Methods and compositions for substance use disorder vaccine formulations and uses thereof
Inventors
Janda, Kim • ON HO, Sam • Fujii, Gary
Assignees
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Publication Number
US-11739054-B2
Publication Date
2023-08-29
Expiration Date
Abstract
The present invention relates to vaccine compositions for treatment of substance use disorders, methods for the manufacture thereof, and methods for the use thereof to treat an animal. These compositions comprise a hapten conjugated via a linker to a protein scaffold and mixed with a particulate carrier and at least one immunostimulatory adjuvant molecule.
Core Innovation
The invention relates to stimulating an immune response to methamphetamine by immunizing an animal with a conjugate. The conjugate includes one or more compounds that are covalently bound through a defined linkage chemistry on the compound to a corresponding coupling site on a protein, polypeptide, detectable label, nucleic acid, or solid phase. The methamphetamine-related compound is organized through a general formula having linker/connector features R1, R2, and R3, where R3 provides the covalent coupling functionality to the selected coupling partner.
R1 is defined as a (O—CH2—CH2)p moiety or optionally substituted C1-6 alkyl, with substitution(s) selected from a defined set including —NO2, —NH2, —OH, —OR′, —CH2OH, and —CONH2. R2 is defined as a peptide of m amino acid residues, an alkylene oxide of m alkylene oxide monomers, or (CH2)m, where m=2 to 6. R3 is selected from protected or unprotected maleimide, alkyl halide, aryl halide, alpha-haloacyl, pyridyl disulfide, aldehyde, ketone, carboxyl, thiol, thioester, disulfide, N-hydroxy-succinimide, or cyclic thiolactone, or salts thereof.
The described constructs are presented as drug-of-abuse vaccine conjugates that include immunizing an animal with methamphetamine conjugates formed by the defined covalent linker/linkage chemistry. The partial content further describes optional use of immunostimulating vaccine compositions that combine the conjugate with particulate carriers and immunostimulatory adjuvant molecules to support immune responses, including anti-methamphetamine antibody responses. Documented examples in the partial content describe immunogenicity and functional outcomes using methamphetamine conjugates prepared with protein scaffolds and vaccine formulations incorporating immunostimulatory components.
Claims Coverage
The independent claim covers a method of stimulating an immune response to methamphetamine by immunizing an animal with a methamphetamine conjugate. The claim is structured around three main inventive linkage/connector elements (R1, R2, and R3) and the covalent coupling of the compound(s) to a selected coupling partner, with dependent claims further refining the animal subject, optional co-administration of immunostimulatory adjuvant molecules, and specific permitted R2 sequences and coupling partners.
Covalent methamphetamine conjugate defined by R1/R2/R3 linker chemistry
Immunizing an animal by administering a conjugate comprising one or more compounds having a general formula in which R1, R2, and R3 are defined such that the one or more compounds or salts thereof are covalently bound through R3 on the compound(s) to a corresponding coupling site on a protein, polypeptide, detectable label, nucleic acid, or solid phase.
R1-defined linker moiety enabling substitution-controlled conjugate construction
R1 is selected as —(O—CH2—CH2)p where p is 1 to 6 or as an optionally substituted C1-6 alkyl, where substitution(s) are independently selected from —NO2, —NH2, —OH, —OR′ where R′ is H or lower alkyl, —CH2OH, and —CONH2.
R2-defined spacing unit selected as peptide, alkylene oxide, or (CH2)m
R2 is a peptide of m amino acid residues, an alkylene oxide of m alkylene oxide monomers, or (CH2)m, where m=2 to 6.
R3 functional coupling group for covalent attachment to coupling sites
R3 is selected from protected or unprotected maleimide, alkyl halide, aryl halide, alpha-haloacyl, pyridyl disulfide, aldehyde, ketone, carboxyl, thiol, thioester, disulfide, N-hydroxy-succinimide, or cyclic thiolactone, or salts thereof, where R3 enables covalent binding to a corresponding coupling site on the selected protein, polypeptide, detectable label, nucleic acid, or solid phase.
The claim coverage requires immunizing an animal with a methamphetamine conjugate whose covalent structure is defined by R1, R2, and R3 and whose R3 group covalently binds through a coupling site on the selected coupling partner. Dependent claims further narrow the animal to a human, optionally co-administer immunostimulatory adjuvant molecules, and specify concrete R2 dipeptide sequences and example categories of proteins, labels, solid phases, and protein carriers.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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