Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Structurally-modified antibody – immunoglobulin – or fragment...
Reexamination Certificate
2003-03-05
2009-11-24
Chen, Stacy B (Department: 1648)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Structurally-modified antibody, immunoglobulin, or fragment...
C424S135100, C424S159100
Reexamination Certificate
active
07622111
ABSTRACT:
Construction of a recombinant gene fusion encoding a human IgG1 heavy chain constant region and a single-chain variable fragment antibody of 1A4A1 monoclonal antibody is disclosed. The recombinant antibody of the present invention confers human immune effector functions on murine antibodies. After expression in bacteria as inclusion bodies, the recombinant antibody was purified and refolded in vitro. The recombinant soluble antibody retains high antigen-binding affinity to VEE and possesses some human IgG crystallizable fragment domain functions. On non-reducing gel electrophoresis analysis, disulfide bond formation was found in the hinge region of the recombinant antibody. The present invention shows that the recombinant antibody is in a native, functionally active form and it provides the basis to characterize the recombinant antibody for efficacy in vivo.
REFERENCES:
Alvi et al., “Development of a Functional Monoclonal Single-Chain Variable Fragment Antibody Against Venezuelan Equine Encephalitis Virus,” Hybridoma, vol. 18, No. 5, pp. 413-421, Mary Ann Liebert Inc. (1999).
Long et al., “Construction and Characterization of a Novel Recombinant Single-Chain Variable Fragment Antibody Against Western Equine Encephalitis Virus,” Hybridoma, vol. 19, No. 1, pp. 1-13, Mary Ann Liebert Inc. (2000).
Roehrig et al., “Use of a New Synthetic-Peptide-Derived Monoclonal Antibody to Differentiate Between Vaccine and Wild-Type Venezuelan Equine Encephalomyelitis Viruses,” Journal of Clinical Microbiology, vol. 29, No. 3, pp. 630-631 American Society for Microbiology, (1991).
Roehrig et al., “Antigenic Analysis of the Surface Glycoproteins of a Venezuelan Equine Encephalomyelitis Virus (TC-83) Using Monoclonal Antibodies,” Virology, vol. 118, pp. 269-278 Academic Press Inc. (1982).
Roehrig et al., “The Neutralization Site on the E2 Gylcoprotein of Venezuelan Equine Encphalomyelitis (TC-83) Virus is Composed of Multiple Conformationally Stable Epitopes,” Virology, vol. 142, pp. 347-356, Academic Press Inc. (1985).
Alvi et al., “Functional Enhancement of a Partially Active Single-Chain Variable Fragment Antibody to Venezuelan Equine Encephalitis Virus,” Viral Immunology, vol. 16, No. 2, pp. 213-222, Mary Ann Liebert Inc. (2003).
Alvi, A.Z., Stadnyk, L.L., Nagata, L.P., Fulton, R.E., Bader, D.E., Roehrig, J.T. and Suresh, M.R.,Development of a Functional Monoclonal Single-Chain Variable Fragment Antibody Against Venezuelan Equine Encephalitis Virus, Hybridoma, vol. 18, No. 5, 413-421, (1999).
Long, M.C., Jager, S., Mah, D.C., Jebailey, L., Mah, M.A., Masri, S.A. and Nagata, L.P.,Construction and Characterization of a Novel Recombinant Single-Chain Variable Fragment Antibody Against Western Equine Encephalitis Virus, Hybridoma, vol. 19, No. 1, 1-13, (2000).
Xu, B., Kriangkum, J., Nagata, L.P., Fulton, R.E. and Suresh, M.R.,A Single Chain Fv Specific Against Western Equine Encephalitis Virus, Hybridoma, 18, 315-323, (1999).
Alvi Azhar Z.
Fulton R. Elaine
Hu Weigang
Nagata Leslie P.
Chen Stacy B
Her Majesty the Queen in right of Canada as represented by the
Rader & Fishman & Grauer, PLLC
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