Greenwich LifeSciences Provides Update on Commercial Manufacturing

Core Viewpoint - Greenwich LifeSciences, Inc. is making significant progress in the commercial manufacturing of GP2, an immunotherapy aimed at preventing breast cancer recurrences, as it prepares for the filing of a Biological License Application (BLA) in the US and other countries [1][5]. Group 1: Commercial Manufacturing - The first three commercial lots of GP2 active ingredient were manufactured in 2023, capable of preparing approximately 200,000 doses [3]. - In 2024, the first commercial lot of GP2 was filled into vials for sale or clinical use, with final testing nearing completion [4]. - The company plans to manufacture at least two more lots of finished GP2 product while conducting the FLAMINGO-01 clinical trial [5]. Group 2: Regulatory and Filing Updates - Submission of commercial manufacturing data is critical for the BLA filing for GLSI-100 in the US and for regulatory filings in other countries [2]. - The company is expanding clinical sites into Europe and discussing the marketing license pathway with the European Medicines Agency (EMA) [5]. Group 3: Clinical Trial Information - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100 in HER2 positive breast cancer patients, with plans to include up to 150 clinical sites globally [7]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7]. Group 4: Intellectual Property Developments - In 2024, the company made refinements in the manufacturing of GP2 and may file additional patent applications [6]. Group 5: Company Overview - Greenwich LifeSciences is focused on developing GP2, a 9 amino acid peptide of the HER2 protein, to prevent breast cancer recurrences in patients post-surgery [9].