Reengineering Endogenous Targeting Lipid Nanoparticles (ENDO) for Systemic Delivery of mRNA to Pancreas

Adv Mater. 2025 Oct;37(40):e2507657. doi: 10.1002/adma.202507657. Epub 2025 Jun 12.

Abstract

Lipid nanoparticles (LNPs) hold transformative potential for nucleic acid delivery, with applications ranging from clinical use, particularly in COVID-19 vaccines, to gene therapy and cancer immunotherapy. However, a major limitation lies in their preferential accumulation in the liver following intravenous administration, making most targets hard-to-reach. In this study, a novel platform called endogenous targeting lipid nanoparticles (ENDO), containing cholecalciferol (vitamin D3) as a fifth component is reported, that selectively delivers mRNA to the pancreas - a target previously inaccessible through intravenous administration. The top formulation, C-CholF3, demonstrates an unprecedented 99% pancreas selectivity with robust and sustained protein expression for up to 3 days in a dose-dependent manner with minimal toxicity that makes it suitable for repeat administration. This organ-specific delivery is proposed to be mediated by an endogenous targeting mechanism involving the Vitamin D receptor (VDR). C-CholF3 also enables selective pancreatic delivery of plasmid DNA and circular mRNA, underscoring its versatility and therapeutic potential. Furthermore, C-CholF3 exhibits pancreas-specific gene editing in the Ai14 transgenic mouse model, showing high expression of tdTomato in the β cells. These findings highlight its potential for translational applications in protein replacement and CRISPR/Cas9-mediated gene editing for currently incurable pancreatic diseases, including pancreatic cancer and diabetes.

Keywords: fifth component LNPs; lipid nanoparticles (LNP); mRNA delivery; pancreas‐targeted delivery; vitamin‐based LNPs.

MeSH terms

  • Animals
  • Cholecalciferol / chemistry
  • Gene Editing
  • Gene Transfer Techniques*
  • Humans
  • Lipids* / chemistry
  • Liposomes
  • Mice
  • Mice, Transgenic
  • Nanoparticles* / chemistry
  • Pancreas* / metabolism
  • RNA, Messenger* / administration & dosage
  • RNA, Messenger* / chemistry
  • RNA, Messenger* / genetics
  • RNA, Messenger* / metabolism
  • Receptors, Calcitriol / metabolism

Substances

  • RNA, Messenger
  • Lipids
  • Cholecalciferol
  • Lipid Nanoparticles
  • Receptors, Calcitriol
  • Liposomes