Greenwich LifeSciences Expands GLSI-100 Potential With New Patent Claims Backed By FLAMINGO-01 Trial Data, Signals Broader Breast Cancer Use And Market Expansion

Greenwich LifeSciences, Inc. has announced an update on newly filed patent claims for its investigational immunotherapy GLSI-100, based on statistically significant findings from its Phase III FLAMINGO-01 trial. The therapy, which has received Fast Track designation, is being developed to prevent breast cancer recurrence and has shown promising immune response and recurrence rate data in ongoing studies.

The new patent claims highlight that GLSI-100 may also provide clinical benefit to patients who are not HLA-A02 positive, effectively expanding its potential patient population. According to the company, this could double the addressable market, adding approximately 88,000 new patients annually across the United States and Europe. The findings also demonstrate favorable comparisons with blinded HLA-A02 study arms without requiring unblinding.

CEO Snehal Patel commented, "We believe that these patent claims, based on statistically significant data, support the enrollment of patients independent of HLA type. In the US, we have already started to enroll both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms in FLAMINGO-01, based on the FDA’s recent review of such protocol changes. The Company will have the option to pursue approval for both HLA-A*02 and non-HLA-A*02 patients using the increased statistical power of a combined analysis of the two patient groups together with the potential to double the market for GP2 to up to $10 billion in revenue per year."

Greenwich LifeSciences retains full ownership of the invention, and if the patent is granted, it could secure protection for GLSI-100 through 2045. This would strengthen the company’s long-term commercial and intellectual property position in the immunotherapy space.

In addition, the company plans to deepen its understanding of immune responses by analyzing GP2-specific T cells through DNA sequencing. By comparing T cell profiles before and after treatment, researchers aim to better track immune activity and further validate the therapy’s mechanism of action over time.