Identification and inhibition of drug target interference in immunogenicity assays

Journal of Immunological Methods

Volumn 355, Issue 1-2, 2010, Pages 21-28

  Zhong, Zhandong D ^a   Dinnogen, Steve ^a   Hokom, Martha ^a   Ray, Chad ^a,b   Weinreich, David ^a   Swanson, Steven J ^a   Chirmule, Narendra ^a  

^a AMGEN INC   (United States)

^b Radix BioSolutions   (United States)

Author keywords

Angiopoietin; Anti drug antibody; Design of experiments; Drug target interference; Immunoassay; Immunogenicity

Indexed keywords

AMG 386; ANGIOPOIETIN; ANGIOPOIETIN 1; ANGIOPOIETIN 2; ANTINEOPLASTIC AGENT; DRUG ANTIBODY; EPITOPE; MONOCLONAL ANTIBODY; UNCLASSIFIED DRUG;

ANTIBODY AFFINITY; ANTIBODY DETECTION; ANTIGEN ANTIBODY COMPLEX; ARTICLE; CHEMOLUMINESCENCE; CONTROLLED STUDY; DRUG COMPETITION; DRUG PROTEIN BINDING; DRUG TARGETING; ELECTROCHEMICAL ANALYSIS; FALSE POSITIVE RESULT; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; MOLECULAR INTERACTION; PRIORITY JOURNAL; PROTEIN ANALYSIS; STATISTICAL ANALYSIS; VALIDATION PROCESS;

ANGIOPOIETINS; ANIMALS; ANTIBODIES, MONOCLONAL; BIOLOGICAL ASSAY; CLINICAL TRIALS AS TOPIC; DRUG INTERACTIONS; FEMALE; HUMANS; IMMUNOASSAY; IMMUNOGLOBULIN FC FRAGMENTS; MALE; MICE; NEOPLASMS; NEOVASCULARIZATION, PATHOLOGIC; PEPTIDES; RECEPTOR, TIE-2; SENSITIVITY AND SPECIFICITY;

EID: 77951257480     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2010.02.008     Document Type: Article

References (45)

1. Altekar M., Homon C.A., Kashem M.A., Mason S.W., Nelson R.M., Patnaude L.A., Yingling J., Taylor P.B. Assay optimization: a statistical design of experiments approach. Clin. Lab. Med. 2007, 27:139.
2. Augustin H.G., Koh G.Y., Thurston G., Alitalo K. Control of vascular morphogenesis and homeostasis through the angiopoietin-Tie system. Nat. Rev. Mol. Cell Biol. 2009, 10:165.
3. Barton W.A., Tzvetkova D., Nikolov D.B. Structure of the angiopoietin-2 receptor binding domain and identification of surfaces involved in Tie2 recognition. Structure 2005, 13:825.
4. Barton W.A., Tzvetkova-Robev D., Miranda E.P., Kolev M.V., Rajashankar K.R., Himanen J.P., Nikolov D.B. Crystal structures of the Tie2 receptor ectodomain and the angiopoietin-2-Tie2 complex. Nat. Struct. Mol. Biol. 2006, 13:524.
5. Bunone G., Vigneri P., Mariani L., Buto S., Collini P., Pilotti S., Pierotti M.A., Bongarzone I. Expression of angiogenesis stimulators and inhibitors in human thyroid tumors and correlation with clinical pathological features. Am. J. Pathol. 1999, 155:1967.
6. Committee for Medicinal Product for Human Use (CHMP). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, Doc. Ref. EMEA/CHMP/BMWP/14327/2006, London, 2007.
7. Davis S., Papadopoulos N., Aldrich T.H., Maisonpierre P.C., Huang T., Kovac L., Xu A., Leidich R., Radziejewska E., Rafique A., Goldberg J., Jain V., Bailey K., Karow M., Fandl J., Samuelsson S.J., Ioffe E., Rudge J.S., Daly T.J., Radziejewski C., Yancopoulos G.D. Angiopoietins have distinct modular domains essential for receptor binding, dimerization and superclustering. Nat. Struct. Biol. 2003, 10:38.
8. De Groot A.S., Martin W. Reducing risk, improving outcomes: bioengineering less immunogenic protein therapeutics. Clin. Immunol. 2009, 131:189.
9. Dvorak H.F. Vascular permeability factor/vascular endothelial growth factor: a critical cytokine in tumor angiogenesis and a potential target for diagnosis and therapy. J. Clin. Oncol. 2002, 20:4368.
10. Etoh T., Inoue H., Tanaka S., Barnard G.F., Kitano S., Mori M. Angiopoietin-2 is related to tumor angiogenesis in gastric carcinoma: possible in vivo regulation via induction of proteases. Cancer Res. 2001, 61:2145.
11. Fidler I.J., Kerbel R.S., Ellis L.M. Biology of cancer: angiogenesis. Principles and Practice of Oncology 2001, 137. Lippinciott-Raven Publisher, Philadelphia, PA. V.T. Devita, S. Hellman, S.A. Rosenberg (Eds.).
12. Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat. Med. 1995, 1:27.
13. Food and Drug Administration (FDA). Guidance for industry: assay development for immunogenicity testing of therapeutic proteins (draft guidance). Published as a notice in the Federal Register: 74 Fed. Reg. 63758, December 4, 2009. Docket No. FDA-2009-D-0539.
14. Hammond O., Reynolds J., Rubinstein L.J., Sikkema D., Marchese R.D. Complexities of clinical assay development and optimization prior to first-in-man immunization trials - a description of immunogenicity assay development for the testing of samples from a phase 1 Alzheimer's vaccine trial. J. Immunoassay Immunochem. 2008, 29:332.
15. Hong D., Gordon M., Appleman L., Kurzrock R., Sun Y., Rasmussen E., Zhong D., Le N., L.R. Interim results from a phase 1b study of safety, pharmacokinetics (PK) and tumor response of the angiopoietin 1/2-neutralizing peptibody AMG 386 in combinations with AMG 706, bevacizumab (B) or sorafenib (S) in advanced solid tumors. Ann. Oncol. 2008, 19:viii154.
16. Hurwitz H., Fehrenbacher L., Novotny W., Cartwright T., Hainsworth J., Heim W., Berlin J., Baron A., Griffing S., Holmgren E., Ferrara N., Fyfe G., Rogers B., Ross R., Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N. Engl. J. Med. 2004, 350:2335.
17. Joelsson D., Moravec P., Troutman M., Pigeon J., DePhillips P. Optimizing ELISAs for precision and robustness using laboratory automation and statistical design of experiments. J. Immunol. Methods 2008, 337:35.
18. Jones D.S., Silverman A.P., Cochran J.R. Developing therapeutic proteins by engineering ligand-receptor interactions. Trends Biotechnol. 2008, 26:498.
19. Koren E., Smith H.W., Shores E., Shankar G., Finco-Kent D., Rup B., Barrett Y.C., Devanarayan V., Gorovits B., Gupta S., Parish T., Quarmby V., Moxness M., Swanson S.J., Taniguchi G., Zuckerman L.A., Stebbins C.C., Mire-Sluis A. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J. Immunol. Methods 2008, 333:1.
20. Leek R.D. The prognostic role of angiogenesis in breast cancer. Anticancer Res. 2001, 21:4325.
21. Lofgren J.A., Dhandapani S., Pennucci J.J., Abbott C.M., Mytych D.T., Kaliyaperumal A., Swanson S.J., Mullenix M.C. Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab. J. Immunol. 2007, 178:7467.
22. Mehta R., Kyshtoobayeva A., Kurosaki T., Small E.J., Kim H., Stroup R., McLaren C.E., Li K.T., Fruehauf J.P. Independent association of angiogenesis index with outcome in prostate cancer. Clin. Cancer Res. 2001, 7:81.
23. Mire-Sluis A.R., Barrett Y.C., Devanarayan V., Koren E., Liu H., Maia M., Parish T., Scott G., Shankar G., Shores E., Swanson S.J., Taniguchi G., Wierda D., Zuckerman L.A. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 2004, 289:1.
24. Mita A., Wang D., Takimoto C.H., Martin D., Nguyen L., Rasmussen E., Storgard C., LoRusso P. AMG 386, a first-in-class, selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. Eur. J. Cancer Suppl. 2007, 5:109.
25. Mita A.C., Wang D., Takimoto C.H., Malseed E., Nguyen L., Rasmussen E., Storgard C., LoRusso P. AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. J. Clin. Oncol. (Meeting Abstracts) 2007, 25:14033.
26. Moxness M., Tatarewicz S., Weeraratne D., Murakami N., Wullner D., Mytych D., Jawa V., Koren E., Swanson S.J. Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies. Clin. Chem. 2005, 51:1983.
27. Oliner J., Min H., Leal J., Yu D., Rao S., You E., Tang X., Kim H., Meyer S., Han S.J., Hawkins N., Rosenfeld R., Davy E., Graham K., Jacobsen F., Stevenson S., Ho J., Chen Q., Hartmann T., Michaels M., Kelley M., Li L., Sitney K., Martin F., Sun J.R., Zhang N., Lu J., Estrada J., Kumar R., Coxon A., Kaufman S., Pretorius J., Scully S., Cattley R., Payton M., Coats S., Nguyen L., Desilva B., Ndifor A., Hayward I., Radinsky R., Boone T., Kendall R. Suppression of angiogenesis and tumor growth by selective inhibition of angiopoietin-2. Cancer Cell 2004, 6:507.
28. Papamichael D. Prognostic role of angiogenesis in colorectal cancer. Anticancer Res. 2001, 21:4349.
29. Patton A., Mullenix M.C., Swanson S.J., Koren E. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J. Immunol. Methods 2005, 304:189.
30. Peters K.G., Kontos C.D., Lin P.C., Wong A.L., Rao P., Huang L., Dewhirst M.W., Sankar S. Functional significance of Tie2 signaling in the adult vasculature. Recent Prog. Horm. Res. 2004, 59:51.
31. Ray C.A., Patel V., Shih J., Macaraeg C., Wu Y., Thway T., Ma M., Lee J.W., Desilva B. Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins. J. Pharm. Biomed. Anal. 2009, 49:311.
32. Reinmuth N., Parikh A.A., Ahmad S.A., Liu W., Stoeltzing O., Fan F., Takeda A., Akagi M., Ellis L.M. Biology of angiogenesis in tumors of the gastrointestinal tract. Microsc. Res. Tech. 2003, 60:199.
33. Scappaticci F.A. Mechanisms and future directions for angiogenesis-based cancer therapies. J. Clin. Oncol. 2002, 20:3906.
34. Scharpfenecker M., Fiedler U., Reiss Y., Augustin H.G. The Tie-2 ligand angiopoietin-2 destabilizes quiescent endothelium through an internal autocrine loop mechanism. J. Cell Sci. 2005, 118:771.
35. Sfiligoi C., de Luca A., Cascone I., Sorbello V., Fuso L., Ponzone R., Biglia N., Audero E., Arisio R., Bussolino F., Sismondi P., De Bortoli M. Angiopoietin-2 expression in breast cancer correlates with lymph node invasion and short survival. Int. J. Cancer 2003, 103:466.
36. Shim W.S., Ho I.A., Wong P.E. Angiopoietin: a TIE(d) balance in tumor angiogenesis. Mol. Cancer Res. 2007, 5:655.
37. Sickert D., Kroeger K., Zickler C., Chokote E., Winkler B., Grenet J.M., Legay F., Zaar A. Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore. J. Immunol. Methods 2008, 334:29.
38. Sittampalam G.S., Smith W.C., Miyakawa T.W., Smith D.R., McMorris C. Application of experimental design techniques to optimize a competitive ELISA. J. Immunol. Methods 1996, 190:151.
39. Swanson S.J. New technologies for the detection of antibodies to therapeutic proteins. New Technologies for the Detection of Antibodies to Therapeutic Proteins 2003, Vol. 112:127. Karger, Basel.
40. Swanson S.J. Immunogenicity issues in drug development. J. Immunotoxicol. 2006, 3:165.
41. Swanson S.J., Chirmule N. Assessing specificity for immunogenicity assays. Bioanalysis 2009, 1:611.
42. Swanson S.J., Ferbas J., Mayeux P., Casadevall N. Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin. Nephron Clin. Pract. 2004, 96:c88.
43. Thorpe R., Swanson S.J. Assays for detecting and diagnosing antibody-mediated pure red cell aplasia (PRCA): an assessment of available procedures. Nephrol. Dial. Transplant. 2005, 20(Suppl 4). iv16-22.
44. Thorpe R., Swanson S.J. Current methods for detecting antibodies against erythropoietin and other recombinant proteins. Clin. Diagn. Lab. Immunol. 2005, 12:28.
45. Undesser L.P., Desai S., Krohn R., Bell P.A. A novel purification method for monoclonal antibodies. FASEB J. 2006, 20. A961-c-.