Business
Greenwich LifeSciences Announces Commencement of the First Commercial Line Filling of GP2
The first commercial line filling of GP2 was commenced today, setting the scale and path forward for commercial manufacturing of GP2. STAFFORD,
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n\nThe first commercial line filling of GP2 was commenced today, setting the scale and path forward for commercial manufacturing of GP2.\n\n\n STAFFORD, Texas--(BUSINESS WIRE)--\nGreenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provides manufacturing and clinical updates on Phase III clinical trial FLAMINGO-01.\n\nOver the past six months, the Company has been actively selecting and contracting partners to manufacture clinical and commercial lots of GP2 and to manage the Phase III clinical trial. An update on these activities follows:\n\n\nToday, the Company ran its first commercial fill line of GP2 at its fill and finish partner’s production facility with sufficient scale to produce up to 80,000 doses of GP2 per lot. Three commercial lots of GP2 will be required to file a Biologics License Application (BLA) for GP2. The three lots combined should treat approximately 22,000 patients, and in the initial GP2 indication, approximately 17,000 new patients could be treated per year, saving up to 1,500 to 2,000 lives per year.\n\n\nClinical research organization (CRO) has been engaged to manage the Phase III clinical trial.\n\n\nGP2 active ingredient manufacturer has been engaged to produce commercial scale GP2 lots.\n\n\nCommercial testing laboratory has been engaged to release clinical and commercial GP2 lots and to manage GP2 stability program.\n\n\nIn addition to their operational role, these partners will play a key role in preparing the manufacturing and clinical information necessary to submit a BLA upon a successful interim analysis of the Phase III clinical trial.\n\n\nPartners for HLA typing, blood test collection, GP2 storage and distribution, GM-CSF distribution, immune response testing, and blood sample storage have been selected to support the Phase III clinical trial.\n\n\nCEO Snehal Patel commented, “Commencing commercial scale manufacturing is a major milestone for the Company. We are carefully selecting partners who are leaders in the industry with whom we hope to work with over the long term. At the same time, the Company is developing a back-up strategy by location and function to reduce risk and provide multiple opt...