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Cancer Nanotechnology – New Opportunities for Diagnostics and Therapeutics in Oncology Maryland Technology Day February

Cancer Nanotechnology – New Opportunities for Diagnostics and Therapeutics in Oncology Maryland Technology Day February 28, 2013. Piotr Grodzinski, Ph.D. Office of Cancer Nanotechnology Research, NCI. 1. By Nearly All Measures Cancer Already Represents a Healthcare Crisis

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Cancer Nanotechnology – New Opportunities for Diagnostics and Therapeutics in Oncology Maryland Technology Day February

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  1. CancerNanotechnology–NewOpportunitiesfor DiagnosticsandTherapeuticsinOncology MarylandTechnologyDay February28,2013 PiotrGrodzinski,Ph.D. OfficeofCancerNanotechnologyResearch,NCI 1

  2. ByNearlyAllMeasuresCancerAlready RepresentsaHealthcareCrisis •569,490Americansdiedofcancerin2010 •1,529,560Americanswillbediagnosedwithcancerthisyear •$228.1billionin2008forcancerhealthcarecosts •Numbersofnewcancercaseswillincreaseby30-50%asweapproach2020(aging ofbabyboomers,demographicshifts) UnlikeOtherMajorDiseaseKillers,CancerContinuesto TaketheNearlySameTollasitdidin1950 586.8 600 500 400 1950 2008 100,000Americans DeathsPer 300 200 203.15 193.9186.2 180.7 44 100 48.1 18.5 0 Heart CerebrovascularPneumonia/ Cancer Diseases Diseases Influenza Sourcefor2010deathsanddiagnoses:AmericanCancerSociety(ACS)2006CancerFacts&Figures;Atlanta,Georgia Sourcefor2008age-adjusteddeathrate:NationalCenterforHealthStatistics,U.S.DepartmentofHealthandHumanServices, NCHSPublic-usefilefor2008deaths. 2

  3. CostofCancer T.O’Callaghan,Nature471,S2(2011) 3

  4. CancerNanotechnology: TheOpportunity •Combinepowerofinnovationinnano-materialsand cancerbiologytodevelopnewsolutionsincancer • • DetectDiseaseBeforeHealthHasDeteriorated –Sensors –Imaging DeliverTherapeutics –Localdelivery –Improvedefficacy –Post-therapymonitoring •DevelopResearchToolstoEnhanceUnderstandingof theDisease Liposome Goldnanoshell Dendrimer QuantumDot 4

  5. NationalNanotechnologyInitiative-History Sept.1998-InteragencyWorkingGrouponNanoscience, Engineering,andTechnology(IWGN)formed Mar.1999:OSTP/CTpresentationonNNI Jan.2000:NNIannouncedbyPresidentClinton Aug.2000:IWGNbecomesstandingNSETsubcommittee Oct.2000:NNIbeginsasaformalcrosscutinFY2001budget Dec.2003:21stCenturyNanotechnologyR&DActsignedby President Bush CourtesyofClaytonTeague(formNNCO)andAltafCarim(OSTP) 5

  6. GrowthofResearchUsingNanoparticles Publicationswithnanoparticles 16000 14000 12000 10000 8000 6000 4000 2000 0 PubmedEntriesPerYear Series1 1995 2000 2005 2010 2015 Year ShiJ,XiaoZ,KamalyN,FarokhzadOC. AccChemRes.201144:1123-34 6

  7. NIHNanotechnologyFunding 500 450 400 350 300 250 200 150 100 50 0 Estimated Actual NNI begins MillionsofDollars FY FY FY FY FY FY FY FY FY FY FY FY FY FY FY 199819992000200120022003200420052006200720082009201020112012 7

  8. NIHCampus:75Buildingson322acres HometoWorld’sLargestClinicalResearchHospital 8

  9. NCIAllianceforNanotechnologyinCancer •Scientificoutput–over1500peer- reviewedjournalpapersandcloseto 250patentsandpatentsubmissions published •Clinicaltranslation–over70 companiesinthespaceofdiagnostics andtherapyareassociatedwiththe program.Majorityofthemarestart-ups. •Over10clinicaltrialsareassociated withprogramprojects •severalcompaniesareinpre-IND discussionswithFDA •formedaconsortiumtoinvolvelarge pharmaandbiotechcompaniesto assisttranslationalprocess •PhaseI:2005–2010 •PhaseII:2010-2015 CentersforCancer Nanotechnology Excellence(CCNE) U54CooperativeAgr. CancerNanotechnology PlatformPartnerships U01CooperativeAgr. Multi-disciplinaryTraining Awards:K99/R00andR25 Nanotechnology CharacterizationLaboratory 9

  10. ObjectivesforPhaseII TheANCprogramwasdesignedtodevelopresearchcapabilities formulti-disciplinaryteamresearch,withthegoalofadvancing researchdiscovery prevention,diagnosticand/ortreatmentefforts. TheANC’sdevelopmentmodel callsforthemostpromising strategiesdiscoveredand developedbyANCgranteesto behandedofftofor-profit partnersforeffectiveclinical translationandcommercial development. Focusoncancerswithlow survivalratessuchasbrain, lung,pancreas,andovarian cancer pre-clinical Challengeareas: •Earlydiagnosisusinginvitroassaysand devicesorinvivoimagingtechniques •Multifunctionalnano-therapeuticsand post-therapymonitoringtools •Devicesandtechniquesforcancer preventionandcontrol clinical 10

  11. CentersofCancerNanotechnologyExcellence (U54) DartmouthCenterforCancer NanotechnologyExcellence DartmouthCollege,Hanover,NH MIT-HarvardCenterofCancer NanotechnologyExcellence, Cambridge,MA CenterforTranslationalCancer Nanomedicine, NortheasternUniversity,Boston,MA NanomaterialsforCancer DiagnosticsandTherapeutics, NorthwesternUniversity,Evanston,IL CenterforCancerNanotechnology ExcellenceandTranslation, StanfordUniversity,PaloAlto,CA NanosystemsBiology CancerCenter2,California InstituteofTechnology, Pasadena,CA JohnsHopkinsCenterforCancer NanotechnologyExcellence, Baltimore,MD CarolinaCenterofCancerNanotechnology Excellence,UniversityofNorthCarolina, ChapelHill,NC TexasCenterforCancerNanomedicine, UniversityofTexas&MDAnderson, Houston,TX CentersofCancerNanotechnology Excellence(9) 11

  12. NanomedicineinMaryland •InstituteforNanobiotechnology,JohnsHopkinsUniversity •MarylandNanoCenter •CenterforNanoscaleScienceandTechnology •NanotechnologyCharacterizationLaboratory,NCI,Frederick Nat.LabforCancerResearch •NanomedicinesAlliance 12

  13. Nextmeeting: July14-19,2013 MountSnowResort,Vermont 13

  14. Nano-therapyStrategies Deliveryofchemotherapeutics Hyperthermia Photothermal J.Baker,etal.,CancerRes. (2005)65:5317 DeliveryofsiRNA M.Davisetal.Nature(2010)464:1067 N.Halas,J.Westetal, AnnBiomedEng. (2006)34:15 RF-heated Liposome Magnetitenanoparticle A.Itoetal.,J.of BioscienceandBioeng. (2005100:1) 14

  15. TimelineforClinicalDevelopmentof NanoparticleTherapies KamalyN,XiaoZ,ValenciaPM,Radovic-MorenoAF,FarokhzadOC. ChemSocRev.2012:41:2971-3010 15

  16. CytImmuneSciences,Inc. CytimmuneSciences Rockville,MD Aurimune®:PEG-coatedcolloidal gold+TNF- • • • • TNF-(tumornecrosisfactor)discontinued inclinicaltrials~10yearsagoduetosevere immunotoxicity AmountofTNF-αfarbeyondprevious amountsadministeredasAurimune®with minimalilleffect Canexceedlethaldose(LD50)ofTNF-α alone Illustratesutilityofnanotechreformulations forreducingtoxicityandadverseside- effects. InitialNCLsubmissioninJan2007 PhaseIIclinicaltrialstobeginin 2013 16

  17. NanotechnologyCharacterizationLaboratory: ServingtheCommunity ScottMcNeil NCLisaformalcollaborationbetweenNCI,FDAandNIST 17

  18. CurrentIndustryTrendsinR&D DevelopmentandCommercialization Outsourcing,In-andout-licensing Mergers&Acquisitions Pharma/Biotech Patient Care Approval TargetIdentification and Validation Animal Studies Clinical Trials LeadDevelopment Academia Biotech Pharma 18

  19. 19

  20. PartnershiponTranslationof NanotechnologyinCancer(TONIC) 20

  21. ValuePropositionofPartnership •Bringtogetherexpertiseandresourcesofparticipantsin thefield: –CreateadiscussionFORUMonopportunitiesinnanotechnology- basedcancersolutions –DevelopaROADMAPforthedevelopmentofnanotechnology- basedcancerproducts –DeveloparobusttranslationalMODELtomovetechnologiesfrom universitylaboratoriestothemarket –EvaluatethemostpromisingtechnologycandidatesCASE STUDIESforthismodel •Recognizeandpromotetranslationaleffortsateverystage ofdevelopmentthroughappropriatepartnershipsamong industry,academia,government,andphilanthropy 21

  22. HighValueGoalsforNanotechnologyin Cancer ImproveDiagnosticDetection– •highlysensitiveinvitronanosensors(proteins,RNAs)tomeasurediagnosticor prognosticbiomarkers •sequencingtechniquesforsmalltumorbiopsies(ex.fineneedleaspirates) •multiplexed,multi-modalimagingagentsfordiagnosis,surgicalresection,and therapeuticmonitoring(e.g.Invivoenzymeactivity-basedassays) ImproveTherapeuticIndex– •nano-basedvehiclestodelivernucleicacidsandproteins(increasedcirculationtime) •smallmoleculedrugs(lowertoxicity,sideeffects) •combinationtherapieswithinasingleformulation •treatmentregimesforlowerincidencemalignancies. OvercomeBiologicalBarriers(includingmicroenvironment)– • constructstopenetrate(forexample): –Blood-brainbarrier –Fibroticstroma –Plasmamembrane(e.g.Varioustargetingmoieties) OvercomeFailureofTherapy– • techniquestomonitor(andintervenewhenpossible): –acquireddrugresistance –presenceofcirculatingtumorcells(CTCs) –theestablishmentofmetastaticspread 22

  23. OfficeofCancerNanotechnologyResearch DorothyFarrell NicholasPanaro SaraHook GeorgeHinkal StephanieMorris LynnHull Consultants: SubhasMalghan–FDA http://www.nano.cancer.gov/ UmaPrabhakar–formerlyJ&J 23

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