FORT LAUDERDALE, FL / ACCESS Newswire / April 2, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) ("We", "Our", the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has completed additional studies on orthotopic human tumor models in mice confirming its K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) product as a novel therapeutic agent for human hepatocellular carcinoma.
Human hepatocellular carcinoma (HCC) 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 treatment options were made 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%.
We have optimized the expression level of our full-length mRNA (K1.1c) as well as a smaller, truncated version (K1.1d) in HCC tumors in mice. Following encapsulation in two specifically designed Lipid Nanoparticles, the resulting K1.1c-mRNA-LNP and K1.1d-mRNA-LNP were efficiently delivered to orthotopic engrafted HCC tumors in mice in a dose-dependent manner by systemic administration. Under repeated dosing, the full-length K1.1c was found to reduce growth of three different types of human HCC tumors in mice with good tolerability. Proof-of-concept study of the truncated version K1.1d was conducted to assess its anti-tumor activity in HCC models in mice. A preliminary study suggested the truncated form of K1.1c could be highly expressed in engrafted tumors and had significant anti-tumor activity in mouse HCC models in a dose-dependent manner.
We are currently conducting additional animal studies to delineate optimum dosing of our truncated version (K1.1d) in different HCC model in mice to compare its dose-response and therapeutic window with those of the full-length (K1.1c). The smaller-sized mRNA of the truncated version offers the advantage of better efficacy at lower doses.
"We are pushing the frontier of mRNA therapy for cancer with our novel mRNA-LNP formulation," said Dr. Steve Slilaty, CEO of the Company. "Delivering mRNA via Lipid Nanoparticles (mRNA-LNP) 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."
About Sunshine Biopharma Inc.
Sunshine Biopharma currently has 70 generic prescription drugs on the market in Canada and 13 additional drugs scheduled to be launched in the remainder of 2025. Among the new drugs to be launched is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy. In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.
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Safe Harbor Forward-Looking Statements
This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.
For more information, please contact:
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
SOURCE: Sunshine Biopharma Inc.
