On December 6, 2021 Greenwich 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, reported that manufacturing and clinical updates on Phase III clinical trial FLAMINGO-01 (Press release, Greenwich LifeSciences, DEC 6, 2021, View Source [SID1234596500]).
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Over 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:
Today, 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.
Clinical research organization (CRO) has been engaged to manage the Phase III clinical trial.
GP2 active ingredient manufacturer has been engaged to produce commercial scale GP2 lots.
Commercial testing laboratory has been engaged to release clinical and commercial GP2 lots and to manage GP2 stability program.
In 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.
Partners 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.
CEO 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 options going forward. In addition, all of the various parties required to operate the Phase III clinical trial testing, storage, and distribution activities have been integrated well through our management team and CRO. The expertise of our partners has served to enhance the quality and accelerate the progress of our manufacturing and clinical plans."
About FLAMINGO-01 and GLSI-100
The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.