Methods and compositions to evaluate antibody treatment...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C435S091200, C435S007100, C536S024300, C424S130100, C530S350000

Reexamination Certificate

active

07858300

ABSTRACT:
The present invention relates to methods and compositions to evaluate or assess the response of a subject to particular therapeutic treatment. More particularly, the invention provides methods to determine the response of subjects, or to adapt the treatment protocol of subjects treated with therapeutic antibodies. The invention is based on a determination of the FCGR3A genotype of a subject. The invention can be used for patients with malignancies, particularly lymphoma, and is suited to select best responders and/or adjust treatment condition or protocol for low responders.

REFERENCES:
patent: 5552526 (1996-09-01), Nakamura et al.
patent: 5830652 (1998-11-01), Kimberly et al.
patent: 5866337 (1999-02-01), Schon
patent: 5985561 (1999-11-01), Kimberly et al.
patent: 6294347 (2001-09-01), Peltz et al.
patent: 6444789 (2002-09-01), Luo
patent: 6676927 (2004-01-01), Ravetch
patent: 2002/0076702 (2002-06-01), Anand et al.
patent: WO 01/12848 (2001-02-01), None
patent: WO 0112848 (2001-02-01), None
patent: WO 03035904 (2003-05-01), None
Koene, Harry et al. FCGRIIIAV/F Polymorphism Influences the Binding of IfG by Natural Killer Cell FCGIIIA, Independtly of the FCGIIIA-48L/R/H Phenotype. Aug. 1997. Blood, vol. 90, No. 3 pp. 1109-1114.
Colombat, Phillippe et al. Rituximab (anti CD20 monoclonal antibody) as single first line therapy for patients with follicular lymphoma with a low tumore burden; clinical and molecular evaluation. Jan. 2001. Blood, vol. 97, No. 1 pp. 101-106.
Farag, Sherif et al. FCGRIIIA and FCGRIIA polymorhisms do not predict response to rituximab in B-cell chronic lymphocytic leukemia. Feb. 2004. Blood, vol. 103, No. 4 pp. 1472-1474.
Syvanen, Ann Christine. Accessing genetic variation: genotyping single nucleotide polymoprhisms. 2001. Nature Reviews Genetics. vol. 2, pp. 930-942.
Maloney, David et al. IDEC-C2B8 9rituximab) anti CD20 monoclonal antibody therapy in patients with relapsed low grade non Hodgkins lymphoma. 1997. Blood vol. 90 pp. 2188-2195.
Shevchenko, Andrej et al. Mass spectrometric sequencing of proteins from silver stained polyacrylamide gels. 1996. Analytical Chemistry. vol. 68 pp. 850-858.
Wu, Jianming et al. A novel polymoprhism of FCGR3a (CD16) alters receptor function and predisposes to autoimmune disease. 1997. Journal of Clinical Investigations. vol. 100 pgaes 1059-1070.
GenBank Accession NM—000569 GI: 10835136 Oct. 17, 2000.
Colombat, P., et al. “Rituximab (anti-CD-20 monoclonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden: clinical and molecular evaluation”Blood(2001), 97(1)101-106.
Caltz, R., et al. “Association of Fcγ RIIIA-158F allele with rheumatoid arthritis” Arthritis and Rheumatism, Lippincott, Philadephia, PA, U.S., vol. 42, Sep. 1999, p. S245.
Leppers-Van E Straat, F.G.J., et al. “A novel PCR-based method for direct Fcβ receptor IIIa (CD16) allotyping”J. Immunol. Methods(2000), 242:127-132.
Cartron, G et al. (2002) “Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcγRIIIa gene” Blood 99(3):754-758.
Cartron, G. et al. (2004) “From the bench to the bedside: Ways to improve rituximab efficiency”BloodFirst Edition Paper, prepublished on-line Jun. 29, 2004; DOI 10.1182/blood-2004-03-1110.
Cheson, B.D. et al. (1999) “Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas”J. Clin. Oncol. 17(4):1244-1257.
Clynes, R. et al. (1998) “Fc receptors are required in passive and active immunity to melanoma”Proc. Natl. Acad. Sci. U.S.A.95:652-656.
Clynes, R.A. et al. (2000) “Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets”Nature Medicine6(4):443-446.
Farag, S.S. et al. (2004) Fcγ and FcγRIIa polymorphisms do not predict response to rituximab inB-cell chronic lymphocytic leukemia.Blood103(4):1472-1474.
de Haas, M. et al.(1996) “A triallelic Fcγreceptor type IIIA polymorphism influences the binding of human IgG by NK cell Fcγ RIIIa”J. Immunol. 156:3948-3955.
Jiang, X.M. et al. (1996) “Rapid detection of the FcγRIIA-H/R 131 ligand-binding polymorphism using an allele-specific restriction enzyme digestion (ASRED)”J. Immunol Methods199:55-59.
Kaplan, E. and P. Meier. (1958) “Nonparametric estimation from incomplete observations”J. Am. Stat. Assoc. 53:457-481.
Kennedy, A.D. et al. (2004) “Rituximab infusion promotes rapid complement depletion and acute CD20 loss in chronic lymphocytic leukemia”J. Immunol. 172:3280-3288.
Koene, H.R. et al. (1997) “FcγRIIIa-158V/F polymorphism influences the binding of IgG by natural killer cell FcγRIIIa, independently of the FcγRIIIa-48L/R/H phenotype”Blood90(3):1109-1114.
Lehrnbecher, T. et al. (1999) “Variant genotypes of the low-affinity Fcγ receptors in two control populations and a review of low-affinity Fcγ receptor polymorphisms in control and disease populations”Blood94(12):4220-4232.
Lin, T.S. et al. (2004) “FCGR3A and FCGR3A polymorphisms may not correlate with response to alemtuzumab (Campath-1H) in chronic lymphocytic leukemia (CLL)”BloodFirst Edition Paper, prepublished on-line Jun. 24, 2004; DOI 10.1182/blood-2004-02-0651.
Peltz, G.A. et al. (1989) Human FcγRIII: Cloning, expression, and identification of the chromosomal locus of two Fc receptors for IgG.Proc. Natl. Acad. Sci. U.S.A. 86:1013-1017.
Ravetch, J.V. (2002) “A full complement of receptors n immune complex disease”J. Clin Invest. 110:1759-1761.
Schnackenberg, L. et al. (1997) Linkage disequilibria between Duffy blood groups, Fcγ IIa and FcγIIIb allotypes.Exp. Clin Immunogenet. 14:235-242.
Shields, R. et al. (2001) “High resolution mapping of the binding site on human IgG1 for FcγRI, FcγRII, FcγRIII, and FcRn and design of IgG1 variants with improved binding to the Fcγ R*”J. Biol. Chem. 276(9):6591-6604.
Vance, B. et al. (1993) “Binding of monomeric human IgG defines an expression polymorphism of FCγRIII on large granular lymphocyte
atural killer cells”J. Immunol. 151:6429-6439.
Wu, J. et al. (1997) “A novel polymorphism of FCγRIIIa (CD16) alters receptor function and predisposes to autoimmune disease”J. Clin. Invest. 100:1059-1070.
Kumpel, B.M. et al. “Clearance of red cells by monoclonal IgG3 anti-D in vivo is effected by the VF polymorphism of FcγRIIIa (CD16)”Clin. Exp. Immunol., 2003, vol. 132, pp. 81-86.
Preithner, S. et al. “High concentrations of therapeutic IgG antibodies are needed to compensate for inhibition of antibody-dependent cellular cytotoxicity by excess endogenous immunoglobulin G”Mol. Immunol., Mar. 2006, vol. 43, No. 8, pp. 1183-1193.
Anderson et al. (1997) “Targeting Cytotoxic Immunotherapy”, Biochem. Soc. Trans. 25: 705-708.
Aster RH, (2005) “Drug-induced immune cytopenias” Toxicology, 209:149-153.
Bowles and Weiner, (2005) “CD16 polymorphisms and NK activation induced by monoclonal antibody-coated target cells”, J. Immunol. Methods 304: 88-99.
Carcao, M. et al. (2003) “Fcγ Receptor IIa and IIIa polymorphisms in childhood immune thrombocytopenic purpura”, British Journal of Haematology, pp. 135-141, vol. 120, No. 1.
Carlotti et al. (2007) “FcγRIIIA and FcγRIIA polymorphisms do not predict clinical outcome of follicular non-Hodgkin's lymphoma patients treated with sequential CHOP and rituximab”, Haematologica 92: 1127-1130.
Citizen Petition of Genentech (2008) “Require all in Vitro Diagnostic Tests Intended for use in Drug or Biologic Therapeutic Decision Making be Held to the Same Scientific and Regulatory Standards”, Docket FDA-2008-P-0638.
Dall'Ozzo et al., (2003) “Rapid single-step FCGR3A genotyping based on SYB

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Methods and compositions to evaluate antibody treatment... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Methods and compositions to evaluate antibody treatment..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods and compositions to evaluate antibody treatment... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-4231989

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.