Greenwich LifeSciences updates on new patent claims based on FLAMINGO-01

Greenwich LifeSciences (GLSI) provided an update on new patent claims based on FLAMINGO-01 statistically significant open label immune response and recurrence rate data. Statistically significant immune response and recurrence rate data is the basis for new claims recently filed that GLSI-100 clinically benefits non-HLA-A*02 patients, which the company believes increases the market for GLSI-100 by an additional 100% to 88,000 new patients per year in the US and Europe. The claims also show a favorable comparison to the blinded HLA-A 02 arms of FLAMINGO-01, without any unblinding. The invention is solely owned by the company. If the patent claims are granted, following successful patent prosecution, the patent could provide patent protection through 2045. The company plans to expand its immune response analysis of GP2 specific T cells by sequencing the DNA of a patient’s T cells at baseline and after treatment with GP2. The T cell sequences can be compared to the immune response changes over time. 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.”