Sunshine Biopharma Inc. has announced promising preclinical results for its K1.1 mRNA product as a potential treatment for human hepatocellular carcinoma (HCC). Mouse model studies demonstrated that K1.1 mRNA, when delivered via lipid nanoparticles, significantly reduced the growth of HCC tumors in the livers of mice.
HCC is a major global health challenge, ranking as the third leading cause of cancer-related deaths worldwide. The current five-year survival rate for HCC patients is only 18-21%, highlighting the urgent need for more effective therapies.
K1.1 mRNA Mechanism and Efficacy
In vitro experiments showed that K1.1 mRNA exhibited dose-dependent anti-proliferative activity when transfected into cultured human HCC cell lines and patient-derived HCC cells. To enhance delivery and targeting, the K1.1 mRNA was encapsulated in specifically engineered lipids, forming K1.1 mRNA-Lipid Nanoparticles (K1.1/LNP).
In vivo studies demonstrated that K1.1/LNP was efficiently delivered to the livers of mice in a dose-dependent manner. Repeated systemic dosing of K1.1/LNP led to a reduction in the 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 correlated well with antitumor efficacy in mice.
Future Development
"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. The company is currently conducting additional animal studies to optimize dosing and delineate the therapeutic window of K1.1/LNP for potential use as a single agent in future treatment of HCC patients.
Sunshine Biopharma's Pipeline
In addition to K1.1 mRNA, Sunshine Biopharma has 63 generic prescription drugs on the market in Canada and plans to launch 31 more drugs in 2024 and 2025. These include NIOPEG®, a biosimilar of NEULASTA®, indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy. The company is also developing a PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections.
