The discovery of rituxan

The Process of New Drug Discovery and Development, Second Edition

Volumn , Issue , 2006, Pages 565-584

  Reff, Mitchell E ^a  

^a BIOGEN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84903646156     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (61)

1. Kohler, G. and Milstein, C., Continuous cultures of fused cells secreting antibody of predefined specificity, Nature, 256, 495-497, 1975.
2. Nadler, L.M., Stashenko, P., Hardy, R., Kaplan, W.D., Button, L.N., Kufe, D.W., Antman, K.H., and Schlossman, S.F., Serotherapy of a patient with a monoclonal antibody directed against a human lymphoma-associated antigen, Cancer Res, 40, 3147-3154, 1980.
3. Morrison, S.L., Johnson, M.J., Herzenberg, L.A., and Oi, V.T., Chimeric human antibody molecules:mouse antigen-binding domains with human constant region domains, Immunology, 81, 6851-6855, 1984.
4. Newman, R., Alberts, J., Anderson, D., Carner, K., Heard, C., Norton, F., Raab, R., Reff, M., Shuey, S., and Hanna, N., “Primitization” of recombinant antibodies for immunotherapy of human diseases: a macaque/human chimeric antibody against human CD4, Biotechnology, 10, 1455-1460, 1992.
5. Weidle, U.H., Borgya, A., Mattes, R., Lenz, H., and Buckel, P., Reconstitution of functionally active antibody directed against creatine kinase from separately expressed heavy and light chains in non-lymphoid cells, Gene, 51, 21-29, 1987.
6. Cattaneo, A. and Neuberger, M.S., Polymeric immunoglobulin M is secreted by transfectants of non-lymphoid cells in the absence of immunoglobulin J chain, EMBO J, 6, 2753-2758, 1987.
7. de Waele, P., Feys, V., van de Voorde, A., Molemans, F., and Fiers, W., Expression in non-lymphoid cells of mouse recombinant immunoglobulin directed against the tumor marker human placental alkaline phosphatase, Eur. J. Biochem., 176, 287-295, 1988.
8. Vandamme, A.M., Bulens, F., Bernar, H., Nelles, L., Lijnen, R.H., and Collen, D., Construction and characterization of recombinant murine monoclonal antibody directed against human fibrin fragment-D dimer, Eur. J. Biochem, 192, 767-775, 1990.
9. Wood, C.R., Dorner, A.J., Morris, G.E., Alderman, E.M., Wilson, D., O’Hara, R.M., and Kaufman, R.J., High level synthesis of immunoglobulins in Chinese hamster ovary cells, J. Immunol, 145, 3011-3016, 1990.
10. Sheeley, D.M., Merrill, B.M., and Taylor, L.C.E., Characterization of monoclonal antibody glycosylation:comparison of expression systems and identification of terminal α-linked galactose, Anal. Biochem., 247, 102-110, 1997.
11. Lifely, M.R., Hale, C., Boyce, S., Keen, M.J., and Phillips, J., Glycosylation and biological activity of CAMPATH-1H expressed in different cell lines and grown under different culture conditions, Glycobiology, 5, 813-822, 1995.
12. Reff, M.E., Adams, K., and Anderson, D.R., Comparison of recombinant chimeric immunoglobulin secreted and purified from Chinese hamster ovary (CHO) and murine SP2/0 myeloma cells, in American Chemical Society Conference: Recovery of Biological Products VII, American Chemical Society, San Diego, CA, September 25-30, 1994, p. 26.
13. Reff, M.E., Carner, K., Chambers, K.S., Chinn, P.C., Leonard, J.E., Raab, R., Newman, R.A., Hanna, N., and Anderson, D.R., Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20, Blood, 83, 435-445, 1994.
14. Liu, A.Y., Robinson, R.R., Murray, E.D., Jr., Ledbetter, J.A., Hellstrom, I., and Hellstrom, K.E., Production of a mouse-human chimeric monoclonal antibody to CD20 with potent Fcdependent biologic activity, J. Immunol, 139, 3521-3526, 1987.
15. Urlaub, G., Mitchell, P.J., Kas, E., Chasin, L.A., Funanage, V.L., Myoda, T.T., and Hamlin, J., Effect of gamma rays at the dihydrofolate reductase locus: deletions and inversions, Somat. Cell Mol. Genet, 12, 555-556, 1986.
16. Davies, J. and Reff, M., Chromosome localization and gene-copy-number quantification of three random integrations in Chinese-hamster ovary cells and their amplified cell lines using fluorescence in situ hybridization, Biotechnol. Appl. Biochem, 33, 99-105, 2001.
17. Ringold, G., Dieckmann, B., and Lee, F., Co-expression and amplification of dihydrofolate reductase cDNA and the Escherichia coli XGPRT gene in Chinese hamster ovary cells, J. Mol. Appl. Genet, 1, 165-175, 1981.
18. Davies, J., Jiang, L., Pan, L.-Z., LaBarre, M., Anderson, D., and Reff, M., Expression of GnTIII in a recombinant anti-CD20 CHO production cell line: expression of antibodies with altered glycoforms leads to an increase in ADCC through higher affinity for Fc_RIII, Biotechnol. Bioeng, 74, 288-294, 2001.
19. Miller, R.A., Maloney, D.G., Warnke, R., and Levy, R., Treatment of B-Cell lymphoma with monoclonal idiotype antibody, N. Engl. J. Med, 306, 517-522, 1982.
20. Stashenko, P., Nadler, L.M., Hardy, R., and Schlossman, S.F., Characterization of a human B lymphocyte-specific antigen, J. Immunol, 125, 1678-1685, 1980.
21. Manshouri, T., Do, K.A., Wang, X., Giles, F.J., O’Brien, S.M., Saffer, H., Thomas, D., Jilani, I., Kantarjian, H.M., Keating, M.J., and Albitar, M., Circulating CD20 is detectable in the plasma of patients with chronic lymphocytic leukemia and is of prognostic significance, Blood, 101, 2507-2513, 2003.
22. Jilani, I., O’Brien, S., Manshuri, T., Thomas, D.A., Thomazy, V.A., Imam, M., Naeem, S., Verstovsek, S., Kantarjian, H., Giles, F., Keating, M., and Albitar, M., Transient down-modulation of CD20 by rituximab in patients with chronic lymphocytic leukemia, Blood, 102, 3514-3520, 2003.
23. O’Keefe, T.L., Williams, G.T., Davies, S.L., and Neuberger, M.S., Mice carrying a CD20 gene disruption, Immunogenetics, 48, 125-132, 1998.
24. Shan, D., Ledbetter, J.A., and Press, O.W., Signaling events involved in anti-CD20-induced apoptosis of malignant human B cells, Cancer Immunol. Immunother, 48, 673-683, 2000.
25. Demidem, A., Lam, T., Alas, S., Hariharan, K., Hanna, N., and Bonavida, B., Chimeric anti-CD20 (IDEC-C2B8) monoclonal antibody sensitizes a B cell lymphoma cell line to cell killing by cytotoxic drugs, Cancer Biother. Radiopharm, 12, 177-186, 1997.
26. Polyak, M. and Deans, J., Alanine-170 and proline-172 are critical determinants for extracellular CD20 epitopes: heterogeneity in the fine specificity of CD20 monoclonal antibodies is defined by additional requirements imposed by both amino acid sequence and quaternary structure, Blood, 99, 3256-3262, 2002.
27. Chan, H.T., Hughes, D., French, R.R., Tutt, A.L., Walshe, C.A., Teeling, J.L., Glennie, M.J., and Cragg, M.S., CD20-induced lymphoma cell death is independent of both caspases and its redistribution into triton X-100 insoluble membrane rafts, Cancer Res, 63, 5480-5489, 2003.
28. Cragg, M.S., Morgan, S.M., Chan, H.T., Morgan, B.P., Filatov, A.V., Johnson, P.W., French, R.R., and Glennie, M.J., Complement-mediated lysis by anti-CD20 MAb correlates with segregation into lipid rafts, Blood, 101, 1045-1052, 2003.
29. Cartron, G., Dacheux, L., Salles, G., Solal-Celigny, P., Bardos, P., Colombat, P., and Watier, H., Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor Fc_RIIIa gene, Blood, 99, 754-758, 2002.
30. Clynes, R.A., Towers, T.L., Presta, L.G., and Ravetch, J.V., Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets, Nat. Med, 6, 443-446, 2000.
31. Harjunpaa, A., Junnikkala, S., and Meri, S., Rituximab (anti-CD20) therapy of B-cell lymphomas:direct complement killing is superior to cellular effector mechanisms, Scand. J. Immunol, 51, 635-641, 2000.
32. Treon, S., Mitsiades, C., Mitsiades, N., Young, G., Doss, D., Schlossman, R., and Anderson, K., Tumor cell expression of CD59 is associated with resistance to CD20 serotherapy in patients with B-Cell malignancies, J. Immunother, 24, 263-271, 2001.
33. Weng, W.K. and Levy, R., Expression of complement inhibitors CD46, CD55, and CD59 on tumor cells does not predict clinical outcome after rituximab treatment in follicular non-Hodgkin lymphoma, Blood, 98, 1352-1357, 2001.
34. Byrd, J., Kitada, S., Flinn, I., Aron, J., Pearson, M., Lucas, D., and Reed, J.C., The mechanism of tumor cell clearance by rituximab leukemia: evidence of caspase activation and apoptosis induction, Blood, 99, 1038-1043, 2002.
35. Anderson, D.R., Grillo-Lopez, A., Varns, C., Chambers, K.S., and Nanna, N., Targeting cytotoxic immunotherapy, Biochem. Soc. Trans, 25, 705-708, 1997.
36. Grillo-Lopez, A., White, C., Dallaire, B., Varns, C., Shen, C., Wei, A., Leonard, J., McClure, A., Weaver, R., Cairelli, S., and Rosenberg, J., Rituximab: an insider’s historical perspective, Semin. Oncol, 27, 9-16, 2000.
37. Czuczman, M., Grillo-Lopez, A.J., White, C.A., Saleh, M., Gordon, L., LoBuglio, A.F., Jonas, C., Dallaire, B., and Varns, C., IDEC-C2B8/CHOP chemoimmunotherapy in patients with low grade lymphoma: clinical and BCL-2 (PCR) results, J. Mol. Med, 75, B231, 1997.
38. Grillo-Lopez, A.J., White, C.A., Varns, C., Shen, D., Wei, A., McClure, A., and Dallaire, B.K., Overview of the clinical development of Rituximab: first monoclonal antibody approved for the treatment of Lymphoma, Semin. Oncol., 26(suppl. 14), 66-73, 1999.
39. Maloney, D.G., Grillo-Lopez, A.J., White, C.A., Bodkin, D., Schilder, R.J., Neidhart, J.A., Janakiraman, N., Foon, K.A., Liles, T.-M., Dallaire, B.K., Wey, K., Royston, I., Davis, T., and Levy, R., IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin’s lymphoma, Blood, 90, 2188-2195, 1997.
40. Grillo-Lopez, A., White, C., Dallaire, B., Varns, C., Shen, C., Wei, A., Leonard, J., McClure, A., Weaver, R., Cairelli, S., and Rosenberg, J., Rituximab: the first monoclonal antibody approved for the treatment of lymphoma, Curr. Pharm. Biotechnol, 1, 1-9, 2000.
41. Manz, R.A., Thiel, A., and Radbruch, A., Lifetime of plasma cells in the bone marrow, Nature, 388, 133-134, 1997.
42. Foran, J., Norton, A.J., Micallef, I., Taussig, D., Amess, J., Rohatiner, A., and Lister, T.A., Loss of CD20 expression following treatment with Rituximab (chimeric monoclonal anti-CD20): a retrospective cohort analysis, Br. J. Haematol, 114, 881-883, 2001.
43. Hainsworth, J.D., Burris III, H.A., Morrissey, L.H., Litchy, S., Scullin, D.C., Jr., Bearden III, J.D., Richards, P., and Greco, F.A., Rituximab monoclonal antibody as initial systemic therapy for patients with low-grade non-Hodgkin’s lymphoma, Blood, 95, 3052-3056, 2000.
44. Hainsworth, J., Rituximab as first-line systemic therapy for patients with low-grade lymphoma, Semin. Oncol, 27, 25-29, 2000.
45. Hainsworth, J., Rituximab as first-line and maintenance therapy for patients with indolent non-Hodgkin’s lymphoma: interim follow-up of a multicenter phase II trial, Semin. Oncol, 29(Suppl. 2), 25-29, 2002.
46. Hainsworth, J.D., First-line and maintenance treatment with rituximab for patients with indolent non-Hodgkin’s lymphoma, Semin. Oncol, 30(Suppl. 2), 9-15, 2003.
47. Hainsworth, J.D., Litchy, S., Barton, J.H., Houston, G.A., Hermann, R.C., Bradof, J.E., and Greco, F.A., Single-agent rituximab as first-line and maintenance treatment for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: a phase II trial of the Minnie Pearl Cancer Research Network, J. Clin. Oncol, 21, 1746-2751, 2003.
48. Keating, M. and O’Brien, S., High-dose rituximab therapy in chronic lymphocytic leukemia, Semin. Oncol, 27, 86-90, 2000.
49. Lin, T.S., Lucas, M.S., and Byrd, J.C., Rituximab in B-cell chronic lymphocytic leukemia, Semin. Oncol, 30, 483-492, 2003.
50. Czuczman, M., Fallon, A., Mohr, A., Stewart, C., Bernstein, Z., McCarthy, P., Skipper, M., Brown, K., Miller, K., Wentling, D., Klippenstein, D., Loud, P., Rock, M., Benyunes, M., Grillo-Lopez, A., and Bernstein, S., Rituximab in combination with CHOP or fludarabine in low-grade lymphoma, Semin. Oncol, 29(Suppl. 2), 36-40, 2002.
51. Hiddemann, W., Dreyling, M., and Unterhalt, M., Rituximab plus chemotherapy in follicular and mantle cell lymphomas, Semin. Oncol, 30(Suppl. 2), 16-20, 2003.
52. Van Oers, M.H., Hagenbeek, A., Van Glabbeke, M., and Teodorovic, I., Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin’s lymphoma: a phase III randomized clinical trial -Intergroup Collaborative Study, Ann. Hematol, 81, 553-557, 2002.
53. Coiffier, B., Rituximab in combination with CHOP improves survival in elderly patients with aggressive non-Hodgkin’s lymphoma, Semin. Oncol, 29, 18-22, 2002.
54. Coiffier, B., Immunochemotherapy: the new standard in aggressive non-Hodgkin’s lymphoma in the elderly, Semin. Oncol, 30(Suppl. 2), 21-27, 2003.
55. Protheroe, A., Edwards, J.C.W., Simmons, A., Maclennan, K., and Selby, P., Remission of inflammatory arthropathy in association with anti-CD20 therapy for non-Hodgkin’s lymphoma, Rheumatology (Oxford), 38, 1150-1152, 1999.
56. Edwards, J.C.W. and Cambridge, G., Sustained improvement in rheumatoid arthritis following a protocol designed to deplete B lymphocytes, Rheumatology (Oxford), 40, 205-211, 2001.
57. Leandro, M.J., Edwards, J.C., and Cambridge, G., Clinical outcome in 22 patients with rheumatoid arthritis treated with B lymphocyte depletion, Ann. Rheum. Dis, 61, 883-888, 2002.
58. Cambridge, G., Leandro, M.J., Edwards, J.C., Ehrenstein, M.R., Salden, M., Bodman-Smith, M., and Webster, A.D., Serologic changes following B lymphocyte depletion therapy for rheumatoid arthritis, Arthritis Rheum, 48, 2146-2154, 2003.
59. Zaja, F., Iacona, I., Masolini, P., Russo, D., Sperotto, A., Prosdocimo, S., Patriarca, F., de Vita, S., Regazzi, M., Baccarani, M., and Fanin, R., B-cell depletion with rituximab as treatment for immune hemolytic anemia and chronic thrombocytopenia, Haematologica, 87, 189-195, 2002.
60. Zaja, F., Vianelli, N., Sperotto, A., De Vita, S., Iacona, I., Zaccaria, A., Masolini, P., Tomadini, V., Tani, M., Molinari, A.L., Baccarani, M., and Fanin, R., B-cell compartment as the selective target for the treatment of immune thrombocytopenias, Haematologica, 88, 538-546, 2003.
61. Eisenberg, R., SLE - Rituximab in lupus, Arthritis Res. Ther, 5, 157-159, 2003.