of BiomedicalAdvanced Research Authority andDevelopment the European and the Initiative Innovative US Medicines Office in2015,withfundingsourcesThis began inearnest including ofOxford,the University to coordinate program. itsclinicaltrials including theLondon ofHygiene & School Tropical and Medicine $25 millionupfront. deal worth from Nordic, Bavarian to combinewithitsown vaccine, ina &Johnson’sJohnson JanssenPharmaceuticals unitlicensedanEbola ment ofanEbolavaccine( to helpfundand coordinate the develop consortia public–private developed vaccinefacturers candidates licensed in partially and built As the outbreak unfolded in 2014, several major vaccine manu Hunting vaccine for candidates funding sources, important,” iscritically saidHeinrichs. cines companies, and government aswell asbothnon-government own. with biotechs and government agencies or other vac “Working strained by cando whatthey and clinical development resources,vast manufacturing are con such threats; even companies as largetackle as Sanofi-Pasteur, with havecrises alsohighlighted apressing needfor greater fundingto projects leadershipatSanofi’s vaccinesbusinessSanofi-Pasteur. The ing these emerging threats,” Heinrichs, said Jon associate VP in global Sanofi-Pasteur are really to we address critical believe partnerships explore collaborative new modelsofvaccinedevelopment. “At and there are asyet noclinic-ready vaccinecandidates to with. work virus, do. aboutthepathogenicmechanismsofZika Littleisknown have thistimethey again jumpinginto even action, more to work ing to becomeaglobalpandemic. Althoughvaccinedevelopers are spreading in2015,anditisnow through threaten America South virusstarted emerged.than anotherinfectious diseaserisk Zika first-in-human ( trials outbreak beganto ebbin2015,atleastfour vaccineshadentered and scientificaffairsfor Merck . thetimeEbola By for anything,” saidSwatiGupta,executive director ofpublic health clinical trials. there’s“When a public health emergency, you’re looking the few available vaccinecandidates, noneof which hadreached tions. As theepidemicescalated, to advance companiespartnered health organizations companiesscramblingfor andbiopharma solu 2014,theEbolaepidemichit In West leaving Africa, governments, Morrison Chris forays into strategies. public health and catalyzed new partnership Global viral threats have andZika such as Ebola accelerated vaccine developers’ viral epidemics key combating Partnerships to infectious diseases and vaccines, said that to date thecompany has (BARDA). Johan Van Hoof, Janssenglobal therapeuticarea headfor Janssen has since worked with various academicpartners, withvarious Janssen hassinceworked haveThese publichealthcrises spurred companiesto rapidly to subside, however,No soonerhadtheEbolaepidemicstarted Table 1 Table 1 ). — and what they canfund and whatthey ). In October 2014,for October instance,). In — on their ------

Janssen publishedpromising results phase1trial inApril across tenconducted trials theUnited Africa, States andEurope; 25‑ wasa in theEbolaeffort “unique andpositive experience” inhis program. involved amongallstakeholders The highsenseofurgency vaccine,” saidGupta. outbreak hits;you don’t always dosesofthe have clinical-trial-grade from agoodplace. You don’t have often thisdataavailable whenan ners andwe’ve accomplishedatremendous amount,butwe started encouraging results phase1trial inApril Merck with apathforward. Merck published and partner NewLink in 2014 and2015totaled more than$56 millionandprovided ofDefense Grantsfrom Monath. BARDA andtheUSDepartment potential for for preparedness stockpiling and biodefense,” said development, andthe significant for grants andcontracts further funding for Ebolavaccines, anticipated NewLink of prospect “the infectious diseasesdivision. With sources various ofgovernmental vaccines,” said chiefscientificofficerofNewLink’sThomas Monath, interesting candidate avery platform for like usitlooked “to making in 2010,years before themostrecent majorEbolacrisis. At thetime, of Canada,Health Agency from which licensed NewLink the project 2015. beganinearly when clinicaltrials front, andthebiotech received a$20 millionmilestone payment were inthefreezer,” $30 millionup saidGupta.Merck paidNewLink studies.primate were doses of vaccine already available “There that by awealth thatwasbacked ofdatafromrVSV-ZEBOV non-human oncology candidates, it possessed an candidate, for2014. Although is better NewLink of immuno- known its portfolio Gupta, before inNovember signing Genetics adealwithNewLink nerships. angle,The company said evaluated thefieldfrom every “ no potofmoney to dipinto immediate response, butthere’s Van Hoofexpressed similarsentimentsaboutJanssen’s Ebola over was an amazing effort the last 18 “It NewLink’s Ebola vaccinewasinitiallydeveloped by thePublic Merck’s role ofpart inthisspacealsohighlightsthekey work year career invaccinedevelopment, headded. happens it demands an happensitdemands an W hen somethinglike this Thomas Monath, chief scientific officer, infectious diseases,infectious NewLink Genetics 2 . months by all of our part biopharmadealmakers.nature.com |June2016 | 1 .

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feature feature B16 said it had jumped into the Zika vaccinefray, in said ithadjumpedinto theZika citingitsexpertise viruses may provide February 2016,Sanofi-Pasteur atechnical boost.In virus are yet available the clinic( vaccineprogramsactive againstthevirus, butnonehadyet reached landscaperevealed 18 analysisoftheZika Health Organization (WHO) wasdeclared apublichealthemergency, Zika month after a World March 2016,one didinresponseas they In to theEbolaoutbreak. ofvaccineanddrugcandidates to trials to begin expect asquickly However, Zika. over to tocan becarried thwart efforts itisnotrealistic Diseases; NIH, US National Institutes ofHealth;USAMRIID, BCIQand Diseases; NIH,USNationalInstitutes Diseases. ofInfectious Source: Research Biocentury USArmy Institute Medical Thomson Reuters Cortellis. DARPA, MVA, GlaxoSmithKline; USDefense GSK, Advanced NIAID, Research Projects ofAllergy modifiedvacciniaAnkara; USNationalInstitute andInfectious Agency; Table vaccine since Ebola 2014 partnerships 1:Selected October 2014 October February 2016 2015 December 2015 May 2015 April 2015 April November 2014 2014 October Date Nevertheless, successfully developed vaccines against relatedNevertheless, Van of collaborative momentum Hoofandothershopethiskind |June2016 | Table 2 biopharmadealmakers.nature.com ). In addition, no established animal models of Zika addition,noestablishedanimalmodelsofZika ). In 3 . GeoVax Labs, USAMRIID Inc.; Biopharma USAMRIID; Yisheng Hawaii Biotech ofHawaii; University Inc.; Soligenix, GeoVax Labs, NIAID Inc.; ofPennsylvaniaUniversity LifeGeneOne Science/VXGI; Pharmaceuticals; MedImmune; Inovio Genetics NewLink Merck; NIH GSK; Nordic Bavarian and Johnson); ofJohnson Janssen Pharmaceuticals (part Companies

Aunt_Spray/iStock/Thinkstock Summary using GeoVax’s vaccineplatform. vaccine againstEbolaZaire, andLassafever EbolaSudan,Marburg viruses GeoVax andUSAMRIID are collaboratingto test anddevelop atetravalent Ebola vaccinewithUSAMRIID. adjuvanttechnology,Using itsPIKA Yisheng BioPharma willdevelop an technology. to develop itsheat-stable subunitEbolavaccineusing ThermoVax ofHawaii iscollaboratingwiththeUniversity andHawaiiSoligenix Biotech MVA-vectored vaccinecandidates targeting Ebola. GeoVax andtheNIH’s NIAIDare collaboratingto develop GeoVax’s March 2016. DNA-based vaccineIN0‑4212,for whichphase1datawere announcedin to develop productsto prevent andtreat Ebolainfection, includingthe Pharmaceuticals isleadinga$45 millionprogramInovio fundedby DARPA began.Phaseclinical trials 1datawere publishedinApril anda$20 millionmilestone 2015when paymentrVSV-ZEBOV inearly received Genetics NewLink $30millionupfront from Merck for thevaccine Phase 1/2adata were publishedinMarch thevaccinethrough withtheNIHto clinicaltrials; take GSK isnow working GSK acquired itsEbolavaccinethrough the2013acquisitionofOkairos. Phase 1data were publishedinApril regimen.upfront to combinewithitsown vaccineinaprime–boost Janssen licensedanEbolavaccinefrom Nordic Bavarian for $25 million overwhelmingly pegged to its lead respiratory syncytial virus vaccine pegged to syncytial overwhelmingly its lead respiratory vaccines platform ingeneral. Novavax’s value is $1.5 billion market related to Ebolathatcouldbeusedto helpdevelop thebiotech’s For instance, recognized NewLink grant money thatitmightattract orspeculatively to advance theirprojects. opportunistically to act projects focusing solelyonpandemics. Companies instead have development,”for late-stage hesaid. Novavax “sits on the shelf because no funding’s been made available from government fundingsources. AnEbolavaccinedeveloped by ButErck lamented theslowburgeoning response againstZika. work Syndrome (MERS) andEbola,mostrecently its East Respiratory citingthecompany’sCEO StanErck, inpandemicflu, Middle efforts virus vaccinedevelopment four timesinthepastthree years, said as EbolaandZika. The biotech Novavax haswadedinto emerging smaller companiespursuingpotential vaccines for pandemicssuch in order to foster onpotential work vaccines. for greater—and more consistent—funding before pandemicshit argue, crises however,to the Ebola and Zika is that there is a need the Ebolacrisis. Companies thathave beeninvolved intheresponses funds from governments andmultilateral organizations to combat 2015, the December By WHO said it had received $450 Funding challenges is endemic. the ChimeriVax platform attenuated fever Dengue vaccine Dengvaxia safe andeffective. Regulators recently licensedthecompany’s live- into awidelyusedyellow fever vaccinethatisalready deemed Zika relevant offlaviviruses proteins like expressed onthesurface company’s ChimeriVax platform genesthatencode canincorporate as well as moretreating approaches,” long-term Zika, he added. The [based ontheChimeriVax platform] thatwillberapidly evaluated for Heinrichs. “We’re aholisticapproach vaccines forward to bring taking andwe’re onmultipleapproaches,”Zika withpartners working said fever.encephalitis andDengue “We’re well suited to addressing very vaccines againstsimilarflaviviruses, including yellow fever, Japanese Access to traditional venture capital funding sources is rare for alackofavailableIndeed, fundingmay bethegreatest hurdle for — for useinseveral regions where Dengue 1 . 4 . — 2 which cameoutof . million in

billion short inproviding theassistancethatourpublichealth $1.9 billion short funding from the US government. “Congress months late is two and dip into.” it demandsanimmediate response, butthere’s to nopotofmoney source offunding.pre-positioned thishappens somethinglike “When ing no,” according to NewLink’s becausethere’s Monath, stillno the for vaccinedevelopment?WHO aspriorities aresound “That’s orany ofthedozens ofpathogensidentifiedby Zika to tackle risks $350 million ontheopenmarket. of thestandard 12‑monthreview review from the US Foodpriority andDrug Administration instead These vouchers or vaccine (Ebola virus was added to this 2014).list in December successfullydevelop adrug ifthey Review Priority Voucher (PRV) to thelistofdiseasesfor atransferrable whichcompaniescanearn fund hasattempted anything similar. declined to raiseasecond, similarfundandnootherventure capital amongothers, butKPCB Novavaxbacked andflu-fighter BioCryst, and BioDefense Fund in2006 sector speculative foraysits various into vaccinesfor pandemicpathogens. form asinthecaseof canbeappliedto lesstraditionalopportunities, program, but the biotech’s vaccine plat recombinant nanoparticle Organization Zika ProductOrganization Landscape3 March 2016. Zika CDC, USCenters for DiseaseControl andPrevention; ofHealth; NIH,USNationalInstitutes VLP, particle; VSV, virus-like vesicular stomatitis virus. Source: World Health Table 2:Preclinical Zikavaccine candidates Valneva Themis Bioscience Sanofi-Pasteur Replikins Novavax NIH Genetics NewLink PasteurInstitute Pharmaceuticals/GeneOne Inovio Hawaii Biotech CDC Butantan/NIH Bio-Manguinhos/Fiocruz Bharat Institution As yet, Congress hasnotauthorized requests for additionalZika But are biotechs given enoughincentive thenecessary to take virus 12, theUSCongress On April passed a bill thataddedZika in biopreparednessOne experiment funding from the private — Kleiner Perkins Caufield &Byers’ Perkins Kleiner $200 millionKPCBPandemic — which enable access to an 8-month regulatory which enableaccessto an8-monthregulatory — hasn’t beenrepeated. The KPCBfund — have beensoldfor asmuch Purified vaccine inactivated vaccinevirusvector (live)Measles ChimeriVax; otherundisclosedtechnologies Synthetic replilink peptides E-protein nanoparticles mutation,live attenuated;Zika-targeted DNA;live recombinantVSV Purified virus inactivated Lentivirus-vectored, measlesvectored DNA celllineproduced recombinant Insect DNA plasmidexpressing VLP; live recombinant adenovirus Live denguerecombinant; purified inactivated virus; purified Inactivated YF17DDchimeric; VLP; DNA virus; purified Inactivated VLP Technology - -

on thebiotechnology andpharmaceutical industries. Chris Morrisonisafreelance analyst,editor andwriter whoreports 4. 3. 2. 1. isready”.the world president Luc Debruyne, happens,“so Zika thatwhenthenext arsenal againstthethreats identifiedby the WHO, saidGSK Vaccines tion withacademicandgovernment institutionsandbuildupan allow thecompany to dedicate resources to incollabora work tothe world establisha “biopreparedness platform” thatwould withgovernments around isproactivelyGlaxoSmithKline working and vaccinedevelopers canfollow anexpedited route to licensure. drug out in advance so that, in the face of an outbreak, worked cal studydesigns, pathways issuescanbe regulatory andliability crucially, secure R&Dfundingto fillthosegaps. Meanwhile, clini toand academicinstitutionsare identifygapsand, now working pathogens;industry created for anR&Dblueprint alistofpriority for example—haven’t yet been implemented. The WHO has heels thatthoselessons—better outbreak systems, detection camesosoononits butZika oftheEbolaoutbreak, in thewake press inanApril briefing. Earnest Josh secretary appropriately to thesituation,” saidObamaAdministration press professionals sure say needto respond thatthey make thatthey More than a few learned’‘lessons have been published reports De Santis,De O. Becker, R. S. T.Agnandji, I.D.Milligan, Nat. Med. et al et al et al . . Lancet InfectDis. JAMA .

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