Greenwich LifeSciences (NASDAQ:GLSI) shares surged around 54% after the company said the U.S. Food and Drug Administration (FDA) has authorised the use of its first commercially produced batch of GP2 in the FLAMINGO-01 Phase III clinical trial.
The biotech group said the first three commercial-scale lots of the GP2 active ingredient were manufactured in 2023, with the capacity to produce roughly 200,000 doses. During 2024, the company completed vial filling for the first of these three commercial lots, making the product available for either commercial or clinical use.
“With our manufacturing investments in 2023 and 2024, and now the FDA’s review and approval to use the first commercial lot of finished GP2 vials in FLAMINGO-01, we have taken major steps to further de-risk the filing of a BLA in the US,” said chief executive Snehal Patel.
Greenwich LifeSciences said it expects to start deploying the newly approved GP2 vials at all 40 U.S. trial sites in the coming weeks. The company added that it now has three years of stability data supporting the expiration date of the GP2 vials, which could also underpin the product’s eventual commercial shelf life.
The FLAMINGO-01 trial is testing GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence. The company said enrolment is now complete in the 250-patient non-HLA-A02 arm of the study, with early analysis indicating an approximately 80% reduction in recurrence rates following the Primary Immunization Series.
According to the company, this trend is consistent with results from its earlier Phase IIb trial, where breast cancer recurrence rates were reduced by up to 80%, compared with reductions of around 20% to 50% achieved by other approved therapies.
Looking ahead, Greenwich LifeSciences said it plans to submit the same manufacturing data to regulators in Europe, the United Kingdom and Canada as it prepares for a potential commercial launch.