Passive immunization for influenza through antibody therapies, a review of the pipeline, challenges and potential applications
Identifieur interne : 000286 ( Pmc/Checkpoint ); précédent : 000285; suivant : 000287Passive immunization for influenza through antibody therapies, a review of the pipeline, challenges and potential applications
Auteurs : Erin Sparrow [Suisse, Australie] ; Martin Friede [Suisse] ; Mohamud Sheikh [Australie] ; Siranda Torvaldsen [Australie] ; Anthony T. Newall [Australie]Source :
- Vaccine [ 0264-410X ] ; 2016.
Abstract
The Global Action Plan for influenza vaccines (GAP) aims to increase the production capacity of vaccines so that in the event of a pandemic there is an adequate supply to meet global needs. However, it has been estimated that even in the best case scenario there would be a considerable delay of at least five to six months for the first supplies of vaccine to become available after the isolation of the strain and availability of the candidate vaccine virus to vaccine manufacturers. By this time, the virus is likely to have already infected millions of people worldwide, causing significant mortality, morbidity and economic loss.
Passive immunization through broadly neutralizing antibodies which bind to multiple, structurally diverse strains of influenza could be a promising solution to address the immediate health threat of an influenza pandemic while vaccines are being developed. These products may also have a role in seasonal influenza as an alternative to other options such as antivirals for the treatment of severe acute respiratory illness due to influenza.
This article provides an overview of the current clinical pipeline of anti-influenza antibodies and discusses potential uses and the challenges to product development.
Url:
DOI: 10.1016/j.vaccine.2016.08.057
PubMed: 27622299
PubMed Central: 5357764
Affiliations:
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Newall</name><affiliation wicri:level="1"><nlm:aff id="af010">School of Public Health and Community Medicine, University of New South Wales, NSW, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Public Health and Community Medicine, University of New South Wales, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="ISSN">0264-410X</idno><idno type="eISSN">1873-2518</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>The Global Action Plan for influenza vaccines (GAP) aims to increase the production capacity of vaccines so that in the event of a pandemic there is an adequate supply to meet global needs. However, it has been estimated that even in the best case scenario there would be a considerable delay of at least five to six months for the first supplies of vaccine to become available after the isolation of the strain and availability of the candidate vaccine virus to vaccine manufacturers. By this time, the virus is likely to have already infected millions of people worldwide, causing significant mortality, morbidity and economic loss.</p><p>Passive immunization through broadly neutralizing antibodies which bind to multiple, structurally diverse strains of influenza could be a promising solution to address the immediate health threat of an influenza pandemic while vaccines are being developed. These products may also have a role in seasonal influenza as an alternative to other options such as antivirals for the treatment of severe acute respiratory illness due to influenza.</p><p>This article provides an overview of the current clinical pipeline of anti-influenza antibodies and discusses potential uses and the challenges to product development.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Kelso, J K" uniqKey="Kelso J">J.K. Kelso</name></author><author><name sortKey="Halder, N" uniqKey="Halder N">N. Halder</name></author><author><name sortKey="Milne, G J" uniqKey="Milne G">G.J. Milne</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Prager, F" uniqKey="Prager F">F. Prager</name></author><author><name sortKey="Wei, D" uniqKey="Wei D">D. Wei</name></author><author><name sortKey="Rose, A" uniqKey="Rose A">A. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Vaccine</journal-id><journal-id journal-id-type="iso-abbrev">Vaccine</journal-id><journal-title-group><journal-title>Vaccine</journal-title></journal-title-group><issn pub-type="ppub">0264-410X</issn><issn pub-type="epub">1873-2518</issn><publisher><publisher-name>Elsevier Science</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27622299</article-id><article-id pub-id-type="pmc">5357764</article-id><article-id pub-id-type="publisher-id">S0264-410X(16)30744-7</article-id><article-id pub-id-type="doi">10.1016/j.vaccine.2016.08.057</article-id><article-categories><subj-group subj-group-type="heading"><subject>Review</subject></subj-group></article-categories><title-group><article-title>Passive immunization for influenza through antibody therapies, a review of the pipeline, challenges and potential applications</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Sparrow</surname><given-names>Erin</given-names></name><email>sparrowe@who.int</email><xref rid="af005" ref-type="aff">a</xref><xref rid="af010" ref-type="aff">b</xref><xref rid="cor1" ref-type="corresp">⁎</xref></contrib><contrib contrib-type="author"><name><surname>Friede</surname><given-names>Martin</given-names></name><xref rid="af005" ref-type="aff">a</xref></contrib><contrib contrib-type="author"><name><surname>Sheikh</surname><given-names>Mohamud</given-names></name><xref rid="af010" ref-type="aff">b</xref></contrib><contrib contrib-type="author"><name><surname>Torvaldsen</surname><given-names>Siranda</given-names></name><xref rid="af010" ref-type="aff">b</xref><xref rid="af015" ref-type="aff">c</xref></contrib><contrib contrib-type="author"><name><surname>Newall</surname><given-names>Anthony T.</given-names></name><xref rid="af010" ref-type="aff">b</xref></contrib></contrib-group><aff id="af005"><label>a</label>The World Health Organization, Geneva, Switzerland</aff><aff id="af010"><label>b</label>School of Public Health and Community Medicine, University of New South Wales, NSW, Australia</aff><aff id="af015"><label>c</label>Sydney Medical School Northern, University of Sydney, NSW, Australia</aff><author-notes><corresp id="cor1"><label>⁎</label>Corresponding author at: Department of Essential Medicines and Health Products (EMP), World Health Organization, Avenue Appia 20, 1211 Geneva, Switzerland.Department of Essential Medicines and Health Products (EMP)World Health OrganizationAvenue Appia 201211 GenevaSwitzerland <email>sparrowe@who.int</email></corresp></author-notes><pub-date pub-type="pmc-release"><day>26</day><month>10</month><year>2016</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="ppub"><day>26</day><month>10</month><year>2016</year></pub-date><volume>34</volume><issue>45</issue><fpage>5442</fpage><lpage>5448</lpage><permissions><copyright-statement>© 2016 The Authors</copyright-statement><copyright-year>2016</copyright-year><license license-type="CC BY" xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).</license-p></license></permissions><abstract id="ab005"><p>The Global Action Plan for influenza vaccines (GAP) aims to increase the production capacity of vaccines so that in the event of a pandemic there is an adequate supply to meet global needs. However, it has been estimated that even in the best case scenario there would be a considerable delay of at least five to six months for the first supplies of vaccine to become available after the isolation of the strain and availability of the candidate vaccine virus to vaccine manufacturers. By this time, the virus is likely to have already infected millions of people worldwide, causing significant mortality, morbidity and economic loss.</p><p>Passive immunization through broadly neutralizing antibodies which bind to multiple, structurally diverse strains of influenza could be a promising solution to address the immediate health threat of an influenza pandemic while vaccines are being developed. These products may also have a role in seasonal influenza as an alternative to other options such as antivirals for the treatment of severe acute respiratory illness due to influenza.</p><p>This article provides an overview of the current clinical pipeline of anti-influenza antibodies and discusses potential uses and the challenges to product development.</p></abstract><kwd-group id="kg005"><title>Keywords</title><kwd>Influenza</kwd><kwd>Monoclonal antibody</kwd><kwd>Immunization</kwd><kwd>Pandemic</kwd><kwd>Vaccine</kwd><kwd>Prophylaxis</kwd></kwd-group><kwd-group id="kg010"><title>Abbreviations</title><kwd>bNAb, broadly neutralizing antibody</kwd><kwd>GAP, Global Action Plan for influenza vaccines</kwd><kwd>mAb, monoclonal antibody</kwd><kwd>ICTRP, International Clinical Trials Registry Platform</kwd></kwd-group></article-meta></front><floats-group><table-wrap id="t0005" position="float"><label>Table 1</label><caption><p>Pipeline of monoclonal antibody products for influenza under clinical development.</p></caption><table frame="hsides" rules="groups"><thead><tr><th>Candidate name</th><th>Manufacturer/developer</th><th>Preclinical studies</th><th>Latest clinical phase and status</th><th>Clinical trial registration numbers</th><th>Mode of action</th><th>Route of administration and dose</th><th>Clinical trial results</th></tr></thead><tbody><tr><td rowspan="2">CR6261</td><td rowspan="2">Crucell</td><td rowspan="2">In vitro neutralization, in vivo mice and ferret challenge studies</td><td rowspan="2">Phase 2 recruiting</td><td>Phase 1: NCT01406418</td><td rowspan="2">Directed against a highly conserved helical region in the membrane-proximal stem of hemagglutinin</td><td rowspan="2">Single dose, intravenous infusion, 50 mg/kg</td><td rowspan="2">No clinical trial results available</td></tr><tr><td>Phase 2: NCT02371668</td></tr><tr><td rowspan="2">CR8020</td><td rowspan="2">Crucell</td><td rowspan="2">In vitro neutralization and in vivo mice challenges</td><td rowspan="2">Phase 2a completed</td><td>Phase 1: NCT01756950</td><td rowspan="2">Directed against an immune-subdominant, relatively conserved membrane-proximal stem region of hemagglutinin</td><td rowspan="2">Single dose, intravenous infusion, 15 mg/kg</td><td rowspan="2">Some clinical results available for NCT01938352/EUCTR2013-002185-39-GB <xref rid="b0055" ref-type="bibr">[11]</xref></td></tr><tr><td>Phase 2a: NCT01938352 and EUCTR2013-002185-39-GB</td></tr><tr><td>CR802 and CR6261 combined</td><td>Crucell</td><td>See above</td><td>Phase 2a withdrawn prior to enrolment</td><td>Phase 2a: NCT01992276 EUCTR2013-003341-41</td><td>As above</td><td>Single dose, intravenous infusion, 30 mg/kg</td><td>N/A (withdrawn)</td></tr><tr><td rowspan="2">CT-P27</td><td rowspan="2">Celltrion</td><td rowspan="2">In vitro neutralization, in vivo mice and ferret challenge studies</td><td rowspan="2">Phase 2a ongoing</td><td>Phase 1: KCT0001617</td><td rowspan="2">Dual antibody product. Antibodies bind a conformational epitope on the hemagglutinin stem region</td><td rowspan="2">Single dose, intravenous infusion (dose not mentioned)</td><td rowspan="2">No clinical trial results available</td></tr><tr><td>Phase 2a: NCT02071914and EUCTR2013-004544-32-GB</td></tr><tr><td>FGI-101-1A6</td><td>Functional Genetics Inc.</td><td>N/A</td><td>Phase 1 status unknown</td><td>Phase 1: NCT01299142</td><td>Targets the TSG101 protein on the surface of host cells infected by viruses</td><td>Single dose, intravenous infusion (dose not mentioned)</td><td>Press release available <xref rid="b0065" ref-type="bibr">[13]</xref></td></tr><tr><td rowspan="2">MEDI8852</td><td rowspan="2">MedImmune</td><td rowspan="2">In vitro neutralization, in vivo mice and ferret challenge studies</td><td rowspan="2">Phase 1b/2a recruiting</td><td>Phase 1: NCT02350751</td><td rowspan="2">Binds to a novel site in the hemagglutinin stem region that is shared in viruses from all 18 Influenza A subtypes</td><td rowspan="2">Single dose, intravenous infusion (dose not mentioned)</td><td rowspan="2">No clinical trial results available</td></tr><tr><td>Phase 1b/2a: NCT02603952</td></tr><tr><td rowspan="5">MHAA4549A</td><td rowspan="5">Genentech</td><td rowspan="5">In vitro neutralization, in vivo mice and ferret challenge studies</td><td rowspan="2">1 phase 2a trial completed (NCT01980966).</td><td>Phase 1: NCT02284607</td><td rowspan="5">Binds to a highly conserved epitope on the stalk of influenza A hemagglutinin</td><td rowspan="5">Single dose, intravenous infusion (dose not mentioned)</td><td rowspan="5">No clinical trial results available</td></tr><tr><td>Phase 1: NCT01877785</td></tr><tr><td rowspan="3">Other phase 2 trials recruiting</td><td>Phase 2a: NCT01980966</td></tr><tr><td>Phase 2: NCT02293863 and EUCTR2014-000461-43</td></tr><tr><td>Phase 2: NCT02623322</td></tr><tr><td rowspan="2">TCN-032</td><td rowspan="2">Theraclone Sciences</td><td rowspan="2">In vitro neutralization and in vivo mice challenges</td><td rowspan="2">Phase 2a completed</td><td>Phase 1: NCT01390025</td><td rowspan="2">Directed against conserved epitope of the amino-terminal extracellular domain (M2e) of the influenza virus matrix protein 2 (M2)</td><td rowspan="2">Single dose, intravenous infusion, dosing from 1 to 40 mg/kg evaluated</td><td rowspan="2">Results published for NCT01719874 <xref rid="b0090" ref-type="bibr">[18]</xref></td></tr><tr><td>Phase 2a: NCT01719874 and EUCTR2012-000854-73-GB</td></tr><tr><td rowspan="2">VIS410</td><td rowspan="2">Visterra Inc.</td><td rowspan="2">In vitro neutralization, in vivo mice challenges and ferret studies</td><td rowspan="2">Phase 2a completed</td><td>Phase 1: NCT02045472</td><td rowspan="2">Directed against a hierotope on hemagglutinin</td><td rowspan="2">Single dose, intravenous infusion (dose not mentioned for phase 2)</td><td rowspan="2">Results published for NCT02045472 <xref rid="b0105" ref-type="bibr">[21]</xref></td></tr><tr><td>Phase 2a: NCT02468115</td></tr></tbody></table></table-wrap></floats-group></pmc><affiliations><list><country><li>Australie</li><li>Suisse</li></country><region><li>Nouvelle-Galles du Sud</li></region><settlement><li>Sydney</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="Suisse"><noRegion><name sortKey="Sparrow, Erin" sort="Sparrow, Erin" uniqKey="Sparrow E" first="Erin" last="Sparrow">Erin Sparrow</name></noRegion><name sortKey="Friede, Martin" sort="Friede, Martin" uniqKey="Friede M" first="Martin" last="Friede">Martin Friede</name></country><country name="Australie"><noRegion><name sortKey="Sparrow, Erin" sort="Sparrow, Erin" uniqKey="Sparrow E" first="Erin" last="Sparrow">Erin Sparrow</name></noRegion><name sortKey="Newall, Anthony T" sort="Newall, Anthony T" uniqKey="Newall A" first="Anthony T." last="Newall">Anthony T. Newall</name><name sortKey="Sheikh, Mohamud" sort="Sheikh, Mohamud" uniqKey="Sheikh M" first="Mohamud" last="Sheikh">Mohamud Sheikh</name><name sortKey="Torvaldsen, Siranda" sort="Torvaldsen, Siranda" uniqKey="Torvaldsen S" first="Siranda" last="Torvaldsen">Siranda Torvaldsen</name><name sortKey="Torvaldsen, Siranda" sort="Torvaldsen, Siranda" uniqKey="Torvaldsen S" first="Siranda" last="Torvaldsen">Siranda Torvaldsen</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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