Patent application EP15188608A (EP), filed 2015-10-06
Publication number: EP3153519A1
Title: GLYCOSYLATED YGHJ POLYPEPTIDES FROM ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC)
Abstract: The present invention relates to glycosylated YghJ polypeptides from or derived from enterotoxigenic  Escherichia coli  (ETEC) that are immunogenic. In particular, the present invention relates to compositions or vaccines comprising the polypeptides and their application in immunization, vaccination, treatment and diagnosis of ETEC.
IPC codes: A61K  39/   108            A I
C07K  14/   245            A I
Claims: number: 1
text: A polypeptide comprising:
number: 2
text: The polypeptide as defined in claim 1, wherein the polypeptide or polypeptide fragment of b) has at least 90% sequence identity to SEQ ID NO: 1.
number: 3
text: The polypeptide as defined in any of claims 1 or 2, wherein the polypeptide is glycosylated in at least two positions.
number: 4
text: The polypeptide as defined in any of claims 1-3, wherein the polypeptide is glycosylated in at least three positions.
number: 5
text: The polypeptide according to anyone of claims 1-4, wherein the polypeptide is hyperglycosylated.
number: 6
text: The polypeptide as defined in any of claims 1-5, wherein the polypeptide originates from Enterotoxigenic Escherichia coli (ETEC).
number: 7
text: The polypeptide as defined in any of claims 1-6, wherein the glycosylated polypeptide comprises at least one asparagine within seven amino acids from each glycosylated amino acid.
number: 8
text: The polypeptide as defined in any of claims 1-7, wherein the glycosylated polypeptide comprises an amino acid motif selected from the group consisting of XTXNX, XTXXXNX, XTXXXXXXNX, XTTX, XSNX, XSXNX, XSTX, XNXXXXXXSX, XSXXTX, XSXXNX, and XNSX.
number: 9
text: The polypeptide as defined in any of claims 1-8, wherein the glycosylated polypeptide is selected from the group of glycosylated polypeptides consisting of SEQ ID NOs: 2-23.
number: 10
text: The polypeptide as defined in any of claims 1-9, wherein the polypeptide is a fusion polypeptide.
number: 11
text: The polypeptide as defined in any of claims 1-10, wherein the polypeptide is fused to a polypeptide originating from ETEC.
number: 12
text: An immunogenic composition comprising the polypeptide as defined in any of claims 1-11.
number: 13
text: A pharmaceutical composition comprising the polypeptide as defined in any of claims 1-11 and at least one pharmaceutically acceptable carrier, excipient or diluent.
number: 14
text: The immunogenic composition as defined in claim 12 or the pharmaceutical composition of claim 13, which is a vaccine against ETEC.
number: 15
text: An immunogenic composition as defined in claim 12, pharmaceutical composition as defined in claim 13, or vaccine as defined in claim 14, which is formulated for intradermal, transdermal, subcutaneous, intramuscular or mucosal application.
number: 16
text: A nucleic acid sequence encoding a polypeptide as defined in any of claims 1-11.
number: 17
text: The polypeptide as defined in any of claims 1-11, immunogenic composition as defined in claim 12, pharmaceutical composition as defined in claim 13, or vaccine as defined in claim 14 for use in treating infection caused by ETEC.
number: 18
text: The polypeptide as defined in any of claims 1-11, immunogenic composition as defined in claim 12, pharmaceutical composition as defined in claim 13, or vaccine as defined in claim 14 for use in the preparation of a medicament for treating infection caused by ETEC.
number: 19
text: The polypeptide as defined in any of claims 1-11, immunogenic composition as defined in claim 12, pharmaceutical composition as defined in claim 13, or vaccine as defined in claim 14 for use in the diagnosis of an infection caused by ETEC.
number: 20
text: A method for immunizing a mammal, the method comprising administering to the mammal the immunogenic composition as defined in claim 12, pharmaceutical composition as defined in claim 13 or vaccine as defined in claim 14.
number: 21
text: A method for treating a mammal, which is infected with ETEC comprising administering to the mammal the immunogenic composition as defined in claim 12, pharmaceutical composition as defined in claim 13 or vaccine as defined in claim 14.
number: 22
text: The polypeptide, immunogenic composition or pharmaceutical composition for use as defined in any of claims 17-19 or the method as defined in any of claims 20-21, wherein the mammal is a human.
Office action: search_report, dated 2017-04-12
Rejection reasons: novelty_epc_54
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ref_id: WO2011007257A1
ref_type: patent
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ref_id: WO2014102694A1
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ref_id: WO2009104092A2
ref_type: patent
severity: background
ref_id: - BOYSEN ANDERS ET AL: "SILAC-based comparative analysis of pathogenicEscherichia colisecretomes", JOURNAL OF MICROBIOLOGICAL METHODS, vol. 116, 2 July 2015 (2015-07-02), pages 66 - 79, XP029247332, ISSN: 0167-7012, DOI: 10.1016/J.MIMET.2015.06.015
ref_type: npl
severity: background
ref_id: - STINE K. KNUDSEN ET AL: "Effect of glycosylation on the extracellular domain of the Ag43 bacterial autotransporter: enhanced stability and reduced cellular aggregation", BIOCHEMICAL JOURNAL, vol. 412, no. 3, 15 June 2008 (2008-06-15), GB, pages 563 - 577, XP055288883, ISSN: 0264-6021, DOI: 10.1042/BJ20071497
ref_type: npl
severity: background
ref_id: WO2009104092
ref_type: patent
severity: novelty_destroying
ref_id: WO2011007257
ref_type: patent
severity: novelty_destroying
ref_id: WO2014102694
ref_type: patent
severity: novelty_destroying
ref_id: - BOYSEN ANDERS ET AL, "SILAC-based comparative analysis of pathogenicEscherichia colisecretomes", JOURNAL OF MICROBIOLOGICAL METHODS, (20150702), vol. 116, doi:10.1016/J.MIMET.2015.06.015, ISSN 0167-7012, pages 66 - 79, XP029247332 [X] 1-8,10-14,17,18,20-22 * ETEC_3241 = YghJ; page  74, column  l, paragraph  3; tables 5,6 * [I] 15,19
ref_type: npl
severity: novelty_destroying
ref_id: - STINE K. KNUDSEN ET AL, "Effect of glycosylation on the extracellular domain of the Ag43 bacterial autotransporter: enhanced stability and reduced cellular aggregation", BIOCHEMICAL JOURNAL, GB, (20080615), vol. 412, no. 3, doi:10.1042/BJ20071497, ISSN 0264-6021, pages 563 - 577, XP055288883 [AD] 1-22 * the whole document *
ref_type: npl
severity: background
Final disposition: pending (2017-04-12)