The U.S. Food and Drug Administration approved the first commercially manufactured lot of the GP2 peptide on January 22, 2026, clearing a 200,000‑dose supply that will be used in Greenwich LifeSciences’ Phase III FLAMINGO‑01 trial. The GP2 peptide is a nine‑amino‑acid HER2/neu sequence that forms the core of GLSI‑100, the company’s post‑surgical breast‑cancer recurrence vaccine.
This approval removes a critical manufacturing bottleneck and allows Greenwich to deploy the new GP2 vials at all 40 U.S. sites participating in the trial. By securing a commercial lot, the company de‑risks the filing of a Biologics License Application (BLA) under its Fast‑Track designation, potentially accelerating the path to market approval and reducing the likelihood that supply constraints will delay the trial or the BLA submission.
CEO Snehal Patel said, “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.” The comment underscores the strategic importance of the regulatory clearance for the company’s commercialization timeline.
Greenwich’s financial position remains tight; a February 2025 report noted a cash runway of less than a year and an annualized negative cash flow of approximately $7.2 million for the first nine months of 2024. The company has relied on stock sales and private placements to fund its operations, making the manufacturing milestone a key factor in sustaining its clinical program.
The FLAMINGO‑01 trial is a global Phase III study with plans to open up to 150 sites worldwide. Over 1,000 patients have been screened, and a 250‑patient open‑label arm has completed enrollment. GLSI‑100 aims to achieve an 80% or greater reduction in recurrence rates, compared with the roughly 50% reduction seen with existing HER2 therapies such as Herceptin and Kadcyla.
Manufacturing readiness has progressed steadily: commercial lots of GP2 active ingredient were produced in 2023, vials were filled in 2024, and a three‑year stability program has been completed. The company’s Fast‑Track designation, granted in September 2025, further supports a streamlined regulatory pathway.
Investors reacted positively to the FDA approval, reflecting confidence in the company’s ability to advance its lead product and mitigate key operational risks.
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