Preclinical assessment and randomized Phase I study of CT-P63, a broadly neutralizing antibody targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

References

• World Health Organization. WHO coronavirus (COVID-19) dashboard [Internet]. 2022 [cited 2022 May 17]. Available from: https://covid19.who.int/.
   Google Scholar
• Bruzzesi E, Ranzenigo M, Castagna A, et al. Neutralizing monoclonal antibodies for the treatment and prophylaxis of SARS-CoV-2 infection. New Microbiol. 2021;44(3):135–144.
   PubMed Web of Science ®Google Scholar
• Shang J, Ye G, Shi K, et al. Structural basis of receptor recognition by SARS-CoV-2. Nature. 2020;581(7807):221–224.
   PubMed Web of Science ®Google Scholar
• Hoffmann M, Kleine-Weber H, Schroeder S, et al. SARS-CoV-2 cell entry depends on ACE2 and TMPRSS2 and is blocked by a clinically proven protease inhibitor. Cell. 2020;181(2):271–280.e278.
   PubMed Web of Science ®Google Scholar
• Mornese Pinna S, Lupia T, Scabini S, et al. Monoclonal antibodies for the treatment of COVID-19 patients: an umbrella to overcome the storm? Int Immunopharmacol. 2021;101(Pt A):108200–108200.
   PubMedGoogle Scholar
• Gottlieb RL, Nirula A, Chen P, et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2021;325(7):632–644.
   PubMed Web of Science ®Google Scholar
• Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Early treatment for COVID-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med. 2021;385(21):1941–1950.
   PubMed Web of Science ®Google Scholar
• Streinu-Cercel A, Săndulescu O, Preotescu L-L, et al. Efficacy and safety of regdanvimab (CT-P59): a Phase 2/3 randomized, double-blind, placebo-controlled trial in outpatients with mild-to-moderate coronavirus disease 2019. Open Forum Infect Dis. 2022;9(4):ofac053.
   PubMed Web of Science ®Google Scholar
• Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19. N Engl J Med. 2021;384(3):238–251.
   PubMed Web of Science ®Google Scholar
• Planas D, Veyer D, Baidaliuk A, et al. Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization. Nature. 2021;596(7871):276–280.
   PubMed Web of Science ®Google Scholar
• Wang P, Nair MS, Liu L, et al. Antibody resistance of SARS-CoV-2 variants B.1.351 and B.1.1.7. Nature. 2021;593(7857):130–135.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Tracking SARS-CoV-2 variants [Internet]. 2022 [cited 2022 Apr 20]. Available from: https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/.
   Google Scholar
• Callaway E. Heavily mutated Omicron variant puts scientists on alert. Nature. 2021;600(7887):21.
   PubMed Web of Science ®Google Scholar
• Jung C, Kmiec D, Koepke L, et al. Omicron: what makes the latest SARS-CoV-2 variant of concern so concerning? J Virol. 2022;96(6):e0207721.
   PubMed Web of Science ®Google Scholar
• Mahase E. COVID-19: what do we know about omicron sublineages? Br Med J. 2022;376:o358.
   PubMedGoogle Scholar
• Mahase E. Omicron sub-lineage BA.2 may have “substantial growth advantage,” UKHSA reports. Br Med J. 2022;376:o263.
   PubMedGoogle Scholar
• Yu J, Collier AY, Rowe M, et al. Neutralization of the SARS-CoV-2 Omicron BA.1 and BA.2 variants. N Engl J Med. 2022;386(16):1579–1580.
   PubMed Web of Science ®Google Scholar
• Shah M, Woo HG. Omicron: a heavily mutated SARS-CoV-2 variant exhibits stronger binding to ACE2 and potently escapes approved COVID-19 therapeutic antibodies. Front Immunol. 2022;12:830527–830527.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Hu YF, Hu JC, Chu H, et al. In-silico analysis of monoclonal antibodies against SARS-CoV-2 Omicron. Viruses. 2022;14(2):390.
   PubMed Web of Science ®Google Scholar
• VanBlargan LA, Errico JM, Halfmann PJ, et al. An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies. Nat Med. 2022;28(3):490–495.
   PubMed Web of Science ®Google Scholar
• Iketani S, Liu L, Guo Y, et al. Antibody evasion properties of SARS-CoV-2 Omicron sublineages. Nature. 2022;604(7906):553–556.
   PubMed Web of Science ®Google Scholar
• Kim C, Ryu DK, Lee J, et al. A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Nat Commun. 2021;12(1):288.
   PubMed Web of Science ®Google Scholar
• Ryu DK, Kang B, Noh H, et al. The in vitro and in vivo efficacy of CT-P59 against Gamma, Delta and its associated variants of SARS-CoV-2. Biochem Biophys Res Commun. 2021;578:91–96.
   PubMed Web of Science ®Google Scholar
• Halfmann PJ, Iida S, Iwatsuki-Horimoto K, et al. SARS-CoV-2 Omicron virus causes attenuated disease in mice and hamsters. Nature. 2022;603(7902):687–692.
   PubMed Web of Science ®Google Scholar
• Shuai H, Chan JF, Hu B, et al. Attenuated replication and pathogenicity of SARS-CoV-2 B.1.1.529 Omicron. Nature. 2022;603(7902):693–699.
   PubMed Web of Science ®Google Scholar
• Cao Y, Wang J, Jian F, et al. Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. Nature. 2022;602(7898):657–663.
   PubMed Web of Science ®Google Scholar
• Lusvarghi S, Pollett SD, Neerukonda SN, et al. SARS-CoV-2 BA.1 variant is neutralized by vaccine booster-elicited serum, but evades most convalescent serum and therapeutic antibodies. Sci Transl Med. 2022 [Apr 6];14(645):eabn8543.
   PubMed Web of Science ®Google Scholar
• Ryu DK, Song R, Kim M, et al. Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant. Biochem Biophys Res Commun. 2021;566:135–140.
   PubMed Web of Science ®Google Scholar
• Sheward DJ, Kim C, Ehling RA, et al. Neutralisation sensitivity of the SARS-CoV-2 omicron (B.1.1.529) variant: a cross-sectional study. Lancet Infect Dis. 2022;22(6):813–820.
   PubMed Web of Science ®Google Scholar
• Callaway E. Are COVID surges becoming more predictable? New Omicron variants offer a hint. Nature. 2022;605(7909):204–206.
   PubMed Web of Science ®Google Scholar
• Goldin L, Elders T, Werhane L, et al. Reactions and COVID-19 disease progression following SARS-CoV-2 monoclonal antibody infusion. Int J Infect Dis. 2021;112:73–75.
   PubMed Web of Science ®Google Scholar
• Taylor PC, Adams AC, Hufford MM, et al. Neutralizing monoclonal antibodies for treatment of COVID-19. Nat Rev Immunol. 2021;21(6):382–393.
   PubMed Web of Science ®Google Scholar