Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives
Reexamination Certificate
2006-10-03
2006-10-03
Borin, Michael (Department: 1631)
Organic compounds -- part of the class 532-570 series
Organic compounds
Carbohydrates or derivatives
C536S023100, C424S278100, C435S069100
Reexamination Certificate
active
07115730
ABSTRACT:
An immunogenic detoxified protein is provided which comprises the amino acid sequence of subunit A of anE. coliheat labile toxin (LT-A) or a fragment thereof in which at least amino acid Ala-72, numbered relative to SEQ ID NO:1, of the A subunits mutated, preferably by substitution with Arg. The toxoid is useful as vaccine against an enterotoxigenic strain ofE. coliand is produced by recombinant DNA means by site-directed mutagenesis. It is also an effective adjuvant.
REFERENCES:
patent: 5182109 (1993-01-01), Tamura et al.
patent: 5770203 (1998-06-01), Burnette et al.
patent: 0 145 486 (1984-12-01), None
patent: 145486 (1985-06-01), None
patent: 0396964 (1990-11-01), None
patent: 0462534 (1991-12-01), None
patent: WO 92/19265 (1992-11-01), None
patent: WO 92/22326 (1992-12-01), None
patent: 93/13202 (1993-07-01), None
patent: WO 93/13202 (1993-07-01), None
patent: WO 95/09649 (1995-04-01), None
patent: WO 95/17211 (1995-06-01), None
patent: WO 95/34323 (1995-12-01), None
patent: WO 96/06627 (1996-03-01), None
patent: WO 97/02348 (1997-01-01), None
patent: WO 99/58145 (1999-11-01), None
patent: WO 00/18434 (2000-04-01), None
Bowen et al., “Cholera Toxin Acts as a Potent Adjuvant for Induction of Cytotoxic T-Lymphocyte Responses with Non-Replicating Antigents,”Immunology 81:338-342 (1994).
Burnette et al., “Site-Specific Mutagenesis of the Catalytic Subunit of Cholera Toxin: Substituting Lysine for Arginine 7 Causes Loss of Activity,”Inf.&Immunity 59(11):4266-4270 (1991).
Clements et al., “Adjuvant Activity ofEscherichia coliHeat-Labile Enterotoxin and Effect on the Induction of Oral Tolerance in Mice to Unrelated Protein Antigens,”Vaccine 6:269-277 (1988).
Di Tommaso et al., “Induction of Antigen-Specific Antibodies in Vaginal Secretions by Using a Nontoxic Mutant of Heat-Labile Enterotoxin as a Mucosal Adjuvant,”Inf.&Immunity 64(3):974-979 (1996).
Domenighini et al., “MicroCorrespondence,”Mol. Microbiology 15(6):1165-1167 (1995).
Douce et al., “Mutants ofEscherichia coliHeat-Labile Toxin Lacking ADP- Ribosyltransferase Activity Act as Nontoxic, Mucosal Adjuvants,”Proc. Natl. Acad. Sci. 92:1644-1648 (1995).
Douce et al., “Intranasal Immunogenicity and Adjuvanticity of Site-Directed Mutant Derivatives of Cholera Toxin,”Inf.&Immunity 65(7):2821-2828 (1997).
Fontana et al., “Construction of Nontoxic Derivatives of Cholera Toxin and Characterization of Immunological Response Against the A Subunit,”Inf.&Immunity 63(6):2356-2360 (1995).
Harford et al., “Inactivation of theEscherichia coliHeat-Labile Enterotoxin by Invitro Mutagenesis,”Eur. J. Biochem 183:311-316 (1989).
Holmgren et al., “An Oral B Subunit: Whole Cell Vaccine Against Cholera,”Vaccine 10(3):911-914 (1992).
Holmgren et al., “Cholera Toxin and Cholera B Subunit as Oral-Mucosal Adjuvant and Antigen Vector Syst ms,”Vaccine 11(13):1179-1183 (1993).
Jackson et al., “Optimizing Oral Vaccines: Induction of Systemic and Mucosal B-Cell and Antibody Responses to Tetanus Toxoid by Use of Cholera Toxin as an Adjuvant,”Inf&Immunity 61(10):4272-4279 (1993).
Lycke et al., “The Adjuvant Effect of Vibrio Cholera andEscherichia coliHeat-Labile Enterotoxins is Linked to their ADP-Ribosyltransferase,”Eur. J. Immunol. 22:2277-2281 (1992).
Magagnoli et al., “Mutations in the A Subunit Affect Yield, Stability, and Potease Sensitivity og Nontoxic Derivatives of Heat-Labile Enterotoxin,”Inf&Immunity 64(12):5434-5438 (1996).
Nashar et al., “Potent Immunogenicity of the B Subunits ofEscherichia coliHeat-Labile Enterotoxin: Receptor Binding is Essential and Induces Differential Modulation of Lumphocyte Subsets,”Proc. Natl. Acad. Sci. 93:226-230 (1996).
Partidos et al., “The Adjuvant Effect of a Non-Toxic Mutant of Heat-Labile Enterotoxin ofEscherichia colifor the Induction of Measles Virus-Specific CTL Responses After Intranasal Co-Immunization with a Synthetic Peptide,”Immunology 89:483-487 (1996).
Pizza et al., “Probing the Structure-Activity Relationship ofEscherichia coliLT-A by Site-Directed Mutagenesis,”Moloecular Microbiology 14(1):51-60 (1994).
Rollwagen et al., “Killed Campylobacter Elicits Immune Response and Protection When Administered With an Oral Adjuvant,”Vaccine 11(13):1316-1320 (1993).
Snider, Dennis P., “The Mucosal Adjuvant Activities of ADP-Ribosylating Bacterial Enterotoxins,”Critical Reviews in Immunology 15(3&4):317-348 (1995).
Tsuji et al., “A Single Amino Acid Substitution in the A Subunit ofEscherichia coliEnterotoxin Results in a Loss of its Toxic Activity,”Journal of Biological Chemistry 265(36):22520-22525 (1990).
van den Akker et al., “The Arg7Lys Mutant of Heat-Labile Enterotoxin Exhibits Great Flexibility of Active Site Loop 47-56 of the Subunit,”Biochemistry 34:10996-11004 (1995).
Wilson et al., “Adjuvant Action of Cholera Toxin and Pertussis Toxin in the Induction of IgA Antibody Response to Orally Administered Antigen,”Vaccine 11(2):113-118 (1993).
Burnette, “The Advent of Recombinant Pertussis Vaccines.”Biotechnol. 8:1002-1005 (1990).
Burnette,Vaccine Research&DevelopmentsChapter 6, Marcel Dekker Inc., New York, New York (1992).
Communication to EPO Concerning Replacement Claims for Filing with the EPO in Application No. 99922284.7 (2003).
de Haan, et al., “Mutational Analysis of the Role of ADP-Ribosylation Activity in the Adjuvant Properties of theEscherichia coliHeat-Labile Enterotoxin Towards Intranasally Administered Keyhole Limpet Hemocyanin.”Eur. J. Immunol. 28:1243-1250 (1998).
Del Guidice, et al., “Genetically Derived Toxoids for use as Vaccines and Adjuvants.”Vaccine 17:S44-S52 (1999).
Dickinson & Clements, “Dissociation ofEscherichia coliheat-labile enterotoxin adjuvanticity from ADP-ribosyltransferase activity”, Infect. Immunity, 63:1617-1623 (1995).
EPO Communication pursuant to Article 96(2) EPC relating to Application EP No. 94928455.8-2116 (2001).
“Multicomponent Vaccine Development.”NIH Guidevol. 22, No. 28 (1993).
Green, Bruce, Curriculum Vitae.
Grant et al., “Role of trypsin-like cleavage at arginine 192 in the enzymatic and cytotonic activities ofEscherichia coliheat-labile enterotoxin”, Infect. Immun., 62:4270-4278 (1994).
Hagen, Michael, Cirriculum Vitae.
Hagiwar, et al., Effectiveness and Safety of MutantEscherichia coliHeat-Labile Enterotoxin (LT H44A) as an Adjuvant for Nasal Influenza Vaccine.Vaccine 19:2071-2079 (2001).
Hartman, et al., “Native and Mutant Forms of Cholera Toxin and Heat-Labile Enterotoxin Effectively Enhance Protective Efficacy of Live Attenuated and Heat-Killed Shigella Vaccines.”Infect. Immun. 67:5841-5847 (1999).
Hazama, et al., “Intranasal Immunization Against Herpes Simplex Virus Infection by using a Recombinant Glycoprotein D Fused with Immunomodulating Proteins, the B Subunit ofEscherichia coliHeat-Labile Enterotoxin and Interleukin-2.”Immunology 78:643-649 (1993).
Hirst, et al., “Cholera Toxin and Related Enterotoxins as Potent Immune Modulators.”J. Appl. Microb. Symp. Suppl. 48:26S-34S (1998).
Hirst,The Comprehensive Sourcebook of Bacterial Protein Toxins, Chapter 6, Academic Press, pp. 104-130, (1999).
Lobet et al.., “Effect of site-directed mutagenic alterations on ADP-ribosyltransferase activity of the A subunit ofEscherichia coliheat-labile enterotoxin”, Infect. Immun. 59:2870-2879 (1991).
Lycke, et al., “Strong Adjuvant Properties of Cholera Toxin on Gut Mucosal Immune Responses to Orally Presented Antigens.”Immunol. 56:301-308 (1986).
Lycke, et al, “the Mechanism of Cholera Toxin Adjuvanticity.”Res. Immunol. 198:504-520 (1997).
Martindale,Royal Pharmaceutical Society of BritainPharmaceutical Press, London, England, pp. 1277-1304(1993).
Rappou
Giuliani Marzia Monica
Pizza Mariagrazia
Rappuoli Rino
Borin Michael
Chiron SRL
Hale Rebecca M.
Harbin Alisa A.
Pasternak Dahna S.
LandOfFree
Immunogenic detoxified mutant E. coli LT-A-toxin does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Immunogenic detoxified mutant E. coli LT-A-toxin, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Immunogenic detoxified mutant E. coli LT-A-toxin will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3718071