Greenwich LifeSciences Partners with Unicancer Expanding Flamingo-01 into France

Partnership and Clinical Trial Activation - The company has partnered with Unicancer and its breast cancer group (UCBG), the largest academic breast cancer research network in France, to activate the FLAMINGO-01 study in approximately 19 French sites [1] - The UCBG network includes over 100 investigating centers across France, covering various types of institutions, and is internationally recognized for its role in breast cancer research [2] - The FLAMINGO-01 study will be conducted in collaboration with UCBG, with 15 sites initiated in Q2-Q4 2024 and the remaining 4 sites scheduled for start-up activities in Q1-Q2 2025 [1] Unicancer's Role and Network - Unicancer is the only hospital network in France entirely dedicated to oncology, with 18 Cancer Centers (CLCC) and two affiliated member institutions, caring for nearly 530,000 patients annually [6] - Unicancer is the leading academic sponsor of clinical trials in oncology in Europe, with 106 active clinical trials sponsored in 2020 and nearly 7,600 patients enrolled [6] - The Unicancer network contributes to a third of the internationally significant French publications in oncology and is ISO 9001:2015 certified for clinical research [6][10] FLAMINGO-01 Trial Details - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences in HER2-positive breast cancer patients [5][13] - The trial is designed to enroll approximately 500 HLA-A*02 patients randomized to GLSI-100 or placebo, with up to 250 patients of other HLA types treated with GLSI-100 in a third arm [13] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned after 14 events [13] Breast Cancer Statistics in France - In 2022, 66,328 new cases of breast cancer were diagnosed in France, representing approximately 33% of all cancers in women [9] - Breast cancer is the leading cause of cancer-related deaths in women in France, with 14,739 deaths reported in 2022 [9] Key Figures and Leadership - Dr. F.C. Bidard, a Medical Oncologist and Head of Breast Cancer Group at Institut Curie, serves as the national Principal Investigator for FLAMINGO-01 in France and is a member of the trial's Steering Committee [11] - Dr. T. Bachelot, President of UCBG, emphasized the importance of the FLAMINGO study in advancing clinical research in cancer vaccination [7] - CEO Snehal Patel highlighted the partnership with Unicancer and the involvement of Dr. Bidard in the Steering Committee as key factors in the trial's development [8]