License Application (BLA) in the US. Group 1: Clinical Trial Updates - The first three commercial lots of GP2 were manufactured in 2023, capable of preparing approximately 200,000 doses [2] - The first commercial lot of GP2 vials has been approved for use in FLAMINGO-01 in the US [2][3] - More than 1,000 patients have been screened in FLAMINGO-01, with a current screening rate of approximately 600 patients per year [5] Group 2: Manufacturing and Regulatory Progress - The company plans to start using the new GP2 vials at all 40 US sites in the coming weeks [3] - The submission of commercial manufacturing data for three lots is critical for the BLA filing in the US and other countries [4] - At least two more lots of finished GP2 product will be manufactured to support clinical and manufacturing data review by the FDA [4] Group 3: Efficacy and Safety Data - Preliminary analysis shows an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) in the non-HLA-A02 arm of FLAMINGO-01 [6] - The immune response and safety profile of non-HLA-A02 patients are trending similarly to HLA-A*02 arms and the Phase IIb study [6] - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences in HER2/neu 3+ patients treated with GLSI-100 [8] Group 4: Future Plans and Market Potential - The company aims to conduct FLAMINGO-01 at 150 leading clinical sites in the US and Europe, facilitating a smooth transition to product launch if GLSI-100 is approved [5] - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned when at least 14 events have occurred [9] - The company is preparing to submit the same manufacturing data to regulatory agencies in Europe, the UK, and Canada [5]