The company disclosed that the Food and Drug Administration (FDA) has reviewed and authorized the use of its first commercially produced batch of the GP2 drug product in the ongoing FLAMINGO-01 trial.
- The company is running a Phase III study known as FLAMINGO-01, which is testing GLSI-100.
- The approval follows the submission of manufacturing and stability data tied to multiple production runs.
- More than 1,000 patients have already been screened for FLAMINGO-01.
Greenwich LifeSciences, Inc. (GLSI) announced on Thursday that it has cleared another regulatory step in the development of its breast cancer immunotherapy as the company advances its late-stage clinical program.
The clinical-stage biotechnology firm is running a Phase III study known as FLAMINGO-01, which is testing GLSI-100, a therapy designed to reduce the risk of cancer returning in certain breast cancer patients.
FDA Manufacturing Clearance
The company disclosed that the Food and Drug Administration (FDA) has reviewed and authorized the use of its first commercially produced batch of the GP2 drug product in the ongoing FLAMINGO-01 trial.
Following the update, Greenwich LifeSciences stock traded over 16% higher in Thursday’s premarket. However, on Stocktwits, retail sentiment around the stock remained in ‘bearish’ territory amid ‘low’ message volume levels.
The approval follows the submission of manufacturing and stability data tied to multiple production runs completed over the past two years.
"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.”
-Snehal Patel, CEO, Greenwich LifeSciences
Trial Progress And Early Signals
More than 1,000 patients have already been screened for FLAMINGO-01, with enrollment continuing at a steady pace. One treatment arm involving patients without the HLA-A*02 marker has now completed enrollment, providing a larger dataset than earlier mid-stage research.
Preliminary observations following the initial dosing period suggest a sharp decline in recurrence rates, though the company cautioned that the findings remain early and incomplete.
GLSI stock has gained over 75% higher in the last 12 months.
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