Immune response stimulating composition comprising nanoparticles based on a methyl vinyl ether-maleic acid copolymer
Inventors
Irache Garreta, Juan Manuel • De La Rasilla, Carlos Gamazo • Larruga, Maria Luisa Sanz • Puga, Marta Ferrer • Aberasturi, Beatriz San Román • Salman, Hesham H. A. • Martinez, Sara Gómez • Rep{dot over (a)}raz, Javier Ochoa
Assignees
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Publication Number
US-8895067-B2
Publication Date
2014-11-25
Expiration Date
Abstract
The composition for stimulating an immune response in a subject comprises methyl vinyl ether and maleic anhydride copolymer-based nanoparticles. Said nanoparticles may further contain an allergen or an antigen and/or an immunostimulating agent, which may be contained inside said nanoparticles and/or at least partially coating the surface of said nanoparticles, and optionally a cross-linking agent. The immune response stimulating composition is useful as an adjuvant in immunotherapy and vaccines.
Core Innovation
The invention relates to an immune-response-stimulating composition for immunotherapy and vaccines comprising nanoparticles based on a methyl vinyl ether and maleic anhydride (PVM/MA) copolymer. The composition includes an allergen, wherein the allergen is encapsulated inside PVM/MA copolymer nanoparticles, and the allergen comprises an allergenic food or an allergenic food product extract.
The nanoparticles further comprise an immunostimulating agent at least partially coating the surface of the nanoparticles. The invention addresses oral bioadhesive behavior and localization to Peyer’s patches as part of the immune-response modulation, and it distinguishes immune outcomes based on antigen placement, stating that surface coating tends toward Th2 modulation while encapsulated placement tends to balanced or Th1-predominant responses.
The description characterizes nanoparticle size as sub-1.0 µm, preferably 10–900 nm, and PVM/MA molecular weight as 100–2,400 kDa. It also describes optional formulation aspects such as the presence of a cross-linking agent and optional lyophilization, and reports measurements of Th1/Th2-associated biomarkers and antibody isotypes using antigen/allergen examples such as ovalbumin (OVA) and Brucella ovis rough LPS (R-LPS) / Salmonella enteritidis antigen extracts.
Claims Coverage
The document presents one independent claim with multiple dependent claim refinements. The core claim framework is based on Th1 immune stimulation using PVM/MA copolymer nanoparticles containing an encapsulated allergen plus an immunostimulating agent at least partially coating the nanoparticle surface, with additional features narrowing administration, allergen identity, and formulation parameters.
Th1 stimulation using PVM/MA copolymer nanoparticles with encapsulated allergen
A method for stimulating a Th1 immune response against an allergen by administering a Th1 immune response stimulating composition comprising nanoparticles based on a methyl vinyl ether and maleic anhydride (PVM/MA) copolymer and an allergen, wherein the allergen is encapsulated inside the PVM/MA copolymer nanoparticles and wherein the stimulation of the Th1 immune response is due to the nanoparticles based on a PVM/MA copolymer.
Allergenic food or allergenic food product extract encapsulated in PVM/MA nanoparticles
The allergen is encapsulated inside the PVM/MA copolymer nanoparticles, and the allergen comprises an allergenic food or an allergenic food product extract.
Surface-coating immunostimulating agent on PVM/MA nanoparticles
The PVM/MA-based nanoparticles further comprise an immunostimulating agent at least partially coating the surface of the nanoparticles.
Cross-linking agent and/or nanoparticle mean size constraint
The method includes nanoparticles that further comprise a cross-linking agent and/or wherein the nanoparticles have a mean size of 1.0 micrometer or less.
PVM/MA copolymer molecular weight constraint
The method includes wherein the PVM/MA copolymer has a molecular weight between 100 and 2,400 kDa.
Nanoparticle mean size between 10 and 900 nm
The method includes administering a Th1 immune response stimulating composition wherein the nanoparticles have a mean size between 10 and 900 nm.
Oral or parenteral administration form for Th1 composition
The method includes administering an immune response stimulating composition for Th1 in either an oral form or a parenteral form.
Allergen comprises an allergenic food
The allergen comprises an allergenic food.
Weight-percentage ranges for PVM/MA, cross-linking agent, and allergen
The method is limited such that the nanoparticle includes specified weight-percentage ranges of PVM/MA, a cross-linking agent, and an allergen, using ranges described as 84–99.998% (PVM/MA), 0.001–1% (cross-linking agent), and 0.001–15% (allergen) by weight with respect to total.
Across the independent claim and dependents, the protected subject matter centers on Th1 stimulation by administering PVM/MA copolymer nanoparticles with an allergen encapsulated inside the particles, while an immunostimulating agent at least partially coats the nanoparticle surface. Dependent claims further constrain the allergen to allergenic food or food product extract, the administration form, nanoparticle mean size, PVM/MA molecular weight, optional cross-linking agent inclusion, and composition weight-percentage ranges.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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