Key bioanalytical measurements for antibody-drug conjugate development: PK/PD modelers perspective

Bioanalysis

Volumn 5, Issue 9, 2013, Pages 989-992

  Shah, Dhaval K ^a   Barletta, Frank ^a   Betts, Alison ^a   Hansel, Steven ^a  

^a PFIZER INC   (United States)

Author keywords

bioanalytical measurements; biomarkers; biomeasures; PK PD; translational strategy

Indexed keywords

ANTIBODY CONJUGATE;

ANTIGEN EXPRESSION; BINDING AFFINITY; DRUG DISPOSITION; DRUG EXPOSURE; DRUG RESEARCH; DRUG SAFETY; INTERNALIZATION; MATHEMATICAL MODEL; PROCESS OPTIMIZATION; REVIEW;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BIOLOGICAL ASSAY; IMMUNOCONJUGATES; MODELS, MOLECULAR;

EID: 84877280582     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.78     Document Type: Review

References (19)

1. Shah DK, Haddish-Berhane N, Betts A. Bench to bedside translation of antibody-drug conjugates using a multiscale mechanistic PK/PD model: a case study with brentuximab-vedotin. J. Pharmacokinet. Pharmacodyn. 39(6), 643-659 (2012).
2. Wiley HS, Shvartsman SY, Lauffenburger DA. Computational modeling of the EGF-receptor system: a paradigm for systems biology. Trends Cell Biol. 13(1), 43-50 (2003).
3. Okeley NM, Miyamoto JB, Zhang X et al. Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Clin. Cancer Res. 3, 888-897 (2010).
4. Shah DK, Balthasar JP. Physiologically based pharmacokinetic model for topotecan in mice. J. Pharmacokinet. Pharmacodyn. 38(1), 121-142 (2011).
5. Shah DK, Betts AM. Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human.J. Pharmacokinet. Pharmacodyn. 39(1), 67-86 (2012).
6. Sapra P, Damelin M, Dijoseph J et al. Long-term tumor regression induced by an antibody-drug conjugate that targets 5T4, an oncofetal antigen expressed on tumor-initiating cells. Mol. Cancer Therap. 12(1), 38-47 (2013).
7. Kovtun YV, Audette CA, Mayo MF et al. Antibody-maytansinoid conjugates designed to bypass multidrug resistance. Cancer Res. 70(6), 2528-2537 (2010).
8. Shen BQ, Xu K, Liu L et al. Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates. Nat. Biotechnol. 30(2), 184-189 (2012).
9. Ritchie M, Tchistiakova L, Scott N. Implications of receptor-mediated endocytosis and intracellular trafficking dynamics in the development of antibody drug conjugates. mAbs 5(1), 13-21 (2013).
10. Kaur S, Xu K, Saad OM, Dere RC, Carrasco-Triguero M. Bioanalytical assay strategies for the development of antibody-drug conjugate biotherapeutics. Bioanalysis 5(2), 201-226 (2013).
11. Xu K, Liu L, Saad OM et al. Characterization of intact antibody-drug conjugates from plasma/serum in vivo by affinity capture capillary liquid chromatography-mass spectrometry. Anal. Biochem. 412(1), 56-66 (2011).
12. Erickson HK, Park PU, Widdison WC et al. Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing. Cancer Res. 66(8), 4426-4433 (2006).
13. Fromm JR, McEarchern JA, Kennedy D, Shustov AR, Gopal AK. Preclinical and clinical binding properties, internalization kinetics, and clinicopathological activity of brentuximab vedotin (SGN-35): a novel antibody drug conjugate for anaplastic large cell lymphoma and classical Hodgkin lymphoma. Presented at: American Society of Hematology 2010 Annual Meeting. Orlando, FL, USA, 4-7 December 2010.
14. Schatz CA, Golfier S, Scheider C et al. Efficacy and candidate biomarker evaluation for the anti-mesothelin antibody-drug conjugate (ADC) BAY 94-9343, mesothelin-ADC in mesothelin-positive preclinical xenograft models Cancer Res. 72(8 Suppl. 1), abstract 2726 (2012).
15. Hsieh FY, Tengstrand E, Lee JW et al. Drug safety evaluation through biomarker analysis-a toxicity study in the cynomolgus monkey using an antibody-cytotoxic conjugate against ovarian cancer. Toxicol. Appl. Pharmacol. 224(1), 12-18 (2007).
16. Girish S, Gupta M, Wang B et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother. Pharmacol. 69(5), 1229-1240 (2012).
17. Koren E, Smith HW, Shores E et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J. Immunol. Methods 333(1-2), 1-9 (2008).
18. Younes A, Bartlett NL, Leonard JP et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N. Engl. J. Med. 363(19), 1812-1821 (2010).
19. Thudium K, Bilic S, Leipold D et al. American Association of Pharmaceutical Scientists National Biotechnology Conference short course: translational challenges in developing antibody-drug conjugates: San Diego, CA, USA. mAbs 5(1), 5-12 (2013).