EARLI-001

EARLI-001 is a non-viral, DNA nanoplasmid-based diagnostic agent developed by Earli, Inc. for the early detection of cancer through a "synthetic biopsy" approach. The compound consists of a cancer-specific promoter—specifically the survivin (BIRC5) promoter—driving the expression of a synthetic biomarker, Secreted Embryonic Alkaline Phosphatase (SEAP). Survivin is an anti-apoptotic protein that is highly overexpressed in a wide range of malignancies (including lung, breast, and liver cancers) but is virtually absent in healthy adult tissues. When EARLI-001 is administered intravenously using a linear polyethyleneimine (PEI) delivery system, the nanoplasmid is taken up by cells throughout the body; however, the SEAP reporter is only expressed in cells with active survivin transcription (i.e., cancer cells). The resulting SEAP protein is secreted into the blood, where it can be detected via a simple blood test, potentially identifying early-stage tumors that are below the detection limit of current imaging or liquid biopsy technologies.