CO2017003291A2 - Proceso mejorado para la conjugación y conjugados sintéticos de oligosacarido-proteina novedosos obtenidos del mismo - Google Patents

Proceso mejorado para la conjugación y conjugados sintéticos de oligosacarido-proteina novedosos obtenidos del mismo

Info

Publication number
CO2017003291A2
CO2017003291A2 CONC2017/0003291A CO2017003291A CO2017003291A2 CO 2017003291 A2 CO2017003291 A2 CO 2017003291A2 CO 2017003291 A CO2017003291 A CO 2017003291A CO 2017003291 A2 CO2017003291 A2 CO 2017003291A2
Authority
CO
Colombia
Prior art keywords
oligosaccharide
conjugation
synthetic
protein conjugates
protein
Prior art date
Application number
CONC2017/0003291A
Other languages
English (en)
Inventor
Davinder Gill
Manoj Kumar Chhikara
Rakesh Rana
Juned Dalal
Deepti Singh
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
Publication of CO2017003291A2 publication Critical patent/CO2017003291A2/es

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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
    • A61K39/385—Haptens or antigens, bound to carriers
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H3/00—Compounds containing only hydrogen atoms and saccharide radicals having only carbon, hydrogen, and oxygen atoms
    • C07H3/06—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • 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
    • A61K39/095—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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/34—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Corynebacterium (G)
    • 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
    • C08H—DERIVATIVES OF NATURAL MACROMOLECULAR COMPOUNDS
    • C08H1/00—Macromolecular products derived from 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
    • A61K2039/57—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
    • A61K2039/6031—Proteins
    • A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]

Landscapes

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

Abstract

La presente invención se refiere a un procedimiento mejorado de conjugación para obtener conjugados sintéticos de oligosacárido-proteína (OS-PR). El proceso de conjugación sintética OS-PR es un proceso rápido que proporciona conjugados oligosacárido-proteína que son altamente inmunogénicos y provocan respuestas inmunes específicas y homogéneas. El oligosacárido sintético que comprende de cuatro a ocho unidades repetitivas de los respectivos monómeros y al menos un enlazador amino terminal incorporado, dicho polisacárido sintético imita al polisacárido natural obtenido a partir de bacterias gram negativas tales como los serogrupos A, C, Y, W, X de Neisseria meningitidis y Haemophilus influenzae y la proteína portadora que se obtiene a partir de bacterias gram positivas como Clostridium tetani (toxoide tetánico) o Corynebacterium diphtheriae (CRM197) o sus versiones recombinantes. La química de conjugación de dicho conjugado oligosacárido-proteína de la presente invención se da por una unión tioéter. La presente invención toma tiempo de proceso completo en el intervalo de 14-22 horas. Dichos conjugados oligosacárido-proteína son útiles en la producción de vacunas monovalentes o vacunas combinadas multivalentes y como herramienta de diagnóstico.
CONC2017/0003291A 2014-10-09 2017-04-04 Proceso mejorado para la conjugación y conjugados sintéticos de oligosacarido-proteina novedosos obtenidos del mismo CO2017003291A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2884DE2014 2014-10-09
PCT/IB2015/057682 WO2016055957A1 (en) 2014-10-09 2015-10-08 An improved process of conjugation and novel synthetic oligosaccharide- protein conjugates obtained thereof

Publications (1)

Publication Number Publication Date
CO2017003291A2 true CO2017003291A2 (es) 2017-06-30

Family

ID=55652678

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2017/0003291A CO2017003291A2 (es) 2014-10-09 2017-04-04 Proceso mejorado para la conjugación y conjugados sintéticos de oligosacarido-proteina novedosos obtenidos del mismo

Country Status (18)

Country Link
US (1) US10105438B2 (es)
EP (1) EP3204396A4 (es)
JP (1) JP2017531662A (es)
KR (1) KR20170065030A (es)
CN (1) CN106795194A (es)
AU (1) AU2015329590B2 (es)
BR (1) BR112017006447A2 (es)
CA (1) CA2963900A1 (es)
CL (1) CL2017000844A1 (es)
CO (1) CO2017003291A2 (es)
CU (1) CU20170046A7 (es)
EA (1) EA201700177A1 (es)
IL (1) IL251511A0 (es)
MX (1) MX2017004495A (es)
PH (1) PH12017500579A1 (es)
SG (1) SG11201702451WA (es)
TN (1) TN2017000126A1 (es)
WO (1) WO2016055957A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170198004A1 (en) 2014-05-24 2017-07-13 Biological E Limited Novel semi-synthetic meningococcal conjugate vaccine
BR112018001425A2 (pt) * 2015-07-28 2018-09-11 Msd Wellcome Trust Hilleman Laboratories Pvt Ltd novos oligômeros de sorogrupo y de neisseria meningitidis e processos de sintetização dos mesmos
MX2019002489A (es) 2016-09-02 2019-10-21 Sanofi Pasteur Inc Vacuna contra neisseria meningitidis.
BR112019026192B1 (pt) 2017-06-10 2022-05-10 Inventprise, Llc Vacinas de conjugado multivalente com polissacarídeos de conjugado bivalente ou multivalente que fornecem imunogenicidade e avidez melhoradas
US10729763B2 (en) 2017-06-10 2020-08-04 Inventprise, Llc Mixtures of polysaccharide-protein pegylated compounds
JP7297047B2 (ja) * 2018-03-23 2023-06-23 コラネックス・キャピタル 治療用ツールとしての精密なグリココンジュゲート
CN113274488B (zh) * 2021-04-30 2023-08-29 山东省药学科学院 一种特异性预防真菌感染的寡糖疫苗及其制备方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2434668A1 (en) * 2003-07-04 2005-01-04 Laurence Mulard Novel approach to design glycopeptides based on o-specific polysaccharide of shigella flexneri serotype 2a
RU2412944C2 (ru) * 2005-05-06 2011-02-27 Новартис Вэксинз Энд Дайагностикс Срл Иммуногены для вакцин против менингита а
FR2904627B1 (fr) * 2006-08-04 2008-11-07 Pasteur Institut Nouveaux peptides actives, purifies et isoles, derives du recepteur cd4 (mini-cd4) et leur procece de preparation
CA2819366A1 (en) * 2010-12-10 2012-06-14 Merck Sharp & Dohme Corp. Novel formulations which mitigate agitation-induced aggregation of immunogenic compositions
GB201103836D0 (en) * 2011-03-07 2011-04-20 Glaxosmithkline Biolog Sa Conjugation process

Also Published As

Publication number Publication date
AU2015329590A1 (en) 2017-05-04
EP3204396A4 (en) 2018-03-28
TN2017000126A1 (en) 2018-10-19
US20170246313A1 (en) 2017-08-31
KR20170065030A (ko) 2017-06-12
CL2017000844A1 (es) 2017-12-22
AU2015329590B2 (en) 2019-08-22
IL251511A0 (en) 2017-05-29
PH12017500579A1 (en) 2017-08-30
EP3204396A1 (en) 2017-08-16
US10105438B2 (en) 2018-10-23
SG11201702451WA (en) 2017-04-27
EA201700177A1 (ru) 2017-07-31
CU20170046A7 (es) 2017-06-05
BR112017006447A2 (pt) 2017-12-12
JP2017531662A (ja) 2017-10-26
CA2963900A1 (en) 2016-04-14
WO2016055957A1 (en) 2016-04-14
MX2017004495A (es) 2017-12-18
CN106795194A (zh) 2017-05-31

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