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Sunshine Biopharma Announces Breakthrough Research Results on the Company’s K1.1 mRNA Product as a Novel Therapeutic Agent for Human Hepatocellular Carcinoma

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Sunshine Biopharma (NASDAQ:SBFM) has announced breakthrough research results for its K1.1 mRNA product as a treatment for human hepatocellular carcinoma (HCC), the third leading cause of cancer-related deaths worldwide. The company's mouse model studies demonstrated that K1.1 mRNA, when encapsulated in engineered lipids (K1.1/LNP), effectively reduced the growth of human HCC tumors in mice livers. The treatment showed dose-dependent anti-proliferative activity in both cultured human HCC cell lines and patient-derived HCC cells. This development is significant given that current HCC treatments only achieve a 18-21% five-year survival rate.

Sunshine Biopharma (NASDAQ:SBFM) ha annunciato risultati di ricerca rivoluzionari per il suo prodotto mRNA K1.1 come trattamento per il carcinoma epatocellulare umano (HCC), la terza causa principale di decessi legati al cancro nel mondo. Gli studi condotti su modelli murini hanno dimostrato che K1.1 mRNA, quando incapsulato in lipidi ingegnerizzati (K1.1/LNP), ha ridotto efficacemente la crescita dei tumori umani HCC nei fegati dei topi. Il trattamento ha mostrato un'attività antiproliferativa dipendente dalla dose sia in linee cellulari umane HCC coltivate che in cellule HCC derivate da pazienti. Questo sviluppo è significativo considerando che i trattamenti attuali per HCC raggiungono solo un tasso di sopravvivenza del 18-21% a cinque anni.

Sunshine Biopharma (NASDAQ:SBFM) ha anunciado resultados de investigación innovadores para su producto de mRNA K1.1 como tratamiento para el carcinoma hepatocelular humano (HCC), la tercera causa principal de muertes relacionadas con el cáncer en todo el mundo. Los estudios en modelos de ratón demostraron que el mRNA K1.1, cuando está encapsulado en lípidos diseñados (K1.1/LNP), reduce efectivamente el crecimiento de tumores humanos de HCC en el hígado de los ratones. El tratamiento mostró una actividad antiproliferativa dependiente de la dosis tanto en líneas celulares humanas de HCC cultivadas como en células de HCC derivadas de pacientes. Este desarrollo es significativo dado que los tratamientos actuales para el HCC solo logran una tasa de supervivencia del 18-21% a cinco años.

선샤인 바이오파마 (NASDAQ:SBFM)는 인간 간세포암(HCC) 치료를 위한 K1.1 mRNA 제품에 대한 획기적인 연구 결과를 발표했습니다. HCC는 전 세계적으로 암 관련 사망 원인 중 세 번째로 많습니다. 회사의 생쥐 모델 연구에서 K1.1 mRNA가 엔지니어링된 지질(K1.1/LNP)에 캡슐화되었을 때, 쥐의 간에서 인간 HCC 종양의 성장을 효과적으로 감소시켰습니다. 이 치료법은 배양된 인간 HCC 세포주와 환자 유래 HCC 세포 모두에서 용량 의존적인 항증식 활성을 보였습니다. 현재 HCC 치료가 5년 생존율 18-21%만 이루어진다는 점에서 이 개발은 중요합니다.

Sunshine Biopharma (NASDAQ:SBFM) a annoncé des résultats de recherche décisifs pour son produit mRNA K1.1 en tant que traitement du carcinome hépatocellulaire humain (HCC), la troisième principale cause de décès liés au cancer dans le monde. Les études sur des modèles murins ont démontré que le K1.1 mRNA, lorsqu'il est encapsulé dans des lipides conçus (K1.1/LNP), réduisait efficacement la croissance des tumeurs HCC humaines dans le foie des souris. Le traitement a montré une activité antiproliférative dépendante de la dose tant dans des lignées cellulaires HCC humaines cultivées que dans des cellules HCC dérivées de patients. Ce développement est significatif étant donné que les traitements actuels du HCC n'atteignent qu'un taux de survie de 18 à 21 % sur cinq ans.

Sunshine Biopharma (NASDAQ:SBFM) hat bahnbrechende Forschungsergebnisse zu ihrem K1.1 mRNA-Produkt als Behandlung für das menschliche hepatozelluläre Karzinom (HCC) bekannt gegeben, das die dritthäufigste Ursache für krebsbedingte Todesfälle weltweit ist. Die Studien mit Mäusen zeigten, dass K1.1 mRNA, wenn sie in entwickelten Lipiden (K1.1/LNP) eingekapselt ist, das Wachstum von menschlichen HCC-Tumoren in den Lebern der Mäuse wirksam reduzierte. Die Behandlung zeigte eine dosierungsabhängige antiproliferative Wirkung sowohl in kultivierten menschlichen HCC-Zelllinien als auch in Patienten-abgeleiteten HCC-Zellen. Diese Entwicklung ist bedeutsam, da die aktuellen HCC-Behandlungen nur eine fünfjährige Überlebensrate von 18-21% erreichen.

Positive
  • Successful proof-of-concept demonstrated in mouse model studies
  • K1.1 mRNA showed dose-dependent anti-proliferative activity in HCC cells
  • K1.1/LNP effectively reduced tumor growth in mice liver tests
  • Treatment demonstrated efficient liver delivery in dose-dependent manner
Negative
  • None.

Insights

The breakthrough research results for K1.1 mRNA therapy in hepatocellular carcinoma (HCC) treatment represent a significant development. The data shows dose-dependent efficacy both in vitro and in vivo, with successful delivery to liver tissue through lipid nanoparticles. The key findings include:

  • Demonstrated anti-proliferative activity in human HCC cell lines
  • Effective delivery to mouse livers via K1.1/LNP formulation
  • Reduced growth of two different human HCC tumor types in mouse models

With current HCC five-year survival rates at only 18-21%, this novel therapeutic approach could potentially address a critical unmet medical need. However, further studies are needed to determine optimal dosing and therapeutic window before human trials can begin. The technology's ability to target liver cells specifically is particularly promising for reducing potential off-target effects.

FORT LAUDERDALE, FL / ACCESSWIRE / December 2, 2024 / Sunshine Biopharma Inc. (NASDAQ:"SBFM") (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 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 (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 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 (K1.1/LNP) 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.

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 63 generic prescription drugs on the market in Canada and 31 additional drugs scheduled to be launched in the remainder of 2024 and in 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.

All registered trademarks are the property of their respective owners.

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 Additional Information:

Sunshine Biopharma Contact:
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma, Inc.



View the original press release on accesswire.com

FAQ

What are the latest research results for Sunshine Biopharma's (SBFM) K1.1 mRNA product?

Sunshine Biopharma's K1.1 mRNA product showed successful proof-of-concept in mouse model studies, demonstrating dose-dependent anti-proliferative activity against hepatocellular carcinoma cells and reducing tumor growth when delivered to mice livers.

How effective is SBFM's K1.1/LNP treatment in targeting liver cancer?

K1.1/LNP showed efficient delivery to mice livers in a dose-dependent manner and successfully reduced growth of two different types of human HCC tumors when orthotopically grafted into immunodeficient mice.

What is the current survival rate for hepatocellular carcinoma that SBFM's treatment aims to improve?

The current five-year survival rate for hepatocellular carcinoma (HCC) patients is only 18-21%, which Sunshine Biopharma aims to improve with their K1.1 mRNA treatment.

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