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Publication Number
US-12016949-B2
Publication Date
2024-06-25
Expiration Date
Abstract
The invention is in the field of delivery of transgenes to target cells using viral vectors, particularly in the field of gene therapy. Compositions have been identified which allow for oral administration of viral particles, particularly adenoviral particles.
Core Innovation
The invention relates to oral administration of adenoviral particles carrying a transgene that encodes one or more antigens to a patient. A tablet or capsule is prepared by formulating the adenoviral particles into a liquid composition, followed by drying and packaging into the tablet or capsule, and the dosage form is coated with an enteric coating to enable oral administration.
The liquid composition comprises sucrose, N,N-dimethylglycine or a physiologically acceptable salt or ester thereof, and dimethylsulfone. The invention emphasizes the use of these specific excipients together with drying into the final dried composition, which is then packaged into an enterically coated tablet or capsule.
The transgene encodes antigens, including viral antigens for vaccine concepts. Example antigen categories described include Zika virus antigens such as envelope protein (E) and NS1, and Herpes Simplex Virus antigens such as glycoprotein C (gC), glycoprotein D (gD), and glycoprotein E (gE). The transgene expression may be controlled by a tissue-specific promoter.
Claims Coverage
The independent claims cover three inventive aspects: an enterically coated oral tablet or capsule containing dried adenoviral particles carrying an antigen-encoding transgene with a defined sucrose/N,N-dimethylglycine/dimethylsulfone liquid formulation; an oral method of delivering a transgene encoding one or more antigens to target cells using such a dosage form; and a method of preparing the adenoviral particles and enterically coated oral dosage form by culturing and purifying, then formulating, drying, and packaging.
Enterically coated oral tablet or capsule with dried adenoviral particles formulated with sucrose, N,N-dimethylglycine, and dimethylsulfone
A tablet or capsule for oral administration comprising adenoviral particles carrying a transgene encoding one or more antigens, prepared by formulating the adenoviral particles into a liquid composition comprising sucrose, N,N-dimethylglycine or a physiologically acceptable salt or ester thereof, and dimethylsulfone, drying the liquid composition, packaging the dried composition into the tablet or capsule, and coating the tablet or capsule with an enteric coating.
Oral delivery of an antigen-encoding transgene to target cells using an enterically coated dried adenoviral tablet or capsule
A method of delivering a transgene encoding one or more antigens to target cells in a patient by oral administration of a tablet or capsule comprising adenoviral particles carrying the transgene, wherein the tablet or capsule is prepared by formulating the adenoviral particles into the specified liquid composition, drying, packaging, and coating with an enteric coating.
Preparing enterically coated oral dosage form of transgene-carrying adenoviral particles via formulation, drying, and packaging
A method of preparing adenoviral particles carrying a transgene encoding one or more antigens for oral administration by culturing and purifying the adenoviral particles, formulating them in the specified pharmaceutical liquid composition, drying the liquid composition, and packaging the dried composition into tablets or capsules coated with an enteric coating.
The claimed coverage centers on enterically coated oral tablets or capsules containing dried adenoviral particles carrying a transgene encoding one or more antigens, with formulation in a liquid composition comprising sucrose, N,N-dimethylglycine or a physiologically acceptable salt or ester thereof, and dimethylsulfone before drying and packaging.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Oral delivery of an adenovirus encoding proinsulin under a glucose-dependent GIP promoter for reduced glucose in diabetic rats.
Oral administration of an adenovirus expressing butyrylcholinesterase showing enzymatic activity and elevated plasma levels.
Oral Zika vaccine concepts where immunity efficacy is described in Callithrix after ambient storage.
Oral delivery of viral vaccine concepts associated with Zika virus antigens including envelope protein (E) and NS1, and Herpes Simplex Virus antigens including glycoprotein D (gD), glycoprotein C (gC), and glycoprotein E (gE).
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