Greenwich Lifesciences Inc - GLSI STOCK NEWS

Greenwich LifeSciences (NASDAQ: GLSI) has reported positive preliminary immune response data from its FLAMINGO-01 Phase III clinical trial evaluating GLSI-100, an immunotherapy for breast cancer recurrence prevention. The data shows increasing immune responses over time in both HLA-A*02 and non-HLA-A*02 patient arms.

Key findings include baseline immune response to GP2 before treatment and increasing response with vaccinations through months 4-6, consistent with Phase IIb trial results. The company has filed patent claims for non-HLA-A*02 patients, potentially doubling eligible patients to 88,000 annually in the US and Europe, with market potential of $8-10 billion per year.

Previous Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences over 5 years in HER2/neu 3+ patients treated with GLSI-100. The company is considering adding a randomized placebo arm for non-HLA-A*02 patients, effectively creating a second pivotal Phase III trial.

Greenwich LifeSciences (NASDAQ: GLSI) has announced an extension of the lock-up period for shares owned by company directors, officers, and pre-IPO investors until March 31, 2026. This extension represents approximately 66 months from the company's IPO date.

During this lock-up period, these insiders will be restricted from selling their common stock holdings unless modified by the Board of Directors. After the lock-up expiration, daily and periodic trading restrictions will still apply to these shares, subject to Board modification.

The company is currently conducting the Phase III FLAMINGO-01 clinical trial of GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.

Greenwich LifeSciences (NASDAQ: GLSI) has provided an update on the safety data from its Phase III FLAMINGO-01 clinical trial evaluating GLSI-100, an immunotherapy for breast cancer recurrence prevention. The Data Safety Monitoring Board (DSMB) met twice in 2024 and recommended continuing the study without modifications, with no serious adverse events reported.

The update includes comparison with Phase IIb trial results, which showed an 80% or greater reduction in cancer recurrences in HER2/neu 3+ patients treated with GLSI-100. The Phase IIb trial, involving 96 patients across 16 sites, demonstrated no serious adverse events and a well-tolerated safety profile.

Preliminary FLAMINGO-01 safety data analysis shows GP2 immunotherapy continues to be well-tolerated across all study arms, with injection site reactions being the most frequent adverse event. The safety profile is trending similarly to the Phase IIb study, requiring no protocol modifications.

Greenwich LifeSciences (NASDAQ: GLSI) has provided an update on the open label HLA data from its Phase III FLAMINGO-01 trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The analysis reveals that 46% of screened patients have at least one HLA-A*02 allele, meeting the expected 40-50% prevalence rate and supporting sample size estimates for the trial.

The study includes three arms: two blinded arms for HLA-A*02 patients (treatment vs. placebo) and an expanded open-label arm for non-HLA-A*02 patients, recently increased from 100 to 250 participants. Notably, 8% of patients have received HLA-A*02 alleles from both parents, which could potentially lead to greater immune response and efficacy. The trial's design allows for analysis of various HLA combinations and their prevalence across different racial and ethnic groups, which may inform future commercial development strategies.

Greenwich LifeSciences (NASDAQ: GLSI) has received EMA approval to add 11 new clinical trial sites in Spain, Germany, and Poland for its Phase III FLAMINGO-01 trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The expansion involves academic networks including Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and Polish sites, bringing the total approved European sites to approximately 110-115.

The company plans to submit applications for an additional 5-10 sites in Ireland, Romania, and potentially other European countries. Currently, GLSI has activated approximately 100 sites globally that are screening patients, with notable increased patient screening activity in the second half of 2024. The company completed site activations across five European countries in 2024, including team training for study personnel.

Greenwich LifeSciences (NASDAQ: GLSI) has announced the activation of clinical sites in Poland for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The company is collaborating with Dr. Piotr Wysocki, who leads one of Poland's largest breast cancer research networks, with 9-11 sites participating in the trial.

According to European Cancer Information System data, Poland recorded 24,599 new breast cancer cases in 2022, representing 25% of all cancers in women, with 8,723 deaths. The first patient treatment in Poland began in 2024 after site approvals by Polish authorities. Clinical sites are established across multiple cities including Konin, Kraków, Opole, Poznań, Rzeszów, Slupsk, and Warszawa.

Greenwich LifeSciences (NASDAQ: GLSI) has announced significant additions to its Phase III FLAMINGO-01 clinical trial, with Harvard University and Johns Hopkins University joining as new participating sites. The trial is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.

Dr. Laura Spring from Harvard Medical School/Massachusetts General Hospital and Dr. Cesar Santa-Maria from Johns Hopkins have joined the trial's Steering Committee, which now includes ten prominent experts representing major breast oncology networks in the US, Germany, France, and Spain. Both new committee members bring significant expertise: Dr. Spring specializes in biomarker strategies and targeted therapies, while Dr. Santa-Maria is recognized for his work in breast immunotherapy and vaccine development.

Both institutions will offer the FLAMINGO-01 trial to patients with high-risk HER2-positive breast cancer, with both physicians expressing enthusiasm about the vaccine strategy's potential to reduce recurrence risk.

Greenwich LifeSciences (NASDAQ: GLSI) provided an update on the commercial manufacturing of GP2, its immunotherapy product for preventing breast cancer recurrences. The company manufactured three commercial lots of GP2 active ingredient in 2023, sufficient for approximately 200,000 doses. In 2024, they completed the first of three commercial lots filling GP2 into vials, with final testing near completion.

The manufacturing data has been submitted to both the FDA and European regulators (EMA) for review. The company plans to complete manufacturing activities parallel to conducting the Phase III FLAMINGO-01 trial. If approved, GLSI-100 could receive up to 12 years of market exclusivity. The company is working to ensure manufacturing meets both US and European regulatory standards, with up to 150 participating clinical sites across these regions.

Greenwich LifeSciences (NASDAQ: GLSI) has announced a partnership with GBG (German Breast Group) for its Phase III clinical trial, FLAMINGO-01. The collaboration involves approximately 38 German clinical sites, with most already approved by German authorities and initiating start-up activities in 2024.

GBG, Germany's largest breast cancer research network, includes over 1,000 doctors across 800+ centers, managing 67,000+ study participants and 3,500 new patients annually. The FLAMINGO-01 trial evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences in HER2+ high-risk patients.

The first German patient was randomized and treated in October 2024. This partnership is significant given that Germany reported 75,267 new breast cancer cases in 2022, representing 29% of all cancers in women, with 20,601 deaths that year.