EMA Approves Greenwich LifeSciences' Flamingo-01 Expansion

Greenwich LifeSciences, a biopharmaceutical firm engaged in a Phase III clinical trial for GLSI-100, an immunotherapy for post-surgery breast cancer patients, has received approval from the European Medicines Agency (EMA) to extend its Flamingo-01 trial to Europe. The EMA has deemed the company's application satisfactory in all required areas, including manufacturing, non-clinical, clinical, statistical, and regulatory aspects.

The next step involves five European countries making a final decision on the trial's initiation. If approved, approximately 105 European sites will be authorized to begin the process of initiating and activating the trial. This will enable the screening and enrollment of patients.

The company's CEO, Snehal Patel, highlighted the value of the interactions with the EMA and the participating countries, stating that they provided significant insights into the expectations for a marketing license application in Europe for GLSI-100. He also mentioned that the dialogue with EMA regulators will continue as the trial progresses in Europe, which will aid in preparing for a future EU licensing application concurrently with filing a BLA in the US.

The Flamingo-01 trial (NCT05232916) is designed to assess the safety and efficacy of GLSI-100 in HER2/neu positive breast cancer patients who have completed trastuzumab-based treatments post-surgery. The trial is led by Baylor College of Medicine and is set to expand globally, with plans to include up to 150 sites. The Phase III trial will involve approximately 500 HLA-A*02 patients randomized to either GLSI-100 or placebo, with an additional 250 patients of other HLA types receiving GLSI-100. The trial aims to detect a significant improvement in invasive breast cancer-free survival.

HER2/neu is a cell surface receptor protein expressed in various cancers, including 75% of breast cancers at varying levels. Greenwich LifeSciences is focused on developing GP2, an immunotherapy derived from the HER2/neu protein, to prevent breast cancer recurrences in post-surgery patients.
Breast cancer is a prevalent health concern, with one in eight US women at risk of developing invasive breast cancer in their lifetime. In 2021, there were about 282,000 new breast cancer patients and 3.8 million survivors in the US. The company's efforts in developing GLSI-100 underscore the importance of advancing immunotherapies to combat this disease.

Greenwich LifeSciences is a clinical-stage company dedicated to the advancement of immunotherapies for cancer prevention, with a focus on the development of GP2. The company's ongoing Flamingo-01 trial represents a significant step towards potentially improving outcomes for breast cancer patients.