Pharmacokinetics and pharmacodynamics of DSTA4637A: A novel THIOMAB™ antibody antibiotic conjugate against Staphylococcus aureus in mice

mAbs

Volumn 8, Issue 8, 2016, Pages 1612-1619

  Zhou, Chenguang ^a   Lehar, Sophie ^a   Gutierrez, Johnny ^a   Rosenberger, Carrie M ^a   Ljumanovic, Nina ^a   Dinoso, Jason ^a   Koppada, Neelima ^a   Hong, Kyu ^a   Baruch, Amos ^a   Carrasco Triguero, Montserrat ^a   Saad, Ola ^a   Mariathasan, Sanjeev ^a   Kamath, Amrita V ^a  

^a GENENTECH INC   (United States)

Author keywords

antibody antibiotic conjugate; Antibody drug conjugate; pharmacodynamics; pharmacokinetics; Staphylococcus aureus infections; THIOMAB antibody antibiotic conjugate

Indexed keywords

ANTIBODY CONJUGATE; ANTIINFECTIVE AGENT; DMDNA31; DSTA4637A; UNCLASSIFIED DRUG; BACTERIUM ANTIBODY; MONOCLONAL ANTIBODY;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ANTIBODY BLOOD LEVEL; AREA UNDER THE CURVE; BACTERIAL LOAD; BLOOD SAMPLING; COLONY FORMING UNIT; CONTROLLED STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MOUSE; NONHUMAN; SINGLE DRUG DOSE; STAPHYLOCOCCUS AUREUS; STAPHYLOCOCCUS INFECTION; STEADY STATE; ANIMAL; STAPHYLOCOCCAL INFECTIONS;

ANIMALS; ANTI-BACTERIAL AGENTS; ANTIBODIES, BACTERIAL; ANTIBODIES, MONOCLONAL; IMMUNOCONJUGATES; MICE; STAPHYLOCOCCAL INFECTIONS; STAPHYLOCOCCUS AUREUS;

EID: 84990946526     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2016.1229722     Document Type: Article

References (17)

1. S.J.van Hal, S.O.Jensen, V.L.Vaska, B.A.Espedido, D.L.Paterson, I.B.Gosbell. Predictors of mortality in Staphylococcus aureus Bacteremia. Clin Microbiol Rev 2012; 25:362-86; PMID:22491776; http://dx.doi.org/10.1128/CMR.05022-11
2. F.R.DeLeo, H.F.Chambers. Reemergence of antibiotic-resistant Staphylococcus aureus in the genomics era. J Clin Invest 2009; 119:2464-74; PMID:19729844; http://dx.doi.org/10.1172/JCI38226
3. I.Youngster, J.Sauk, C.Pindar, R.G.Wilson, J.L.Kaplan, M.B.Smith, E.J.Alm, D.Gevers, G.H.Russell, E.L.Hohmann. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors:a randomized, open-label, controlled pilot study. Clin Infect Dis 2014; 58:1515-22; PMID:24762631; http://dx.doi.org/10.1093/cid/ciu135
4. G.E.Thwaites, V.Gant. Are bloodstream leukocytes Trojan Horses for the metastasis of Staphylococcus aureus? Nat Rev Microbiol 2011; 9:215-22; PMID:21297670; http://dx.doi.org/10.1038/nrmicro2508
5. S.M.Lehar, T.Pillow, M.Xu, L.Staben, K.K.Kajihara, R.Vandlen, L.DePalatis, H.Raab, W.L.Hazenbos, J.Hiroshi Morisaki, et al. Novel antibody-antibiotic conjugate eliminates intracellular S. aureus. Nature 2015; PMID:26536114; http://dx.doi.org/10.1038/nature16057
6. C.L.S.Zhou, J.Gutierrez, C.Rosenberger, N.Ljumanovic, A.Baruch, M.Carrasco, O.Saad, S.Mariathasan, A.Kamath. Thiomab Antibiotic Conjugate (TAC):PKPD of a novel platform for invasive staphylococcus aureus infections. Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) 2015
7. B.Q.Shen, K.Xu, L.Liu, H.Raab, S.Bhakta, M.Kenrick, K.L.Parsons-Reponte, J.Tien, S.F.Yu, E.Mai, et al. Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates. Nat Biotechnol 2012; 30:184-9; PMID:22267010; http://dx.doi.org/10.1038/nbt.2108
8. S.Kaur, K.Xu, O.M.Saad, R.C.Dere, M.Carrasco-Triguero. Bioanalytical assay strategies for the development of antibody-drug conjugate biotherapeutics. Bioanalysis 2013; 5:201-26; PMID:23330562; http://dx.doi.org/10.4155/bio.12.299
9. B.Gorovits, S.C.Alley, S.Bilic, B.Booth, S.Kaur, P.Oldfield, S.Purushothama, C.Rao, S.Shord, P.Siguenza. Bioanalysis of antibody-drug conjugates:American association of pharmaceutical scientists antibody-drug conjugate working group position paper. Bioanalysis 2013; 5:997-1006; PMID:23641692; http://dx.doi.org/10.4155/bio.13.38
10. R.Deng, F.Jin, S.Prabhu, S.Iyer. Monoclonal antibodies:what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin Drug Metab Toxicol 2012; 8:141-60; PMID:22248267; http://dx.doi.org/10.1517/17425255.2012.643868
11. R.Deng, S.Iyer, F.P.Theil, D.L.Mortensen, P.J.Fielder, S.Prabhu. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data:what have we learned? MAbs 2011; 3:61-6; PMID:20962582; http://dx.doi.org/10.4161/mabs.3.1.13799
12. J.R.Junutula, H.Raab, S.Clark, S.Bhakta, D.D.Leipold, S.Weir, Y.Chen, M.Simpson, S.P.Tsai, M.S.Dennis, et al. Site-specific conjugation of a cytotoxic drug to an antibody improves the therapeutic index. Nat Biotechnol 2008; 26:925-32; PMID:18641636; http://dx.doi.org/10.1038/nbt.1480
13. W.Wang, J.J.Yang, L.Liu, Z.C.Chen, Y.Gao, J.E.Gao, L.G.An, Q.H.Sun. Generation and characterization of monoclonal antibody against HSD11B1. Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi 2008; 24:38-40; PMID:18177616
14. W.Wang, P.Lu, Y.Fang, L.Hamuro, T.Pittman, B.Carr, J.Hochman, T.Prueksaritanont. Monoclonal antibodies with identical Fc sequences can bind to FcRn differentially with pharmacokinetic consequences. Drug Metab Dispos 2011; 39:1469-77; PMID:21610128; http://dx.doi.org/10.1124/dmd.111.039453
15. S.Sukumaran, K.Gadkar, C.Zhang, S.Bhakta, L.Liu, K.Xu, H.Raab, S.F.Yu, E.Mai, A.Fourie-O'Donohue, et al. Mechanism-based pharmacokinetic/pharmacodynamic model for Thiomab drug conjugates. Pharm Res 2015; 32:1884-93; PMID:25446772; http://dx.doi.org/10.1007/s11095-014-1582-1
16. http://www.lymepa.org/Antibiotics_spreadsheet_2004-1215.pdf
17. F.C.Tenover, S.W.Sinner, R.E.Segal, V.Huang, S.S.Alexandre, J.E.McGowan, Jr, M.P.Weinstein. Characterisation of a Staphylococcus aureus strain with progressive loss of susceptibility to vancomycin and daptomycin during therapy. Int J Antimicrob Agents 2009; 33:564-8; PMID:19233622; http://dx.doi.org/10.1016/j.ijantimicag.2008.12.010