Update on Flamingo-01 Phase III Trial

Greenwich LifeSciences, Inc., a biopharmaceutical firm centered on developing GLSI-100, an immunotherapy targeting breast cancer recurrence post-surgery, has shared updates on the Phase III Flamingo-01 clinical trial. The trial's Data Safety Monitoring Board (DSMB) convened twice in 2023, endorsing the study's continuation without changes. No severe adverse events associated with GLSI-100 have been reported.

In the U.S., nearly 30 clinical sites across various hospitals and the largest oncology network are recruiting patients for the trial. The first patient was treated in December 2022, with additional sites progressively enrolling patients throughout 2023. The company plans to increase the U.S. sites to 35-40, with potential European regulatory approval expected in 2024, aiming to add 105-120 sites across Europe, including Spain, France, Germany, Italy, Poland, and more.

The European clinical sites are part of academic networks that are leaders in oncology, collaborating to advance new treatments. These include GEICAM in Spain, Unicancer in France, GBG in Germany, and GIM in Italy. At the 2023 San Antonio Breast Cancer Symposium and ASCO Annual Meeting, the Steering Committee of Flamingo-01, composed of renowned experts in the field, discussed unpublished data and the expansion of the non-HLA-A*02 patient arm to 250.

The Phase III trial involves approximately 500 HLA-A*02 patients randomized to GLSI-100 or placebo, with up to 250 other HLA types treated with GLSI-100. The interim analysis for the trial is planned when half of the required events have occurred. The CEO, Snehal Patel, highlighted the potential of the Flamingo-01 trial and the significance of the European sites in contributing to patient enrollment and the trial's conduct.

Preparations for the Biologics License Application (BLA) filing in the U.S. include commercial manufacturing data and reports from previous trials. The company has completed the first three commercial lots of GP2 active ingredient and plans to fill GP2 into vials for commercial sale or clinical use in 2024.

Additionally, the company is considering additional clinical trials, subject to funding and resources, including a Phase IIb trial for extended follow-up and a Phase II/III trial for low-risk HER2 positive patients. A new patent application has been filed for GLSI-100's use in reversing a suppressed immune state against HER2 positive cancer cells, with plans for more patent applications regarding manufacturing and processes.

Greenwich LifeSciences participated in several corporate events in 2023, including scientific and clinical conferences, showcasing the promising data of GP2 and the potential of Flamingo-01. The Flamingo-01 trial (NCT05232916) evaluates the safety and efficacy of GLSI-100 in HER2/neu positive breast cancer patients and is led by Baylor College of Medicine with plans to expand globally. The company's focus is on developing GP2 to prevent breast cancer recurrences, with the Phase III trial designed to detect a significant hazard ratio in invasive breast cancer-free survival.