• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    "NATURAL OCCURRENCE H FACTOR BINDING PROTEIN, IMMUNOGENIC COMPOSITION, NUCLEIC ACID, RECOMBINANT EXPRESSION VECTOR, GENETICALLY MODIFIED HOST CELL, METHODS OF DETERMINING PROBABILITIES OF ELICITING MODIFIED ANTICORPS AND PRODUCED ANTICORPOSAL USE. The present invention relates to factor H binding proteins that can elicit antibodies that are bactericidal to at least one strain of N. meningitidis, and methods of using such proteins, which are provided.
    公开号:BR112012024348A2
    申请号:R112012024348-9
    申请日:2011-03-29
    公开日:2021-04-20
    发明作者:Peter T. Beernink；Dan M. Granoff；Rolando Pajon Feyt
    申请人:Children's Hospital & Research Center Oakland；Novartis Vaccines And Diagnostics Srl；
    IPC主号:
    专利说明:

    Descriptive Report of the Patent of Invention for "NATURAL OCCURRENCE H FACTOR BINDING PROTEIN, IMMUNOGENIC COMPOSITION, NUCLEIC ACID, RECOMBINANT EXPRESSION VECTOR, GENETICALLY MODIFIED HOST CELL, 5 METHODS OF DETERMINING PROBABILITY POS BACTERICIDES AND FOR MODIFIED CELL PRODUCTION AND USE OF SUCH PROTEIN OR IMMUNOGENIC COMPOSITION".
    CROSS REFERENCE This patent application claims the benefit of Provisional Patent Application US 61/319,181, filed March 30, 2010, 61/334,542, filed May 13, 2010, 61/381,025, filed September 8 of 2010, 61/423,757, filed December 16, 2010, and 61/440,227, filed February 7, 2011, each of these patent applications are hereby incorporated by reference in their entirety.
    STATEMENT REGARDING FEDERAL SPONSORSHIP RESEARCH This invention was made with government support under grant numbers R01 AI 046464, R01 AI 082263, and AI 070955 granted by the National Institute of Allergy and Infectious Diseases, National Institutes of Health. The government has certain rights in this invention.
    INTRODUCTION Neisseria meningitidis is a Gram-negative bacterium that colonizes the human upper respiratory tract and is responsible for sporadic and cyclic worldwide epidemics of, more particularly, meningitis and sepsis. Attack and morbidity rates are highest in children under 2 years of age. Like other Gram-negative bacteria, Neisseria meningitidis typically has a cytoplasmic membrane, a peptidoglycan layer, an outer membrane that together with the capsular polysaccharide make up the bacterial wall, and pili that protrude into the external environment. . Encapsulated strains of Neisseria meningitidis are a leading cause of bacterial meningitis and septicemia in children and young adults. The prevalence and economic importance of invasive Neisseria meningitidis infections have driven the search for effective vaccines that can be achieved.
    1a/116 harm immunity across different strains, and particularly across genetically diverse group B strains with different serotypes or serosubtypes.
    Factor H-binding protein (fHbp, also referred to in the art).
    Next page 2/116
    权利要求:
    Claims (21)
    [1]
    1. Non-naturally occurring factor H (fHbp) binding protein that has lower affinity for human factor H (fH) than naturally occurring fHbp, characterized by the fact that said non-naturally occurring fHbp: i) has a lower affinity for human fH than fHbp ID 1, and presents a conformational epitope bound by antibodies that have a bactericidal activity towards at least one strain of Neisseria meningitidis, wherein said non-naturally occurring fHbp is derived from a modular group I fHbp, a modular group IV fHbp, or a modular group VII fHbp; or ii) has a lower affinity for human fH than fHbp ID 22, wherein said non-naturally occurring fHbp has a conformational epitope bound by antibodies having a bactericidal activity towards at least one strain of Neisseria meningitidis, wherein said non-naturally occurring fHbp is derived from a modular group III fHbp.
    [2]
    2. Non-naturally occurring factor H binding protein according to claim 1, characterized in that said fHbp comprises at least one amino acid substitution compared to a naturally occurring reference fHbp.
    [3]
    3. Non-naturally occurring factor H-binding protein according to claim 1, characterized in that said fHbp binds human fH with an affinity that is 50%, 40%, 30%, 20%, 10%, 5%, 2%, 1%, 0.1%, or less than 0.1%, or less of the affinity of fHbp ID 1 or fHbp ID 22 for human fH.
    [4]
    4. Non-naturally occurring factor H-binding protein according to claim 1, characterized in that said fHbp elicits in a host a level of bactericidal antibodies in serum that is at least as high as that elicited by fHbp ID 1 or fHbp ID 22.
    [5]
    5. Non-naturally occurring factor H-binding protein according to claim 1, characterized in that a) said fHbp comprises an amino acid substitution at a position corresponding to amino acid residue 41, 119, 130, 218 , or 239, based on the numbering of the mature fHbp ID 1, optionally wherein said fHbp comprises R41S or R41A as said amino acid substitution, optionally wherein said fHbp comprises R130A, H119A, E218A, or E239A as said amino acid substitution; or b) wherein said fHbp comprises an amino acid substitution at a position corresponding to amino acid residue 80, 211, 218, 248, 236, 220, or 222, based on the numbering of the mature fHbp ID 1, optionally wherein said fHbp comprises R80A, D211A, E218A, E248A, G236I, T220A, or H222A as said amino acid substitution.
    [6]
    6. Non-naturally occurring factor H-binding protein according to claim 1, characterized in that said fHbp is an artificial chimera.
    [7]
    7. A non-naturally occurring factor H-binding protein according to claim 1, characterized in that the non-naturally occurring fHbp comprises an amino acid substitution for arginine at position 41 (R41) based on the numbering of SEQ ID NO : 1, wherein said fHbp binds to human factor H (fH) with an affinity that is less than about 50% of the affinity of fHbp ID 1 for human fH, wherein fHbp ID 1 has the amino acid sequence of SEQ ID NO: 1, and wherein the non-naturally occurring amino acid sequence has at least 80% amino acid sequence identity with the amino acid sequence shown in SEQ ID NO: 1 or SEQ ID NO: 5.
    [8]
    8. A non-naturally occurring factor H-binding protein according to claim 1, characterized in that the non-naturally occurring fHbp comprises an amino acid substitution for aspartic acid at position 211 (D211) based on the numbering of SEQ ID NO: 1, wherein said fHbp binds to human factor H (fH) with an affinity that is 50% or less of the affinity of fHbp ID 22 for human fH, wherein fHbp ID 22 has the amino acid sequence of SEQ ID
    NO: 2, and wherein the non-naturally occurring amino acid sequence has at least 80% amino acid sequence identity with the amino acid sequence shown in SEQ ID NO: 2 or SEQ ID NO: 4.
    [9]
    9. Immunogenic composition, characterized in that 5 comprises: a) an fHbp or a vesicle, in which the fHbp or vesicle is: i) an fHbp as defined in any one of claims 1 to 8; ii) an isolated fHbp comprising at least 85% amino acid sequence identity to fHbp ID 4, fHbp ID 14, fHbp ID 15, wherein said fHbp has lower affinity for fH than for fHbp ID 1; or iii) a vesicle obtained from a genetically modified Neisseria host cell which is genetically modified with a nucleic acid encoding the fHbp as defined in any one of claims 1 to 6, such that the non-naturally occurring fHbp encodes. each is produced by the genetically modified host cell, wherein the vesicle comprises the encoded non-naturally occurring fHbp; and b) a pharmaceutically acceptable excipient.
    [10]
    10. Immunogenic composition according to claim 9, characterized in that said fHbp is in a preparation of vesicles prepared from a strain of Neisseria meningitidis.
    [11]
    11. Immunogenic composition according to claim 9, characterized in that said pharmaceutically acceptable excipient comprises an adjuvant or NspA.
    [12]
    12. Factor H-binding protein according to any one of claims 1 to 6, or the immunogenic composition according to any one of claims 9 to 11, characterized in that it is for use in the preparation of a medicine in a method of eliciting an antibody response in a mammal, wherein said mammal is a human.
    [13]
    13. A factor H-binding protein according to any one of claims 1 to 8, or the immunogenic composition according to any one of claims 9 to 11, characterized in that it is for use in the method as defined in claim 12, in that said antibody response comprises the production of bactericidal antibodies to N. meningitidis. 5
    [14]
    14. Nucleic acid, characterized in that it encodes the factor H-binding protein as defined in any one of claims 1 to 8.
    [15]
    15. Recombinant expression vector, characterized in that it comprises the nucleic acid as defined in claim 14.
    [16]
    16. Genetically modified host cell, characterized in that it comprises the nucleic acid as defined in claim 14 or the recombinant expression vector as defined in claim 15.
    [17]
    17. Method of determining the probability that a factor H-binding protein (fHbp) elicits a bactericidal response in an individual to at least one strain of Neisseria meningitidis, characterized by the fact that it comprises: determining the ability of the antibody, present in serum obtained from an individual who has been immunized with an fHbp to inhibit the binding of human factor H (fH) to the fHbp, wherein the inhibition of the binding of fH to the fHbp by the antibody at a level that is at least about 25% greater than the level of inhibition of fH to fHbp by a control antibody that inhibits fH binding to fHbp but does not generate a bactericidal response, indicates that the fHbp is likely to elicit a bactericidal response for at least one strain of Neisseria meningitidis.
    [18]
    18. Method according to claim 17, characterized in that fHbp is a non-naturally occurring fHbp that has lower affinity for fH than fHbp ID 1.
    [19]
    19. Method of determining the probability that a non-naturally occurring factor H binding protein (fHbp) that has lower affinity for human factor H (fH) than fHbp ID 1 will elicit bactericidal antibodies in an individual to at least one strain of Neisseria meningitidis,
    characterized by the fact that it comprises: determining the ability of an antibody elicited in a non-human test animal for the non-naturally occurring fHbp to inhibit the binding of fH to fHbp, 5 in which the inhibition of the binding of fH to fHbp by antibody elicited to the non-naturally occurring fHbp at a level that is at least about 25% greater than the level of inhibition of fH to fHbp by an antibody elicited in the non-human test animal for fHbp ID 1 indicates that the non-naturally occurring fHbp is likely to elicit a bactericidal response for at least one strain of Neisseria meningitidis.
    [20]
    20. Use of a factor H-binding protein as defined in any one of claims 1 to 6, or the immunogenic composition as defined in any one of claims 9 to 11, characterized in that it is for the preparation of a drug to elicit an antibody response in a mammal, wherein said mammal is a human.
    [21]
    21. Method for the production of a modified cell, characterized in that it comprises introducing the nucleic acid as defined in claim 14, or the recombinant expression vector as defined in claim 15, into a host cell.
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    CN104888209B|2015-05-13|2017-10-20|北京民海生物科技有限公司|A kind of B groups of epidemic meningitises coccus recombinant protein vaccine and preparation method thereof|
    WO2016184860A1|2015-05-18|2016-11-24|Universita' Degli Studi Di Trento|Immunogenic compositions containing bacterial outer membrane vesicles and therapeutic uses thereof|
    PE20191107A1|2017-01-31|2019-08-26|Pfizer|COMPOSITIONS OF NEISSERIA MENINGITIDIS AND RESPECTIVE METHODS|
    EP3607967A1|2018-08-09|2020-02-12|GlaxoSmithKline Biologicals S.A.|Modified meningococcal fhbp polypeptides|
    法律状态:
    2021-05-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2021-05-25| B07D| Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]|Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI N? 10196/2001, QUE MODIFICOU A LEI N? 9279/96, A CONCESS?O DA PATENTE EST? CONDICIONADA ? ANU?NCIA PR?VIA DA ANVISA. CONSIDERANDO A APROVA??O DOS TERMOS DO PARECER N? 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL N? 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVID?NCIAS CAB?VEIS. |
    2021-06-22| B25D| Requested change of name of applicant approved|Owner name: CHILDREN'S HOSPITAL AND RESEARCH CENTER OAKLAND (US) ; GSK VACCINES S.R.L. (IT) |
    2021-07-13| B07E| Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]|Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI |
    2021-07-13| B25A| Requested transfer of rights approved|Owner name: CHILDREN'S HOSPITAL AND RESEARCH CENTER OAKLAND (US) |
    2021-07-20| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-10-26| B25K| Entry of change of name and/or headquarter and transfer of application, patent and certificate of addition of invention: republication|Owner name: CHILDREN S HOSPITAL AND RESEARCH CENTER AT OAKLAND (US) Free format text: RETIFICACAO DO DESPACHO (25.1) ? TRANSFERENCIA DE TITULAR PUBLICADO NA RPI NO 2636, DE 13/07/2021, QUANTO AO ITEM (71) - DEPOSITANTE.ONDE SE LE: CHILDRENS HOSPITAL AND RESEARCH CENTER OAKLANDLEIA-SE: CHILDRENS HOSPITAL AND RESEARCH CENTER AT OAKLAND |
    优先权:
    申请号 | 申请日 | 专利标题
    US31918110P| true| 2010-03-30|2010-03-30|
    US61/319,181|2010-03-30|
    US33454210P| true| 2010-05-13|2010-05-13|
    US61/334,542|2010-05-13|
    US38102510P| true| 2010-09-08|2010-09-08|
    US61/381,025|2010-09-08|
    US42375710P| true| 2010-12-16|2010-12-16|
    US61/423,757|2010-12-16|
    US201161440227P| true| 2011-02-07|2011-02-07|
    US61/440,227|2011-02-07|
    PCT/US2011/030400|WO2011126863A1|2010-03-30|2011-03-29|Factor h binding proteinswith altered properties and methods of use thereof|
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