Toxicokinetics of a humanized anti-cocaine monoclonal antibody in male and female rats and lack of cross-reactivity

References

• Richards JR, Le JK. Cocaine toxicity. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jun 8. PMID: 28613695
   Google Scholar
• Hantson P. Mechanisms of toxic cardiomyopathy. Clin Toxicol (Philadelphia, Pa). 2019;57:1–11. PMID: 30260248. doi:10.1080/15563650.2018.1497172.
   PubMed Web of Science ®Google Scholar
• Mikhail A, Tanoli O, Légaré G, Dubé PA, Habel Y, Lesage A, Low NCP, Lamarre S, Singh S, Rahme E. Over-the-counter drugs and other substances used in attempted suicide presented to emergency departments in Montreal, Canada. Crisis. 2019;40:166–75. PMID: 30215303. doi:10.1027/0227-5910/a000545.
   PubMedGoogle Scholar
• Narula N, Siddiqui F, Katyal N, Krishnan N, Chalhoub M. Cracking the crack dance: a case report on cocaine-induced choreoathetosis. Cureus. 2017;9:e1981. PMID: 29503775. doi:10.7759/cureus.1981.
   PubMedGoogle Scholar
• EMCDD. Treatment for cocaine dependence — reviewing current evidence. http://www.emcdda.europa.eu/topics/pods/treatment-for-cocaine-dependence_en:2014Date.
   Google Scholar
• NIDA. Cocaine. Vol. 2018. https://www.drugabuse.gov/publications/research-reports/cocaine/what-treatments-are-effective-cocaine-abusers2016.
   Google Scholar
• Vocci FJ Ph.D., Acri J Ph.D, Elkashef A M.D. Medication development for addictive disorders: the state of the science. Am J Psychiatry. 2005;162(8):1432–40. PMID: 16055764. doi:10.1176/appi.ajp.162.8.1432.
   PubMed Web of Science ®Google Scholar
• Kosten T, Domingo C, Orson F, Kinsey B. Vaccines against stimulants: cocaine and MA. Br J Clin Pharmacol. 2014;77(2):368–74. doi:10.1111/bcp.12115.
   PubMed Web of Science ®Google Scholar
• Kosten TR, Domingo CB, Shorter D, Orson F, Green C, Somoza E, Sekerka R, Levin FR, Mariani JJ, Stitzer M, et al. Vaccine for cocaine dependence: a randomized double-blind placebo-controlled efficacy trial. Drug Alcohol Depen. 2014;140:42–7. PMID: 24793366. doi:10.1016/j.drugalcdep.2014.04.003.
   PubMed Web of Science ®Google Scholar
• Havlicek DF, Rosenberg JB, De BP, Hicks MJ, Sondhi D, Kaminsky SM, Crystal RG. Cocaine vaccine dAd5gne protects against moderate daily and high-dose “binge” cocaine use. PloS One. 2020;15(11):e0239780. doi:10.1371/journal.pone.0239780.
   PubMed Web of Science ®Google Scholar
• Martell BA, Orson FM, Poling J, Mitchell E, Rossen RD, Gardner T, Kosten TR. Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. Arch Gen Psychiatry. 2009;66:1116–23. PMID: 19805702. doi:10.1001/archgenpsychiatry.2009.128.
   PubMed Web of Science ®Google Scholar
• Lin M, Marin A, Ellis B, Eubanks LM, Andrianov AK, KD J. Polyphosphazene: a new adjuvant platform for cocaine vaccine development. Mol Pharm. 2022;19(9):3358–66. doi:10.1021/acs.molpharmaceut.2c00489.
   PubMedGoogle Scholar
• Koch SE, Marckel JA, Rubinstein J, Norman AB. A humanized anti-cocaine mAb antagonizes the cardiovascular effects of cocaine in rats. Pharmacol Res Perspect. 2023;11(1):e01045. doi:10.1002/prp2.1045.
   PubMed Web of Science ®Google Scholar
• Scendoni R, Bury E, Ribeiro ILA, Cameriere R, Cingolani M. Vaccines as a preventive tool for substance use disorder: a systematic review including a meta-analysis on nicotine vaccines’ immunogenicity. Hum Vaccin Immunother. 2022;18:2140552. doi:10.1080/21645515.2022.2140552.
   PubMed Web of Science ®Google Scholar
• Norman AB, Gooden FC, Tabet MR, Ball WJ. A recombinant humanized anti-cocaine monoclonal antibody inhibits the distribution of cocaine to the brain in rats. Drug Metab Dispos. 2014;42:1125–31. PMID: 24733787. doi:10.1124/dmd.114.057034.
   PubMed Web of Science ®Google Scholar
• Wetzel HN, Webster RP, Saeed FO, Kirley TL, Ball WJ, Norman AB. Characterization of a recombinant humanized anti-cocaine monoclonal antibody produced from multiple clones for the selection of a master cell bank candidate. Biochem Biophys Res Commun. 2017;487(3):690–4. PMID: 28442345. doi:10.1016/j.bbrc.2017.04.117.
   PubMed Web of Science ®Google Scholar
• Kirley TL, Norman AB. Characterization of a recombinant humanized anti-cocaine monoclonal antibody and its fab fragment. Hum Vaccin Immunother. 2015;11:458–67. PMID: 25692880. doi:10.4161/21645515.2014.990856.
   PubMed Web of Science ®Google Scholar
• Norman AB, Norman MK, Buesing WR, Tabet MR, Tsibulsky VL, Ball WJ. The effect of a chimeric human/murine anti-cocaine monoclonal antibody on cocaine self-administration in rats. J Pharmacol Exp Ther. 2009;328:873–81. PMID: 19088302. doi:10.1124/jpet.108.146407.
   PubMed Web of Science ®Google Scholar
• Wetzel HN, Tsibulsky VL, Norman AB. The effects of a repeated dose of a recombinant humanized anti-cocaine monoclonal antibody on cocaine self-administration in rats. Drug Alcohol Depen. 2016;168:287–92. PMID: 27736682. doi:10.1016/j.drugalcdep.2016.09.024.
   PubMed Web of Science ®Google Scholar
• Turner ME, Wetzel HN, Zinani DB, Crutchfield CA, Norman AB. Effects of a recombinant humanized anti-cocaine monoclonal antibody on the metabolism and distribution of cocaine in vitro and in mice. Pharmacol Res Perspect. 2022;10(5):e01009. PMID: 36121122. doi:10.1002/prp2.1009.
   PubMed Web of Science ®Google Scholar
• Bazin-Redureau MI, Renard CB, Scherrmann JM. Pharmacokinetics of heterologous and homologous immunoglobulin G, F(ab‘)2 and fab after intravenous administration in the rat. J Pharm Pharmacol. 1997;49(3):277–81. PMID: 9231345. doi:10.1111/j.2042-7158.1997.tb06795.x.
   PubMed Web of Science ®Google Scholar
• Joos B, Trkola A, Kuster H, Aceto L, Fischer M, Stiegler G, Armbruster C, Vcelar B, Katinger H, Günthard HF. Long-term multiple-dose pharmacokinetics of human monoclonal antibodies (MAbs) against human immunodeficiency virus type 1 envelope gp120 (MAb 2G12) and gp41 (MAbs 4E10 and 2F5). Antimicrob Agents Chemother. 2006;50(5):1773–9. PMID: 16641449. doi:10.1128/aac.50.5.1773-1779.2006.
   PubMed Web of Science ®Google Scholar
• Paula S, Tabet MR, Keenan SM, Welsh WJ, Ball WJ Jr. Three-dimensional structure–activity relationship modeling of cocaine binding to two monoclonal antibodies by comparative molecular field analysis. J Mol Biol. 2003;325(3):515–30. PMID: 12498800. https://www.ncbi.nlm.nih.gov/pubmed/12498800.
   PubMed Web of Science ®Google Scholar
• 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. 2012;39:67–86. PMID: 22143261. doi:10.1007/s10928-011-9232-2.
   PubMed Web of Science ®Google Scholar
• Soldin OP, Mattison DR. Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. 2009;48:143–57. PMID: 19385708. doi:10.2165/00003088-200948030-00001.
   PubMed Web of Science ®Google Scholar
• Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ. 2020;11:32. doi:10.1186/s13293-020-00308-5.
   PubMed Web of Science ®Google Scholar
• Ng CM, Bruno R, Combs D, Davies B. Population pharmacokinetics of rituximab (anti-CD20 monoclonal antibody) in rheumatoid arthritis patients during a phase II clinical trial. J Clin Pharmacol. 2005;45:792–801. PMID: 15951469. doi:10.1177/0091270005277075.
   PubMed Web of Science ®Google Scholar
• Ternant D, Ducourau E, Fuzibet P, Vignault C, Watier H, Lequerré T, Le Loët X, Vittecoq O, Goupille P, Mulleman D, et al. Pharmacokinetics and concentration–effect relationship of adalimumab in rheumatoid arthritis. Br J Clin Pharmacol. 2015;79(2):286–97. PMID: 25223394. doi:10.1111/bcp.12509.
   PubMed Web of Science ®Google Scholar
• Daniels GH, Vladic A, Brinar V, Zavalishin I, Valente W, Oyuela P, Palmer J, Margolin DH. Alemtuzumab-related thyroid dysfunction in a phase 2 trial of patients with relapsing-remitting multiple sclerosis. J Clin Endocr Metab. 2014;99:80–9. doi:10.1210/jc.2013-2201.
   PubMed Web of Science ®Google Scholar
• Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018;194:295–314. doi:10.1111/cei.13208.
   PubMed Web of Science ®Google Scholar
• Lublin FD, Cutter G, Giovannoni G, Pace A, Campbell NR, Belachew S. Natalizumab reduces relapse clinical severity and improves relapse recovery in MS. Mult Scler Relat Disord. 2014;3:705–11. doi:10.1016/j.msard.2014.08.005.
   PubMed Web of Science ®Google Scholar
• Radue E-W, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Rudick RA, Lublin FD, Weinstock-Guttman B, Wynn DR, Fisher E, et al. Natalizumab plus interferon beta-1a reduces lesion formation in relapsing multiple sclerosis. J Neurol Sci. 2010;292(1–2):28–35. doi:10.1016/j.jns.2010.02.012.
   PubMed Web of Science ®Google Scholar
• Turner B, Cree BAC, Kappos L, Montalban X, Papeix C, Wolinsky JS, Buffels R, Fiore D, Garren H, Han J, et al. Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis. J Neurol. 2019;266:1182–93. doi:10.1007/s00415-019-09248-6.
   PubMed Web of Science ®Google Scholar
• Wolinsky JS, Montalban X, Hauser SL, Giovannoni G, Vermersch P, Bernasconi C, Deol-Bhullar G, Garren H, Chin P, Belachew S, et al. Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial. Ann Neurol. 2018;84(4):527–36. doi:10.1002/ana.25313.
   PubMed Web of Science ®Google Scholar
• Ornello R, Baraldi C, Guerzoni S, Lambru G, Fuccaro M, Raffaelli B, Gendolla A, Barbanti P, Aurilia C, Cevoli S, et al. Gender differences in 3-month outcomes of erenumab treatment-study on efficacy and safety of treatment with erenumab in men. Front Neurol. 2021;12:774341. PMID: 34975732. doi:10.3389/fneur.2021.774341.
   PubMed Web of Science ®Google Scholar
• Maranini B, Bortoluzzi A, Silvagni E, Govoni M. Focus on sex and gender: what we need to know in the management of rheumatoid arthritis. J Pers Med. 2022;12(3):499. doi:10.3390/jpm12030499.
   PubMed Web of Science ®Google Scholar
• Hambardzumyan K, Hermanrud C, Marits P, Vivar N, Ernestam S, Wallman JK, van Vollenhoven RF, Fogdell-Hahn A, Saevarsdottir S. Association of female sex and positive rheumatoid factor with low serum infliximab and anti-drug antibodies, related to treatment failure in early rheumatoid arthritis: results from the SWEFOT trial population. Scand J Rheumatol. 2019;48(5):362–6. doi:10.1080/03009742.2019.1602670.
   PubMed Web of Science ®Google Scholar
• Shehab M, Alasfour H, Abdullah I, Alhendi G, Alhadab A, Alfadhli A, Ziyab AH, Battat R. Relationship between patient sex and serum tumor necrosis factor antagonist drug and anti-drug antibody concentrations in inflammatory bowel disease; a nationwide cohort study. Front Med. 2021;8:801532. PMID: 35004778. doi:10.3389/fmed.2021.801532.
   PubMed Web of Science ®Google Scholar
• Hansel TT, Kropshofer H, Singer T, Mitchell JA, George AJT. The safety and side effects of monoclonal antibodies. Nat Rev Drug Discov. 2010;9:325–38. doi:10.1038/nrd3003.
   PubMed Web of Science ®Google Scholar
• Norman AB, Ball WJ Jr. Predicting the clinical efficacy and potential adverse effects of a humanized anticocaine monoclonal antibody. Immunotherapy. 2012;4:335–43. PMID: 22401638. doi:10.2217/imt.12.19.
   PubMed Web of Science ®Google Scholar
• Ovacik M, Lin K. Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development. Clin Transl Sci. 2018;11:540–52. PMID: 29877608. doi:10.1111/cts.12567.
   PubMed Web of Science ®Google Scholar
• Gerber H-P, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res. 2005;65:671–80. doi:10.1158/0008-5472.671.65.3.
   PubMed Web of Science ®Google Scholar
• Wang Y, Zheng C, Zhuang C, Fu Q, Qin J, Zhang B, Bian Y, Qi N, Zhu J. Preclinical pharmacology and toxicology evaluation of an anti-CD52 monoclonal antibody produced by perfusion fermentation process. J Ind Microbiol Biotechnol. 2021;48(9–10):48. PMID: 34669957. doi: 10.1093/jimb/kuab078.
   Web of Science ®Google Scholar
• Durandy A, Kaveri SV, Kuijpers TW, Basta M, Miescher S, Ravetch JV, Rieben R. Intravenous immunoglobulins–understanding properties and mechanisms. Clin Exp Immunol. 2009;158(Supplement_1):2–13. PMID: 19883419. doi:10.1111/j.1365-2249.2009.04022.x.
   PubMedGoogle Scholar
• Velikova T, Sekulovski M, Bogdanova S, Vasilev G, Peshevska-Sekulovska M, Miteva D, Georgiev T. Intravenous immunoglobulins as immunomodulators in autoimmune diseases and reproductive medicine. Antibodies. 2023;12:20. doi:10.3390/antib12010020.
   Web of Science ®Google Scholar
• Treadwell SD, Robinson TG. Cocaine use and stroke. Postgrad Med J. 2007;83:389–94. doi:10.1136/pgmj.2006.055970.
   PubMed Web of Science ®Google Scholar
• Fishwild DM, O’Donnell SL, Bengoechea T, Hudson DV, Harding F, Bernhard SL, Jones D, Kay RM, Higgins KM, Schramm SR, et al. High-avidity human IgG kappa monoclonal antibodies from a novel strain of minilocus transgenic mice. Nat Biotechnol. 1996;14(7):845–51. PMID: 9631008. doi:10.1038/nbt0796-845.
   PubMed Web of Science ®Google Scholar
• Haney M, Gunderson EW, Jiang H, Collins ED, Foltin RW. Cocaine-specific antibodies blunt the subjective effects of smoked cocaine in humans. Biol Psychiatry. 2010;67:59–65. PMID: 19846066. doi:10.1016/j.biopsych.2009.08.031.
   PubMed Web of Science ®Google Scholar
• Martell BA, Mitchell E, Poling J, Gonsai K, Kosten TR. Vaccine pharmacotherapy for the treatment of cocaine dependence. Biol Psychiatry. 2005;58:158–64. PMID: 16038686. doi:10.1016/j.biopsych.2005.04.032.
   PubMed Web of Science ®Google Scholar
• National Research Council (US) Committee for the Update of the Guide for the Care and Use of Laboratory Animals. Guide for the care and use of laboratory animals. Washington (DC): National Academies Press; 2011. doi:10.17226/12910.
   Google Scholar