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Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01
STAFFORD, Texas, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01. FDA Reviews and Approves Use of 1st GP2 Commercial Lot in FLAMINGO-01 The first three commercial lots of GP2 a
About this update from Greenwich Lifesciences, Inc.
[{"type":"image","alt":"Greenwich LifeSciences, Inc.","displaySize":"","headline":null,"caption":"Greenwich LifeSciences, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":123,"url":"https://media.zenfs.com/en/globenewswire.com/5236cbdf62d9160f7f17a269e6a93fa7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/CdB3UijgWjtUF2S9KALplg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE3MjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/5236cbdf62d9160f7f17a269e6a93fa7","width":300,"height":123}},"lazy":false},{"type":"text","content":"STAFFORD, Texas, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01.","length":399,"tagName":"p"},{"type":"text","content":"FDA Reviews and Approves Use of 1st GP2 Commercial Lot in FLAMINGO-01","length":69,"tagName":"p"},{"type":"text","content":"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 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials is now approved for use in FLAMINGO-01 in the US.","length":577,"tagName":"p"},{"type":"text","content":"CEO Snehal Patel commented, "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. We plan to start using these new GP2 vials in the coming weeks at all 40 US sites. We have 3 years of stability data to support the GP2 vial expiration date which may translate to the commercial expiration date of GP2 vials."","length":505,"tagName":"p"},{"type":"text","content":"Preparation for Filing of BLA in the US under Fas...