Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline

References

• Tuccori M, Convertino I, Ferraro S, Cappello E, Valdiserra G, Focosi D, Blandizzi C. The impact of the COVID-19 “Infodemic” on drug-utilization behaviors: implications for pharmacovigilance. Drug Saf. 2020;43(8):699–8. doi:https://doi.org/10.1007/s40264-020-00965-w.
   PubMed Web of Science ®Google Scholar
• Convertino I, Tuccori M, Ferraro S, Valdiserra G, Cappello E, Focosi D, Blandizzi C. Exploring pharmacological approaches for managing cytokine storm associated with pneumonia and acute respiratory distress syndrome in COVID-19 patients. Crit Care. 2020;24(1):331. doi:https://doi.org/10.1186/s13054-020-03020-3.
   PubMed Web of Science ®Google Scholar
• Ramiro S, Mostard RLM, Magro-Checa C, van Dongen CMP, Dormans T, Buijs J, Gronenschild M, de Kruif MD, van Haren EHJ, van Kraaij T, et al. Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study. Ann Rheum Dis. 2020;79(9):1143–51. doi:https://doi.org/10.1136/annrheumdis-2020-218479.
   PubMed Web of Science ®Google Scholar
• Focosi D, Anderson AO, Tang JW, Tuccori M. Convalescent plasma therapy for COVID-19: state of the art. Clin Microbiol Rev. 2020;33(4). doi:https://doi.org/10.1128/CMR.00072-20.
   PubMed Web of Science ®Google Scholar
• Focosi D, Maggi F, Mazzetti P, Pistello M. Viral infection neutralization tests: a focus on severe acute respiratory syndrome-coronavirus-2 with implications for convalescent plasma therapy. Rev Med Virol. 2020 Aug. doi:https://doi.org/10.1002/rmv.2170.
   Google Scholar
• Daniele F, Marco T, Guido A, Fabrizio M. What is the optimal usage of Covid-19 convalescent plasma donations? Clin Microbiol Infect Off Publ Eur Soc Clin Microbiol Infect Dis. 2020 Sep. doi:https://doi.org/10.1016/j.cmi.2020.09.036.
   Google Scholar
• Dong J, Huang B, Jia Z, Wang B, Gallolu Kankanamalage S, Titong A, Liu Y. Development of multi-specific humanized llama antibodies blocking SARS-CoV-2/ACE2 interaction with high affinity and avidity. Emerg Microbes Infect. 2020;9(1):1034–36. doi:https://doi.org/10.1080/22221751.2020.1768806.
   PubMed Web of Science ®Google Scholar
• Kreer C, Zehner M, Weber T, Ercanoglu MS, Gieselmann L, Rohde C, Halwe S, Korenkov M, Schommers P, Vanshylla K, et al. Longitudinal isolation of potent near-germline SARS-CoV-2-neutralizing antibodies from COVID-19 patients. Cell. 2020;182(4):843–854.e12. doi:https://doi.org/10.1016/j.cell.2020.06.044.
   PubMed Web of Science ®Google Scholar
• Karthik K, Senthilkumar TMA, Udhayavel S, Raj GD. Role of antibody-dependent enhancement (ADE) in the virulence of SARS-CoV-2 and its mitigation strategies for the development of vaccines and immunotherapies to counter COVID-19. Hum Vaccin Immunother. Aug 2020;1–6. doi:https://doi.org/10.1080/21645515.2020.1796425.
   Google Scholar
• Andabaka T, Nickerson JW, Rojas-Reyes MX, Rueda JD, Bacic Vrca V, Barsic B. Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children. Cochrane Database Syst Rev. 2013;(4)CD006602. doi:https://doi.org/10.1002/14651858.CD006602.pub4.
   Google Scholar
• Mulangu S, Dodd LE, Davey RTJ, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, et al. A randomized, controlled trial of ebola virus disease therapeutics. N Engl J Med. 2019;381(24):2293–303. doi:https://doi.org/10.1056/NEJMoa1910993.
   PubMed Web of Science ®Google Scholar
• Sajna KV, Kamat S. Antibodies at work in the time of SARS-CoV-2. Cytotherapy. 2020 Aug. doi:https://doi.org/10.1016/j.jcyt.2020.08.009.
   Google Scholar
• Yang L, Liu W, Yu X, Wu M, Reichert JM, Ho MCOVID-19. Antibody therapeutics tracker: a global online database of antibody therapeutics for the prevention and treatment of COVID-19. Antib Ther. 2020 Aug. doi:https://doi.org/10.1093/abt/tbaa020.
   Google Scholar
• Pinto D, Park Y-J, Beltramello M, Walls AC, Tortorici MA, Bianchi S, Jaconi S, Culap K, Zatta F, De Marco A, et al. Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody. Nature. 2020;583(7815):290–95. doi:https://doi.org/10.1038/s41586-020-2349-y.
   PubMed Web of Science ®Google Scholar
• [no author listed]. Vir biotechnology and GSK start phase 2/3 study of COVID-19 antibody treatment. GSK website.
   Google Scholar
• [no author listed]. VIR-7831 for the early treatment of COVID-19 in outpatients (COMET-ICE). clinicaltrials.gov.
   Google Scholar
• Abbasi J. COVID-19 antibody trials have begun. JAMA. 2020;324(2):128. doi:https://doi.org/10.1001/jama.2020.11582.
   Web of Science ®Google Scholar
• Yaragalla S, Narang P, Kadam KJ, Remedios, Kimberly C, Sahni S, Singh A, Khan N, Yadav S, et al. COVID-19 pandemic: a comprehensive updated review with an artificial intelligence (AI). [ Accessed 2020 Oct 1]. http://www.onlinescientificresearch.com/articles/covid19-pandemic-a-comprehensive-updated-review-with-an-artificial-intelligence-ai.pdf.
   Google Scholar
• Florindo HF, Kleiner R, Vaskovich-Koubi D, Acúrcio RC, Carreira B, Yeini E, Tiram G, Liubomirski Y, Satchi-Fainaro R. Immune-mediated approaches against COVID-19. Nat Nanotechnol. 2020;15(8):630–45. doi:https://doi.org/10.1038/s41565-020-0732-3.
   PubMed Web of Science ®Google Scholar
• [no author listed]. Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting. Eli Lilly webpage.
   Google Scholar
• A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19 - Full Text View - ClinicalTrials.gov. [Accessed 2020 Oct 1]. https://clinicaltrials.gov/ct2/show/NCT04411628?cond=NCT04411628&draw=2&rank=1.
   Google Scholar
• A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1). clinicaltrials.gov.. [Accessed 2020 Nov 9].
   Google Scholar
• Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. N Engl J Med. 2020 Oct:NEJMoa2029849. doi:https://doi.org/10.1056/NEJMoa2029849.
   Google Scholar
• Kinch MS. Oh, the frustration of antibodies! ACS Pharmacol Transl Sci. Sep 2020;acsptsci.0c00138. doi:https://doi.org/10.1021/acsptsci.0c00138.
   Google Scholar
• Bamlanivimab COVID-19 Treatment — Precision Vaccinations. [Accessed 2020 Nov 4]. https://www.precisionvaccinations.com/vaccines/bamlanivimab-covid-19-treatment.
   Google Scholar
• [no author listed]. A study of LY3819253 (LY-CoV555) in preventing SARS-CoV-2 infection and COVID-19 in nursing home residents and staff (BLAZE-2). clinicaltrials.gov.
   Google Scholar
• [no author listed]. ACTIV-2: a study for outpatients with COVID-19. clinicaltrials.gov.
   Google Scholar
• [no author listed]. ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO). clinicaltrials.gov.
   Google Scholar
• Lovelace B, Farr C U.S. pauses Eli Lilly’s trial of a coronavirus antibody treatment over safety concerns. CNBC website. Published 2020 [Accessed 2020 Oct 15]. https://www.cnbc.com/2020/10/13/us-pauses-eli-lillys-trial-of-a-coronavirus-antibody-treatment-over-safety-concerns.html.
   Google Scholar
• [no author listed]. Coronavirus (COVID-19) update: FDA authorizes monoclonal antibody for treatment of COVID-19. FDA Official Website. Published 2020 [Accessed 2020 Nov 10]. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19.
   Google Scholar
• [no author listed]. A message from BeiGene regarding our COVID-19 (coronavirus) response. Beigene website.
   Google Scholar
• Cao Y, Su B, Guo X, Sun W, Deng Y, Bao L, Zhu Q, Zhang X, Zheng Y, Geng C, et al. Potent neutralizing antibodies against SARS-CoV-2 identified by high-throughput single-cell sequencing of convalescent patients’ B cells. Cell. 2020;182(1):73–84.e16. doi:https://doi.org/10.1016/j.cell.2020.05.025.
   PubMed Web of Science ®Google Scholar
• Prabakaran P, Gan J, Feng Y, Zhu Z, Choudhry V, Xiao X, Ji X, Dimitrov DS. Structure of severe acute respiratory syndrome coronavirus receptor-binding domain complexed with neutralizing antibody. J Biol Chem. 2006;281(23):15829–36. doi:https://doi.org/10.1074/jbc.M600697200.
   PubMed Web of Science ®Google Scholar
• [no author listed]. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody BGB-DXP593 in participants with mild-to-moderate coronavirus disease 2019 (COVID-19). clinicaltrials.gov.
   Google Scholar
• Prabakaran P, Gan J, Feng Y,  Zhu Z, Choudhry V, Xiao X, Ji X, Dimitrov DS. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody BGB-DXP593 in participants with mild-to-moderate coronavirus disease 2019 (COVID-19) - full text view - clinicaltrials.gov. J Biol Chem. 2006. [Accessed 2020 Sep 29]. https://clinicaltrials.gov/ct2/show/study/NCT04551898?term=BGB-DXP593&draw=2&rank=1.
   PubMed Web of Science ®Google Scholar
• Pascal KE, Dudgeon D, Trefry JC, Anantpadma M, Sakurai Y, Murin CD, Turner HL, Fairhurst J, Torres M, Rafique A, et al. Development of clinical-stage human monoclonal antibodies that treat advanced ebola virus disease in nonhuman primates. J Infect Dis. 2020;612(5):218. doi:https://doi.org/10.1093/infdis/jiy285.
   Google Scholar
• Hansen J, Baum A, Pascal KE, Russo V, Giordano S, Wloga E, Fulton BO, Yan Y, Koon K, Patel K, et al. Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail. Science (80-). 2020;369(6506):1010–14. doi:https://doi.org/10.1126/science.abd0827.
   PubMed Web of Science ®Google Scholar
• Baum A, Fulton BO, Wloga E, Copin R, Pascal KE, Russo V, Giordano S, Lanza K, Negron N, Ni M, et al. Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies. Science (80-). 2020;1018(August):1014–18.
   Web of Science ®Google Scholar
• Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19. [ Accessed 2020 Oct 4]. https://clinicaltrials.gov/ct2/show/NCT04426695?term=REGN-10933&cond=COVID-19&phase=1235&draw=2&rank=2.
   Google Scholar
• [no author listed]. Safety, tolerability, and efficacy of anti-spike (S) SARS-CoV-2 monoclonal antibodies for the treatment of ambulatory adult patients with COVID-19. clinicaltrials.gov.
   Google Scholar
• [no author listed]. Regeneron’s REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients. Regeneron website.
   Google Scholar
• Regeneron Pharmaceuticals. Regeneron’ s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention. Published online. PRNewswire Oct. 28, 2020 PRNewswire.
   Google Scholar
• Regeneron Pharmaceuticals. REGN-COV2 independent data monitoring committee recommends holding enrollment in hospitalized patients with high oxygen requirements and continuing enrollment in patients with low or no oxygen requirements. 2021.
   Google Scholar
• [no author listed]. Monoclonal antibodies study for prevention of SARS CoV-2 infection in healthy adults who are household contacts to an individual with a positive COVID-19 test. niaid.nih.gov.
   Google Scholar
• Mahase E. Covid-19: RECOVERY trial will evaluate “antiviral antibody cocktail”. Br Med J. 2020;370(m3584). doi:https://doi.org/10.1136/bmj.m3584.
   Google Scholar
• [no author listed]. Randomised Evaluation of COVID-19 Therapy (RECOVERY). clinicaltrials.gov.
   Google Scholar
• Casirivimab and Imdevimab. https://www.regeneron.com/casirivimab-imdevimab. [Accessed November 27, 2020]
   Google Scholar
• Celltrion accelerates development of COVID-19 antiviral treatment. [Accessed 2020 Nov 3]. https://www.celltrionhealthcare.com/en-us/board/newsdetail?modify_key=174&pagenumber=1&keyword=&keyword_type=.
   Google Scholar
• Soo-Young L, Cheolmin K, Dong-Kyun, Jihun L, Young-Il K, Ji-Min S, Yeon-Gil K, Jae-Hee J, Minsoo K, Jong-In K, et al. A Novel Neutralizing Antibody Targeting Receptor Binding Domain of SARS-CoV-2, 10 September 2020, PREPRINT (Version 1); Research Square. https://doi.org/10.21203/rs.3.rs–59639/v1
   Google Scholar
• Li Q, Wu J, Nie J, Zhang L, Hao H, Liu S, Zhao C, Zhang Q, Liu H, Nie L, et al. The impact of mutations in SARS-CoV-2 spike on viral infectivity and antigenicity. Cell. 2020;182(5):1284–1294.e9. doi:https://doi.org/10.1016/j.cell.2020.07.012.
   PubMed Web of Science ®Google Scholar
• To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects - Full Text View - ClinicalTrials.gov. [Accessed 2020 Nov 3]. https://clinicaltrials.gov/ct2/show/NCT04525079?term=NCT04525079&draw=2&rank=1.
   Google Scholar
• Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59. [Accessed 2020 Nov 3]. https://www.celltrionhealthcare.com/en-us/board/newsdetail?modify_key=364&keyword=&keyword_type=.
   Google Scholar
• This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) - Full Text View - ClinicalTrials.gov. [Accessed Nov 3]. https://clinicaltrials.gov/ct2/show/NCT04593641?term=NCT04593641&draw=2&rank=1.
   Google Scholar
• Celltrion receives Korean MFDS approval to initiate Phase I trial of CT-P59 in patients. [Accessed Nov 3]. https://www.celltrionhealthcare.com/en-us/board/newsdetail?modify_key=353&keyword=&keyword_type=.
   Google Scholar
• To Evaluate the Safety and Efficacy of CT-P59 in Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19 - Full Text View - ClinicalTrials.gov. [Accessed 2020 Nov 3]. https://clinicaltrials.gov/ct2/show/study/NCT04602000?term=CT-P59&draw=2&rank=2.
   Google Scholar
• Shi R, Shan C, Duan X, Chen Z, Liu P, Song J, Song T, Bi X, Han C, Wu L, et al. A human neutralizing antibody targets the receptor-binding site of SARS-CoV-2. Nature. 2020;584(7819):120–24. doi:https://doi.org/10.1038/s41586-020-2381-y.
   PubMed Web of Science ®Google Scholar
• Chakraborty S. Neutralizing antibodies: viable treatment modality for COVID-19. Biotechnol Kiosk. 2020;2(6):10–16. doi:https://doi.org/10.37756/bk.20.2.6.2.
   Google Scholar
• Nalawansha DA, Samarasinghe KTG. Double-barreled CRISPR technology as a novel treatment strategy for COVID-19. ACS Pharmacol Transl Sci. 2020 Sep;3:790–800. doi:https://doi.org/10.1021/acsptsci.0c00071.
   PubMedGoogle Scholar
• Phelan J, Deelder W, Ward D, Campino S, Hibberd ML, Clark TG. Controlling the SARS-CoV-2 outbreak, insights from large scale whole genome sequences generated across the world. bioRxiv. 2020 Jan. doi:https://doi.org/10.1101/2020.04.28.066977.
   Google Scholar
• Koyama T, Weeraratne D, Snowdon JL, Parida L. Emergence of drift variants that may affect COVID-19 vaccine development and antibody treatment. Pathog (Basel, Switzerland). 2020;9(5). doi:https://doi.org/10.3390/pathogens9050324.
   Google Scholar
• Zhang L, Jackson CB, Mou H, Ojha A, Rangarajan E, Izard T, Farzan M, Choe H, et al. The D614G mutation in the SARS-CoV-2 spike protein reduces S1 shedding and increases infectivity. bioRxiv. 2020 Jan. doi:https://doi.org/10.1101/2020.06.12.148726.
   Google Scholar
• Weissman D, Alameh MG, de Silva T, Collini P, Hornsby H, Brown R, LaBranche CC, Edwards RJ, Sutherland L, Santra S, et al. D614G spike mutation increases SARS CoV-2 susceptibility to neutralization. medRxiv. 2020 Jan. doi:https://doi.org/10.1101/2020.07.22.20159905.
   Google Scholar
• Lee CY-P, Amrun SN, Chee RS-L, Goh Y S, Mak T-M, Octavia S, Yeo N K-W, Chang ZW, Tay MZ, Torres-Ruesta A, et al. Neutralizing antibodies from early cases of SARS-CoV-2 infection offer cross-protection against the SARS-CoV-2 D614G variant. bioRxiv. 2020 Jan. doi:https://doi.org/10.1101/2020.10.08.332544.
   Google Scholar
• Klingler J, Weiss S, Itri V, Liu, Xiaomei, Oguntuyo KY, Stevens C, Ikegame S, Hung C-T, Enyindah-Asonye G, Amanat F, et al. Role of IgM and IgA antibodies to the neutralization of SARS-CoV-2. medRxiv. 2020 Jan. doi:https://doi.org/10.1101/2020.08.18.20177303.
   Google Scholar
• Gasser R, Cloutier M, Prévost J, Fink C, Ducas E, Ding S, Dussault N, Landry P, Tremblay T, Laforce-Lavoie A, et al. Major role of IgM in the neutralizing activity of convalescent plasma against SARS-CoV-2. bioRxiv. 2020 Jan. doi:https://doi.org/10.1101/2020.10.09.333278.
   Google Scholar
• Subbarao K, Mordant F, Rudraraju R. Convalescent plasma treatment for COVID-19: tempering expectations with the influenza experience. Eur J Immunol. 2020;50(10):1447–53. doi:https://doi.org/10.1002/eji.202048723.
   PubMed Web of Science ®Google Scholar
• Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw F-M, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR, et al. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015;211(1):80–90. doi:https://doi.org/10.1093/infdis/jiu396.
   PubMed Web of Science ®Google Scholar
• Wang K, Chen W, Zhou Y-S, Lian J-Q, Zhang Z, Du P, Gong L, Zhang Y, Cui H-Y, Geng J-J, et al. SARS-CoV-2 invades host cells via a novel route: CD147-spike protein. bioRxiv. 2020 Mar. doi:https://doi.org/10.1101/2020.03.14.988345.
   Google Scholar