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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Urgent development of effective therapeutic and prophylactic agents to control the emerging threat of Middle East respiratory syndrome (MERS)</title><author><name sortKey="Lu, Lu" sort="Lu, Lu" uniqKey="Lu L" first="Lu" last="Lu">Lu Lu</name><affiliation><nlm:aff id="aff1"><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></nlm:aff></affiliation></author><author><name sortKey="Xia, Shuai" sort="Xia, Shuai" uniqKey="Xia S" first="Shuai" last="Xia">Shuai Xia</name><affiliation><nlm:aff id="aff1"><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></nlm:aff></affiliation></author><author><name sortKey="Ying, Tianlei" sort="Ying, Tianlei" uniqKey="Ying T" first="Tianlei" last="Ying">Tianlei Ying</name><affiliation><nlm:aff id="aff1"><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></nlm:aff></affiliation></author><author><name sortKey="Jiang, Shibo" sort="Jiang, Shibo" uniqKey="Jiang S" first="Shibo" last="Jiang">Shibo Jiang</name><affiliation><nlm:aff id="aff1"><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26954884</idno><idno type="pmc">4773045</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4773045</idno><idno type="RBID">PMC:4773045</idno><idno type="doi">10.1038/emi.2015.37</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000119</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000119</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Urgent development of effective therapeutic and prophylactic agents to control the emerging threat of Middle East respiratory syndrome (MERS)</title><author><name sortKey="Lu, Lu" sort="Lu, Lu" uniqKey="Lu L" first="Lu" last="Lu">Lu Lu</name><affiliation><nlm:aff id="aff1"><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></nlm:aff></affiliation></author><author><name sortKey="Xia, Shuai" sort="Xia, Shuai" uniqKey="Xia S" first="Shuai" last="Xia">Shuai Xia</name><affiliation><nlm:aff id="aff1"><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></nlm:aff></affiliation></author><author><name sortKey="Ying, Tianlei" sort="Ying, Tianlei" uniqKey="Ying T" first="Tianlei" last="Ying">Tianlei Ying</name><affiliation><nlm:aff id="aff1"><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></nlm:aff></affiliation></author><author><name sortKey="Jiang, Shibo" sort="Jiang, Shibo" uniqKey="Jiang S" first="Shibo" last="Jiang">Shibo 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Emerg Microbes Infect</journal-id><journal-id journal-id-type="iso-abbrev">Emerg Microbes Infect</journal-id><journal-title-group><journal-title>Emerging Microbes & Infections</journal-title></journal-title-group><issn pub-type="epub">2222-1751</issn><publisher><publisher-name>Nature Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26954884</article-id><article-id pub-id-type="pmc">4773045</article-id><article-id pub-id-type="pii">emi201537</article-id><article-id pub-id-type="doi">10.1038/emi.2015.37</article-id><article-categories><subj-group subj-group-type="heading"><subject>Letter to the Editor</subject></subj-group></article-categories><title-group><article-title>Urgent development of effective therapeutic and prophylactic agents to control the emerging threat of Middle East respiratory syndrome (MERS)</article-title><alt-title alt-title-type="running">Letter to the Editor</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Lu</surname><given-names>Lu</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Xia</surname><given-names>Shuai</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Ying</surname><given-names>Tianlei</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Jiang</surname><given-names>Shibo</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><aff id="aff1"><label></label><institution>Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Medical College and Institute of Medical Microbiology, Fudan University</institution>, Shanghai 200032,<country>China</country></aff></contrib-group><author-notes><corresp id="caf1"><label>*</label>E-mail: <email>shibojiang@fudan.edu.cn</email></corresp></author-notes><pub-date pub-type="ppub"><month>06</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>17</day><month>06</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>6</month><year>2015</year></pub-date><volume>4</volume><issue>6</issue><fpage>e37</fpage><lpage></lpage><history><date date-type="received"><day>02</day><month>06</month><year>2015</year></date><date date-type="rev-recd"><day>04</day><month>06</month><year>2015</year></date><date date-type="accepted"><day>09</day><month>06</month><year>2015</year></date></history><permissions><copyright-statement>Copyright © 2015 Shanghai Shangyixun Cultural Communication Co., Ltd</copyright-statement><copyright-year>2015</copyright-year><copyright-holder>Shanghai Shangyixun Cultural Communication Co., Ltd</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/3.0/legalcode"><pmc-comment>author-paid</pmc-comment>
<license-p>This license allows readers to copy, distribute and transmit the Contribution as long as it is attributed back to the author. Readers are permitted to alter, transformor build upon the Contribution, and use the article for commercial purposes. Please read the full legal code for further details at - <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/3.0/legalcode">http://creativecommons.org/licenses/by/3.0/legalcode</ext-link></license-p></license></permissions></article-meta></front><body><p><bold>Dear Editor,</bold></p><p>As of June 12, 2015, the World Health Organization had been notified of 1289 laboratory-confirmed cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection globally, including at least 455 related deaths (case-fatality rate of 35%) (<ext-link ext-link-type="uri" xlink:href="http://www.who.int/csr/don/12-june-2015-mers-korea/en/">http://www.who.int/csr/don/12-june-2015-mers-korea/en/</ext-link>). On May 20, a 68-year-old man returning to the Republic of Korea from a trip to Saudi Arabia was diagnosed with MERS-CoV infection, and since then, the virus has spread, resulting in a cluster of 145 MERS-CoV cases, including 14 deaths, in South Korea and China (<ext-link ext-link-type="uri" xlink:href="http://www.who.int/csr/disease/coronavirus_infections/en/">http://www.who.int/csr/disease/coronavirus_infections/en/</ext-link>), bringing the total number of countries reporting MERS-CoV infection to 25. This patient became the one of the most active “MERS super-spreader”, while the MERS super-spreader in Abu Dhabi was linked to 28 confirmed MERS cases (<ext-link ext-link-type="uri" xlink:href="http://www.recombinomics.com/News/04291401/UAE_MERS_Superspreader_28.html">http://www.recombinomics.com/News/04291401/UAE_MERS_Superspreader_28.html</ext-link>).</p><p>Most of these cases in this cluster represent medical staff, family and other caregivers, or those close to the original patient before he was diagnosed with MERS-CoV infection and isolated. Therefore, an understandable sense of panic has arisen among those who have had contact with the newly diagnosed cases. This is yet another alarm sounding the necessity for the rapid development of therapeutic and prophylactic agents to treat MERS patients and protect high-risk populations from MERS-CoV until an effective and safe vaccine is available.<sup><xref ref-type="bibr" rid="bib1">1</xref>,<xref ref-type="bibr" rid="bib2">2</xref></sup></p><p>Based on our previous experience in developing viral fusion inhibitors against HIV<sup><xref ref-type="bibr" rid="bib3">3</xref></sup> and SARS-CoV,<sup><xref ref-type="bibr" rid="bib4">4</xref></sup> we designed and synthesized a peptide (HR2P) derived from the HR2 domain in the S2 subunit of the spike (S) protein of the MERS-CoV EMC/2012 strain. We found that HR2P could bind with the HR1 domain to form a stable six-helix bundle and thus inhibit viral fusion core formation and S protein-mediated cell-cell fusion. HR2P was demonstrated to potently inhibit infection by both pseudotyped and live MERS-CoV in different cell lines.<sup><xref ref-type="bibr" rid="bib5">5</xref></sup> We then modified the HR2P peptide by introducing Glu (E) and Lys (K) residues at the <italic>i</italic> to <italic>i</italic>+4 or <italic>i</italic> to <italic>i</italic>+3 arrangements. We found that one of these HR2P analogous peptides, HR2P-M2, exhibited significantly improved stability, solubility and antiviral activity.<sup><xref ref-type="bibr" rid="bib5">5</xref></sup></p><p>Interestingly, the HR2P-M2 peptide could potently inhibit infection by pseudoviruses expressing MERS-CoV S protein with or without mutation in the HR1 region, suggesting that it could be effective against most currently available MERS-CoV mutants. We further demonstrated that the HR2P-M2 peptide administered via the intranasal route could protect Ad5-hDPP4-transduced mice<sup><xref ref-type="bibr" rid="bib6">6</xref></sup> from challenge by MERS-CoV strains with or without mutations in the HR1 region, indicating that this peptide could be used as a nasal spray to protect high-risk populations, including healthcare workers, MERS patients' family members, and those having close contacts with the patients, from MERS-CoV infection.<sup><xref ref-type="bibr" rid="bib7">7</xref></sup> Intranasal application of the peptide to MERS-CoV-infected patients may suppress viral replication in epithelial cells of the respiratory tract and thus reduce the release of virions, thereby preventing the spreading of MERS-CoV to other people.</p><p>Furthermore, we and other groups have identified monoclonal antibodies (mAbs) targeting neutralizing epitopes in the receptor-binding domain of the S1 subunit of MERS-CoV S protein. These mAbs, including m336,<sup><xref ref-type="bibr" rid="bib8">8</xref></sup> MERS-4,<sup><xref ref-type="bibr" rid="bib9">9</xref></sup> 3B11,<sup><xref ref-type="bibr" rid="bib10">10</xref></sup> and Mersmab1,<sup><xref ref-type="bibr" rid="bib11">11</xref></sup> have shown potent neutralizing activity against MERS-CoV. The human mAb m336, which was derived from a very large naive antibody library, belongs to the IgG1 subclass, with high avidity (99 pM) and neutralizing activity against pseudotyped and authentic MERS-CoV (the half maximal inhibitory concentration of 0.033 and 0.47 nM, respectively).<sup><xref ref-type="bibr" rid="bib12">12</xref></sup> More interestingly, the m336 mAb is a germline-like antibody with only one mutation in the heavy chain and five in the light chain. As such, it is safe for humans, highly expressible, and highly soluble. <italic>In vivo</italic> studies have shown that this mAb is very effective in protecting MERS-CoV-susceptible animals from viral challenge (unpublished data), suggesting that the m336m mAb is a very promising drug candidate for the urgent treatment of MERS-CoV-infected patients.<sup><xref ref-type="bibr" rid="bib12">12</xref></sup></p><p>We have also performed <italic>in vitro</italic> studies demonstrating that the combination of HR2P-M2 peptide with m336 mAb exhibited a strong synergistic effect against MERS-CoV infection (unpublished data). This observation suggests that intranasal administration of HR2P-M2 peptide combined with intravenous administration of m336 mAb may be a powerful strategy for treatment of MERS patients.</p><p>Laboratory-produced mAbs m102.4, a human mAb against Hendra virus and Nipah virus, and Zmapp, comprising three chimeric mAbs against Ebola virus, have shown good <italic>in vivo</italic> efficacy in animal models<sup><xref ref-type="bibr" rid="bib13">13</xref>,<xref ref-type="bibr" rid="bib14">14</xref></sup> and have been successfully used in clinics to treat patients infected by Hendra virus or Nipah virus<sup><xref ref-type="bibr" rid="bib13">13</xref></sup> and Ebola virus,<sup><xref ref-type="bibr" rid="bib15">15</xref></sup> respectively. Therefore, it can be plausibly suggested that m336 mAb and HR2P-M2 peptide, both of which have demonstrated excellent <italic>in vivo</italic> efficacy in animal models, may also have high potential for clinical application in both urgent and prophylactic treatment of MERS patients.</p></body><back><ack><p>We thank Drs. Rongguang Zhang, Yun Zhu, and Sheng Ye at the Institute of Biophysics, Chinese Academy of Sciences, Beijing, China; Drs. Kwok-Yung Yuen, Kwok-Hung Chan, Bo-Jian Zheng, Jasper Fuk-Woo Chan, and Candy C. Y. Lau at the University of Hong Kong, Hong Kong, China; Drs. Stanley Perlman, Rudragouda Channappanavar, and David K. Meyerholz at the University of Iowa, Iowa City, Iowa, USA; Drs. Dimiter S Dimitrov, Ponraj Prabakaran, Tina W Ju, Yang Feng, and Yanping Wang at the National Cancer Institute, National Institutes of Health, Frederick, Maryland, USA; Drs. Lanying Du, Cuiqing Ma, and Lili Wang at the New York Blood Center, New York, New York, USA; and Drs. 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