Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Structurally-modified antibody – immunoglobulin – or fragment...
Reexamination Certificate
2008-03-04
2008-03-04
Blanchard, David J. (Department: 1643)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Structurally-modified antibody, immunoglobulin, or fragment...
C424S141100, C424S144100, C424S155100, C435S069600, C435S070210, C530S387100, C530S388100, C530S388220, C530S388800
Reexamination Certificate
active
10482759
ABSTRACT:
Framework (FR)-patching is a novel approach to modify immunoglobulin for reducing potential immunogenicity without significant alterations in specificity and affinity. Unlike previous described methods of humanization, which graft CDRs from a donor onto the frameworks of a single acceptor immunoglobulin, we patch segments of framework (FR1, FR2, FR3, and FR4), or FRs, to replace the corresponding FRs of the parent immunoglobulin. Free assortment of these FRs from different immunoglobulins and from different species can be mixed and matched into forming the final immunoglobulin chain. A set of criteria in the choice of these FRs to minimize or eliminate the need to reintroduce framework amino acids from the parent immunoglobulin for patching is described. The approach gives greater flexibility in the choice of framework sequences, minimizes the need to include parent framework amino acids, and, most importantly, reduces the chances of creating new T- and B-cell epitopes in the resultant immunoglobulin.
REFERENCES:
patent: 4704362 (1987-11-01), Itakura et al.
patent: 5693761 (1997-12-01), Queen et al.
patent: 5693762 (1997-12-01), Queen et al.
patent: 5789554 (1998-08-01), Leung et al.
patent: 5859205 (1999-01-01), Adair et al.
patent: 5908925 (1999-06-01), Cohen et al.
patent: 6187287 (2001-02-01), Leung et al.
patent: 6632927 (2003-10-01), Adair et al.
patent: 4225853 (1994-02-01), None
patent: 0239400 (1987-09-01), None
patent: WO 87/02671 (1987-05-01), None
patent: WO 97/34632 (1997-09-01), None
patent: WO 98/41641 (1998-09-01), None
patent: WO 99/55369 (1999-11-01), None
Paul, William E. Fundamental Immunology, 3rd Ed., pp. 292-295, 1993.
Coleman P. M. Research in Immunology, 145:33-36, 1994.
MacCallum et al. J. Mol. Biol., 262, 732-745, 1996.
Casset et al. Biochemical and Biophysical Research Communications, 307:198-205, 2003.
Qu Z. et al. Clinical Cancer Research, 5(10 Suppl):3095s-3100s, Oct. 1999.
Chatterjee, et al., Cancer Immunol. Immunother. 38:75-82, 1994.
Gure, Science 278:1041-2, 1997.
Hamilton, A.A., Manual, D.M. Grundy, J.E., Turner, A.J., King, S.I., Adair, J.R., White, P.. Carr, F.J. and Harris, W.J. “A humanized antibody against Human Cytomegalovirus (CMV) gpUL75 (gH) for prophylaxis or treatment of CMV infections” J. Infect. Diseases (1997) 176:59-68.
Ohtomo, et al., Molecular Immunology 32:407-416, 1995.
Paul, Fundamental Immunology. Raven Press, NY, Chapter 8. p. 242, 1993.
Riechmann, L., Clark, M., Weldmann, H. and Winter, G.“Reshaping human antibodies for therapy.” Nature (1998) 332:323-327.
Rosok, M.J., Yelton, D.E., Harris, L.J., Bajorath, J., Hellstrom, K-E., Hellstron, I., Cruz. G.A., Kristensson, K., Lin, H., Huse, W.D. and Glaser, S.M. “A combinatorial library strategy for the rapid humanization of anticarcinoma BR96 Fab” J. Biol. Chem. (1996) 271:22611-22618.
Rudikoff, et al., Proc. Natl. Acad. Sci. USA vol. 79:1979, 1982.
Shearman, C.W., Pollock, D., White, G., Hehir, K., Moore, G.P., Kanzy, E.J. and Kurrie, R. “Construction, expression and characterization of humanized antibodies directed against the human alpha/beta T cell receptor.” J. Immunol. (1991) 147:4366-4373.
Berihar et al. Proc. Nat. Acad. Sci. U.S.A. 91: 12051-12055, 1994.
Fiona Adair, “Immunogenicity: The Last Hurdle for Clinically Successful Therapeutic Antibodies”, BioPharm, Oct. 2000, pp. 42-46.
Man Sung Co et al., “Humanized Antibodies for Antiviral Therapy”, PNAS USA, vol. 88: 2869-2973, Apr. 1991.
Elvin A. Kabat et al., “Identical V Region Amino Acid Sequences and Segment of Sequences in Antibodies of Different Specificities”, Journal of Immunology, vol. 147 (5): 1709-1719, Sep. 1991.
Eduardo A. Padlan, “Anatomy of the Antibody Molecule”,Molecular Immunology, vol. 31 (3): 169-217 (1994).
Tai Te Wu et al., “Possible Use of Similar Framework Region Amino Acid Sequences Between Human and Mouse Immunoglobulins for Humanizing Mouse Antibodies”, Molecular Immunology, vol. 29 (9): 1141-1146, 1992.
Jones, et al., “Replacing the complementarity-determining regions in a human antibody with those from a mouse”; Nature, 321:522-525, 1988.
Verhoyen, et al., “Reshaping Human Antibodies: Grafting an Antilysozyme Activity”; Science, 239:1534-1536, 1988.
Huston, et al., “Protein engineering of antibody binding sites: Recovery of specific activity in an anti-digoxin single-chain Fv analogue produced inEscherichia coli”; Proc. Nat. Acad. Sci. USA, 85:5879-5883, 1988.
Bird, et al., “Single-Chain Antigen-Binding Proteins”; Science, 242:423-426, 1988.
T. Hunkapiller and L. Hood, “The growing immunoglobulin gene superfamily”; Nature, 323:15-16, 1986.
Davis, et al., “Single-Agent-Monoclonal Antibody Efficacy in Bulky Non-Hodgkin's Lymphoma: Results of a Phase II Trial Rituximab”, J. Clin. Oncol., 17:1851-1867, 1999.
Coiffier, et al., “Rituximab (Anti-CD20 Monoclonal Antibody) for the Treatment of Patients with Relapsing or Refractory Aggressive Lymphoma: A Multicenter Phase II Study”; Blood, 92:1927-1932, 1998.
McLaughlin, et al., “Rituximab Chimeric Anti-CD20 Monoclonal Antibody Therapy for Relapsed Indolent Lymphoma: Half of Patients Respond to a Four-Dose Treatment Program”; J. Clin. Oncol., 16:2825-2833, 1998.
A.G. Amit, et al., “Three Dimensional Structure of an Antigen-Antibody Complex at 2.8 Å Resolution”; Science, 233; 747-753, 1986.
C. Chotha and A.M. Lesk, “Canonical Structures for the Hypervariable Regions of Immunoglobulins”; J. Mol. Biol., 196:901, 1987.
Chothia, et al., “Conformations of immunoglobulin hypervariable regions”, Nature, 342:877, 1989.
A. Tramontano, C. Chothia and A.M. Lesk, “Framework Residue 71 is a Major Determinant of the Position and Conformation of the Second Hypervariable Region in the VH Domains of Immunoglobulins”: J. Mol. Biol.. 215:175. 1990.
Levy, et al., “Probing Antibody Diversity by 2D NMR: Comparison of Amino Acid Sequences, Predicted Structures, and Observed Antibody -Antigen Interactions in Complexes of Two Antipeptide Antibodies”: Biochemistry, 28:7168-7175, 1989.
R.E. Bruccoleri, E. Haber and J. Novotny, “Structure of antibody hypervariable loops reproduced by a conformational search algorithm”; Nature, 335:564-568, 1988.
Chothia, et al., “The Predicted Structure of Immunoglobulin D1.3 and Its Comparison with the Crystal Structure”; Science, 233:755-758, 1986.
Shaw, et al., Characterization of a Mouse/Human Chimeric Monoclonal Antibody (17-1A) To Colon Cancer Tumor-Associated Antigen; J. Immunol., 138(12):4534-4538, 1987.
Leung, et al., “Construction and Characterization of a Humanized, Internalizing, B-Cell (CD22)-Specific, Leukemia/Lymphoma Antibody. LL2”;Mol. Immunol. 32:1413-1427, 1995.
Daugherty, et al., “Polymerase chain reaction facilitates the cloning, CDR-grafting, and rapid expression of a murine monoclonal antibody directed against the CD18 component of leukocyte integrins”: Nucl. Acid Res., 19:2471-2476, 1991.
S. Gillam and M. Smith, “Site-Specific Mutagenesis Using Synthetic Oligodeoxyribonucleotide Primers: I. Optimum Conditions and Minimum Oligodexyribonucleotide Length”; Gene, 8:81-97, 1979.
S. Roberts, J.C. Cheetham and A.R. Rees, “Generation of an antibody with enhanced affinity and specificity for its antigen by protein engineering”; Nature, 328:731-734, 1987.
Li, et al., “The Epitope Specificity and Tissue Reactivity of Four Murine Monoclonal Anti-CD22 Antibodies”; Cell Immunol., 118:85, 1989.
Mansfield, et al., “Recombinant RFB4 Immunotoxins Exhibit Potent Cytotoxic Activity for CD22-Bearing Cells and Tumors”; Blood, 90:2020-2036, 1997.
F. Sanger, S. Nicklen and A.R. Coulson, “DNA sequencing with chain-terminating inhibitors”; PNAS, 74:5463-5467, 1977.
PCT Notification of Transmittal of the Internati
Blanchard David J.
Skytech Technology Limited
Smith Chalin A.
Smith Patent Consulting
LandOfFree
Reducing immunogenicities of immunoglobulins by... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Reducing immunogenicities of immunoglobulins by..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Reducing immunogenicities of immunoglobulins by... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3949598