EP0530216A1 - Administration d'anticorps monoclonaux contre des virus respiratoires - Google Patents

Administration d'anticorps monoclonaux contre des virus respiratoires

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Publication number
EP0530216A1
EP0530216A1 EP91908428A EP91908428A EP0530216A1 EP 0530216 A1 EP0530216 A1 EP 0530216A1 EP 91908428 A EP91908428 A EP 91908428A EP 91908428 A EP91908428 A EP 91908428A EP 0530216 A1 EP0530216 A1 EP 0530216A1
Authority
EP
European Patent Office
Prior art keywords
mab
monoclonal antibody
administered
virus
respiratory
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP91908428A
Other languages
German (de)
English (en)
Other versions
EP0530216A4 (en
Inventor
James F. Young
Gregory A. Prince
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MedImmune LLC
Henry M Jackson Foundation for Advancedment of Military Medicine Inc
Original Assignee
MedImmune LLC
Henry M Jackson Foundation for Advancedment of Military Medicine Inc
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 MedImmune LLC, Henry M Jackson Foundation for Advancedment of Military Medicine Inc filed Critical MedImmune LLC
Publication of EP0530216A1 publication Critical patent/EP0530216A1/fr
Publication of EP0530216A4 publication Critical patent/EP0530216A4/en
Withdrawn legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1027—Paramyxoviridae, e.g. respiratory syncytial virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Definitions

  • This invention relates to the prophylaxis and/or treatment of respiratory viruses. More particularly, this invention relates to the prophylaxis and/or treatment of respiratory viruses through the administration of monoclonal antibodies against a respiratory virus .
  • Walsh, et al. , Infect, and Immun. . Vol. 43, pgs. 756-758 discloses the intraperitoneal administration of monoclonal antibodies against glycoproteins of respiratory syncytial virus to cotton rats, followed by an intranasal challenge of respiratory syncytial virus three hours after administration of the monoclonal antibody.
  • Such treatment with the monoclonal antibodies resulted in the reduction of viral titers or in the absence of virus in the lungs of the cotton rats which were given the monoclonal antibodies, while virus was detected in the lungs of all rats in the control group.
  • the treated group of rats also showed a decrease in virus growth in nasal turbinates.
  • USSR Patent No. 745,523 (1978) discloses the intranasal administration of secretory IgA antibodies, isolated from female colostrum, to a group of infants in a children's hospital, prior to an outbreak of respiratory syncytial virus. Those infants who were given the antibodies prior to the outbreak contracted less severe cases of respiratory syncytial virus and had developed fewer complications associated with the virus , than those infants who were not administered the antibodies.
  • U. S . Patent No. 4,800,078, issued to Prince, et al. discloses a method of treating respiratory disease caused by respiratory syncytial virus (RSV) by topically administering RSV antibodies into the lower respiratory tract.
  • RSV respiratory syncytial virus
  • the antibodies are administered as a purified human gamma globulin, and may be administered in an amount of from about 0.025 to 0.05g/kg of body weight.
  • the purified human gamma globulin preparation may contain RSV neutralizing antibodies at a titer greater than 1 :2 ,000.
  • a process for the prophylaxis of at least one respiratory virus in an animal comprising topically administering to the animal at least one monoclonal antibody against the at least one respiratory virus.
  • the at least one monoclonal antibody is administered to the respiratory tract.
  • Such administration may be by intranasal administration or by breathing an aerosol containing said at least one monoclonal antibody.
  • the animal is a human animal.
  • the at least one monoclonal antibody is also a neutralizing antibody.
  • Representative respiratory viruses include respiratory syncytial viruses, or RSV, parainfluenza viruses (types 1, 2, and 3) , influenza A viruses, influenza B viruses, and adenoviruses .
  • the at least one respiratory virus is a respiratory syncytial virus, and the monoclonal antibody or antibodies administered are preferably against a fusion protein of RSV.
  • monoclonal antibodies against a fusion protein of respiratory syncytial virus include MAb 1436C , MAb 1153 , MAb 1142 , MAb 151, MAb 1200, MAb 1214, MAb 1237, MAb 1129, MAb 1121 , MAb 1107, MAb 13-1 , MAb 43-1 , MAb 1112 , MAb 1269, MAb 1243 , MAb 1331H, MAb 1308F, MAb 1302 A.
  • Such antibodies are neutralizing antibodies.
  • Particularly preferred monoclonal antibodies are MAb 1121 , MAb 1129, MAb 1142 , MAb 1153 , MAb 1243, MAb 1302A, MAb 1308F, and MAb 1331H.
  • monoclonal antibodies as hereinabove described may be employed in the prophylaxis of respiratory syncytial virus.
  • These antibodies have been characterized with regard to their neutralizing potential, both to parental RSV strains used to immunize mice to generate these antibodies, as well as a number of different virus strains isolated from 1956 to 1985 from various geographical locations.
  • These antibodies have also been mapped by competitive binding and reactivity profiles of virus escape mutants to three broad antigenic sites (A, B, and C) containing 16 distinct epitopes . Epitopes within antigenic sites A and C show the least variability in natural isolates.
  • Such monoclonal antibodies are further described in Beeler, et al. , J. Virol. , Vol. 63, No. 7, pgs. 2941-2950 (July, 1989) .
  • non-neutralizing monoclonal antibodies against a fusion protein of respiratory syncytial virus include MAb 1224-1, MAb 1175-40, MAb 1105-1, MAb 1219-22 , MAb 1228-28, and MAb 1113-44. These monoclonal antibodies do not neutralize virus infectivity in vitro; however, these antibodies prevent virus replication in cells in vivo . These antibodies may be obtained from Dr. Judy A. Beeler, of the Laboratory of Infectious Diseases, National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland 20892.
  • monoclonal antibodies against parainfluenza viruses include MAb 271/7, MAb 170/7, MAb 423/4, MAb 61/5, MAb 403/7 , MAb 77/5 , MAb 447/12 , MAb 101/1, MAb 128/9, MAb 454/11, MAb 149/3, MAb 429/5, MAb 66/4, MAb 68/2, MAb 451/4 and MAb 166/11.
  • Such monoclonal antibodies recognize one of 10 epitopes of the hemagglutinin-neuraminidase (HN) protein of human parainfluenza Type 3 virus.
  • HN hemagglutinin-neuraminidase
  • monoclonal antibodies against influenza A viruses include MAb 22/1, MAb70/l, MAb 110/1, MAb 264/2, MAb W18/1, MAb 14/3, MAb 24/4, MAb 47/8, MAb 198/2 and MAb 215/2. These monoclonal antibodies are further described in Webster, et al. , Virology, Vol. 96 , pgs 258-264 (1979) . Further examples of monoclonal antibodies against influenza A virus include monoclonal antibodies H2/6A5, H3/4C4, H2/6C4, H2/4B3, H9/B20, H2/4B1, and PEG-1. These monoclonal antibodies are further described in Laver, et al. Proc. Nat. Acad. Sci. , Vol 76, No. 3 , pgs. 1425-1429 (March 1979) . The hereinabove described monoclonal antibodies react against the hemagglutinin protein or the neuraminidase protein of influenza A virus.
  • monoclonal antibodies against influenza B viruses inlcude monoclonal antibodies 113/2 , 124/4, 128/2 , 134/1, 146/1 , 152/2 , 160/1 , 162/1, 195/3, 206/2 , 238/4, and 280/2.
  • the monoclonal antibodies react against the hemagglutinin protein of influenza B virus.
  • Such monoclonal antibodies are further described in Oxford, et al. , J ⁇ Gen. Virol. Vol. 64, pgs 2367-2377 (1983) .
  • Monoclonal antibodies against adenoviruses include monoclonal antibodies 5Hx-l, 5Hx-2 , 5Hx-3, 5Hx-4, 5Hx-5, 5.100K-1 , 5PB-1, and 5Fb-l. Monoclonal antibodies 5Hx-l, 5Hx-2 , 5Hx-3 , 5Hx-4 , and 5Hx-5 were found to react against the hexon polypeptide of adenovirus type 5. Monoclonal antibody 5.100K-1 was found to react against the 100K polypeptide of adenovirus type 5.
  • Monoclonal antibody 5PB-1 was found to react against the penton base polypeptide of adenovirus type 5, and monoclonal antibody 5Fb-l was found to react against the fibre polypeptide of adenovirus type 5.
  • monoclonal antibodies are further described in Russell, et al. , J. Gen. Virol. . Vol. 56, pgs. 393-408 (1981) .
  • a mixture of monoclonal antibodies may be administered against more than one type of respiratory virus .
  • one may administer at least one monoclonal antibody against a respiratory syncytial virus and at least one monoclonal antibody against parainfluenza Type 3 virus for the prophylaxis of respiratory syncytial virus and parainfluenza Type 3 virus.
  • other combinations of monoclonal antibodies may be administered as well, with such combinations depending upon the combination of respiratory viruses one wishes to prevent.
  • the at least one monoclonal antibody when administered to the respiratory tract, either intranasally or by breathing an aerosol containing said at least one monoclonal antibody, is administered in an amount of from about lO ⁇ g to about 250mg, preferably of from about 5mg to about 125mg.
  • a process for the prophylaxis of at least one respiratory virus in an animal which comprises intramuscularly administering to the animal at least one monoclonal antibody against the at least one respiratory virus.
  • the at least one respiratory virus may be selected from those hereinabove described, and the monoclonal antibody or antibodies which may be administered, may be selected from those hereinabove described as well.
  • the at least one monoclonal antibody when administered intramuscularly, is administered in an amount of from about lmg to about 250mg, preferably from about 5mg to about lOOmg.
  • One monoclonal antibody, or a mixture of monoclonal antibodies against one or more respiratory viruses, may be administered.
  • a process for the treatment of at least one respiratory virus in an animal which comprises administering to the animal at least one monoclonal antibody against the at least one respiratory virus.
  • the at least one respiratory virus may be selected from those hereinabove described, and the monoclonal antibody or antibodies which may be administered, may be selected from those hereinabove described as well.
  • One monoclonal antibody, or a mixture of monoclonal antibodies against one or more respiratory viruses may be administered.
  • the at least one monoclonal antibody may be administered topically or systemically. Examples of topical administration include intranasal administration, or administration by breathing an aerosol containing the at least one monoclonal antibody. Examples of systemic administration include intramuscular administration and intravenous administration .
  • the at least one monoclonal antibody when administered topically , is administered to the animal in an amount of from about lO ⁇ g to about 500mg preferably of from about 5mg to about 250mg.
  • the at least one monoclonal antibody is administered in an amount of from about lmg to about 250mg, preferably from about 5mg to about lOOmg.
  • the at least one monoclonal antibody whether administered topically or systemically, and whether administered for the prophylaxis or treatment of at least one respiratory virus, preferably is administered in conjunction with a suitable amount of a pharmaceutical carrier.
  • suitable pharmaceutical carriers include isotonic solutions such as 5% dextrose or 0.9% saline. If a lyopholized preparation is desired , stabilizers such as 0.25M glycine, 10% maltose or 10% sucrose may be included.
  • Example 1 Eight different monoclonal antibodies, each of which is specific for RSV fusion protein (F glycoprotein) , were tested for their ability to block RSV replication when administered to cotton rats by the intranasal route prior to the virus challenge. These antibodies represent seven different epitopes, reacted with at least 13 of 14 virus isolates tested, and retained the greatest neutralizing activity against virus escape mutants selected with the other antibodies. The features of each of the eight antibodies are summarized in Table I below.
  • Cotton rats S. fulviventer
  • Cotton rats in groups of three rats each, average weight 100 grams, were anesthetized with methoxyflurane and given 0.1ml of an antibody solution at a concentration of lOmg/ml or lmg/ml in phosphate buffered saline (PBS) by intranasal (i.n. ) instillation.
  • PBS phosphate buffered saline
  • the antibody was one of the eight monoclonal antibodies hereinabove described, or a pooled mixture of all eight monoclonal antibodies (lOmg/ml total, 1.25mg/ml each or lmg/ml total, 0.125mg/ml each) , or standard human immune globulin (Sandoglobulin, Sandoz, Inc . , East Hanover, N.J. ) .
  • Control rats were given 0.1ml of a bovine serum albumin (BSA) suspension (lOmg/ml or lmg/ml) in PBS .
  • BSA bovine serum albumin
  • Each of the monoclonal antibodies showed a significant reduction in pulmonary virus titer, and were at least as effective and in most cases more effective than the standard immune globulin or the pool of the eight monoclonal antibodies. Five of the eight monoclonal antibodies appear to prevent infection at the high dose (lOmg/ml) and one (1331H) even at the low dose (lmg/ml) .
  • Example 2 Cotton rats (S. fulviventer) in groups of three rats each, average weight 100 grams, were injected with 0.1ml in each flank (0.2ml total) of bovine serum albumin (BSA) , or 0.1ml in each flank (0.2ml total) of either MAb 1129 or MAb 1331H.
  • the monoclonal antibodies are at a concentration of lOmg/ml.
  • the rats were anesthetized with methoxyflurane and challenged by in tra- nasal instillation of 10 5 0 PFU of the Long Strain of RSV.
  • Four days after the virus challenge the rats were sacrificed by carbon dioxide asphyxiation, the lungs were harvested, and the virus content was determined.
  • FIG 2 there was a significant reduction in pulmonary virus titers in rats treated with either of the monoclonal antibodies as compared with the BSA treated rats.
  • Example 3 Cotton rats (S. fulviventer) in groups of three rats each, average weight 100 grams, were anesthetized with methoxyflurane and challenged with 10 5 * 0 PFU of the Long strain of RSV. Three days later, the animals were anesthetized with methoxyflurane and given 0.1ml of a solution of
  • Example 4 The eight monoclonal antibodies described above in Example 1 were further examined for their ability to block RSV replication when administered to cotton rats by the intranasal route prior to virus challenge.
  • Cotton rats S . hispidus, 4 animals per group, average weight 100 grams
  • PBS phosphate-buffered saline
  • Control animals were given 0.1 ml of a bovine serum albumin suspension (1 mg/ml) in PBS .
  • Virus titers were determined using a plaque assay on HEp-2 cell monolayers as disclosed by Prince, et al. , Am. J. Pathol. , Vol. 93, pgs. 771-792 (1978) and are expressed as PFU per gram of tissue.
  • Figure 4 shows that each of the monoclonal antibodies, except MAb 1243, showed a significant reduction in pulmonary virus titer when given at the 0.1 mg or 1 mg doses.
  • Example 5 Neutralizing monoclonal antibodies (MAbs) reactive with the F protein of RSV were examined for effectiveness in blocking RSV replication when combined and administered to cotton rats.
  • MAbs 1121 and 1302 A were mixed in equal amounts.
  • Cotton rats (S. hispidus. 4 animals per group, average weight 100 grams) were anesthetized with methoxyflurane and given 0.1 ml of antibody solution, either the mixture or the individual antibodies at 1 mg/ml, 0.1 mg/ml or 0.01 mg/ml in phosphate -buffered saline (PBS) by intranasal (i.n. ) instillation.
  • Control animals were given 0.1 ml of a bovine serum albumin solution (1 mg/ml) in PBS .
  • Figure 5 shows that MAbs 1121 and 1302A when combined together are more effective in reducing viral titers as compared to their individual effects even at a total concentration of 0.01 mg/ml.
  • Example 6 Six non- neutralizing MAbs, reactive with the F protein of RSV were examined for their ability to block RSV replication when adminsitered to cotton rats by the intranasal route prior to challenge with virus.
  • Cotton rats S . hispidus. 4 animals per group, average weight 100 grams
  • PBS phosphate-buffered saline
  • Control animals were given 0.1 ml of a bovine serum albumin solution (10 mg/ml) in PBS .
  • animals were again anesthetized with methoxyflurane and challenged by i.n.
  • plaque forming units 10 ' plaque forming units (PFU) of the Long strain of RSV.
  • PFU plaque forming units
  • Lungs were harvested and homogenized in 10 parts (wt/vol) of Hanks balanced salt solution supplemented with 0.218 M sucrose, 4.4 mM glutamate, 3.8 mM KH j PO. and 3.2 mM K j HPO, and the resulting suspension was stored at -70°C until assayed for virus content.
  • Virus titers were determined using a plaque assay on HEp-2 cell monolayers as disclosed by Prince et al (1978) and are expressed as PFU per gram of tissue.
  • these non-neutralizing antibodies were effective in significantly decreasing pulmonary viral titers in treated animals even though they do not neutralize virus infectivity in vitro .

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pulmonology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Procédé de prophylaxie et/ou de traitement de virus respiratoires consistant à administrer localement ou par voie générale, à un animal, au moins un anticorps monoclonal contre au moins un virus respiratoire. L'invention est applicable notamment à la prophylaxie du virus respiratoire syncytial, ou VRS, par administration d'au moins un anticorps monoclonal contre une protéine de fusion du virus respiratoire syncytial.
EP19910908428 1990-04-19 1991-04-18 Administration of monoclonal antibodies against respiratory viruses Withdrawn EP0530216A4 (en)

Applications Claiming Priority (2)

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US52292290A 1990-04-19 1990-04-19
US522922 1990-04-19

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EP0530216A1 true EP0530216A1 (fr) 1993-03-10
EP0530216A4 EP0530216A4 (en) 1993-06-30

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Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU644210B2 (en) * 1990-07-19 1993-12-02 United States of America, as represented by the Secretary, U.S. Department of Commerce, The Improved immunotherapeutic method of preventing or treating viral respiratory tract disease
US6685942B1 (en) 1993-12-10 2004-02-03 The Scripps Research Institute Human neutralizing monoclonal antibodies to respiratory syncytial virus
DK0671927T3 (da) * 1992-09-16 2003-04-22 Us Gov Health & Human Serv Neutraliserende humane monoklonale antistoffer mod respiratorisk syncytialvirus
EP0724602A4 (fr) * 1993-07-30 1998-12-23 Oravax Inc ANTICORPS IgA MONOCLONAL DIRIGE CONTRE LE VIRUS RESPIRATOIRE SYNCYTIAL
AU2003256823B9 (en) * 2002-07-25 2009-01-08 Medimmune, Llc Methods of treating and preventing RSV, hMPV, and PIV using anti-RSV, anti-hMPV, and anti-PIV antibodies
US20050271660A1 (en) * 2002-09-06 2005-12-08 Alexion Pharmaceuticals, Inc. Nebulization of monoclonal antibodies for treating pulmonary diseases
WO2004061104A2 (fr) 2003-01-07 2004-07-22 Symphogen A/S Methode de production de proteines polyclonales de recombinaison
AU2006261920A1 (en) * 2005-06-23 2007-01-04 Medimmune, Llc Antibody formulations having optimized aggregation and fragmentation profiles
AU2008255383B2 (en) 2007-05-25 2012-11-01 Symphogen A/S Method for manufacturing a recombinant polyclonal protein
EP3105250B1 (fr) 2014-02-10 2020-08-05 IGM Biosciences, Inc. Molécules de liaison multispécifiques iga

Citations (1)

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Publication number Priority date Publication date Assignee Title
WO1992001473A1 (fr) * 1990-07-19 1992-02-06 The United States Of America, As Represented By The Secretary, U.S. Department Of Commerce Procede immunotherapeutique ameliore pour la prevention ou le traitement des maladies virales des voies respiratoires

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US4625015A (en) * 1982-08-23 1986-11-25 Scripps Clinic & Research Foundation Broad spectrum influenza antisera
US4719235A (en) * 1984-10-16 1988-01-12 Gerald N. Kern Methods and compositions for treating viral infection
FR2590674B1 (fr) * 1985-11-25 1989-03-03 Inst Nat Sante Rech Med Nouveaux reactifs de diagnostic
US4800078A (en) * 1987-05-28 1989-01-24 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Immunotherapeutic method of treating respiratory disease by intranasal administration of Igb
US4891221A (en) * 1988-11-23 1990-01-02 Edward Shanborm Whole blood antiviral process and composition

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992001473A1 (fr) * 1990-07-19 1992-02-06 The United States Of America, As Represented By The Secretary, U.S. Department Of Commerce Procede immunotherapeutique ameliore pour la prevention ou le traitement des maladies virales des voies respiratoires

Non-Patent Citations (3)

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Title
JOURNAL OF VIROLOGY vol. 63, no. 7, July 1989, BALTIMORE pages 2941 - 2950 BEELER, J.A. ET AL 'Neutralization epitopes of the F glycoprotein of respiratory syncytial virus: Effect of mutation upon fusion function' *
See also references of WO9116074A1 *
VACCINES 91 vol. 91, 1991, NEW YORK pages 283 - 288 BANSAL, G.P. ET AL 'Efficacy of passively administered monoclonal antibodies against respiratory syncytial virus infection in cotton rats' Modern approaches to new vaccines including prevention of aids;eighth annual meeting, cold spring harbor, new york, USA, september 1990. *

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Publication number Publication date
EP0530216A4 (en) 1993-06-30
WO1991016074A1 (fr) 1991-10-31

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