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. Author manuscript; available in PMC: 2018 Jan 11.
Published in final edited form as: Vaccine. 2016 Sep 28;35(3):496–502. doi: 10.1016/j.vaccine.2016.09.026

Table 1.

Anti-RSV antibodies at different stages of development

Antibody
Class		 Name/
Company		 Development
phase		 Route Target Class Endpoints/
Target Population		 Comments
(1) Nanobodies ALX0171 (Ablynx) Phase-IIa RCT completed Inhaled F Antibody
nanobody		 Treatment of infants and toddlers with RSV LRTI

  • In healthy adult volunteers: no dose- limiting toxicity, no significant changes in lung function.

  • Potential for once-daily dosing.
(2) Monoclonal antibodies (mAb) Palivizumab (Medimmune) Phase-IV Marketed IM F Humanized mAb Prevention of RSV LRTI in high-risk infants

  • Reduces RSV-related hospitalizations in high-risk infants.

  • Once per month dosing during RSV season (~ 5 doses).
Motavizumab (Medimmune) Phase-III RCT completed
Not-licensed (no FDA approval)		 IM F Humanized mAb Prevention of RSV LRTI in high-risk infants

  • 20 fold more potent than palivizumab.

  • Associated with increased type I skin hypersensitivity reactions

  • Decreased outpatient MALRI.
Motavizumab-YTE (MEDI-557; Medimmune) Phase-II RCT interrupted IV F Humanized mAb derived from motavizumab with YTE technology Prevention of RSV LRTI in high-risk infants

  • Extended half-life.

  • Once per season dosing.
MEDI-8897 (Medimmune) Phase-II RCT ongoing IM Prefusion
F		 Human mAb derived from D25 Prevention of RSV LRTI in healthy and high-risk infants.

  • 150 fold more potent than palivizumab.

  • Extended half-life.

  • Once per season dosing.
REGN2222 (Regeneron pharmaceutics) Phase-III RCT ongoing IM F Human mAb anti- RSV Prevention of RSV LRTI in premature healthy infants not candidates for palivizumab

  • ~ 30 fold greater in vitro activity than palivizumab.

  • Extended half-life (1–2 doses per season).
(3) Polyclonal antibodies RI-001 (ADMA) Phase-II RCT completed IV Various viral epitopes Polyclonal IG Prevention of progression from RSV URI to LRTI in immunocompromised patients Decreased RSV titers at day 18 from baseline.
4-fold rise in antibody titers.
RI-002 (ADMA) Phase-III RCT completed IV Various viral epitopes Polyclonal IG Prevention of RSV and serious bacterial infections in patients with PIDD No adverse events and no serious bacterial infections.
Unclear benefits for RSV specifically

DISCOVERY: (1) EV-046120 and EV-046135 (Evec, Inc): also targeting RSV and MPV; (2) Monoclonal antibodies (vanderBilt Univ): human mAb anti-F protein and human mAb anti G-protein.

PRECLINICAL: (1) AR-201 (Aridis Pharm) and Palivizumab Biosimilar (bioXPRESS Therapeutic, Celltrion, iBio, mAbxience & UCAB): mAb anti-F protein; (2) MPE-8 (Humabs BioMed): mAb anti prefusion-F protein. Possible prophylaxis and therapy of severe HRSV and HMPV infections; (3) Sym-003 (Symphogen): polyclonal antibody targeting various non- overlapping RSV epitopes (F and G proteins).

*

RCT: Randomized clinical trial; LRTI: Lower respiratory tract infection; FDA: Food and Drug Administration; MALRI: medically attended lower respiratory tract infections; URI: upper respiratory infection; IG: immunoglobulin; PIDD: Primary immunodeficiency diseases.