AU2015218769B2 - Formulations for small intestinal delivery - Google Patents

Formulations for small intestinal delivery Download PDF

Info

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
Authority
AU
Australia
Prior art keywords
immunogenic composition
poly
enteric coating
methacrylic acid
immunogenic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2015218769A
Other languages
English (en)
Other versions
AU2015218769A1 (en
Inventor
George Trager
Sean Tucker
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vaxart Inc
Original Assignee
Vaxart Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vaxart Inc filed Critical Vaxart Inc
Publication of AU2015218769A1 publication Critical patent/AU2015218769A1/en
Application granted granted Critical
Publication of AU2015218769B2 publication Critical patent/AU2015218769B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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 (OSRAM)
EP (2) EP3107568B1 (OSRAM)
JP (2) JP6797692B2 (OSRAM)
KR (1) KR102396817B1 (OSRAM)
CN (1) CN106255508B (OSRAM)
AU (1) AU2015218769B2 (OSRAM)
CA (1) CA2939581C (OSRAM)
DK (1) DK3107568T3 (OSRAM)
EA (1) EA033248B1 (OSRAM)
ES (1) ES2978921T3 (OSRAM)
IL (1) IL247301B (OSRAM)
SG (1) SG11201606814RA (OSRAM)
WO (1) WO2015127278A1 (OSRAM)
ZA (1) ZA201605787B (OSRAM)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3307239B1 (en) 2015-06-12 2020-09-16 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
AU2018206304A1 (en) * 2017-01-06 2019-07-04 Stabilitech Biopharma Ltd Virus

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998018453A1 (en) * 1996-10-28 1998-05-07 Pfizer Inc. Oral vaccines for young animals with an enteric coating
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

Family Cites Families (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4152413A (en) * 1978-08-18 1979-05-01 Chromalloy American Corporation Oral vaccine for swine dysentery and method of use
US4520019A (en) 1982-04-29 1985-05-28 Ribi Immunochem Research, Inc. Stable composition and preparation thereof
US4579945A (en) 1982-04-29 1986-04-01 Ribi Immunochem Research, Inc. Purification of trehalose dimycolates
US4505899A (en) 1982-05-26 1985-03-19 Ribi Immunochem Research, Inc. Refined detoxified endotoxin product
US4436727A (en) 1982-05-26 1984-03-13 Ribi Immunochem Research, Inc. Refined detoxified endotoxin product
US4505900A (en) 1982-05-26 1985-03-19 Ribi Immunochem Research, Inc. Refined detoxified endotoxin product
US4435386A (en) 1982-05-26 1984-03-06 Ribi Immunochem Research, Inc. Refined detoxified endotoxin product
US4436728A (en) 1982-05-26 1984-03-13 Ribi Immunochem Research, Inc. Refined detoxified endotoxin product
US4866034A (en) 1982-05-26 1989-09-12 Ribi Immunochem Research Inc. Refined detoxified endotoxin
US5811128A (en) 1986-10-24 1998-09-22 Southern Research Institute Method for oral or rectal delivery of microencapsulated vaccines and compositions therefor
US5075109A (en) 1986-10-24 1991-12-24 Southern Research Institute Method of potentiating an immune response
US5057540A (en) 1987-05-29 1991-10-15 Cambridge Biotech Corporation Saponin adjuvant
CA1331443C (en) 1987-05-29 1994-08-16 Charlotte A. Kensil Saponin adjuvant
US4897268A (en) 1987-08-03 1990-01-30 Southern Research Institute Drug delivery system and method of making the same
JPH08505625A (ja) 1993-01-11 1996-06-18 ダナ−ファーバー キャンサー インスティチュート 細胞毒性ｔリンパ球応答の誘導
GB9412394D0 (en) * 1994-06-21 1994-08-10 Danbiosyst Uk Colonic drug delivery composition
AUPM873294A0 (en) 1994-10-12 1994-11-03 Csl Limited Saponin preparations and use thereof in iscoms
UA56132C2 (uk) 1995-04-25 2003-05-15 Смітклайн Бічем Байолоджікалс С.А. Композиція вакцини (варіанти), спосіб стабілізації qs21 відносно гідролізу (варіанти), спосіб приготування композиції вакцини
US6676935B2 (en) * 1995-06-27 2004-01-13 Cell Genesys, Inc. Tissue specific adenoviral vectors
AUPO856097A0 (en) * 1997-08-14 1997-09-04 Commonwealth Scientific And Industrial Research Organisation Vector
US7264771B2 (en) 1999-04-20 2007-09-04 Baxter International Inc. Method and apparatus for manipulating pre-sterilized components in an active sterile field
US6355270B1 (en) * 1999-01-11 2002-03-12 The Regents Of The University Of California Particles for oral delivery of peptides and proteins
AU2003240978A1 (en) 2002-05-31 2003-12-19 Genteric, Inc. Multi-functional polyamines for delivery of biologically-active polynucleotides
WO2004020592A2 (en) 2002-08-30 2004-03-11 Genteric, Inc. Retroductal salivary gland genetic vaccination
GB2407500A (en) * 2003-11-03 2005-05-04 Ist Superiore Sanita Use of microparticles for antigen delivery
US20060128653A1 (en) * 2004-12-10 2006-06-15 Chunlin Tang Pharmaceutical formulation of decitabine
CN103122360A (zh) 2006-02-28 2013-05-29 瓦克萨特公司 嵌合腺病毒载体
JP2009298707A (ja) * 2008-06-11 2009-12-24 Ohara Yakuhin Kogyo Kk 粒子加工方法
WO2010002418A2 (en) * 2008-07-01 2010-01-07 The Johns Hopkins University Quick-dissolving oral thin film for targeted delivery of therapeutic agents
AU2009322285B2 (en) * 2008-12-03 2016-07-28 Bausch Health Ireland Limited Formulations of guanylate cyclase C agonists and methods of use
EP2477652B1 (en) 2009-09-16 2015-04-15 Vaxart, Inc. Immunization strategy to prevent h1n1 infection
US20130273154A1 (en) * 2011-03-02 2013-10-17 Joseph M. Fayad Oral formulations Mimetic of Roux-en-Y gastric bypass actions on the ileal brake; Compositions, Methods of Treatment, Diagnostics and Systems for treatment of metabolic syndrome manifestations including insulin resistance, fatty liver disease, hpperlipidemia, and type 2 diabetes
US9370528B2 (en) * 2011-03-02 2016-06-21 Volant Holdings Gmbh Compositions, methods of treatment and diagnostics for treatment of hepatic steatosis alone or in combination with a hepatitis C virus infection
AU2013243971B2 (en) * 2012-04-04 2017-01-05 Vaxform Llc Improved adjuvant system for oral vaccine adminstration

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

Similar Documents

Publication Publication Date Title
JP7269285B2 (ja) Ｒｓｖおよびノロウイルス抗原の小腸送達のための製剤
US20250032602A1 (en) Formulations for small intestinal delivery
AU2018202765B2 (en) Gastrointestinal site-specific oral vaccination formulations active on the ileum and appendix
JP2023528446A (ja) キメラアデノウイルスベクター
US20240093234A1 (en) Chimeric adenoviral vectors

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)