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Anti-Influenza A Neuraminidase (NA) Monoclonal Antibodies

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Technology Summary

Anti-influenza A neuraminidase (NA) antibodies may be useful for diagnostic tests, research, quality control, and vaccine development. The antibodies may be useful for identifying antigens or epitopes specific for a NA subtype of a virus responsible for influenza infection and for validating the conformation of antigenic proteins.

Multiple anti-neuraminidase (NA) monoclonal antibodies are available to license, including antibodies for NA subtypes N1, N2, and N9. These monoclonal antibodies were produced using influenza viruses that include A/Anhui/1/2013 (N9), A/Victoria/361/2012 (N2), A/California/07/2009 (N1), and A/Brisbane/59/2007 (N1). The antibodies are characterized for specificity, epitope binding, and cross reactivity to other influenza viruses. In particular, the monoclonal antibody designated as CD6 binds a novel epitope spanning two NA monomers, protects mice from lethal H1N1 infection, and is broadly reactive. Additional antibodies for other NA subtypes may be available upon request.

Potential Commercial Applications Competitive Advantages
  • A diagnostic test to detect influenza virus subtypes
  •  Immunoassays 
  • Vaccine development and manufacture
  • Potential therapeutic use to treat influenza A infection
  • Antibodies are categorized based on specificity, epitope binding, and neutralizing capability
  • CD6 demonstrated protective immunity in a lethal challenge mouse study with the homologous and heterologous N1-containing viruses

Development Stage: Monoclonal antibodies, hybridoma cell lines, and in vitro characterization data are available

Inventors: Hongquan Wan (FDA) et al.

Publications:

“Molecular basis for broad neuraminidase immunity: conserved epitopes in seasonal and pandemic H1Nq as well as H5N1 influenza viruses/” J. Virol. 2013 Aug; 87(16) 9290-300. PMID: 23785204

“Structural characterization of a protective epitope spanning A(H1N1)pdm09 influenza virus neuraminidase monomers.” Nat Commun. 2015 Feb 10; 6: 6114. PMID: 25668439

“Comparative Efficacy of the Monoclonal Antibodies That Bind to Different Epitopes of the 2009 Pandemic H1N1 Influenza Virus Neuraminidase.” J. Virol. 2015 Oct 14; (90)1: 117-28. PMID: 26468531

“Assessment of influenza A neuraminidase (subtype N1) potency by ELISA.” J. Virol. Methods. 2017 Jun; 244: 23-28. PMID: 28257802

“Comparison of the Efficacy of N9 Neuraminidase-Specific Monoclonal Antibodies against Influenza A(H7N9) Virus Infection.” J. Virol. 2018 Jan 30; (92)(4). PMID: 29167344

“Antigenic Drift of the Influenza A(H1N1)pdm09 Virus Neuraminidase Results in Reduced Effectiveness of A/California/7/2009 (H1N1pdm09)-Specific Antibodies.” MBio. 2019 Apr 9; 10(2). PMID: 30967460

Product Area:  Research tools; diagnostic assays; vaccine development

FDA Reference No: E-2015-001 (N1), E-2013-008 (N1), E-2019-012 (N2, N9)

Licensing Contact:
Bill Ronnenberg, JD/MIP, MS
FDA Technology Transfer Program
FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-4561

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