Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Combination of viral and bacterial antigens
Reexamination Certificate
2008-04-22
2008-04-22
Navarro, Mark (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Combination of viral and bacterial antigens
C424S261100, C424S161100, C530S350000
Reexamination Certificate
active
07361355
ABSTRACT:
Mutant cholera holotoxins comprising a cholera toxin subunit A having single amino acid substitutions in the amino acid positions 16 or 72 or a double amino acid substitution in the amino acid positions 16 and 68 or 68 and 72 have reduced toxicity compared to the wild-type cholera holotoxin. The mutant cholera holotoxins are useful as adjuvants in immunogenic compositions to enhance the immune response in a vertebrate host to a selected antigen from a pathogenic bacterium, virus, fungus, or parasite, a cancer cell, a tumor cell, an allergen, or a self-molecule.
REFERENCES:
patent: 4666829 (1987-05-01), Glenner et al.
patent: 4883761 (1989-11-01), Keith et al.
patent: 5171568 (1992-12-01), Burke et al.
patent: 5182109 (1993-01-01), Tamura
patent: 5601831 (1997-02-01), Green et al.
patent: 5643747 (1997-07-01), Baker et al.
patent: 5679352 (1997-10-01), Chong et al.
patent: 5709879 (1998-01-01), Barchfeld et al.
patent: 5770203 (1998-06-01), Burnette et al.
patent: 5786189 (1998-07-01), Locht et al.
patent: 5925546 (1999-07-01), Pizza et al.
patent: 5965354 (1999-10-01), Burke et al.
patent: 5972336 (1999-10-01), Michetti et al.
patent: 6040427 (2000-03-01), Locht et al.
patent: 6245337 (2001-06-01), St. Geme, III et al.
patent: 6290962 (2001-09-01), Michetti et al.
patent: 6395964 (2002-05-01), Arntzen et al.
patent: 6514503 (2003-02-01), Gizurarson et al.
patent: 6558677 (2003-05-01), Zollinger et al.
patent: 6685949 (2004-02-01), Gu et al.
patent: 7105161 (2006-09-01), Gajewczyk et al.
patent: 2003/0113345 (2003-06-01), Clements
patent: 2003/0176653 (2003-09-01), Mason et al.
patent: 2004/0176571 (2004-09-01), Green et al.
patent: 2005/0175631 (2005-08-01), Vajdy et al.
patent: 2006/0057155 (2006-03-01), Masignani et al.
patent: 2006/0069052 (2006-03-01), Hone
patent: 2006/0177469 (2006-08-01), Ruppuoli
patent: 2006/0251675 (2006-11-01), Hagen
patent: WO-92/19265 (1992-11-01), None
patent: WO-93/13202 (1993-07-01), None
patent: WO-95/17211 (1995-06-01), None
patent: WO-96/06627 (1996-03-01), None
patent: WO-97/02348 (1997-01-01), None
patent: WO-97/05267 (1997-02-01), None
patent: WO-97/29771 (1997-08-01), None
patent: WO-98/32461 (1998-07-01), None
patent: WO-98/42375 (1998-10-01), None
patent: WO-98/45324 (1998-10-01), None
patent: WO-99/27944 (1999-06-01), None
patent: WO-00/18434 (2000-04-01), None
patent: WO-02/098369 (2002-12-01), None
Jobling and Holmes Jul. 2001, reference of record.
Vaheim, Kirsten L et al, Microbial Pathogenesis, 1994, vol. 17, pates 339-346, Expression and mutagenesis of recombinant cholera toxin A subunit.
Jobling, Michael G et al, Identification of motifs in cholera toxin A1 polypeptide that are required for its interaction with human ADP-ribosylation factor 6 in a bacterial two-hybrid system.
Audibert, et al., Adjuvants: current status, clinical perspectives and future prospects,Immunology Today, Jun. 1993, 14:281-284.
Barbieri, et al., ADP-Ribosyltransferase mutations in the catalytic S-1 subunit of Pertussis toxin,Infection and Immunity, Aug. 1988, 56(8): 1934-1941.
Bazin, et al., Predominant contribution of IgA antibody-forming cells to an immune response detected in extrainterstinal lymphoid tissues of germ-free mice exposed to antigen by the oral route,J. Immunol., Oct. 1970, 105:1049-1051.
Brandtzaeg, et al., Immune functionsof human nasal mucosa and tonsils in health and disease, inImmunology of the Lung and Upper Respiratory Tract, Bienenstock, J. (Ed.) Mcraw-Hill, New York, 1984, pp. 28.
Brandtzaeg, et al., Immunohistochemical characterization of local immunoglobulin formation In Crohn's disease of the ileum,Scand. J. Gastroenterol., 1976, 11:447-457.
Cortina, et al., Tryptophan 26 in the NAD Glycohydrolase reaction of the S-1 subunit of pertussis toxin,J. Biol. Chem., Oct. 15, 1989, v. 269(29), pp. 17322-17328.
Crabbe, et al., Antibodies of the IgA type in intestinal plasma cells of germfree mice after oral or parenteral immunization with ferritin,J. Exp. Med., Oct. 1969, 130:723-744.
Craig, et al., Peyer's patches: an enriched source of precursors for IgA-producing immunocytes in the rabbit,J. Exp. Med., Jul. 1971, 134:188-200.
Cuatrecasas, P., Gangliosides and membrane receptors for cholera toxin,Biochem., Aug. 1973, 12:3558-3566.
Elson, et al. Generalized systemic and mucosal immunity in mice after mucosal stimulation with cholera toxin,J. Immunol., Jun. 1984, 132(6):2736-2741.
Elson, et al., Cholera toxin feeding did not induce oral tolerance in mice and abrogated oral tolerance to an unrelated protein antigen,J. Immunol., Dec. 1984, 133(6):2892-2897.
Feil, et al., Protein engineering studies of A-chain loop 47-56 ofEscherichia coliheat-labile enterotoxin point to a prominent role of this loop for cytotoxicity,Mol. Microbiol., May 1996, 20(4):823-832.
Gill, D.M., The arrangement of subunits in Cholera toxin,Biochem., 1976, 15:1242-1248.
Gill, et al., ADP-ribosylation of membrane proteins catalyzed by cholera toxin: basis of the activation of adenylate cyclase,Proc. Natl. Acad. Sci., Jul. 1978, 75:3050-3054.
Giuliani, et al., Mucosal adjuvanticity and immunogenicity of LTR72, A novel mutant ofEscherichia coliheat labile enterotoxin with partial knockout of ADP-ribosyltransferase activity,J. Exp. Med., Apr. 1998, 187(7):1123-1132.
Glineur, et al., Importance of ADP-ribosylation in the morphological changes of PC12 cells induced by cholera toxin,Infect. Immun., Oct. 1994, 62(10): 4175-4185.
Hanson, L.A., Comparative immunological studies of the immune globulins of human milk and of blood serum,Intl Arch. Allergy Appl. Immunol. 1961, 18:241-267.
Holmes, et al., Cholera toxins and related enterotoxins of gram-negative bacteria, inHandbook of Nature Toxins: Bacterial Toxins and Virulence Factors in Disease, vol. 8, Moss, et al. (Eds.), Marcel Dekker, Inc., New York, 1995, 225-256.
Holmes, R.K., Heat-labile enterotoxins (Escherichia coli), inGuidebook to Protein Toxins and Their Use in Cell Biology, Montecucco and Rappuoli (Eds.), Oxford University Press, Oxford, England, 1997.
Janeway and Travers (Eds.), The Immune System in Health and Disease, inImmunobiologySecond Edition, Current Biology Ltd., Great Britain, 1996.
Jobling, et al., Fusion proteins containing the A2 domain of cholera toxin assemble with B polypeptides of cholera toxin to form immunoreactive and fuction holotoxin-like chimeras,Infect. Immun., Nov. 1992, 60(11):4915-4924.
Jobling, M., Analysis of the structure and function of cholera toxin A subunit,Abstracts of the General Meeting-American Society for Microbiology, 1991, p. 59, Abstract No. B-205.
Jobling, M., Biological and biochemical characterization of variant A. Subunits of cholera toxin constructed by site-directed mutagenesis,J. Bacteriol., Jul. 2001, 183(13):4024-4032.
Jobling, M., Identification of motifs in cholera toxin A1 polypeptide that are required for its interaction with human ADP-ribosylation factor 6 in a bacterial two-hybrid system,Proc. Natl. Acad. Sci. USA, Dec. 2000, 97(26):14662-14667.
Kassis, et al., Mechanism of action of cholera toxin on intact cells. Generation of A1 peptide and activation of adenylate cyclase,J. Biol. Chem., Oct. 1982, 257:12148-12152.
Lobet, et al., Effect of site-directed mutagenic alterations on ADP-ribosyltransferase activity of the A subunit ofEscherichia coliheat-labile enterotoxin,Infection and Immunity, Sep. 1991, 59(9):2870-2879.
Locht, et al., Identification of amino acid residues essential for the enzymatic activities of pertussis toxin,PNAS(USA), May 1989, 86:3075-3079.
Locht, et al., Probing the structure-function relationship of the pertussis toxin S1 subunit by site-directed mutagensis, inBacterial Protein Toxins, Suppl. 19, Rappuoli, et al. (Eds.), Gustav Fischer Verlag, New York, 1990, pp. 89-90.
Lycke, et al., Strong adjuvant properties of cholera toxin on gut mucosal immune response to orally presented antigens,Immunology, Oct. 1986, 59(2):301-308.
Mastecky, et al., Selective induction of an immune response in human external secretions by ingestion of bacterial antigen,J. Clin. Invest., Mar. 1978, 61:731-737.
McKenzie, et al., Cholera toxin subunit as a ca
Green Bruce A.
Holmes Randall K.
Jobling Michael G.
Zhu Duzhang
Fontenot J. Darrell
Howson & Howson LLP
Navarro Mark
Portner Ginny Allen
The Regents of the University of Colorado, a body corporate
LandOfFree
Mutant forms of cholera holotoxin as an adjuvant does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Mutant forms of cholera holotoxin as an adjuvant, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Mutant forms of cholera holotoxin as an adjuvant will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2785547