Pharmaceutical compositions, comprising a combination of select carriers, vitamins, tannins and flavonoids as antigen-specific immuno-modulators
Inventors
Vajdy, Michael • Padrah, Shore
Assignees
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Publication Number
US-10561720-B2
Publication Date
2020-02-18
Expiration Date
Abstract
The present invention provides adjuvant compositions that are capable of modulating the immune response in a subject, including enhancing or suppressing the immune response. These adjuvant compositions may also be used to enhance or suppress the immunogenicity of antigens by enhancing or suppressing antigen-presentation activity, enhancing or suppressing innate immune responses through activation or suppression of, e.g., natural killer cells, and/or direct activation of subsets of B and/or T cells. Also provided are methods of making the adjuvant compositions as well as methods of using the adjuvant compositions. In certain embodiments, the compositions comprise combinations of the following: a pharmaceutically acceptable carrier, a flavonoid, a tannin and a vitamin. The compositions may further comprise an antigen.
Core Innovation
The invention relates to adjuvant compositions for modulating immune responses. The compositions are described as an emulsion that consists essentially of at least one vitamin selected from Vitamin A, Vitamin D, Vitamin E, or a mixture thereof, a pharmaceutically acceptable carrier, and at least one flavonoid. The emulsion is used in an antigen-containing context to support antigen-associated immune modulation.
The pharmaceutically acceptable carrier includes an oil carrier selected from grape seed oil and squalene oil, or other oil components such as oleic acid and mustard seed oil, or an inorganic carrier such as aluminum hydroxide. The compositions define ranges for vitamin A and vitamin E when present, define ranges for carrier content, and define ranges for the flavonoid amount. The flavonoid component includes catechin and/or epigallocatechin gallate (EGCG), and tannins such as gallic acid.
The document describes comparative and functional evaluation, including modulation of cytokine profiles such as IL-6, IL-1α, TNF-α and antigen-specific antibody responses including IgG1, IgG2a, and IgE. Overall, the core concept is to combine vitamins with flavonoids in a defined carrier emulsion to modulate immune responses in the presence of an antigen.
Claims Coverage
The independent claims are clm-00001, clm-00005, clm-00006, clm-00016, clm-00022, clm-00024, clm-00030, clm-00032, clm-00038, clm-00040, clm-00043, and clm-00050. Across these claims, the coverage centers on an emulsion formulation with specified vitamins, a selected carrier, specified flavonoid amounts, and in several claims the presence of at least one antigen or immune-response modulation upon administration.
Vitamin-and-flavonoid emulsion with grape seed oil or squalene oil
An emulsion consisting essentially of at least one vitamin selected from Vitamin A, Vitamin D, Vitamin E, or mixtures thereof; a pharmaceutically acceptable oil carrier selected from grape seed oil and squalene oil; and at least one flavonoid in a defined amount range, with specified vitamin and oil content ranges.
Vitamin-flavonoid emulsion including an antigen
An emulsion consisting essentially of at least one vitamin selected from Vitamin A, Vitamin D, Vitamin E or mixtures thereof; a pharmaceutically acceptable oil carrier selected from grape seed oil and squalene oil; at least one flavonoid; and at least one antigen.
Vitamin-flavonoid emulsion with aluminum hydroxide carrier
An emulsion consisting essentially of at least one vitamin selected from Vitamin A, Vitamin D, Vitamin E, or mixtures thereof; aluminum hydroxide; and at least one flavonoid, with defined ranges for each component.
Vitamin-flavonoid emulsion with oleic acid
An emulsion consisting essentially of at least one vitamin selected from Vitamin A, Vitamin D, Vitamin E or mixtures thereof; oleic acid; and at least one flavonoid, with specified ranges for vitamin amounts, oleic acid content, and flavonoid amount.
Vitamin-tannin emulsion with mustard seed oil
An emulsion consisting essentially of at least one vitamin selected from Vitamin A, Vitamin D, Vitamin E or mixtures thereof; mustard seed oil; and at least one tannin, with specified vitamin amounts, mustard seed oil content, and tannin amount.
Across the independent claims, the invention is covered as a defined emulsion adjuvant composition combining selected vitamins, a selected pharmaceutically acceptable carrier, and specified flavonoid or tannin content. Several independent claims further require an antigen, and some claims connect administration of the composition to modulating an immune response in a subject.
Stated Advantages
Modulates immune responses.
Modulates immune response in a subject upon administration.
Modulates cytokine profiles.
Supports antigen-specific antibody responses, including changes in IgG1, IgG2a, and IgE.
Documented Applications
Used as an adjuvant composition to modulate immune responses, including in the presence of an antigen and upon administration to a subject.
Antigen-specific immune response contexts are described in evaluations including cytokine modulation (e.g., IL-6, IL-1α, TNF-α) and antigen-specific antibody responses (e.g., IgG1, IgG2a and IgE).
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