Sunshine Biopharma Announces Positive Results of mRNA Therapy for Cancer
Sunshine Biopharma (NASDAQ:SBFM) has announced positive results from studies of its K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) therapy for human hepatocellular carcinoma (HCC), the third leading cause of cancer-related deaths globally.
The company tested two versions of the treatment: a full-length mRNA (K1.1c) and a truncated version (K1.1d). Key findings include:
- The full-length K1.1c reduced growth of three different types of human HCC tumors in mice with good tolerability
- The truncated K1.1d showed significant anti-tumor activity in mouse HCC models in a dose-dependent manner
- Both versions were efficiently delivered to orthotopic engrafted HCC tumors through systemic administration
Additional animal studies are ongoing to determine optimal dosing of the truncated K1.1d version, which may offer better efficacy at lower doses compared to the full-length version.
Sunshine Biopharma (NASDAQ:SBFM) ha annunciato risultati positivi da studi sulla sua terapia K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) per il carcinoma epatocellulare umano (HCC), la terza causa principale di morte per cancro a livello globale.
L'azienda ha testato due versioni del trattamento: un mRNA a lunghezza intera (K1.1c) e una versione troncata (K1.1d). I risultati chiave includono:
- Il K1.1c a lunghezza intera ha ridotto la crescita di tre diversi tipi di tumori HCC umani in topi con buona tollerabilità
- Il K1.1d troncato ha mostrato una significativa attività antitumorale nei modelli di HCC nei topi in modo dose-dipendente
- Entrambe le versioni sono state efficacemente somministrate a tumori HCC ortotopici trapiantati attraverso somministrazione sistemica
Ulteriori studi sugli animali sono in corso per determinare il dosaggio ottimale della versione troncata K1.1d, che potrebbe offrire una migliore efficacia a dosi più basse rispetto alla versione a lunghezza intera.
Sunshine Biopharma (NASDAQ:SBFM) ha anunciado resultados positivos de estudios sobre su terapia K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) para el carcinoma hepatocelular humano (HCC), la tercera causa principal de muertes relacionadas con el cáncer a nivel mundial.
La compañía probó dos versiones del tratamiento: un mRNA de longitud completa (K1.1c) y una versión truncada (K1.1d). Los hallazgos clave incluyen:
- El K1.1c de longitud completa redujo el crecimiento de tres tipos diferentes de tumores HCC humanos en ratones con buena tolerancia
- El K1.1d truncado mostró una actividad antitumoral significativa en modelos de HCC en ratones de manera dependiente de la dosis
- Ambas versiones fueron entregadas de manera eficiente a tumores HCC ortotópicos injertados a través de administración sistémica
Se están llevando a cabo estudios adicionales en animales para determinar la dosis óptima de la versión truncada K1.1d, que podría ofrecer una mejor eficacia a dosis más bajas en comparación con la versión de longitud completa.
Sunshine Biopharma (NASDAQ:SBFM)는 인체 간세포암(HCC) 치료를 위한 K1.1 mRNA 지질 나노입자(K1.1-mRNA-LNP) 요법의 연구 결과가 긍정적이라고 발표했습니다. HCC는 전 세계적으로 암 관련 사망의 세 번째 주요 원인입니다.
회사는 두 가지 버전의 치료법을 시험했습니다: 전체 길이 mRNA(K1.1c)와 잘린 버전(K1.1d). 주요 발견 사항은 다음과 같습니다:
- 전체 길이 K1.1c는 좋은 내약성으로 세 가지 유형의 인간 HCC 종양의 성장을 감소시켰습니다.
- 잘린 K1.1d는 마우스 HCC 모델에서 용량 의존적으로 유의미한 항종양 활성을 보였습니다.
- 두 가지 버전 모두 체계적 투여를 통해 이식된 HCC 종양에 효과적으로 전달되었습니다.
잘린 K1.1d 버전의 최적 용량을 결정하기 위한 추가 동물 연구가 진행 중이며, 이는 전체 길이 버전보다 낮은 용량에서 더 나은 효능을 제공할 수 있습니다.
Sunshine Biopharma (NASDAQ:SBFM) a annoncé des résultats positifs d'études sur sa thérapie K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) pour le carcinome hépatocellulaire humain (HCC), la troisième cause de décès liés au cancer dans le monde.
La société a testé deux versions du traitement : un mRNA de longueur complète (K1.1c) et une version tronquée (K1.1d). Les résultats clés incluent :
- Le K1.1c de longueur complète a réduit la croissance de trois types différents de tumeurs HCC humaines chez des souris avec une bonne tolérance.
- Le K1.1d tronqué a montré une activité antitumorale significative dans des modèles de HCC chez la souris de manière dépendante de la dose.
- Les deux versions ont été efficacement administrées à des tumeurs HCC orthotopiques greffées par voie systémique.
Des études supplémentaires chez l'animal sont en cours pour déterminer le dosage optimal de la version tronquée K1.1d, qui pourrait offrir une meilleure efficacité à des doses plus faibles par rapport à la version de longueur complète.
Sunshine Biopharma (NASDAQ:SBFM) hat positive Ergebnisse aus Studien zu seiner K1.1 mRNA Lipidnanopartikel (K1.1-mRNA-LNP) Therapie für das menschliche hepatozelluläre Karzinom (HCC) bekannt gegeben, das die dritthäufigste Ursache für krebsbedingte Todesfälle weltweit ist.
Das Unternehmen testete zwei Versionen der Behandlung: ein vollständiges mRNA (K1.1c) und eine verkürzte Version (K1.1d). Zu den wichtigsten Ergebnissen gehören:
- Das vollständige K1.1c verringerte das Wachstum von drei verschiedenen Arten menschlicher HCC-Tumoren in Mäusen bei guter Verträglichkeit.
- Die verkürzte K1.1d-Version zeigte eine signifikante antitumorale Aktivität in Maustumormodellen in einer dosierungsabhängigen Weise.
- Beide Versionen wurden effizient an orthotopische transplantierte HCC-Tumoren durch systemische Verabreichung abgegeben.
Zusätzliche Tierversuche sind im Gange, um die optimale Dosierung der verkürzten K1.1d-Version zu bestimmen, die möglicherweise eine bessere Wirksamkeit bei niedrigeren Dosen im Vergleich zur vollständigen Version bietet.
- Successful proof-of-concept showing tumor growth reduction in three different HCC types
- Demonstrated dose-dependent efficacy in animal studies
- Truncated version (K1.1d) shows potential for better efficacy at lower doses
- Good tolerability in animal studies
- Still in early animal testing phase, far from human trials
- Additional studies needed to determine optimal dosing
Insights
Sunshine Biopharma's announcement represents a significant advancement in their mRNA cancer therapy program. Their K1.1 mRNA Lipid Nanoparticle (mRNA-LNP) therapy shows promising preclinical efficacy against hepatocellular carcinoma (HCC) - a cancer with dismal
The data reveals two key formulations: a full-length mRNA (K1.1c) and a truncated version (K1.1d), both encapsulated in custom lipid nanoparticles. These were systematically administered to mice with human HCC tumors, demonstrating dose-dependent delivery to the tumor site. The full-length version reduced growth across three different HCC tumor types with good tolerability, while preliminary data suggests the truncated version may offer enhanced efficacy at lower doses.
What makes this approach scientifically notable is the application of mRNA technology to cancer treatment. Unlike conventional therapies, mRNA can potentially instruct cancer cells to produce proteins that trigger their own destruction or enhance immune recognition. The lipid nanoparticle delivery system addresses one of the critical challenges in cancer therapeutics - getting sufficient therapeutic concentration to the tumor site while minimizing systemic exposure.
While these results mark important preclinical progress, the path to clinical implementation remains substantial, requiring human trials to confirm safety, dosing, and efficacy. The optimization work on the truncated version suggests the company is prioritizing therapeutic window - the balance between efficacy and toxicity - which will be crucial for clinical translation.
This preclinical milestone for Sunshine Biopharma represents meaningful progress for their oncology pipeline, specifically targeting hepatocellular carcinoma - a cancer with substantial unmet medical need. The positive data from multiple mouse models establishes proof-of-concept for their proprietary mRNA-LNP platform in cancer treatment.
What's particularly noteworthy is the company's dual-track approach with both full-length and truncated mRNA constructs. The truncated version (K1.1d) potentially offers manufacturing advantages, reduced production costs, and improved efficacy at lower doses - critical factors for eventual commercialization and market competitiveness.
For a micro-cap company with approximately
However, investors should recognize the substantial development timeline ahead. The company is still conducting additional animal studies to optimize dosing before potential IND-enabling studies. Clinical trials, if initiated, would require significant capital that might necessitate partnerships or dilutive financing given the company's current resources.
The technology's versatility and early efficacy signals provide reasonable scientific validation of their approach, though the path from preclinical success to approved therapy remains lengthy and capital-intensive. The company's ability to advance this promising program while managing resource constraints will be crucial for realizing the potential value of this technology platform.
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
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.
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 more information, please contact:
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
SOURCE: Sunshine Biopharma Inc.
View the original press release on ACCESS Newswire
FAQ
What are the key findings of SBFM's mRNA cancer therapy trials in April 2025?
How does SBFM's K1.1d version differ from K1.1c in treating liver cancer?
What type of cancer is SBFM's mRNA therapy targeting?
How is SBFM's K1.1-mRNA-LNP treatment administered to patients?
