Sunshine Biopharma Inc. (NASDAQ:SBFM) announced positive results from additional studies of its novel mRNA therapy for hepatocellular carcinoma (HCC), demonstrating significant anti-tumor activity in preclinical models. The company's stock surged on Wednesday following the announcement, with trading volume reaching 19.07 million compared to an average of 88.16K.
The pharmaceutical company has successfully completed studies on orthotopic human tumor models in mice, confirming its K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) as a promising therapeutic agent for human hepatocellular carcinoma, the most common type of primary liver cancer in adults.
Addressing a Critical Unmet Need
Hepatocellular carcinoma represents the third leading cause of cancer-related deaths worldwide. Despite several treatment options becoming available in recent years as first-line or second-line therapies, the five-year survival rate for HCC patients remains dismally low at only 18-21%, highlighting the urgent need for innovative treatment approaches.
Promising Preclinical Results
Sunshine Biopharma has optimized the expression levels of two versions of its therapeutic mRNA: a full-length version (K1.1c) and a smaller, truncated version (K1.1d). Both were encapsulated in specially designed Lipid Nanoparticles and efficiently delivered to orthotopic engrafted HCC tumors in mice through systemic administration.
The results showed that under repeated dosing, the full-length K1.1c reduced growth of three different types of human HCC tumors in mice with good tolerability. The truncated version K1.1d also demonstrated significant anti-tumor activity in a dose-dependent manner.
"We are pushing the frontier of mRNA therapy for cancer with our novel mRNA-LNP formulation," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "Delivering mRNA via Lipid Nanoparticles is a new, revolutionary way to treat cancer. The performance of our K1.1-mRNA-LNP to date is simply remarkable, as we look ahead to the opportunity of delivering new life-saving treatments for cancer patients around the world."
Advancing the Development Program
The company is currently conducting additional animal studies to determine the optimum dosing of the truncated version (K1.1d) in different HCC mouse models. These studies aim to compare its dose-response and therapeutic window with those of the full-length version (K1.1c).
A key advantage of the truncated version is its smaller-sized mRNA, which potentially offers better efficacy at lower doses. This could translate to improved clinical outcomes and potentially fewer side effects if the therapy advances to human trials.
Broader Company Portfolio
Beyond its mRNA therapy program, Sunshine Biopharma currently markets 70 generic prescription drugs in Canada with 13 additional drugs scheduled for launch in the remainder of 2025. Among these is NIOPEG®, a biosimilar of NEULASTA®, a long-acting form of recombinant human granulocyte colony-stimulating factor indicated to decrease infection incidence in patients with non-myeloid malignancies receiving anti-neoplastic therapy.
The company's proprietary drug development program also includes a PLpro protease inhibitor, a small molecule for the treatment of SARS Coronavirus infections.
Financial Performance
Sunshine Biopharma reported strong financial results for 2024, with revenue reaching $34.9 million, representing a 45% increase year over year. This financial growth provides the company with resources to continue advancing its innovative therapeutic pipeline.
The positive preclinical results for the K1.1 mRNA therapy represent a significant step forward in Sunshine Biopharma's oncology program and highlight the potential of mRNA-based approaches in addressing difficult-to-treat cancers like hepatocellular carcinoma.
