Greenwich LifeSciences, Inc. engages in the development of a breast cancer immunotherapy designed to prevent the recurrence of breast cancer following surgery. The company was founded by Eric Rothe on August 29, 2006 and is headquartered in Stafford, TX.
Clinical Trials
2
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2006
Recruiting
2
100.0%
No approval data available
- Stony Brook University Hospital is the only Long Island site participating in the worldwide FLAMINGO-01 phase 3 clinical trial testing a breast cancer vaccine for HER2-positive patients. - The vaccine from Greenwich LifeSciences has demonstrated an 80% or greater reduction in metastatic breast cancer recurrence over 5 years, compared to no more than 50% reduction from other approved products. - The treatment works by injecting patients with a piece of the HER2 protein combined with an immune adjuvant to stimulate the patient's immune system to fight cancer. - If successful, the vaccine could become the standard of care for HER2-positive breast cancer patients, potentially reducing recurrence rates from 25% to 10% per 100 patients treated.
- Greenwich LifeSciences has completed enrollment of 250 patients in the non-HLA-A*02 arm of its Phase III FLAMINGO-01 trial evaluating GLSI-100 immunotherapy for preventing breast cancer recurrence. - The company has screened over 1,000 patients across 140 active sites globally, maintaining a screening rate of approximately 150 patients per quarter. - Preliminary analysis suggests promising trends in immune response and safety profiles similar to previous Phase IIb results, where breast cancer recurrences were reduced by up to 80%. - The non-HLA-A*02 patient population could potentially double the eligible patient pool to approximately 88,000 new patients annually with an estimated market potential of $8-10 billion per year.
- Greenwich LifeSciences received European regulatory approval to expand its Phase III FLAMINGO-01 clinical trial to Ireland, adding to a global network of 150 trial sites across seven countries. - The trial evaluates GLSI-100 immunotherapy in HER2-positive breast cancer patients with residual disease or high-risk pathologic complete response after surgery and trastuzumab treatment. - Ireland diagnosed 3,723 new breast cancer cases in 2022, representing 30% of all cancers in women and the second leading cause of cancer death with 883 deaths. - Dr. Janice Walshe from St Vincent's University Hospital in Dublin will serve as national principal investigator, bringing extensive experience in international breast cancer trials.
- Greenwich LifeSciences' GLSI-100 immunotherapy received FDA Fast Track designation on September 10, 2025, for treating HLA-A02-positive HER2-positive breast cancer patients. - The designation enables expedited regulatory review and rolling BLA submissions, potentially compressing development timelines by up to 30%. - Phase IIb data demonstrated greater than 80% reduction in metastatic recurrence over five years, significantly outperforming existing therapies. - The ongoing Phase III FLAMINGO-01 trial is enrolling 750 patients across 117 global sites, targeting a $13.4 billion HER2-positive breast cancer market by 2030.
- Greenwich LifeSciences announced that the FDA has granted Fast Track designation for GLSI-100, an immunotherapy designed to prevent breast cancer recurrences in HLA-A*02 patients with HER2-positive breast cancer. - The designation enables more frequent FDA communication and potential rolling review of the Biologic License Application, potentially accelerating approval timelines for the investigational treatment. - Previous Phase IIb data demonstrated an 80% or greater reduction in metastatic breast cancer recurrence rates over 5 years compared to placebo in HER2/neu 3+ patients. - The company is currently conducting FLAMINGO-01, a Phase III trial designed to evaluate GLSI-100's safety and efficacy in approximately 750 patients across up to 150 global sites.
- Greenwich LifeSciences is conducting FLAMINGO-01, a Phase III trial evaluating GLSI-100 immunotherapy to prevent breast cancer recurrences in HER2-positive patients with residual disease. - The global trial, led by Baylor College of Medicine, plans to enroll up to 750 patients across 150 sites and is designed to detect a 70% reduction in recurrence risk. - GLSI-100 targets the HER2 protein expressed in 75% of breast cancers, addressing a significant unmet need among approximately 300,000 new breast cancer patients annually in the U.S. - Noble Capital Markets has initiated equity research coverage on the company, highlighting the clinical and commercial potential of this novel immunotherapy approach.
- Greenwich LifeSciences is transitioning from external Clinical Research Organizations to an internal clinical trial management team for its Phase III FLAMINGO-01 study to reduce costs and improve efficiency. - The strategic shift aims to lower the company's baseline burn rate while enhancing data quality and site monitoring capabilities for the breast cancer immunotherapy trial. - The internal team expansion positions Greenwich to potentially conduct multiple simultaneous trials and manage additional pipeline indications or in-licensed drug candidates more cost-effectively. - FLAMINGO-01 is evaluating GLSI-100 immunotherapy in HER2-positive breast cancer patients, with plans to enroll approximately 750 patients across up to 150 global sites.
- Initial analysis of FLAMINGO-01 trial reveals 46% of screened patients carry at least one HLA-A*02 allele, a crucial factor for GLSI-100 breast cancer vaccine treatment. - The trial's open-label arm studying non-HLA-A*02 patients has been expanded from 100 to 250 participants following FDA and EMA approval. - The Phase III trial design includes approximately 500 HLA-A*02 positive patients in randomized arms, with an additional open-label arm to investigate vaccine efficacy in other HLA types.
- Greenwich LifeSciences broadens its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence, by adding new clinical sites in the U.S. and Europe. - The trial expands into France through a partnership with Unicancer, activating 19 sites, and collaborates with GBG in Germany, adding approximately 38 sites to the study. - Harvard and Johns Hopkins join the trial in the U.S., with principal investigators Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee. - EMA approves the addition of 11 sites in Spain, Germany, and Poland, potentially activating 110-115 sites in Europe, with plans to expand to Ireland, Romania, and other countries.
- MAIA Biotechnology's lead candidate, THIO, is currently in Phase II clinical trials, evaluating its potential in treating patients with non-small cell lung cancer. - Recent SEC filings reveal that Geode Capital Management LLC increased its stake in MAIA Biotechnology by 22.9% during the third quarter, indicating growing investor confidence. - Greenwich LifeSciences' GP2 immunotherapy is in Phase III clinical trials, aimed at preventing breast cancer recurrences in patients post-surgery. - Institutional investors and hedge funds have shown increased interest in Greenwich LifeSciences, with Geode Capital Management LLC raising its position by 4.6%.
