Preparation for Filing of BLA in the US
In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data will be critical to the filing of a Biological License Application (BLA) for GLSI-100 in the US and for regulatory filings in other countries.
Commercial Manufacturing
The first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In addition, drug stability programs have been initiated. Data on these commercial lots were submitted to the FDA in the US and European regulators (EMA) in Europe and will continue to be reviewed.
In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in an approved commercial facility, and final testing of this first lot is nearing completion. The Company may choose to use these finished commercial vials in FLAMINGO-01, subject to regulatory review.
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