CD20-directed small modular immunopharmaceutical, TRU-015, depletes normal and malignant B cells

Clinical Cancer Research

Volumn 15, Issue 8, 2009, Pages 2739-2746

  Hayden Ledbetter, Martha S ^a   Cerveny, Chuck G ^a   Espling, Erik ^a   Brady, William A ^a   Grosmaire, Laura S ^a   Tan, Philip ^a   Bader, Robert ^a   Slater, Sonya ^a   Nilsson, Christy A ^a   Barone, Dauphine S ^a   Simon, Alexander ^a   Bradley, Cheryl ^a   Thompson, Peter A ^a   Wahl, Alan F ^a   Ledbetter, Jeffrey A ^a  

^a Trubion Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; RITUXIMAB; TRU 015; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTINEOPLASTIC ACTIVITY; ARTICLE; B CELL LYMPHOMA; B LYMPHOCYTE; CONTROLLED STUDY; CYTOTOXICITY; FEMALE; GEL PERMEATION CHROMATOGRAPHY; GROWTH DISORDER; MOUSE; NONHUMAN; PRIORITY JOURNAL; SIGNAL TRANSDUCTION;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODY-DEPENDENT CELL CYTOTOXICITY; ANTIGENS, CD20; B-LYMPHOCYTES; CELL LINE, TUMOR; FEMALE; HUMANS; LYMPHOCYTE DEPLETION; LYMPHOMA, B-CELL; MACACA FASCICULARIS; MALE; MICE; MICE, NUDE; RECOMBINANT FUSION PROTEINS; RECOMBINANT PROTEINS; TRANSPLANTATION, HETEROLOGOUS;

EID: 65249090847     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-08-1694     Document Type: Article

References (44)

1. Liu AY, Robinson RR, Murray ED Jr, Ledbetter JA, Hellstrom I, Hellstrom KE. Production of a mouse- human chimeric monoclonal antibody to CD20 with potent Fc-dependent biologic activity. J Immunol 1987;139:3521 -6.
2. Press OW,Appelbaum F, LedbetterJA,et al. Monoclonal antibody 1F5 (anti-CD20) serotherapy of human B cell lymphomas. Blood 1987;69:584-91.
3. Tedder TF, Boyd AW, Freedman AS, Nadler LM, Schlossman SF. The Bcell surface molecule B1 is functionally linked with Bcell activation and differentiation. J Immunol 1985;135:973-9.
4. Tedder TF, Forsgren A, Boyd AW, Nadler LM, Schlossman SF. Antibodies reactive with the B1 molecule inhibit cell cycle progression but not activation of human Blymphocytes. Eur J Immunol 1986; 16: 881 -7.
5. Clark EA, Shu G, Ledbetter JA. Role of the Bp35 cell surface polypeptide in human B-cell activation. Proc Natl Acad Sci U S A 1985;82:1766-70.
6. Clark EA, Ledbetter JA. Activation of human Bcells mediated through two distinct cell surface differentiation antigens, Bp35 and Bp50. Proc Natl Acad Sci USA1986;83:4494-8.
7. Demidem A, Lam T, Alas S, Hariharan K, Hanna N, Bonavida B. Chimeric anti-CD20 (IDEC-C2B8) monoclonal antibody sensitizes a Bcell lymphoma cell line to cell killing by cytotoxic drugs. Cancer Bio- ther Radiopharm 1997;12:177-86.
8. Shan D, Ledbetter JA, Press OW. Apoptosis of malignant human Bcells by ligation of CD20 with monoclonal antibodies. Blood 1998;91:1644-52.
9. Shan D, Ledbetter JA, Press OW. Signaling events involved in anti-CD20-induced apoptosis of malignant human Bcells. Cancer Immunol Immunother 2000; 48:673-83.
10. Emmanouilides C, Jazirehi AR, Bonavida B. Ritux- imab-mediated sensitization of B-non-Hodgkin's lymphoma (NHL) to cytotoxicity induced by paclitaxel, gemcitabine, and vinorelbine. Cancer Biother Radiopharm 2002;17:621-30.
11. Jazirehi AR,Gan XH,De Vos S, Emmanouilides C, Bonavida B. Rituximab (anti-CD20) selectively modifies Bcl-xL and apoptosis protease activating factor-1 (Apaf-1) expression and sensitizes human non-Hodgkin's lymphoma Bcell lines to paclitaxelinduced apoptosis. Mol Cancer Ther 2003;2: 1183-93.
12. Czuczman MS, Weaver MS, Alkuzweny B, et al. Prolonged clinical and molecular remission in patients with low-grade or follicular non-Hodgkin's lymphoma treated with rituximab plus CHOP chemotherapy: 9-year follow-up. J Clin Oncol 2004;22:4711 -6.
13. Maloney DG, Grillo-Lopez AJ, White CA, et al. IDEC-C2B8 (rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 1997;90:2188-95.
14. McLaughlin P, Grillo-Lopez AJ, Link BK, 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 1998;16:2825-33.
15. Vose JM, Link BK, Grossbard ML, et al. Phase II study of rituximab in combination with chop chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma. J Clin Oncol 2001;19:389-97.
16. Coiffier B. Rituximab in combination with CHOP improves survival in elderly patients with aggressive non-Hodgkin's lymphoma. Semin Oncol 2002;29: 18-22.
17. Coiffier B. Effective immunochemotherapy for aggressive non-Hodgkin's lymphoma. Semin Oncol 2004;31:7-11.
18. Marcus R, Imrie K, Belch A, et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood 2005;105:1417-23.
19. Hiddemann W, Kneba M, Dreyling M, et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood 2005;106:3725-32.
20. Herold M, Haas A, Srock S, et al. Rituximab added to first-line mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma: an East German Study Group Hematology and Oncology Study. J Clin Oncol 2007;25:1986-92.
21. Sebban C, Brice P, Delarue R, et al. Impact of rituximab and/or high-dose therapy with autotransplant at time of relapse in patients with follicular lymphoma: a GELA study. J Clin Oncol 2008;26: 3614-20.
22. Press OW, Eary JF, Appelbaum FR, et al. Phase II trial of131I-B1 (anti-CD20) antibody therapy with autologous stem cell transplantation for relapsed Bcell lymphomas. Lancet 1995;346:336-40.
23. Press OW, EaryJF, GooleyT, et al. A phase I/II trial of iodine-131-tositumomab (anti-CD20), etoposide, cyclophosphamide, and autologous stem cell transplantation for relapsed B-cell lymphomas. Blood 2000;96: 2934-42.
24. Oriuchi N, Higuchi T, Hanaoka H, Iida Y, Endo K. Current status of cancer therapy with radiolabeled monoclonal antibody. Ann Nucl Med 2005;19: 355-65.
25. Denardo GL. Treatment of non-Hodgkin's lymphoma (NHL) with radiolabeled antibodies (mAbs). Semin Nucl Med 2005;35:202-11.
26. Presta LG, ShieldsRL, Namenuk AK, Hong K, Meng YG. Engineering therapeutic antibodies for improved function. Biochem SocTrans 2002;30:487-90.
27. Miller K, Meng G, Liu J, et al. Design, construction, and in vitroanalyses of multivalent antibodies. J Immunol 2003;170:4854-61.
28. Shinkawa T, Nakamura K, Yamane N, et al. The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity. J Biol Chem 2003;278:3466-73.
29. Presta LG. Selection, design, and engineering of therapeutic antibodies. J Allergy Clin Immunol 2005; 116:731 -6.
30. Teeling JL, Mackus WJ,Wiegman LJ, et al. The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol 2006;177:362-71.
31. van der Kolk LE, Grillo-Lopez AJ, Baars JW, Hack CE, van Oers MH. Complement activation plays a key role in the side-effects of rituximab treatment. Br J Haematol 2001;115:807-11.
32. Gilliland LK, Norris NA, Marquardt H, et al. Rapid and reliable cloning of antibody variable regions and generation of recombinant single chain antibody fragments. Tissue Antigens 1996;47:1 -20.
33. Hayden MS, Linsley PS, Gayle MA, et al. Singlechain mono- and bispecific antibody derivatives with novel biological properties and antitumour activity from a COS cell transient expression system. Ther Immunol 1994;1:3-15.
34. Boussif O, Lezoualc'h F, Zanta MA, et al. A versatile vector for gene and oligonucleotide transfer into cells in culture and in vivo: polyethylenimine. Proc Natl Acad Sci U S A1995;92:7297-301.
35. Pollard H, Remy JS, Loussouarn G, Demolombe S, Behr JP, Escande D. Polyethylenimine but not cationic lipids promotes transgene delivery to the nucleus in mammalian cells. J Biol Chem 1998;273:7507-11.
36. Einfeld DA, Brown JP, Valentine MA, Clark EA, Ledbetter JA. Molecular cloning of the human B cell CD20 receptor predicts a hydrophobic protein with multiple transmembrane domains. EMBO 1988;J7: 711 -7.
37. KennedyAD, Beum PV, Solga MD, et al. Rituximab infusion promotes rapid complement depletion and acute CD20 loss in chronic lymphocytic leukemia. J Immunol 2004;172:3280-8.
38. Jain RK. Physiological barriers to delivery of monoclonal antibodies and other macromolecules in tumors. Cancer Res 1990;50:814-9s.
39. Adams GP, Schier R, McCall AM, et al. High affinity restricts the localization and tumor penetration of single-chain Fv antibody molecules. Cancer Res 2001; 61:4750-5.
40. Weng WK, Levy R. Two immunoglobulin G fragment C receptor polymorphisms independently predict response to rituximab in patients with follicular lymphoma.J Clin Oncol2003;21:3940-7.
41. Di Gaetano N, Cittera E, Nota R, et al. Complement activation determines the therapeutic activity of rituximab in vivo.J Immunol 2003;171:1581 -7.
42. Harjunpaa A, Wiklund T,Collan J,et al. Complement activation in circulation and central nervous system after rituximab (anti-CD20) treatment of B-cell lymphoma. Leuk Lymphoma 2001;42:731 -8.
43. Burge D, Shu C, Martin RW, Littlejohn TW, et al. TRU-015, a small modular immunopharmaceutical (SMIPTM) drug candidate directed against CD20, demonstrates clinical improvement in subjects with rheumatoid arthritis. Arthritis Rheum 2006;54:S230.
44. Burge D, Martin R, Wallace D, et al. Safety and pharmacodynamics of repeat administration of TRU- 015, a CD20-directed SMIP therapeutic, in subjects with rheumatoid arthritis. Arthritis Rheum 2007; 56:S168.