A whole blood in vitro cytokine release assay with aqueous monoclonal antibody presentation for the prediction of therapeutic protein induced cytokine release syndrome in humans

Cytokine

Volumn 60, Issue 3, 2012, Pages 828-837

  Wolf, Babette ^a   Morgan, Hannah ^a   Krieg, Jennifer ^a   Gani, Zaahira ^a   Milicov, Adriana ^a   Warncke, Max ^a   Brennan, Frank ^a   Jones, Stewart ^a   Sims, Jennifer ^a   Kiessling, Andrea ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Cytokine release; Monoclonal antibody; TGN1412; Whole blood

Indexed keywords

CYTOKINE; GAMMA INTERFERON; INTERLEUKIN 10; INTERLEUKIN 2; INTERLEUKIN 4; INTERLEUKIN 6; INTERLEUKIN 8; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY ANC28.1; MONOCLONAL ANTIBODY TGN1412L; NATALIZUMAB; ORTHOCLONE; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ARTICLE; CELL ISOLATION; CELL STRAIN HEK293; CONTROLLED STUDY; CYTOKINE RELEASE; CYTOKINE RELEASE SYNDROME; GEL PERMEATION CHROMATOGRAPHY; HUMAN; HUMAN CELL; IMMUNOASSAY; IN VITRO CYTOKINE RELEASE ASSAY; NUCLEOTIDE SEQUENCE; PERIPHERAL BLOOD MONONUCLEAR CELL; PLASMA; PREDICTION; PRIORITY JOURNAL; RISK ASSESSMENT; SUPERNATANT;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD28; CELLS, CULTURED; CYTOKINES; HUMANS; IMMUNE SYSTEM DISEASES; LEUKOCYTES, MONONUCLEAR; RISK ASSESSMENT;

EID: 84867988873     PISSN: 10434666     EISSN: 10960023     Source Type: Journal    
DOI: 10.1016/j.cyto.2012.08.018     Document Type: Article

References (23)

1. Genovese M.C. Biologic therapies in clinical development for the treatment of rheumatoid arthritis. J Clin Rheumatol 2005, 11:45-54.
2. Menter A. The status of biologic therapies in the treatment of moderate to severe psoriasis. Cutis 2009, 84:14-24.
3. Rommer P.S., Strüve O., Goertsches R., Mix E., Zettl U.K. Monoclonal antibodies in the therapy of multiple sclerosis: an overview. J Neurol 2008, 255:28-35.
4. Melero I., Hervas-Stubbs S., Glennie M., Pardoll D.M., Chen L. Immunostimmulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer 2007, 7:95-101.
5. Brennan F.R., Morton L.D., Spindeldreher S., Kiessling A., Allenspach R., Hey A., et al. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies. MAbs 2010, 2:233-255.
6. Suntharalingam G., Perry M.R., Ward S., Brett S.J., Castello-Cortes A., Brunner M.D., et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal mAb TGN1412. New Engl J Med 2006, 355:1018-1028.
7. Vidal J.M., Kawabata T.T., Thorpe R., Silva-Lima B., Cederbrant K., Poole S., et al. In vitro cytokine release assays for predicting cytokine release syndrome: the current state-of-the-science. Report of a European medicines agency workshop. Cytokine 2010, 51:213-215.
8. Findlay L., Eastwood D., Ball C., Robinson C.J., Bird C., Wadhwa M., et al. Comparison of novel methods for predicting the risk of pro-inflammatory clinical infusion reactions during monoclonal antibody therapy. J Immunol Methods 2011, 371:134-142.
9. Hellwig K., Schimrigk S., Fischer M., Haghikia A., Müller T., Chan A., et al. Allergic and nonallergic delayed infusion reactions during natalizumab therapy. Arch Neurol 2008, 65:656-658.
10. Camacho-Halili M., George R., Gottesman M., Davis-Lorton M. An approach to natalizumab hypersensitivity: a case series of induction of tolerance. Mult Scler 2011, 17:250-253.
11. Stebbings R., Findlay L., Edwards C., Eastwood D., Bird C., North D., et al. Cytokine storm in the phase I trial of monoclonal mAb TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol 2007, 179:3325-3331.
12. Findlay L., Eastwood D., Stebbings R., Sharp G., Mistry Y., Ball C., et al. Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412. J Immunol Methods 2010, 352:1-12.
13. Wing M. Monoclonal mAb first dose cytokine release syndromes-mechanisms and prediction. J Immunotoxicol 2008, 5:11-15.
14. Carpenter P.A., Pavlovic S., Tso J.Y., Press O.W., Gooley T., Yu X.Z., et al. Non-Fc receptor-binding humanized anti-CD3 antibodies induce apoptosis of activated human T cells. J Immunol 2000, 165:6205-6213.
15. Eastwood D., Findlay L., Poole S., Bird C., Wadhwa M., Moore M., et al. Monoclonal mAb TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells. Br J Pharmacol 2010, 161:512-526.
16. Römer P.S., Berr S., Avota E., Na S.Y., Battaglia M., ten Berge I., et al. Preculture of PBMCs at high cell density increases sensitivity of T-cell responses, revealing cytokine release by CD28 superagonist TGN1412. Blood 2011, 118:6772-6782.
17. Muller P.Y., Milton M., Lloyd P., Sims J., Brennan F.R. The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies. Curr Opin Biotechnol 2009, 20:722-729.
18. Langezaal I., Hoffmann S., Hartung T., Coecke S. Evaluation and prevalidation of an immunotoxicity test based on human whole-blood cytokine release. Altern Lab Anim 2002, 30:581-595.
19. Walker M.R., Makropoulos D.A., Achuthanandam R., van Arsdell S., Bugelski P.J. Development of a human whole blood assay for prediction of cytokine release similar to anti-CD28 superagonists using multiplex cytokine and hierarchical cluster analysis. Int Immunopharmacol 2011, 11:1697-1705.
20. Dhir V., Fort M., Mahmood A., Higbee R., Warren W., Narayanan P., et al. A predictive biomimetic model of cytokine release induced by TGN1412 and other therapeutic monoclonal antibodies. J Immunotoxicol 2012, 9:34-42.
21. Waibler Z., Sender L.Y., Kamp C., Müller-Berghaus J., Liedert B., Schneider C.K., et al. Toward experimental assessment of receptor occupancy: TGN1412 revisited. J Allergy Clin Immunol 2008, 122:890-892.
22. Waibler Z., Sender L.Y., Merten C., Hartig R., Kliche S., Gunzer M., et al. Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies. PLoS One 2008, 3:e1708.
23. Wing M.G., Waldmann H., Isaacs J., Compston D.A., Hale G. Ex vivo whole blood cultures for predicting cytokine-release syndrome: dependence on target antigen and mAb isotype. Ther Immunol 1995, 2:183-190.