Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Austria, which is aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery [6] - The company has initiated the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [4][6] Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes sites in the US and Europe, with plans to expand to 150 sites globally [4] - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [4] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [4] Market Context - In Austria, breast cancer is the most common cancer among women, accounting for about 28% of all female cancers, with 6,070 new cases diagnosed in 2022 [3] - Breast cancer was the leading cause of cancer-related deaths in women in Austria, with 1,789 deaths reported in 2022 [3] Collaboration and Expansion - The company is collaborating with principal investigators at Ordensklinikum Linz in Upper Austria, with plans to activate this site within the year and explore additional sites in Vienna and Salzburg [4]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Belgium, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Belgium, adding to its existing sites in Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US [2]. - The trial is led by Baylor College of Medicine and plans to open up to 150 sites globally, with a focus on university-based hospitals and academic networks [5]. Group 2: Breast Cancer Statistics in Belgium - In 2022, Belgium reported 11,366 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 33% of all female cancers [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Belgium, with 2,324 deaths recorded in 2022 [3]. Group 3: Principal Investigator and Collaboration - The company is collaborating with Dr. Patrick Neven, a prominent figure in breast oncology, who will serve as the national principal investigator for FLAMINGO-01 in Belgium [4]. - Dr. Neven has extensive experience in clinical trials and has published over 300 peer-reviewed papers, contributing significantly to breast cancer research [4]. Group 4: Trial Design and Objectives - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [5].

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Portugal, focusing on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2] Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Portugal, joining other countries such as Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US [2] - The trial is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5] Group 2: Breast Cancer Statistics in Portugal - In 2022, there were 9,065 new cases of breast cancer diagnosed in Portugal, making it the most common cancer among women, accounting for approximately 30% of all cancers in this demographic [3] - Breast cancer was the leading cause of cancer-related deaths in women in Portugal, with 2,211 deaths reported in 2022 [3] Group 3: Principal Investigator and Collaboration - Dr. Luís António Marques da Costa has been appointed as the national principal investigator for FLAMINGO-01 in Portugal, bringing extensive experience in oncology and clinical trials [4] - The CEO of Greenwich LifeSciences expressed enthusiasm for collaborating with Dr. Costa and his team, indicating ongoing efforts to activate clinical trial sites in Lisbon and other regions of Portugal [5] Group 4: Trial Design and Objectives - FLAMINGO-01 aims to randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [5] - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [5]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Ireland, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients who have previously undergone surgery [7][8]. Clinical Trial Details - FLAMINGO-01 (NCT05232916) is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery [5]. - The trial is led by Baylor College of Medicine and includes clinical sites in the US and Europe, with plans to open up to 150 sites globally [5]. - Approximately 500 HLA-A*02 patients will be randomized to receive GLSI-100 or placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [5]. Expansion to Ireland - The application to European regulators for including Ireland in the FLAMINGO-01 trial has been formally approved, adding to existing sites in Spain, France, Germany, Italy, Poland, Romania, and the US [2]. - Dr. Janice Walshe will serve as the national principal investigator in Ireland, collaborating with Cancer Trials Ireland to provide access to novel agents for Irish women affected by breast cancer [4]. Breast Cancer Statistics - In 2022, Ireland reported 3,723 new cases of breast cancer, making it the most common cancer diagnosed in women, accounting for approximately 30% of all cancers in women [3]. - Breast cancer is the second leading cause of cancer-related deaths among women in Ireland, with 883 deaths recorded in 2022 [3].

Core Viewpoint - Greenwich LifeSciences, Inc. has received Fast Track designation from the FDA for its immunotherapy GLSI-100, aimed at preventing breast cancer recurrences in HLA-A*02 positive patients who have completed standard HER2/neu targeted therapy [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients post-surgery [9][11] - The company is currently conducting a Phase III clinical trial named FLAMINGO-01, which evaluates the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [7][11] Fast Track Designation - The Fast Track designation allows for more frequent communication between the FDA and the company, potentially leading to earlier drug approval and the ability to submit parts of the Biologic License Application (BLA) as they are completed [2][5] - The designation is granted to drugs that address serious conditions and fill unmet medical needs, with GLSI-100 showing potential to improve invasive breast cancer-free survival [2][4] Clinical Trial Details - FLAMINGO-01 is designed to include approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or placebo, with an interim analysis planned after 14 events of invasive breast cancer [7] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, providing 80% power if the annual event rate in placebo-treated subjects is 2.4% or greater [7] Previous Clinical Data - In a Phase IIb trial, GLSI-100 demonstrated an 80% or greater reduction in cancer recurrences over five years in HER2/neu 3+ patients, with no serious adverse events reported [6][10] - The immunotherapy was well tolerated, and booster injections every six months prolonged the immune response, indicating a strong safety profile [6][10]

Core Viewpoint - Greenwich LifeSciences, Inc. has announced the initiation of company-sponsored equity research coverage by Noble Capital Markets, focusing on its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 as an immunotherapy for preventing breast cancer recurrences [1] Group 1: Clinical Trial Details - FLAMINGO-01 is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients with residual disease or high-risk pathologic complete response after surgery [2] - The trial will involve approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types receiving GLSI-100 [2] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [2] Group 2: Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery [4] - GP2 is a 9 amino acid transmembrane peptide derived from the HER2 protein, which is expressed in 75% of breast cancers at varying levels [4] - The company is actively conducting the FLAMINGO-01 trial, with plans to expand to 150 clinical sites globally [2][4] Group 3: Breast Cancer Statistics - One in eight U.S. women will develop invasive breast cancer in their lifetime, with around 300,000 new cases and 4 million survivors annually [3] - HER2 protein is expressed in 75% of breast cancers, indicating its significance in treatment strategies [3][4]

Core Viewpoint - Greenwich LifeSciences, Inc. is enhancing its internal clinical trial management by hiring dedicated staff for the FLAMINGO-01 trial, aiming to reduce costs and improve efficiency in the evaluation of GLSI-100, an immunotherapy for breast cancer recurrence [1][2][4]. Group 1: Company Strategy - The company is transitioning from reliance on Clinical Research Organizations (CROs) to an in-house team to manage the FLAMINGO-01 trial, which is expected to lower operational costs and enhance trial quality [2][4]. - By building an internal clinical operations team, the company aims to conduct multiple trials simultaneously and respond more effectively to the needs of FLAMINGO-01 and potential new drug candidates [3][4]. Group 2: Clinical Trial Details - FLAMINGO-01 is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients, with plans to open up to 150 sites globally [5]. - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [5]. - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [5]. Group 3: Market Context - One in eight U.S. women will develop invasive breast cancer, with around 300,000 new cases annually and 4 million survivors, highlighting the significant market potential for effective therapies like GLSI-100 [6]. - HER2 protein is expressed in 75% of breast cancers, indicating a broad patient population for the company's immunotherapy approach [6][8].

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Romania to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The European regulators have formally approved the addition of Romanian clinical sites to the FLAMINGO-01 trial, which already includes approximately 150 sites across several countries including Spain, France, Germany, Italy, Poland, and the US [2]. - Currently, there are about 123 actively enrolling sites globally for the FLAMINGO-01 trial [2]. Group 2: Breast Cancer Statistics in Romania - In 2022, Romania reported 12,861 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 28% of all cancers in women [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Romania, with 3,877 deaths recorded in 2022 [3]. Group 3: Collaboration and Leadership - The company is collaborating with Dr. Nicoleta Antone, who leads a major academic breast cancer center in Cluj Napoca, Romania, and is supported by colleagues from at least three other sites in the country [4][5]. - Dr. Antone will serve as the national principal investigator for FLAMINGO-01 in Romania [5]. Group 4: Future Plans and Expectations - The CEO of Greenwich LifeSciences indicated that Romania is the first of several additional European countries planned for inclusion in the FLAMINGO-01 trial, focusing on mid-sized population countries with significant population centers [6]. - The company has conducted multiple site visits in Romania to assess feasibility and provide training, with plans to potentially start screening and enrolling Romanian patients in the coming months [6]. Group 5: Trial Design and Objectives - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [7]. - The trial aims to randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [7]. - The trial is structured to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7].

Core Insights - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][26] - The trial has shown promising preliminary data regarding safety and immune response, leading to potential expansions in patient enrollment and trial design [2][12] Group 1: Trial Progress and Future Plans - The FLAMINGO-01 trial has confirmed that preliminary data for HLA prevalence, safety, and immune response is trending positively in both HLA-A*02 and non-HLA-A*02 patient arms [2] - The non-HLA-A*02 arm was expanded to 250 patients in 2024, with regulatory approval from both EU and US authorities, and further changes are being considered to enhance the trial's market potential [2] - In Q1 2025, the company achieved a screening rate of over 150 patients per quarter across 117 active sites, with plans to activate an additional 40 sites in the EU [3] Group 2: Clinical Sites and Networks - The trial includes approximately 40 US clinical sites, featuring prominent teaching hospitals such as Yale, Johns Hopkins, and Stanford, which are actively recruiting patients [4] - In Europe, the trial has expanded into five countries with 77 activated clinical sites, primarily in Spain, France, Germany, Italy, and Poland [5][6] - Major academic networks in Europe, such as GEICAM in Spain and GBG in Germany, are collaborating in the trial, enhancing its credibility and outreach [7][9] Group 3: Steering Committee and Expert Involvement - The Steering Committee consists of leading experts in breast cancer oncology from prominent hospitals and networks in the US and Europe, contributing to the trial's design and execution [12] - The company is focused on improving the trial's conduct and design to replicate Phase IIb results and prepare for commercialization of GLSI-100 [12] Group 4: About GLSI-100 and Breast Cancer - GLSI-100 is designed for HER2 positive breast cancer patients who have residual disease post-surgery and have completed neoadjuvant and postoperative adjuvant trastuzumab treatment [24] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [24]

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial FLAMINGO-01 for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with promising preliminary immune response data indicating effectiveness in both HLA-A*02 and non-HLA-A*02 patient groups [1][4][6]. Group 1: Clinical Trial Updates - The preliminary immune response data from FLAMINGO-01 shows increasing immune responses over time in both HLA-A*02 treated and placebo arms, as well as in the non-HLA-A*02 arm [2][6]. - The company is considering adding a randomized placebo arm for non-HLA-A*02 patients, which could effectively transform the current open label arm into a pivotal Phase III trial [4]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [8]. Group 2: Market Potential and Patient Eligibility - The potential market for GP2 treatment could reach up to $10 billion annually, with the possibility of doubling the number of eligible patients to approximately 88,000 new patients per year in the US and Europe [4][6]. - The company has filed patent claims for non-HLA-A*02 patients, which may be solely owned by the company, enhancing its market position [6]. Group 3: Previous Clinical Data - In a Phase IIb clinical trial, GLSI-100 demonstrated an 80% or greater reduction in cancer recurrences over five years in HER2/neu 3+ patients, compared to a 20-50% reduction by other approved products [5][11]. - The immune response peaked at six months after the initial vaccinations, indicating a sustained immune response that correlates with reduced metastatic breast cancer recurrences [12]. Group 4: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences, particularly in patients who have undergone surgery [13]. - The company is currently conducting the FLAMINGO-01 trial, which is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [8].