Sunshine Biopharma Reports Breakthrough Findings on K1.1 mRNA for Hepatocellular Carcinoma Therapy

Sunshine Biopharma Inc., a pharmaceutical company listed on NASDAQ under the ticker "SBFM," announced the completion of mouse model studies demonstrating the proof-of-concept for their novel therapeutic agent, the K1.1 mRNA product, aimed at treating human hepatocellular carcinoma (HCC). HCC is a significant health concern, being the third leading cause of cancer-related deaths worldwide and the most prevalent form of primary liver cancer in adults. Despite available first-line and second-line treatments, the five-year survival rate for HCC patients remains dismally low at 18-21%.

In the conducted studies, K1.1 mRNA showcased dose-dependent anti-proliferative activity when transfected into both cultured human HCC cell lines and HCC cells derived from patients. The K1.1 mRNA was encapsulated in specially engineered lipids to form K1.1 mRNA-Lipid Nanoparticles (K1.1/LNP), which were then administered to mice. These nanoparticles were effectively delivered to the livers of mice in a dose-responsive manner. Furthermore, repeated systemic dosing of K1.1/LNP resulted in the reduced growth of two different types of human HCC tumors that had been orthotopically grafted into the livers of immunodeficient mice. The pharmacodynamics observed in intrahepatic tumors correlated positively with the antitumor efficacy in the animal models.

Dr. Steve Slilaty, CEO of Sunshine Biopharma and inventor of the K1.1 mRNA technology, expressed enthusiasm about these promising results. He highlighted that the technology not only demonstrated the ability to penetrate malignant liver cells in a dose-dependent manner but also inhibited the growth of these cells. Dr. Slilaty mentioned that the company is currently conducting further animal studies to better understand the therapeutic window and optimize the dosing regimen of K1.1/LNP for future use as a single-agent treatment for HCC patients.

Sunshine Biopharma Inc. also has a substantial portfolio of 63 generic prescription drugs currently available in the Canadian market, with plans to launch an additional 31 drugs by the end of 2024 and into 2025. Among these upcoming products is NIOPEG®, a biosimilar to NEULASTA®, which is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim) used to reduce the incidence of infection in patients undergoing anti-neoplastic therapy for non-myeloid malignancies.

Additionally, Sunshine Biopharma is advancing a proprietary drug development program that includes the K1.1 mRNA for liver cancer and a PLpro protease inhibitor, a small molecule targeting SARS Coronavirus infections. This development program underlines the company's commitment to addressing critical medical needs in oncology and antiviral therapies.