Sunshine Biopharma announces research results on K1.1 mRNA product

Sunshine Biopharma (SBFM) has completed mouse model studies providing proof-of-concept for the Company’s K1.1 mRNA product as a novel therapeutic agent for human hepatocellular carcinoma. Human hepatocellular carcinoma is the third leading cause of cancer-related deaths worldwide and the most common type of primary liver cancers in adults. In recent years, several systematic treatment options were available to HCC patients either as first-line or second-line treatment. Yet, the five-year survival rate of HCC patients remains at only 18-21%. When transfected into cultured human HCC cell lines and patient-derived HCC cells, K1.1 mRNA exhibited dose-dependent anti-proliferative activity in vitro. Following encapsulation in specifically engineered lipids, the resulting K1.1 mRNA-Lipid Nanoparticles were efficiently delivered to livers of mice in a dose-dependent manner in vivo. K1.1/LNP, under repeated systemic dosing, was found to reduce growth of two different types of human HCC tumors orthotopically grafted into the livers of immunodeficient mice. The pharmacodynamics of K1.1/LNP in intrahepatic tumors was well correlated with antitumor efficacy in mice. “We are excited about these findings which show the feasibility of K1.1 mRNA technology to not only enter malignant liver cells in a dose dependent fashion, but also in a manner that inhibits growth of these same cells” said Dr. Steve Slilaty, CEO of Sunshine Biopharma and inventor of the Company’s K1.1 mRNA technology. “We are currently conducting additional animal studies to delineate the therapeutic window and optimize dosing of our K1.1/LNP for use as a single agent in future treatment of HCC patients,” he added.