Patent application EP16305664A (EP), filed 2016-06-07
Publication number: EP3254691A1
Title: POLYCLONAL ANTIBODIES FOR USE IN THE PREVENTION AND/OR TREATMENT OF EBOLA VIRUS DISEASE
Abstract: The present invention relates to polyclonal antibodies for use in the prevention and/or treatment of the Ebola virus disease. In one embodiment, the polyclonal antibodies are specific for a truncated Ebola virus GP glycoprotein. Said polyclonal antibodies are preferably non-human antibodies and are provided in a serum free pharmaceutical composition. The present invention also relates to a method of prevention and/or treatment of Ebola virus disease in a subject in need thereof, comprising administering to said subject polyclonal antibodies specific for the Ebola virus.
IPC codes: A61K  39/    12            A I
C07K  16/    06            A I
C07K  16/    10            A I
Claims: number: 1
text: Polyclonal antibodies for use in a method for the prevention and/or treatment of Ebola virus disease, wherein said polyclonal antibodies are specific for the Ebola virus.
number: 2
text: The polyclonal antibodies for use according to claim 1, wherein said polyclonal antibodies are non-human polyclonal antibodies.
number: 3
text: The polyclonal antibodies for use according to claim 1 or 2, wherein said polyclonal antibodies specifically bind to Ebola virus GP glycoprotein, Ebola virus GP1 subunit, Ebola virus GP2 subunit and/or a variant thereof.
number: 4
text: The polyclonal antibodies for use according to claim 3, wherein said variant comprises or consists of a sequence at least 80% identical to sequence SEQ ID NO: 3, SEQ ID NO: 5, SEQ ID NO: 7 and/or SEQ ID NO: 11.
number: 5
text: The polyclonal antibodies for use according to claim 3 or 4, wherein said variant is encoded by a nucleic acid comprising or consisting of a sequence at least 80% identical to sequence SEQ ID NO: 2, SEQ ID NO: 4 and/or SEQ ID NO: 6.
number: 6
text: The polyclonal antibodies for use according to any one of claims 1 to 5, wherein said polyclonal antibodies are purified from at least one biological sample of an animal immunized with (i) at least one antigen selected in the group consisting of Ebola virus GP glycoprotein, Ebola virus GP1 subunit, Ebola virus GP2 subunit and a variant thereof, (ii) at least one nucleic acid comprising or consisting of a sequence encoding said antigen and/or (iii) at least one vector comprising at least one nucleic acid comprising or consisting of a sequence encoding said antigen.
number: 7
text: The polyclonal antibodies for use according to any one of claims 1 to 6, wherein said polyclonal antibodies are provided in a pharmaceutical composition.
number: 8
text: The polyclonal antibodies for use according to claim 7, wherein said pharmaceutical composition is suitable for subcutaneous, intradermal, intramuscular, intraperitoneal and/or intravenous administration.
number: 9
text: The polyclonal antibodies for use according to claim 7 or 8, wherein said pharmaceutical composition comprises from 50 mg to 500 mg of said polyclonal antibodies.
number: 10
text: The polyclonal antibodies for use according to any one of claims 1 to 9, wherein said polyclonal antibodies are used in combination with at least another anti-Ebola virus drug and/or at least another anti-Ebola virus vaccine.
number: 11
text: Polyclonal antibodies specific for the Ebola virus obtained from at least one biological sample of an animal immunized with (i) at least one antigen comprising or consisting of a sequence at least 80% identical to sequence SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, or SEQ ID NO: 11, (ii) at least one nucleic acid comprising or consisting of a sequence encoding said antigen and/or (iii) at least one vector comprising at least one nucleic acid comprising or consisting of a sequence encoding said antigen.
number: 12
text: An antigen comprising or consisting of sequence SEQ ID NO: 1, sequence SEQ ID NO: 8, sequence SEQ ID NO: 9 or a sequence at least 80% identical to sequence SEQ ID NO: 3, SEQ ID NO: 5, SEQ ID NO: 7 or SEQ ID NO: 11.
number: 13
text: A nucleic acid comprising or consisting of a sequence encoding an antigen according to claim 12.
number: 14
text: A vector comprising a nucleic acid according to claim 13.
number: 15
text: A method for producing polyclonal antibodies, wherein said method comprises:
Office action: search_report, dated 2017-12-13
Rejection reasons: novelty_epc_54
inventive_step_epc_56
Prior art cited: ref_id: WO2015123777A1
ref_type: patent
severity: background
ref_id: - NEEDLEMAN; WUNSCH, J. MOL BIOL., vol. 48, 1970, pages 443 - 453
ref_type: npl
severity: background
ref_id: - "Remington's Pharmaceutical Sciences", 1985, MACK PUBLISHING COMPANY
ref_type: npl
severity: background
ref_id: - CHARLES D. MURIN ET AL: "Structures of protective antibodies reveal sites of vulnerability on Ebola virus", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, vol. 111, no. 48, 17 November 2014 (2014-11-17), US, pages 17182 - 17187, XP055321303, ISSN: 0027-8424, DOI: 10.1073/pnas.1414164111
ref_type: npl
severity: background
ref_id: - SULLIVAN N J ET AL: "Development of a preventive vaccine for Ebola virus infection in primates", NATURE, NATURE PUBLISHING GROUP, UNITED KINGDOM, vol. 408, no. 6812, 30 November 2000 (2000-11-30), pages 605 - 609, XP002242909, ISSN: 0028-0836, DOI: 10.1038/35046108
ref_type: npl
severity: background
ref_id: WO2015200522A2
ref_type: patent
severity: background
ref_id: WO2015127140A2
ref_type: patent
severity: background
ref_id: WO2016123280A1
ref_type: patent
severity: background
ref_id: - O. MARTINEZ ET AL: "Impact of Ebola Mucin-Like Domain on Antiglycoprotein Antibody Responses Induced by Ebola Virus-Like Particles", JOURNAL OF INFECTIOUS DISEASES. JID, vol. 204, no. suppl 3, 10 October 2011 (2011-10-10), CHICAGO, IL., pages S825 - S832, XP055238414, ISSN: 0022-1899, DOI: 10.1093/infdis/jir295
ref_type: npl
severity: background
ref_id: - WU OU ET AL: "Induction of ebolavirus cross-species immunity using retrovirus-like particles bearing the Ebola virus glycoprotein lacking the mucin-like domain", VIROLOGY JOURNAL, BIOMED CENTRAL, LONDON, GB, vol. 9, no. 1, 25 January 2012 (2012-01-25), pages 32, XP021131564, ISSN: 1743-422X, DOI: 10.1186/1743-422X-9-32
ref_type: npl
severity: background
ref_id: WO2015127140
ref_type: patent
severity: novelty_destroying
ref_id: WO2015200522
ref_type: patent
severity: novelty_destroying
ref_id: WO2016123280
ref_type: patent
severity: novelty_destroying
ref_id: - O. MARTINEZ ET AL, "Impact of Ebola Mucin-Like Domain on Antiglycoprotein Antibody Responses Induced by Ebola Virus-Like Particles", JOURNAL OF INFECTIOUS DISEASES. JID, CHICAGO, IL., (20111010), vol. 204, no. suppl 3, doi:10.1093/infdis/jir295, ISSN 0022-1899, pages S825 - S832, XP055238414 [X] 1-8,11-15 * abstract * [Y] 9,10
ref_type: npl
severity: novelty_destroying
ref_id: - WU OU ET AL, "Induction of ebolavirus cross-species immunity using retrovirus-like particles bearing the Ebola virus glycoprotein lacking the mucin-like domain", VIROLOGY JOURNAL, BIOMED CENTRAL, LONDON, GB, (20120125), vol. 9, no. 1, doi:10.1186/1743-422X-9-32, ISSN 1743-422X, page 32, XP021131564 [X] 1-8,11-15 * abstract * [Y] 9,10
ref_type: npl
severity: novelty_destroying
Final disposition: pending (2017-12-13)