Greenwich LifeSciences Supplies Commercial GP2 to 40 US Sites, Plans 1 Million Vial Capacity
Greenwich LifeSciences has supplied commercially manufactured GP2 vials—derived from three 2023 active-ingredient lots with capacity for 200,000 doses and one 2024 fill—to all 40 US FLAMINGO-01 sites within weeks of FDA approval. The company plans 500,000–1 million vials per year capacity and regulatory submissions across Europe, UK and Canada.
1. Commercial Manufacturing and FDA Approval
In 2023, Greenwich LifeSciences produced three commercial GP2 active-ingredient lots capable of 200,000 doses and completed its first vial fill lot in 2024, with stability programs across four lots. Following FDA review of submitted lot data, the first commercial GP2 vial lot received approval and was distributed to all 40 US FLAMINGO-01 sites within weeks.
2. Expansion Plans
The company has begun regulatory submissions in Europe, the UK and Canada to enable GP2 use at approximately 160 global sites and is targeting annual production of 500,000 to 1 million GP2 vials. Having internalized its clinical team in Q4 2025, it plans larger active-ingredient lots to build inventory ahead of a potential commercial launch.
3. FLAMINGO-01 Trial Progress
More than 1,000 patients have been screened at a rate of about 800 per year, and the 250-patient non-HLA-A*02 arm is now fully enrolled, yielding fivefold more treated individuals than Phase IIb. Preliminary analysis shows an approximately 80% reduction in recurrence rate after the primary immunization series, with immune response and safety profiles aligning with earlier trial findings.