Application of PBPK modeling to predict monoclonal antibody disposition in plasma and tissues in mouse models of human colorectal cancer

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 39, Issue 6, 2012, Pages 683-710

  Abuqayyas, Lubna ^a   Balthasar, Joseph P ^a  

^a UNIVERSITY AT BUFFALO   (United States)

Author keywords

Monoclonal antibody; Monte Carlo simulation; Physiologically based pharmacokinetic (PBPK); Preclinical pharmacokinetic; Target mediated disposition (TMD); Tissue disposition

Indexed keywords

IODINE 125; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY 8C2; MONOCLONAL ANTIBODY T84 66; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ANTIGEN ANTIBODY REACTION; AREA UNDER THE CURVE; ARTICLE; COLORECTAL CANCER; CONTROLLED STUDY; DRUG BINDING; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG MECHANISM; DRUG TARGETING; DRUG TISSUE LEVEL; DRUG UPTAKE; HUMAN; HUMAN CELL; ISOTOPE LABELING; MALE; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; MONTE CARLO METHOD; MOUSE; NONHUMAN; PREDICTION; PRIORITY JOURNAL;

ANIMALS; ANTIBODIES, MONOCLONAL; AREA UNDER CURVE; CELL LINE, TUMOR; COLORECTAL NEOPLASMS; HT29 CELLS; HUMANS; IMMUNOGLOBULIN G; MALE; MICE; MICE, SCID; MODELS, BIOLOGICAL; TISSUE DISTRIBUTION; TRANSPLANTATION, HETEROLOGOUS;

EID: 84880722853     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-012-9279-8     Document Type: Article

References (51)

1. Weiner LM, Surana R, Wang S (2010) Monoclonal antibodies: versatile platforms for cancer immunotherapy. Nat Rev Immunol 10:317-327
2. Yan L, Hsu K, Beckman RA (2008) Antibody-based therapy for solid tumors. Cancer J 14:178-183
3. Jain RK (1990) Physiological barriers to delivery of monoclonal antibodies and other macromolecules in tumors. Cancer Res 50:814s-819s
4. Jain RK (1990) Tumor physiology and antibody delivery. Front Radiat Ther Oncol 24:32-46; discussion 64-38
5. Fujimori K, Covell DG, Fletcher JE, Weinstein JN (1990) A modeling analysis of monoclonal antibody percolation through tumors: a binding-site barrier. J Nucl Med 31:1191-1198 (Pubitemid 20213280)
6. Van Osdol W, Fujimori K, Weinstein JN (1991) An analysis of monoclonal antibody distribution in microscopic tumor nodules: consequences of a "binding site barrier". Cancer Res 51:4776-4784
7. Juweid M, Neumann R, Paik C, Perez-Bacete MJ, Sato J, van Osdol W, Weinstein JN (1992) Micropharmacology of monoclonal antibodies in solid tumors: direct experimental evidence for a binding site barrier. Cancer Res 52:5144-5153
8. Sagan S, Charpentier S, Delfour A, Amiche M, Nicolas P (1992) The aspartic acid in deltorphin I and dermenkephalin promotes targeting to delta-opioid receptor independently of receptor binding. Biochem Biophys Res Commun 187:1203-1210
9. Jain RK, Weissbrod JM, Wei J (1980) Mass transport in tumors: characterization and applications to chemotherapy. Adv Cancer Res 33:251-310
10. Levy G (1994) Pharmacologic target-mediated drug disposition. Clin Pharmacol Ther 56:248-252 (Pubitemid 24323915)
11. Schmidt MM, Thurber GM, Wittrup KD (2008) Kinetics of anti-carcinoembryonic antigen antibody internalization: effects of affinity, bivalency, and stability. Cancer Immunol Immunother 57:1879-1890
12. Weinstein JN, Eger RR, Covell DG, Black CD, Mulshine J, Carrasquillo JA, Larson SM, Keenan AM (1987) The pharmacology of monoclonal antibodies. Ann N Y Acad Sci 507:199-210
13. Fujimori K, Covell DG, Fletcher JE, Weinstein JN (1989) Modeling analysis of the global and microscopic distribution of immunoglobulin G, F(ab')2, and Fab in tumors. Cancer Res 49:5656-5663 (Pubitemid 19256448)
14. Weinstein JN, van Osdol W (1992) Early intervention in cancer using monoclonal antibodies and other biological ligands: micropharmacology and the "binding site barrier". Cancer Res 52:2747s-2751s
15. Fracasso G, Colombatti M (2000) Effect of therapeutic macromolecules in spheroids. Crit Rev Oncol Hematol 36:159-178
16. Ackerman ME, Pawlowski D, Wittrup KD (2008) Effect of antigen turnover rate and expression level on antibody penetration into tumor spheroids. Mol Cancer Ther 7:2233-2240
17. Thurber GM, Wittrup KD (2008) Quantitative spatiotemporal analysis of antibody fragment diffusion and endocytic consumption in tumor spheroids. Cancer Res 68:3334-3341
18. Graff CP, Wittrup KD (2003) Theoretical analysis of antibody targeting of tumor spheroids: importance of dosage for penetration, and affinity for retention. Cancer Res 63:1288-1296 (Pubitemid 36348707)
19. Thurber GM, Zajic SC, Wittrup KD (2007) Theoretic criteria for antibody penetration into solid tumors and micrometastases. J Nucl Med 48:995-999 (Pubitemid 46909929)
20. Baxter LT, Zhu H, Mackensen DG, Jain RK (1994) Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice. Cancer Res 54:1517-1528 (Pubitemid 24106416)
21. Ferl GZ, Wu AM, DiStefano JJ 3rd (2005) A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn). Ann Biomed Eng 33:1640-1652 (Pubitemid 41801648)
22. Garg A, Balthasar JP (2007) Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J Pharmacokinet Pharmacodyn 34:687-709 (Pubitemid 47477039)
23. Urva SR, Yang VC, Balthasar JP (2010) Physiologically based pharmacokinetic model for T84.66: a monoclonal anti-CEA antibody. J Pharm Sci 99:1582-1600
24. Covell DG, Barbet J, Holton OD, Black CD, Parker RJ, Weinstein JN (1986) Pharmacokinetics of monoclonal immunoglobulin G1, F(ab')2, and Fab' in mice. Cancer Res 46:3969-3978 (Pubitemid 16075893)
25. Davda JP, Jain M, Batra SK, Gwilt PR, Robinson DH (2008) A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs. Int Immunopharmacol 8:401-413 (Pubitemid 351221431)
26. Shah DK, Betts AM (2012) Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human. J Pharmacokinet Pharmacodyn 39:67-86
27. Chen J, Balthasar JP (2007) Development and characterization of high affinity anti-topotecan IgG and Fab fragments. In: Gad SC (ed) Handbook of pharmaceutical biotechnology. Wiley, Hoboken, pp 835-850
28. Abuqayyas L, Balthasar JP (2012) Pharmacokinetic mAb-mAb Interaction: Anti-VEGF mAb decreases the distribution of anti-CEA mAb into colorectal tumor xenografts. AAPS J 14(3):445-455
29. Nedelman JR, Gibiansky E, Lau DT (1995) Applying Bailer's method for AUC confidence intervals to sparse sampling. Pharm Res 12:124-128
30. Nedelman JR, Jia X (1998) An extension of Satterthwaite's approximation applied to pharmacokinetics. J Biopharm Stat 8:317-328 (Pubitemid 28239874)
31. Butler TP, Grantham FH, Gullino PM (1975) Bulk transfer of fluid in the interstitial compartment of mammary tumors. Cancer Res 35:3084-3088
32. Greiner JW, Ullmann CD, Nieroda C, Qi CF, Eggensperger D, Shimada S, Steinberg SM, Schlom J (1993) Improved radioimmunotherapeutic efficacy of an anticarcinoma monoclonal antibody (131I-CC49) when given in combination with gamma-interferon. Cancer Res 53:600-608 (Pubitemid 23059443)
33. Guadagni F, Witt PL, Robbins PF, Schlom J, Greiner JW (1990) Regulation of carcinoembryonic antigen expression in different human colorectal tumor cells by interferon-gamma. Cancer Res 50:6248-6255 (Pubitemid 20323683)
34. Esteban JM, Kuhn JA, Felder B, Wong JY, Battifora H, Beatty JD, Wanek PM, Shively JE (1991) Carcinoembryonic antigen expression of resurgent human colon carcinoma after treatment with therapeutic doses of 90Y-alpha-carcinoembryonic antigen monoclonal antibody. Cancer Res 51:3802-3806
35. Shi ZR, Tsao D, Kim YS (1983) Subcellular distribution, synthesis, and release of carcinoembryonic antigen in cultured human colon adenocarcinoma cell lines. Cancer Res 43:4045-4049 (Pubitemid 13041027)
36. Berk DA, Yuan F, Leunig M, Jain RK (1997) Direct in vivo measurement of targeted binding in a human tumor xenograft. Proc Natl Acad Sci USA 94:1785-1790 (Pubitemid 27113913)
37. Wagner HE, Toth CA, Steele GD Jr, Thomas P (1992) Metastatic potential of human colon cancer cell lines: relationship to cellular differentiation and carcinoembryonic antigen production. Clin Exp Metastasis 10:25-31
38. Friedman J, Seger M, Levinsky H, Allalouf D (1987) Modulation of carcinoembryonic antigen release by HT-29 colon carcinoma line in the presence of different agents. Experientia 43:1121-1122 (Pubitemid 18017022)
39. Hefta LJ, Neumaier M, Shively JE (1998) Kinetic and affinity constants of epitope specific anti-carcinoembryonic antigen (CEA) monoclonal antibodies for CEA and engineered CEA domain constructs. Immunotechnology 4:49-57 (Pubitemid 28302184)
40. Wagener C, Clark BR, Rickard KJ, Shively JE (1983) Monoclonal antibodies for carcinoembryonic antigen and related antigens as a model system: determination of affinities and specificities of monoclonal antibodies by using biotin-labeled antibodies and avidin as precipitating agent in a solution phase immunoassay. J Immunol 130:2302-2307 (Pubitemid 13086777)
41. Rowlinson-Busza G, Maraveyas A, Epenetos AA (1995) Effect of tumour necrosis factor on the uptake of specific and control monoclonal antibodies in a human tumour xenograft model. Br J Cancer 71:660-665
42. Shah DK, Shin BS, Veith J, Toth K, Bernacki RJ, Balthasar JP (2009) Use of an anti-vascular endothelial growth factor antibody in a pharmacokinetic strategy to increase the efficacy of intraperitoneal chemotherapy. J Pharmacol Exp Ther 329:580-591
43. Pastuskovas CV, Mundo EE, Williams SP, Nayak TK, Ho J, Ulufatu S, Clark S, Ross S, Cheng E, Parsons-Reponte K, Cain G, Van Hoy M, Majidy N, Bheddah S, Dela Cruz Chuh J, Kozak KR, Lewin-Koh N, Nauka P, Bumbaca D, Sliwkowski M, Tibbitts J, Theil FP, Fielder PJ, Khawli LA, Boswell CA (2012) Effects of Anti-VEGF on Pharmacokinetics, Biodistribution, and Tumor Penetration of Trastuzumab in a Preclinical Breast Cancer Model. Mol Cancer Ther 11:752-762
44. Topp EM, Kitos PA, Vijaykumar V, DeSilva BS, Hendrickson TL (1998) Antibody transport in cultured tumor cell layers. J Control Release 53:15-23 (Pubitemid 28218686)
45. Carmeliet P, Jain RK (2000) Angiogenesis in cancer and other diseases. Nature 407:249-257
46. Jain RK (2001) Normalizing tumor vasculature with anti-angiogenic therapy: a new paradigm for combination therapy. Nat Med 7:987-989 (Pubitemid 32937367)
47. US Food and Drug Administration (FDA) (2011) Label for Avastin (bevacizumab). http://www.accessdata.fda.gov/drugsatfda-docs/label/2009/ 125085s0168lbl.pdf. Accessed April 2011
48. Jain RK (1987) Transport of molecules in the tumor interstitium: a review. Cancer Res 47:3039-3051 (Pubitemid 17082621)
49. Maeda H (2001) The enhanced permeability and retention (EPR) effect in tumor vasculature: the key role of tumor-selective macromolecular drug targeting. Adv Enzyme Regul 41:189-207 (Pubitemid 32520323)
50. Boswell CA, Ferl GZ, Mundo EE, Bumbaca D, Schweiger MG, Theil FP, Fielder PJ, Khawli LA (2011) Effects of anti-VEGF on predicted antibody biodistribution: roles of vascular volume, interstitial volume, and blood flow. PLoS One 6:e17874
51. Abraham AK, Krzyzanski W, Mager DE (2007) Partial derivative-based sensitivity analysis of models describing target-mediated drug disposition. AAPS J 9:E181-E189