sydney nsw 2000 tel: (61-2) 9300 3344 fax: (61-2) 9221 ...jan 13, 2017 · presentation to the...
TRANSCRIPT
Level 2, 66 Hunter Street
Sydney NSW 2000
Tel: (61-2) 9300 3344
Fax: (61-2) 9221 6333
E-mail: [email protected]
Website: www.biotron.com.au
13 January 2017
The Manager Companies
ASX Limited
20 Bridge Street
Sydney NSW 2000 (22 pages by email)
Dear Madam
BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASETM
2017
Biotron Limited advises that Dr Michelle Miller, Managing Director, will be giving the attached
presentation to the Biotech ShowcaseTM
2017 Conference being held this week in San Francisco,
California, USA.
In addition, Dr Miller will give briefings to USA institutional investors and pharmaceutical company
representatives as part of activities surrounding the annual JP Morgan Healthcare Conference. This
is one of the most important annual healthcare investor conferences, attracting thousands of
healthcare and life science business executives, as well as investors and analysts, to San Francisco.
The Biotech ShowcaseTM
features corporate presentations by innovative life science companies to an
audience of public and private investors, business development executives and professional advisors
who are interested in investment opportunities and collaborations. Now in its ninth year, it expects
to attract upwards of 2,800 attendees.
Yours sincerely
Peter J. Nightingale
Company Secretary
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Forward Looking Statements
Thispresenta,onmaycontainforward-lookingstatementswithrespecttothefinancialcondi,on,resultsandbusinessachievements/performanceofBiotronLimited(ACN086399144)andcertainof the plans and objec,ves of its management. These statements are statements that are nothistoricalfacts.Wordssuchas“should”,“expects”,“an,cipates”,“es,mates”,“believes”orsimilarexpressions,astheyrelatetoBiotronLimited,areintendedtoiden,fyforward-lookingstatements.By their nature, forward-looking statements involve risk and uncertainty because they reflectBiotron’scurrentexpecta,onsandassump,onsastofutureeventsandcircumstancesthatmaynotprove accurate. There is no guarantee that the expected events, trends or results will actuallyoccur. Any changes in such assump,ons or expecta,ons could cause actual results to differmateriallyfromcurrentexpecta,ons.
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BiotronLimited
• SpunoutfromJohnCur,nSchoolofMedicalResearchattheAustralianNa,onalUniversityin1999
• ListedonASXinJan2001(ASX:BIT)
• HeadquarteredinSydney,Australia
• Directors• MichaelHoy Chairman
• MichelleMillerCEO&ManagingDirector;ex-Johnson&JohnsonResearch;ex-Start-upAustraliabiotechfund
• DenisWade Independentnon-execu,vedirector;ex-J&J(ChairmanandMDJohnson&JohnsonResearch); DirectorofHeartwareInc(NASDAQ:HTWR)
• SusanPond Independentnon-execu,vedirector;ex-J&J(ChairmanandMDJohnson&JohnsonResearch)
• RobThomas Independentnon-execu,vedirector;DirectorofHeartwareInc(NASDAQ:HTWR);Starpharma (ASX:SPL),REVAMedicalLimited(ASX:RVA);VirginAustraliaLimited(ASX:VAH)
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Biotron–LeaderinViroporin-TargeHngDrugDevelopment
• Biotron’scoreexper,seisbasedondesignanddevelopmentofanewclassofan,viraldrugstarge,ngviralionchannelproteins(viroporins)
• Viroporinsarepresentinbroadrangeofviruses:
• Influenza(M2),HIV-1(Vpu),HepC(p7),DengueandWestNile(Mprotein),SARS(Eprotein)andothers
• Broadplakorm:
• Rapid,proprietaryprimarybacterialcell-basedscreeningassaysfortargetproteins
• Targetedlibraryofcompoundsthattargettheseviralproteins
• Pipelineofinternally-generated,first-in-classsmallmoleculeviroporininhibitorsforkeymarkets
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Viroporins
Slide4
• Smallhydrophobicproteinswithionchannelac,vity
• Formhydrophilicporesinhostcellmembranes
• Keystagesoftheviralcyclesuchasvirusuncoa,ng,transportandmatura,onareion-influencedprocessesinmanyviralspecies
• Crucialforviralpathogenicityduetoinvolvementinvariousstepsofviruslifecycles
• Idealtherapeu,ctargetsNatureReviewsMicrobiology10,563-574
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Biotron’sCoreTechnology
Slide5
Designedlibraryofcompoundstotargetviroporins:
IniHally>250compoundsdesignedandsynthesised;librarynow~350
BIT225(HIV-1andHCV)
BIT314(HCV)
Compoundsscreenedinproprietaryassaysetupforeachvirustargete.g.HIV-1Vpu;HCVp7;InfluenzaM2;DengueM;CoronavirusE.
Hitstestedagainstvirusincellcultures
Leadop,misa,onandselec,on
OTHER“HITS”INLIBRARYinclude:- InfluenzaAandB- Coronaviruses
- IncludingSARS- Epstein-Barrvirus(EBV)- HepaHHsBvirus(HBV)- Zikavirus- others
BIT225:- RepresentaHonofthevalue
thatresideswithinBiotron’scoreexperHse;
- Valuable,Phase2clinicalasset
DENGUE–SeveralcompoundswithpromisinganHviralacHvity
OTHERVIRUSES–Secondaryscreeningofhitsagainstkeyvirusese.g.HepB,influenza,Zika
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BIT225Snapshot
- PreparedbasedonaboveaoertheAugustBoardmee,ng
- Guidedthewordingoftheprospectusdraoandtheuseofproceeds
- Whilecapitalrequirementsaredeterminedbasedonproposedplan,thefinalschedule
ofworkwillbelargelydictatedbyavailablecapital
- FirstinclassdrugandnewdrugtargetfortreatmentofHIV-1andHepa,,sCvirus(HCV)
- Sevenclinicaltrialscompleted;anotherisfullyrecruitedwithdataexpected1Q16
- Over200subjectsdosedintrialstodate
- PromisingclinicalefficacyagainstHIV-1andHCV
- HCVGT1(BIT225-005)–100%receiving400mgBIDfor28daysincombina,onwith48weeksIFN/RBV(perprotocol)werevirus-freeat48weeks
- HIV-1/HCVGT3(BIT225-006)–100%receiving300mgBIDfor28daysincombina,onwith48weeksIFN/RBV(perprotocol)achievedSVR12i.e.curedofHCVinfec,on
- BIT225increasestherateatwhichHCViscleared
- BIT225efficientlyinhibitsHIV-1replica,oninmacrophagereservoircellsinvitroandinvivo(BIT225-004)
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BIT225–FirstofaNewClassofHCVDAADrugs
ü Novel,oral,smallmoleculecompound
ü Onlyoneofitsclass(p7inhibitor)inclinicaltrials
ü Inhibitsviralassemblyandinfec,vity
ü Pan-genotypeac,vity:
ü Ac,veinvitroagainstallmaingenotypes
ü Clinicallyac,veagainsthard-to-treatHCVGT1(1aand1b)andGT3
ü Seekingpartnershipsforfurtherdevelopment,inpar,cularinAsia
POLYMERASE/PROTEASEINHIBITORSe.g.Sofosbuvir/Simeprevir
BIT225-ASSEMBLY/BUDDINGINHIBITOR
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HIV-1:TowardsaCure
• Over1.1millionpeoplelivingwithHIV-1intheUSA,with1in6unawareofdiagnosis
• US$11.9bnsalesinUS,EuropeandJapanin2013;expectedtogrowtoUS$16.8bnby2020
• HIV-1pa,entsneedtostayonan,retroviraldrugs(ART)tokeepviruslevelsundercontrol
• Long-termhealthimplica,onseveninpa,entsonan,retroviraldrugse.g.HAND,immuneac,va,on,etc
• Newmodeofac,onsdrugsareneededtoeradicateorcureHIV-1infec,on
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HIV-1Reservoirs
• HIV-1remainshiddeninreservoirs,leadingtochronic,life-longinfec,on
– Invisibletobody’simmunedefenses
– Notsensi,vetoan,-HIV-1drugs
• Eradica,onwillrequiremul,pleapproaches;approachesinclude:
– An,-latencyagentsforlatently-infectedTcells
– Drugstomodifyimmuneresponse
– Drugstarge,ngHIV-1inmacrophagelineagecells
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MarioStevensonScien@ficAmerican299,78-83(2008)
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• BIT225inhibitsassemblyandbuddingofnewvirusinmacrophages• Phase2atrial(004)demonstratedthatBIT225canreduceHIV-1levelsinmacrophagecellsinvivo,
parallelinginvitrostudies(Wilkinsonetal,JAn,microbChemother.2015Nov29.pii:dkv389.[Epubaheadofprint])
• Poten,albenefitsonimmuneagingandHIV-associateddemen,a• Poten,alforuseinfutureviruseradica,ontreatment
BIT225TargetsHIV-1inReservoirCells
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Time(days)+HIV-1
50100150200
16 17 19 21 22 23 24 25 26 27 28
+BIT225
BIT225StopsHIV-1Replica7onA B
(A)UntreatedControls (B)BIT225treatedcells
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BIT225–ProvenClinicalAcHvityAgainstHIV-1
• BIT225-004:Phase1b/2arandomised,placebocontrolled,double-blindtrial
– 21pa,ents,HIV-1posi,ve,treatment-naïve;10daysdosingwithBIT225(monotherapy)
• Resultsdemonstratedthat:
1. BIT225significantlyreducesHIV-1levelsinthemacrophage(reservoir)cellsBIT225cancrosstheblood-brainbarrier,openingupthepossibilityoftreatmentofAIDS-relateddemenHa
2. BIT225reducedmyeloid-specificimmuneacHvaHonmarkersduringtrial
2 4 6 8
10 12 14 16
5 10 15 20 25
HIV-1Re
plica,
on(p
g/20
0uL)
TimeinCo-culture(days)
BIT225Placebo
ResultssupportapotenHalroleforBIT225incure/eradicaHonstrategies
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Phase2HIV-1trialofBIT225incombinaHonwithcurrentanH-HIV-1drugsscheduledtocommenceearly2017
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CurrentHIV-1ProgramTrials
Slide14
• Phase2trialan,cipatedtocommenceearly2017
• 12weeksBIT225incombina,onwithcART
• Expectedoutcome(s)–Impactonkine7csofviralloaddecayincombina7onwithARTindica7ngimpactonunderlyingviralreservoir,alsoimpactonimmuneac7va7on
• Headlinedata3Q17
• HumanisedMouseStudy
• Modellingtreatmentinterrup,on(ATI)
• Inprogress
• Expectedoutcome(s)–impactonviralkine7csincombina7onwithART,pluspoten7alimpactonreboundonceARTisstopped
• Data1Q17
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UnlockingValueinCompoundLibrary
Slide15
• Renewedindustryinterestintarge,ngviraldiseasesincluding
• Respiratorysyncy,alvirus(RSV)
• Hepa,,sBvirus
• TropicaldiseasesincludingDengue
• Influenza(inpar,culardrugresistantstrains)
• EbolaandMERS-CoVoutbreakshavecausedpublichealthissuesworldwide
• BIT225hasdemonstratedtherobustnessofBiotron’sapproachwithtargeHngviroporinproteins
• Compoundswithac,vityagainstotherkeyviruseshavebeeniden,fied;secondaryscreeningisinprogress,withtheaimofiden,fyingpoten,alcandidatestoprogressintoIND-enablingstudies
• MainfocusremainsoncommercialisingtheCompany’sHIV-1andHCVprograms,butessen,althatotheropportuni,esaredeveloped
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X-axis: compound ID Y-axis: virus Z-axis: strength of hit
Compound Library is Rich Source of Hits
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DengueVirusProgram
• 2.5billionpeople(40%worldpopula,on)liveinareasatriskofDengue
• ~100millionpeopleinfectedyearly
• Aleadingcauseofillnessanddeathintropicsandsubtropics
• Transmissionisbymosquito;mostpreven,onprogramstargetthevector
• NoapprovedDengue-specifictherapeu,cdrug
• Vaccinetrialshavehaddisappoin,ngresults
• Biotronistarge,ngDengueMprotein–SimilartargettoHIV-1/VpuandHCV/p7
• Severalcompoundswithpromisingac,vityhavebeengenerated;testsareon-going
• Poten,alforpan-Flavitherapeu,c
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HepaHHsBVirus
• LimitedscreeningofBiotroncompoundlibraryhasgeneratedinteres,ngdata
• Hitsiden,fied
• Veryexperiencedscien,ficadvisoryandopera,onalteaminplaceforHBV
• Seekingcollabora,ontoexplorehitsanddevelopprogram
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SummaryI• Uniquecoreexper,seagainstnovelviraltargets
• Demonstratedproofofconceptofsuccessfultarge,ngofviroporinswithBIT225
• BIT225isanovelapproachwithdemonstratedpromisingefficacyinPhase2a/2clinicaltrials
• HCVandHIV-1arehighgrowth,mul,-billiondollarmarkets
• Treatmentgapsremain
• Representsanewclassofdirect-ac,ngHCVdrugs
• Poten,altofillsignificantHCVtreatmentgaps,shortentreatmentandreducecosts
• Poten,altoeradicateimportantHIV-1reservoirs,plusmayimpactonimmuneac,va,on
• Robustdatapackagehasbeengeneratedtosupportcombina,onstudieswithpoten,alpartners
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SummaryII
• Technologycoreisanan,viralplakormwithnewclassofsmallmoleculeswithbroadrangeofac,vi,es
• Extendingearlierstageprogramsforotherkeyviruses:
• DevelopingleadsforprogramsincludingDengueandHBV
• Iden,fyinghitsforothervirusesincludingRSV,Zika,BK,andothers
• Denguevirus–applyingfornon-equityfundingfromUSorganisa,ons
• Poten,altoexpandtoareasofpoten,alpartnerinterest
• Seekingcollabora,onsforindividualprogramsoren,replakorm
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