AU2015218769B2 - Formulations for small intestinal delivery - Google Patents

Formulations for small intestinal delivery Download PDF

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Publication number
AU2015218769B2
AU2015218769B2 AU2015218769A AU2015218769A AU2015218769B2 AU 2015218769 B2 AU2015218769 B2 AU 2015218769B2 AU 2015218769 A AU2015218769 A AU 2015218769A AU 2015218769 A AU2015218769 A AU 2015218769A AU 2015218769 B2 AU2015218769 B2 AU 2015218769B2
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Australia
Prior art keywords
immunogenic composition
poly
enteric coating
methacrylic acid
immunogenic
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AU2015218769A
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English (en)
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AU2015218769A1 (en
Inventor
George Trager
Sean Tucker
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Vaxart Inc
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Vaxart Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5256—Virus expressing foreign proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • A61K2039/542—Mucosal route oral/gastrointestinal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/572—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 cytotoxic response
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6093—Synthetic polymers, e.g. polyethyleneglycol [PEG], Polymers or copolymers of (D) glutamate and (D) lysine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10341—Use of virus, viral particle or viral elements as a vector
    • C12N2710/10343—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16171—Demonstrated in vivo effect

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Mycology (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Nutrition Science (AREA)
  • Biotechnology (AREA)
  • Pulmonology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2015218769A 2014-02-20 2015-02-20 Formulations for small intestinal delivery Active AU2015218769B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461942386P 2014-02-20 2014-02-20
US61/942,386 2014-02-20
PCT/US2015/016921 WO2015127278A1 (en) 2014-02-20 2015-02-20 Formulations for small intestinal delivery

Publications (2)

Publication Number Publication Date
AU2015218769A1 AU2015218769A1 (en) 2016-09-08
AU2015218769B2 true AU2015218769B2 (en) 2020-09-17

Family

ID=53879055

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015218769A Active AU2015218769B2 (en) 2014-02-20 2015-02-20 Formulations for small intestinal delivery

Country Status (14)

Country Link
US (2) US20170224805A1 (https=)
EP (2) EP3107568B1 (https=)
JP (2) JP6797692B2 (https=)
KR (1) KR102396817B1 (https=)
CN (1) CN106255508B (https=)
AU (1) AU2015218769B2 (https=)
CA (1) CA2939581C (https=)
DK (1) DK3107568T3 (https=)
EA (1) EA033248B1 (https=)
ES (1) ES2978921T3 (https=)
IL (1) IL247301B (https=)
SG (1) SG11201606814RA (https=)
WO (1) WO2015127278A1 (https=)
ZA (1) ZA201605787B (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016200951A1 (en) 2015-06-12 2016-12-15 Vaxart, Inc. Formulations for small intestinal delivery of rsv and norovirus antigens
CA3046019A1 (en) 2016-12-14 2018-06-21 Progenity Inc. Treatment of a disease of the gastrointestinal tract with a tlr modulator
BR112019014004A2 (pt) * 2017-01-06 2020-02-11 Stabilitech Biopharma Ltd Método de fornecimento de transgene, comprimido ou cápsula, método de preparação de partículas virais e produto

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US6174529B1 (en) * 1991-06-21 2001-01-16 University Of Cincinnati Oral therapy for the treatment of allergies and method of manufacture
US20010043949A1 (en) * 1998-08-27 2001-11-22 West Pharmaceutical Services Drug Delivery & Clinical Research Center, Ltd Microparticulate Composition
US20030133950A1 (en) * 2000-01-07 2003-07-17 Roehm Gmbh & Co., Kg Selective activation of Th1 or Th2 lymphocyte regulated immune response
WO2011026111A1 (en) * 2009-08-31 2011-03-03 The United States Of America, As Represented By The Secretary, Department Of Health And Human Services Oral delivery of a vaccine to the large intestine to induce mucosal immunity
WO2013148258A1 (en) * 2012-03-29 2013-10-03 Jerome Schentag Gastrointestinal site-specific oral vaccination formulations active on the ileum and appendix

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Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6174529B1 (en) * 1991-06-21 2001-01-16 University Of Cincinnati Oral therapy for the treatment of allergies and method of manufacture
WO1998018453A1 (en) * 1996-10-28 1998-05-07 Pfizer Inc. Oral vaccines for young animals with an enteric coating
US20010043949A1 (en) * 1998-08-27 2001-11-22 West Pharmaceutical Services Drug Delivery & Clinical Research Center, Ltd Microparticulate Composition
US20030133950A1 (en) * 2000-01-07 2003-07-17 Roehm Gmbh & Co., Kg Selective activation of Th1 or Th2 lymphocyte regulated immune response
WO2011026111A1 (en) * 2009-08-31 2011-03-03 The United States Of America, As Represented By The Secretary, Department Of Health And Human Services Oral delivery of a vaccine to the large intestine to induce mucosal immunity
WO2013148258A1 (en) * 2012-03-29 2013-10-03 Jerome Schentag Gastrointestinal site-specific oral vaccination formulations active on the ileum and appendix

Also Published As

Publication number Publication date
EP3107568B1 (en) 2024-03-27
EP3107568A4 (en) 2017-10-11
EA033248B1 (ru) 2019-09-30
CN106255508A (zh) 2016-12-21
SG11201606814RA (en) 2016-09-29
KR102396817B1 (ko) 2022-05-11
CA2939581A1 (en) 2015-08-27
IL247301A0 (en) 2016-09-29
CA2939581C (en) 2024-01-23
US20250032602A1 (en) 2025-01-30
ZA201605787B (en) 2017-11-29
DK3107568T3 (da) 2024-06-03
EP3107568A1 (en) 2016-12-28
EP4353255A3 (en) 2024-07-03
JP2017506265A (ja) 2017-03-02
KR20170007726A (ko) 2017-01-20
EA201691458A1 (ru) 2017-02-28
JP6797692B2 (ja) 2020-12-09
JP2021038243A (ja) 2021-03-11
WO2015127278A1 (en) 2015-08-27
IL247301B (en) 2022-07-01
ES2978921T3 (es) 2024-09-23
US20170224805A1 (en) 2017-08-10
EP4353255A2 (en) 2024-04-17
AU2015218769A1 (en) 2016-09-08
JP7168633B2 (ja) 2022-11-09
CN106255508B (zh) 2020-07-07

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