WO2015052684A3 - Polysaccharide-protein conjugates with enhanced immunogenicity and rapid high yielding process of preparation thereof - Google Patents

Polysaccharide-protein conjugates with enhanced immunogenicity and rapid high yielding process of preparation thereof Download PDF

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Publication number
WO2015052684A3
WO2015052684A3 PCT/IB2014/065201 IB2014065201W WO2015052684A3 WO 2015052684 A3 WO2015052684 A3 WO 2015052684A3 IB 2014065201 W IB2014065201 W IB 2014065201W WO 2015052684 A3 WO2015052684 A3 WO 2015052684A3
Authority
WO
WIPO (PCT)
Prior art keywords
polysaccharide
protein
protein conjugates
present
enhanced immunogenicity
Prior art date
Application number
PCT/IB2014/065201
Other languages
French (fr)
Other versions
WO2015052684A2 (en
Inventor
Davinder Gill
Manoj Kumar CHHIKARA
Rakesh RANA
Juned DALAL
Deepti SINGH
Vibhu KANCHAN
Original Assignee
Msd Wellcome Trust Hilleman Laboratories Pvt. Ltd.
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 Msd Wellcome Trust Hilleman Laboratories Pvt. Ltd. filed Critical Msd Wellcome Trust Hilleman Laboratories Pvt. Ltd.
Priority to KR1020167012126A priority Critical patent/KR20160062168A/en
Priority to MYPI2016701265A priority patent/MY194920A/en
Priority to CN201480056001.6A priority patent/CN105636608A/en
Priority claimed from IN3047DE2013 external-priority patent/IN2013DE03047A/en
Publication of WO2015052684A2 publication Critical patent/WO2015052684A2/en
Publication of WO2015052684A3 publication Critical patent/WO2015052684A3/en
Priority to ZA2016/02375A priority patent/ZA201602375B/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • 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
    • A61K39/02—Bacterial antigens
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/095—Neisseria
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/102—Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/6415—Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0003—General processes for their isolation or fractionation, e.g. purification or extraction from biomass

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Virology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Polymers & Plastics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Materials Engineering (AREA)
  • Pulmonology (AREA)
  • Sustainable Development (AREA)
  • Toxicology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

The present invention relates to polysaccharide – protein conjugates with enhanced immunogenicity displaying significantly high antibody titres. The carrier protein is obtained from group of gram positive bacteria, polysaccharide fragment is obtained from group of gram negative bacteria, preferably from Haemophilus influenzae serotype b (Hib), Neisseria meningitidis serogroup A and C (MenA and MenC). The present invention also relates to a rapid and high yielding process of preparing the polysaccharide–protein conjugates in which derivatized carrier protein reacts with cleaved and depolymerized polysaccharide fragments of optimum length to obtain polysaccharide – protein conjugate employing reductive amination chemistry. The present invention further relates to a chemical process of polysaccharide fragmentation to optimum length for use in conjugation.
PCT/IB2014/065201 2013-10-11 2014-10-10 Polysaccharide-protein conjugates with enhanced immunogenicity and rapid high yielding process thereof WO2015052684A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
KR1020167012126A KR20160062168A (en) 2013-10-11 2014-10-10 Polysaccharide-Protein Conjugates With Enhanced Immunogenicity And Rapid High Yielding Process of Preparation Thereof
MYPI2016701265A MY194920A (en) 2013-10-11 2014-10-10 Polysaccharide ? protein conjugates with enhanced immunogenicity and rapid high yielding process thereof
CN201480056001.6A CN105636608A (en) 2013-10-11 2014-10-10 Polysaccharide-protein conjugates with enhanced immunogenicity and rapid high yielding process thereof
ZA2016/02375A ZA201602375B (en) 2013-10-11 2016-04-08 Polysaccharide-protein conjugates with enhanced immunogenicity and rapid high yielding process of preparation thereof

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN3047/DEL/2013 2013-10-11
IN2363/DEL/2014 2014-08-20
IN2363DE2014 2014-08-20
IN3047DE2013 IN2013DE03047A (en) 2013-10-11 2014-10-10

Publications (2)

Publication Number Publication Date
WO2015052684A2 WO2015052684A2 (en) 2015-04-16
WO2015052684A3 true WO2015052684A3 (en) 2015-07-23

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/065201 WO2015052684A2 (en) 2013-10-11 2014-10-10 Polysaccharide-protein conjugates with enhanced immunogenicity and rapid high yielding process thereof

Country Status (4)

Country Link
CN (1) CN105636608A (en)
MY (1) MY194920A (en)
WO (1) WO2015052684A2 (en)
ZA (1) ZA201602375B (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105770890A (en) * 2016-03-08 2016-07-20 苏文全 Specific protein composition and application method thereof
CN106084037B (en) * 2016-06-08 2020-01-07 中国人民解放军第二军医大学 Bacillus anthracis capsule surface trisaccharide conjugate and preparation method and application thereof
MX2019002489A (en) 2016-09-02 2019-10-21 Sanofi Pasteur Inc Neisseria meningitidis vaccine.
KR102388325B1 (en) 2016-10-20 2022-04-18 케이엠 바이올로직스 가부시키가이샤 Manufacturing method of Hib conjugate vaccine using low molecular weight PRP
CN114965784B (en) * 2022-06-01 2023-10-27 艾美探索者生命科学研发有限公司 Method for measuring polysaccharide activation degree

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5651971A (en) * 1993-09-22 1997-07-29 Henry M. Jackson Foundation For The Advancement Of Military Medicine Producing immunogenic constructs using soluble carbohydrates activated via organic cyanylating reagents
US20070141084A1 (en) * 2003-08-06 2007-06-21 Lee Che-Hung R Polysaccharide-protein conjugate vaccines
WO2012119972A1 (en) * 2011-03-07 2012-09-13 Glaxosmithkline Biologicals S.A. Conjugation process

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5651971A (en) * 1993-09-22 1997-07-29 Henry M. Jackson Foundation For The Advancement Of Military Medicine Producing immunogenic constructs using soluble carbohydrates activated via organic cyanylating reagents
US20070141084A1 (en) * 2003-08-06 2007-06-21 Lee Che-Hung R Polysaccharide-protein conjugate vaccines
WO2012119972A1 (en) * 2011-03-07 2012-09-13 Glaxosmithkline Biologicals S.A. Conjugation process

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
CRAIG LAFERRIERE ET AL: "Experimental design to optimize antype b conjugate vaccine made with hydrazide-derivatized tetanus toxoid", GLYCOCONJUGATE JOURNAL, KLUWER ACADEMIC PUBLISHERS, BO, vol. 28, no. 7, 19 August 2011 (2011-08-19), pages 463 - 472, XP019957422, ISSN: 1573-4986, DOI: 10.1007/S10719-011-9344-3 *
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; 1989, ANDERSON P W ET AL: "EFFECT OF OLIGOSACCHARIDE CHAIN LENGTH EXPOSED TERMINAL GROUP AND HAPTEN LOADING ON THE ANTIBODY RESPONSE OF HUMAN ADULTS AND INFANTS TO VACCINES CONSISTING OF HAEMOPHILUS-INFLUENZAE TYPE B CAPSULAR ANTIGEN UNITERMINALLY COUPLED TO THE DIPHTHERIA PROTEIN CRM197", XP002736556, Database accession no. PREV198987115527 *
JOURNAL OF IMMUNOLOGY, vol. 142, no. 7, 1989, pages 2464 - 2468, ISSN: 0022-1767 *
RON DAGAN ET AL: "Glycoconjugate vaccines and immune interference: A review", VACCINE, vol. 28, no. 34, 1 August 2010 (2010-08-01), pages 5513 - 5523, XP055117016, ISSN: 0264-410X, DOI: 10.1016/j.vaccine.2010.06.026 *

Also Published As

Publication number Publication date
CN105636608A (en) 2016-06-01
WO2015052684A2 (en) 2015-04-16
MY194920A (en) 2022-12-23
ZA201602375B (en) 2017-07-26

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