Greenwich LifeSciences announced a strategic operational shift to build an internal clinical trial management team for its Phase III FLAMINGO-01 study, moving away from reliance on more expensive Clinical Research Organizations (CROs). The clinical-stage biopharmaceutical company expects this transition to reduce costs while improving efficiency and data quality for its breast cancer immunotherapy trial.
Strategic Cost Reduction Initiative
The company has begun hiring dedicated staff to manage and operate FLAMINGO-01, which is evaluating GLSI-100 as an immunotherapy to prevent breast cancer recurrences. VP Jaye Thompson noted that while the external CRO experience has been successful, the ability to reduce costs and improve efficiency through dedicated staff and contractors is "quite appealing."
"I am thrilled with the quality of the staff that we have been able to identify and secure to help us efficiently manage the FLAMINGO-01 study," Thompson commented. The company plans to continue utilizing select vendors to optimize efficiency while building internal capabilities.
CEO Snehal Patel emphasized that the new strategy will reduce the baseline burn rate while improving data collection quality and site management. "This internal staff is also helping us to manage our European clinical operations," Patel stated.
Expanding Trial Capabilities
The internal team buildout is designed to develop capabilities for conducting multiple trials simultaneously. This includes potential expansion of HLA-A02 patient enrollment, creation of pivotal treated and placebo arms for non-HLA-A02 patients, pursuit of other populations and trials for GLSI-100, or development of other in-licensed drug candidates.
As the company reduces its burn rate through this transition, management believes it will have more options to respond to FLAMINGO-01 needs or add additional pipeline indications and product lines. The internal clinical team built to manage a Phase III trial can more cost-effectively assimilate additional studies if the company adds another GLSI-100 indication or in-licenses new drug candidates.
FLAMINGO-01 Trial Design and Scope
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial led by Baylor College of Medicine, designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2-positive breast cancer patients. The study targets patients who had residual disease or high-risk pathologic complete response at surgery and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based treatment.
The trial currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks, with plans to expand to up to 150 sites globally. In the double-blinded arms, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, while up to 250 patients of other HLA types will receive GLSI-100 in a third arm.
The study has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events. An interim analysis for superiority and futility will be conducted when at least 14 events have occurred. The sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
Addressing Significant Medical Need
The trial addresses a substantial patient population, as one in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 protein is expressed in 75% of breast cancers at various levels, including low (1+), intermediate (2+), and high (3+ or over-expressor) expression levels.
GLSI-100 is based on GP2, a 9 amino acid transmembrane peptide of the HER2 protein, designed as an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. The approach targets a cell surface receptor protein expressed in various common cancers, with particular relevance to the large population of breast cancer patients with HER2 expression.
