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Publication Number
US-12076396-B2
Publication Date
2024-09-03
Expiration Date
Abstract
Immunogen enhancers for admixture with an antigen of interest are described herein. The enhancers generally comprise a steroid acid and/or a steroid acid-peptide conjugate in an amount sufficient to improve or modify the adaptive immune response to antigens admixed therewith. In embodiments, the steroid acid may be a bile acid and the peptide may comprise one or more functional domains, such as a nuclear localization signal, which may facilitate antigen-presentation and/or antigen cross-presentation, thereby triggering improved cellular immunity, or improved cellular and humoral immunity, against the antigen.
Core Innovation
The invention relates to steroid-acid and steroid acid-peptide conjugate immunogen enhancers used to improve presentation of a polypeptide antigen upon administration to antigen-presenting cells. The enhancer is admixed with an antigen in an amount sufficient to improve antigen presentation compared to a corresponding composition lacking the enhancer.
The described antigen-presentation enhancer uses a steroid acid component and steroid acid analogs linked to a peptide domain containing a nuclear localization signal (NLS). The conjugate design includes modular peptide domains, including a non-immunogenic NLS peptide.
The disclosed scope includes increased cytosolic delivery and total delivery to cells, and increased immune outcomes including IFN-gamma production by CD8+ T cells and humoral immunity. The document further includes vaccine and therapeutic/prophylactic compositions and example antigens such as ovalbumin (OVA) and SARS-related spike proteins.
Claims Coverage
The partial content includes two independent claims. Collectively, they cover a composition and a standalone enhancer formulation using a steroid acid-peptide conjugate with a non-immunogenic NLS peptide.
Steroid acid-peptide conjugate enhancer admixed with polypeptide antigen
A composition comprising a polypeptide antigen admixed with an enhancer of antigen-presentation, the enhancer comprising a steroid acid-peptide conjugate in an amount sufficient to improve presentation of the polypeptide antigen upon administration to antigen-presenting cells, as compared to administration of a corresponding composition lacking the enhancer.
Non-immunogenic NLS peptide included in the conjugate
The peptide comprised in the steroid acid-peptide conjugate comprises a nuclear localization signal (NLS), and the peptide comprised in the steroid acid-peptide conjugate is a non-immunogenic peptide.
Enhancer not covalently conjugated to a polypeptide antigen and excludes cholic acid
An enhancer of antigen presentation comprising a steroid acid-peptide conjugate, wherein the peptide comprises a nuclear localization signal (NLS), wherein the enhancer of antigen presentation is not covalently conjugated to a polypeptide antigen, wherein the peptide is non-immunogenic, and wherein the steroid acid is not or does not comprise cholic acid.
Across the independent claims, the core inventive concept is a steroid acid-peptide conjugate that uses a non-immunogenic NLS peptide to enhance antigen presentation, either as an admixture composition with a polypeptide antigen or as a standalone enhancer formulation that is not covalently conjugated to a polypeptide antigen and excludes cholic acid.
Stated Advantages
Improves presentation of a polypeptide antigen upon administration to antigen-presenting cells compared to a corresponding composition lacking the enhancer.
Enhances antigen delivery in terms of cytosolic delivery and total cellular delivery.
Increases adaptive immune outcomes including IFN-gamma production by CD8+ T cells.
Provides humoral immunity improvements as described in the document.
Documented Applications
Vaccine compositions, including therapeutic vaccine and prophylactic vaccine formulations, using the described steroid acid-peptide conjugate immunogen enhancers with antigens.
Cell culture contexts and assay systems described for antigen presentation and immune response measurements, including OVA (ovalbumin) systems such as BMDCs and reporter and detection systems mentioned in the provided summary.
Use with antigens including SARS-CoV-2 Spike protein and SARS-CoV Spike protein, as described in the document scope provided.
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