2,036
Views
0
CrossRef citations to date
0
Altmetric
Emerging and Re-Emerging Coronaviruses

In vivo delivery of engineered synthetic DNA-encoded SARS-CoV-2 monoclonal antibodies for pre-exposure prophylaxis in non-human primates

, , , , , , , , , , , , , , , , , , , , , , , , , , ORCID Icon, & ORCID Icon show all
Article: 2294860 | Received 11 Jul 2023, Accepted 11 Dec 2023, Published online: 28 Feb 2024

References

  • Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020;20(5):533–534. doi:10.1016/S1473-3099(20)30120-1 PubMed PMID: 32087114; PubMed Central PMCID: PMCPMC7159018.
  • Premkumar L, Segovia-Chumbez B, Jadi R, et al. The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci Immunol. 2020;5(48):eabc8413. doi:10.1126/sciimmunol.abc8413 PubMed PMID: 32527802; PubMed Central PMCID: PMCPMC7292505.
  • CDC. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. [accessed 2022 September]. Available from: https://www.covid19treatmentguidelines.nih.gov/.
  • Cao Y, Yisimayi A, Jian F, et al. BA.2.12.1, BA.4 and BA.5 escape antibodies elicited by Omicron infection. Nature. 2022;608(7923):593–602. doi:10.1038/s41586-022-04980-y. PubMed PMID: 35714668; PubMed Central PMCID: PMCPMC9385493.
  • Takashita E, Kinoshita N, Yamayoshi S, et al. Efficacy of antibodies and antiviral drugs against Covid-19 Omicron variant. N Engl J Med. 2022;386(10):995–998. doi:10.1056/NEJMc2119407. PubMed PMID: 35081300; PubMed Central PMCID: PMCPMC8809508.
  • Yamasoba D, Kosugi Y, Kimura I, et al. Neutralisation sensitivity of SARS-CoV-2 omicron subvariants to therapeutic monoclonal antibodies. Lancet Infect Dis. 2022;22(7):942–943. doi:10.1016/S1473-3099(22)00365-6. PubMed PMID: 35690075; PubMed Central PMCID: PMCPMC9179126 was supported in part by the Japan Agency for Medical Research and Development (AMED) Research Program on Emerging and Re-emerging Infectious Diseases (JP22fk0108146 to KS, JP20fk0108413 to KS, and JP20fk0108451 to G2P-Japan Consortium and KS), the AMED Research Program on HIV/AIDS (JP22fk0410039 to KS), the Japan Science and Technology Agency CREST programme (JPMJCR20H4 to KS), the Japan Society for the Promotion of Science (JSPS) Fund for the Promotion of Joint International Research (Fostering Joint International Research; 18KK0447 to KS), the JSPS Core-to-Core Program JPJSCCA20190008 (A. Advanced Research Networks; to KS), the JSPS Research Fellow DC2 22J11578 (to KU), and The Tokyo Biochemical Research Foundation (to KS).
  • Planas D, Saunders N, Maes P, et al. Considerable escape of SARS-CoV-2 Omicron to antibody neutralization. Nature. 2022;602(7898):671–675. doi:10.1038/s41586-021-04389-z. PubMed PMID: 35016199.
  • Ai J, Wang X, He X, et al. Antibody evasion of SARS-CoV-2 Omicron BA.1, BA.1.1, BA.2, and BA.3 sub-lineages. Cell Host Microbe. 2022;30(8):1077–1083 e4. doi:10.1016/j.chom.2022.05.001. PubMed PMID: 35594867; PubMed Central PMCID: PMCPMC9080084.
  • (NIH) NIoH. COVID-19 Treatment Guidelines 2023 [cited 2023 June 9]. Available from: https://www.covid19treatmentguidelines.nih.gov/therapies/antivirals-including-antibody-products/anti-sars-cov-2-monoclonal-antibodies/.
  • Zost SJ, Gilchuk P, Chen RE, et al. Rapid isolation and profiling of a diverse panel of human monoclonal antibodies targeting the SARS-CoV-2 spike protein. Nat Med. 2020;26(9):1422–1427. doi:10.1038/s41591-020-0998-x. PubMed PMID: 32651581; PubMed Central PMCID: PMCPMC8194108.
  • Dong J, Zost SJ, Greaney AJ, et al. Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail. Nat Microbiol. 2021;6(10):1233–1244. doi:10.1038/s41564-021-00972-2. PubMed PMID: 34548634; PubMed Central PMCID: PMCPMC8543371.
  • Oganesyan V, Gao C, Shirinian L, et al. Structural characterization of a human Fc fragment engineered for lack of effector functions. Acta Crystallogr D Biol Crystallogr. 2008;64(Pt 6):700–704. doi:10.1107/S0907444908007877. PubMed PMID: 18560159; PubMed Central PMCID: PMCPMC2467532.
  • Dall'Acqua WF, Woods RM, Ward ES, et al. Increasing the affinity of a human IgG1 for the neonatal Fc receptor: biological consequences. J Immunol. 2002;169(9):5171–5180. doi:10.4049/jimmunol.169.9.5171. PubMed PMID: 12391234.
  • Zost SJ, Gilchuk P, Case JB, et al. Potently neutralizing and protective human antibodies against SARS-CoV-2. Nature. 2020;584(7821):443–449. doi:10.1038/s41586-020-2548-6. PubMed PMID: 32668443; PubMed Central PMCID: PMCPMC7584396.
  • Chen RE, Winkler ES, Case JB, et al. In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains. Nature. 2021;596(7870):103–108. doi:10.1038/s41586-021-03720-y. PubMed PMID: 34153975; PubMed Central PMCID: PMCPMC8349859.
  • Levin MJ,, Ustianowski A, De Wit S, et al. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022;386(23):2188–2200. doi:10.1056/NEJMoa2116620. PubMed PMID: 35443106; PubMed Central PMCID: PMCPMC9069994.
  • Patel A, Park DH, Davis CW, et al. In vivo delivery of synthetic human DNA-encoded monoclonal antibodies protect against ebolavirus infection in a mouse model. Cell Rep. 2018; 25(7):1982–1993.e4. doi:10.1016/j.celrep.2018.10.062. PubMed PMID: 30428362; PubMed Central PMCID: PMCPMC6319964.
  • Esquivel RN, Patel A, Kudchodkar SB, et al. In vivo delivery of a DNA-encoded monoclonal antibody protects non-human primates against Zika virus. Mol Ther. 2019;27(5):974–985. doi:10.1016/j.ymthe.2019.03.005. PubMed PMID: 30962164; PubMed Central PMCID: PMCPMC6520333.
  • Wise MC, Xu Z, Tello-Ruiz E, et al. In vivo delivery of synthetic DNA-encoded antibodies induces broad HIV-1-neutralizing activity. J Clin Invest. 2020;130(2):827–837. doi:10.1172/JCI132779 PubMed PMID: 31697648; PubMed Central PMCID: PMCPMC6994112.
  • Parzych EM, Du J, Ali AR, et al. DNA-delivered antibody cocktail exhibits improved pharmacokinetics and confers prophylactic protection against SARS-CoV-2. Nat Commun. 2022;13(1):5886. doi:10.1038/s41467-022-33309-6. PubMed PMID: 36202799; PubMed Central PMCID: PMCPMC9537531.
  • Loo YM, McTamney PM, Arends RH, et al. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Sci Transl Med. 2022;14(635):eabl8124. doi:10.1126/scitranslmed.abl8124. PubMed PMID: 35076282; PubMed Central PMCID: PMCPMC8939769.
  • Rosenke K, Jarvis MA, Feldmann F, et al. Hydroxychloroquine prophylaxis and treatment is ineffective in macaque and hamster SARS-CoV-2 disease models. JCI Insight. 2020;5(23):e143174. doi:10.1172/jci.insight.143174. PubMed PMID: 33090972; PubMed Central PMCID: PMCPMC7714406.
  • Munster VJ, Feldmann F, Williamson BN, et al. Respiratory disease in rhesus macaques inoculated with SARS-CoV-2. Nature. 2020;585(7824):268–272. doi:10.1038/s41586-020-2324-7. PubMed PMID: 32396922; PubMed Central PMCID: PMCPMC7486227.
  • Bender MA. Blood volume of the rhesus monkey. Science. 1955;122(3160):156. PubMed PMID: 14396375. doi:10.1126/science.122.3160.156.a
  • Arvin AM, Fink K, Schmid MA, et al. A perspective on potential antibody-dependent enhancement of SARS-CoV-2. Nature. 2020;584(7821):353–363. doi:10.1038/s41586-020-2538-8. PubMed PMID: 32659783.
  • Gartlan C, Tipton T, Salguero FJ, et al. Vaccine-Associated Enhanced Disease and Pathogenic Human Coronaviruses. Front Immunol. 2022;13:882972. doi:10.3389/fimmu.2022.882972. PubMed PMID: 35444667; PubMed Central PMCID: PMCPMC9014240.
  • Dall'Acqua WF, Kiener PA, Wu H. Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn). J Biol Chem. 2006;281(33):23514–23524. doi:10.1074/jbc.M604292200. PubMed PMID: 16793771.
  • Sheets RL, Stein J, Manetz TS, et al. Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. Toxicol Sci. 2006;91(2):620–630. doi:10.1093/toxsci/kfj170. PubMed PMID: 16569728; PubMed Central PMCID: PMCPMC2366098.
  • Sheets RL, Stein J, Manetz TS, et al. Biodistribution of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar, without integration, despite differing plasmid backbones or gene inserts. Toxicol Sci. 2006;91(2):610–619. doi:10.1093/toxsci/kfj169. PubMed PMID: 16569729; PubMed Central PMCID: PMCPMC2377020.
  • Wang Z, Troilo PJ, Wang X, et al. Detection of integration of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Ther. 2004;11(8):711–721. doi:10.1038/sj.gt.3302213. PubMed PMID: 14724672.
  • U.S. Department of Health and Human Services FaDA, Center for Biologics Evaluation and Research. Considerations for plasmid DNA vaccines for infectious disease indications In: U.S. Department of Health and Human Services, editor; 2007.
  • Zhang L, Bisht P, Flamier A, et al. LINE1-Mediated reverse transcription and genomic integration of SARS-CoV-2 mRNA detected in virus-infected but not in viral mRNA-transfected cells. Viruses. 2023;15(3):629. doi:10.3390/v15030629. PubMed PMID: 36992338; PubMed Central PMCID: PMCPMC10057545.
  • Patel A, Bah MA, Weiner DB. In vivo delivery of nucleic acid-encoded monoclonal antibodies. BioDrugs. 2020;34(3):273–293. doi:10.1007/s40259-020-00412-3. PubMed PMID: 32157600; PubMed Central PMCID: PMCPMC7211204 related to DMAbs. D. B. W. has received grant funding, participates in industry collaborations, has received speaking honoraria, and has received fees for consulting, including serving on scientific review committees and board service. Remuneration received by D. B. W. includes direct payments or stock or stock options, and, in the interest of disclosure, he notes potential conflicts associated with this work with Inovio and possibly others. In addition, he has patents on DMAbs and DNA vaccine delivery.
  • Kose N, Fox JM, Sapparapu G, et al. A lipid-encapsulated mRNA encoding a potently neutralizing human monoclonal antibody protects against chikungunya infection. Sci Immunol. 2019;4(35):eaaw6647. doi:10.1126/sciimmunol.aaw6647. PubMed PMID: 31101672; PubMed Central PMCID: PMCPMC6629435.
  • August A, Attarwala HZ, Himansu S, et al. A phase 1 trial of lipid-encapsulated mRNA encoding a monoclonal antibody with neutralizing activity against Chikungunya virus. Nat Med. 2021;27(12):2224–2233. doi:10.1038/s41591-021-01573-6. PubMed PMID: 34887572; PubMed Central PMCID: PMCPMC8674127.
  • Elliott STC, Kallewaard NL, Benjamin E, et al. DMAb inoculation of synthetic cross reactive antibodies protects against lethal influenza A and B infections. NPJ Vaccines. 2017;2:18, doi:10.1038/s41541-017-0020-x. PubMed PMID: 29263874; PubMed Central PMCID: PMCPMC5627301.
  • van Meer PJ, Kooijman M, Brinks V, et al. Immunogenicity of mAbs in non-human primates during nonclinical safety assessment. MAbs. 2013;5(5):810–816. doi:10.4161/mabs.25234. PubMed PMID: 23924803; PubMed Central PMCID: PMCPMC3851233.
  • Brennan FR, Cavagnaro J, McKeever K, et al. Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment. MAbs. 2018;10(1):1–17. doi:10.1080/19420862.2017.1389364. PubMed PMID: 28991509; PubMed Central PMCID: PMCPMC5800363.
  • Flingai S, Plummer EM, Patel A, et al. Protection against dengue disease by synthetic nucleic acid antibody prophylaxis/immunotherapy. Sci Rep. 2015;5:12616, doi:10.1038/srep12616. PubMed PMID: 26220099; PubMed Central PMCID: PMCPMC4518257.
  • Khoshnejad M, Patel A, Wojtak K, et al. Development of novel DNA-encoded PCSK9 monoclonal antibodies as lipid-lowering therapeutics. Mol Ther. 2019;27(1):188–199. doi:10.1016/j.ymthe.2018.10.016. PubMed PMID: 30449662; PubMed Central PMCID: PMCPMC6319316.
  • Ko S, Jo M, Jung ST. Recent achievements and challenges in prolonging the serum half-lives of therapeutic IgG antibodies through fc engineering. BioDrugs. 2021;35(2):147–157. doi:10.1007/s40259-021-00471-0. PubMed PMID: 33608823; PubMed Central PMCID: PMCPMC7894971.