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Publication Number
US-12290533-B2
Publication Date
2025-05-06
Expiration Date
Abstract
The present disclosure relates to materials and methods for extracellular vesicle (e.g., exosome)-mediated delivery of cargo (e.g., endogenous and/or exogenous) to non-bovine mammalian (e.g., human) cells. For example, exosomes isolated from bovine milk for delivering cargo to non-bovine mammalian (e.g., human) cells are provided.
Core Innovation
The invention provides a milk exosome comprising a biological membrane surrounding a lumen, wherein the milk exosome comprises an exogenous microRNA (miRNA) and an exogenous cargo encapsulated in the lumen. The exogenous miRNA is biologically active in a mammal, and the concept is framed around using milk exosomes as delivery vehicles for endogenous/exogenous cargo.
The disclosure describes milk-source exosomes, including bovine milk exosomes and exosomes from other animal milk and/or colostrum sources, for delivery to non-bovine mammalian cells, including human cells. It links milk exosome composition to biologically meaningful uptake and tissue distribution, including endothelial uptake via endocytosis and oral/systemic administration associated with cellular uptake and cargo delivery.
The disclosure further describes engineering strategies that modify exosome surface glycoproteins/glycans, including modified glycan and glycosylation, to alter uptake, targeting, stability, and macrophage degradation. It also identifies broad categories of therapeutic and nutritional agents as potential exogenous cargo and indicates that the engineered properties relate to distribution and characterization, including targeting of tissues.
Claims Coverage
The independent claim set centers on a milk exosome defined by membrane-and-lumen structure carrying an exogenous biologically active miRNA and an exogenous cargo encapsulated in the lumen. The coverage includes additional inventive refinements across dependent claims, with specified miRNA species, cargo categories, permissible animal milk/colostrum sources, and use-context in an oral human composition.
Milk exosome with biologically active exogenous miRNA and encapsulated exogenous cargo
A milk exosome comprising a biological membrane surrounding a lumen, wherein the milk exosome comprises an exogenous microRNA (miRNA) and an exogenous cargo encapsulated in the lumen, wherein the exogenous miRNA is biologically active in a mammal.
Specified exogenous miRNA species
The milk exosome comprises an exogenous miRNA selected from MiR-320a, MiR-34a, MiR-155-5p, or MiR-375.
Exogenous cargo selected from enumerated cargo types
The exogenous cargo can be selected from nucleic acid molecules, polypeptides, lipids, vitamins, minerals, small molecules, pharmaceuticals, hormones, enzymes, or combinations thereof.
Exogenous cargo as selected therapeutic-agent categories
The therapeutic agent is selected from mRNAs, polypeptides, miRNAs, miRNA antagonists, nutrients, antibiotics, cancer drugs, activators of Toll-like receptors, and molecules capable of delivery to macrophages.
Milk exosome isolated from specified animal milk or colostrum sources
The milk exosome is isolated from one of sheep, goat, camel, horse, donkey, reindeer, yak, buffalo, or bovine (cow) milk or colostrum.
Oral human-administered composition comprising the milk exosome
An oral human-administered composition comprising the milk exosome.
Overall claim coverage protects milk exosomes defined by a biological membrane and lumen that encapsulate an exogenous biologically active miRNA together with an exogenous cargo, with refinements specifying miRNA species, broad exogenous cargo categories, allowed milk/colostrum sources, and an oral human use composition.
Stated Advantages
The disclosure links the milk exosome composition to biologically meaningful dietary miRNA/exosome uptake and tissue distribution in mice.
The disclosure describes endothelial uptake via endocytosis.
Surface-associated components can affect exosome uptake and transport, including effects of sonication on size and uptake and effects of glycoprotein/glycan dependence on exosome transport.
In vivo consequences of glycan alterations and macrophage depletion are described, together with physiological outcomes associated with miRNA/exosome depletion.
Documented Applications
Delivery to non-bovine mammalian cells, including human cells.
Oral/systemic administration associated with cellular uptake and cargo delivery.
An oral human-administered composition comprising the milk exosome.
Targeting of tissues.
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