Post on 09-Apr-2018
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October 2010 1
Manish Singh,PhDPresidentandCEO
manish.singh@imuc.com8189922907
OTCBB:
IMUC.OB
www.imuc.com
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October 2010 2
SEC Disclaimer Statement
Thispresentationcontainscertainforwardlookingstatements
(statementsas
to
matters
other
than
historical
facts)
as
defined
in
thePrivateSecuritiesLitigationReformActandinSection27AoftheSecuritiesActof1933andSection21EoftheSecuritiesExchangeActof1934. Suchstatementsinvolverisksanduncertaintiesthatcouldcauseactualeventsorresultstodiffermaterially
from
the
events,
projections
or
results
described
in
the
forwardlookingstatements.TheserisksanduncertaintiesaredescribedinIMUCs mostrecentlyfiledSECdocuments,suchasitsmostrecentannualreportonForm10K,allquarterlyreportson
Form10
Q
and
any
current
reports
on
Form
8K.
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October 2010 3
Overview of ImmunoCellular Therapeutics
NextGenerationActiveImmunotherapyCompany
TargetingCancerStemCells
MultipleTumorAssociatedAntigens
Dendritic cell vaccine to elicit persistent and targeted T cell
immune response
1
st
active immunotherapy targeting CSCs to treat Glioblastoma with IMPROVED SURVIVAL data
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Cancer Stem Cells: Good Guys Turned Bad
Normal
StemCell
mutations
Cancer
StemCell
MatureTissue
BulkTumor
Progenitorcells Cancersoriginateintissue
progenitoror
stem
cells
throughdysregulation oftheselfrenewalprocess.
ThroughouttumorigenesisCSCsdrivetumorgrowth.
WithoutkillingCSCs,itislikespraying
for
weeds
without
killingtheroots. Theweeds(tumors)comeback!
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Recent M&A Transactions in Cancer Stem Cells
Macrogenics(undisclosed)
MonoclonalantibodiestargetingCSC(preclinical)
Raven
Roche$200MillionMonoclonalantibodiestargetingCSC(preclinical)
AriusResearch
GSK$1.4Billioninupfrontandmilestones
MonoclonalantibodiestargetingCSC
(preclinical)
Oncomed
M&A
Transaction
Product
Platform
Company
CancerStemCellsisahotsector!
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Using Both Arms of Immune System
ACTIVEIMMUNOTHERAPIES
CellularVaccineWithSurvivalBenefit(ICT107)
Dendritic cellvaccinetoelicitpersistentandtargetedTcellimmuneresponseagainsttumorassociatedantigens/CSCantigens
PhaseItrialrecentlyshowedsurvivalbenefitforbraintumors
PhaseIIplannedin2H,2010
OfftheshelfCSCPeptide(plusadjuvant)Vaccine(ICT121)
Platform technology for cancer stem cells
Product applicable in glioblastoma, breast, ovarian, pancreatic, colon and othersolid tumors
ANTIBODYIMMUNOTHERAPIES
Antibodytherapeuticstargetingnovelcancerantigensandcancer stemcells
DIAAD: platformtechnologyforcancerantigens
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October 2010 7
ICT-107 targets Cancer Stem Cells & GBM but
has broad potential
BraincancerIL13aR2
HighBreast,ovarian,
colon,
brainAIM
2
Melanoma,braincancerMAGE1
MediumBreast,ovariancancerHer2/neu
HighMelanomaandbraincancerTrp2
Melanoma,braincancergp100
CSC
Expression
TumorExpressionAntigens
FirstIndicationisBrainCancer,butbroadpotential
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October 2010 8
Successful Phase I Trial of ICT-107
Design
PhaseIglioblastoma
trial
initiated
in
May
2007
Todeterminesafetyandimmuneresponse
Patientsreceived
three
vaccinations,
two
weeks
apart
19patients(16newlydiagnosedand3recurrentpatients)treated
Patientspecific
cell
manufacturing
(5
doses)
AllpatientstreatedatCedarsSinaiHospital(LosAngeles)
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Mature antigen-presenting
dendritic cells
Isolation of monocytes
from peripheral blood
Generation of immature
dendritic cells
Culture with
IL-4 + GM-CSF
Pulsing of DC with peptides
Vaccination of the patient
TARGETING CSC AND
TUMOR ANTIGENS
Dendritic Cell Therapy for GBM
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October 2010 10
NEWLY DIAGNOSEDWEEKS FROM 1ST SURGERY
Pt # 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188
5
3
6
1
9
10
13
11
12
14
8
15
16
17
18
19
4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188
RECURRENT
Pt # 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188
7
4
2
4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188
WEEKS FROM 1ST SURGERY
2nd Surgery 1st Chemo Progression Vaccine Death
10
Patient Treatment and Survival Timelines
June 2010 10
Historical Survival(Stupp)
Better Overall Survival than Historical Controls
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October 2010 11
SignificantImprovementinProgressionFreeSurvival
(Comparedto
Historical
Controls
using
Standard
of
Care)
Radiation + Temozolomide* Radiation + Temozolomide +ICT-107
Stupp etal,Radiotherapyplusconcomitantandadjuvanttemozolomide forglioblastoma,
NewEngland
Journal
of
Medicine,
March
2005
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October 2010 12
SignificantImprovement
in
Overall
Survival
Radiation + Temozolomide* Radiation + Temozolomide +ICT-107
Stupp etal,Radiotherapyplusconcomitantandadjuvanttemozolomide forglioblastoma,
NewEngland
Journal
of
Medicine,
March
2005
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October 2010 13
ICT107
+SOC*
(n=16)SOC
(Stupp,
NEJM,
2005)
(n=287)
PFS(%) At6months 100(63.2 99.1)** 53.9(48.1 59.6)
At12
months 62.5
(34.8
81.1) 26.9
(21.8
32.1)
At18months 49.2(23.570.6) 18.4(13.922.9)
At24months 49.2(23.570.6) 10.7(7.014.3)
Median(months) 17.7
(11.1
39.3) 6.9
(5.8
8.2)
OS(%) At6months 100 86.3(82.390.3)
At12months 100 61.1(55.466.7)
At18months 93.7(63.299.1) 39.4(33.845.1)
At24months 81.2(52.493.5) 26.5(21.231.7)
Median(months) NR 14.6(13.216.8)
NR Notreached** value(95%CI)
SummaryPFSandOS NewlyDiagnosedPatients
* SOC=StandardofCare(XRT+TMZ)
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October 2010 14
Progression Free Survival Better Than Competition
RT+TMZ
0 2 4 6 8 10 12 14 16 18 20
TMZ (Merck) EOTRC Trial
TMZ (Merck) UCLA ASCO2009
Avastin (Roche)
Cilengitide (Merck KGA)
Gliadel (Eisai)
CDX-110 (Celldex)
ICT-107 (IMUC)
Time (months)
RT+TMZ+ICT107
RT+TMZ+CDX110
RT+Gliadel
RT+TMZ+Cilengitide
RT+TMZ+Avastin
RT+TMZ
RecentUCLA
Data
PFSinNewlyDiagnosedGBM
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October 2010 15
Centralized GMP manufacturing process for Phase
II clinical trials and commercialization
Outpatient
apheresis
Apheresisproduct
Ship
Outpatienttreatment
GMP manufacturing facility
Monocyte
enrichment
~20 doses from onedoses from oneapheresisapheresis
Culture with
cytokines
Wash, concentrate and freeze
Ship dose
Antigen
pulse
and
maturation
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October 2010 1616
Manufacturing for longer dosing and low COGS
Single process for 20 doses
Better economics than Provenge which produces separate batch foreach dose
Cryopreservation technology to keep it for several
years
Plan in Phase II trial to add boost every 3-6 months toextend the benefit
4 years would be 16 doses
COGS should be 5-10%
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October 2010 17
Phase II Trial Design
102patientsat15centersinUS/Canada
2:1randomization,
double
blind
Placebo:Unloadeddendritic cells
PrimaryEndPoints:OSandPFS
SecondaryEndPoints:
OS/PFSatvarioustimeintervals
ImmuneResponse
Safety
Interimanalysisafter17months(basedon50%events)
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October 2010 18
ICT-107 Summary
TargetingCancerStemCellsviaTcellapproachdemonstrates
significantclinical
utility
ClinicalDatademonstratessignificantdelayindiseaseprogressionafterprimarysurgery(81%survivalafter2yearsisthebestresult
seen
in
GBM
trials
over
2
decades) MulticenteredPhaseIIclinicaltrialplannedtostartinQ4,2010
Potentialinadditionaltumortypes
Recurrentbrain
tumors,
Melanoma,
breast,
ovarian,
and
colon
cancers
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October 2010 19
MarkerstoIdentifyandIsolateCancerStemCells
+++Leukemia
++-+MultipleMyeloma
++++Melanoma
+Liver
+Brain
++Lung
+++++Pancreatic
++Head&Neck
+++++Prostate
+++++Colon++++++Breast
CD20CD166CD34CD1386B1ESAALDH1CD133CD24CD44Cancer
StemCellMarker
From Boman et al, JCO 26:2795, 2008
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October 2010 20
TargetofICT121upregulatedonCSCs andtumor
30,000180,000copiesofCD133onCSCs
Only4500
copies
on
hematopoietic
stem
cells
SelectivityincreasedbydifferencesinMHCclassIexpression
Ontumorcells,notnormalcells
NormalStem
Cells Cancer
Stem
Cells Cancer
Daughter
Cells
PE-HLA-D
R
FITC-HLA-A,B,C
CSCprimed
T
cells
dont
recognizenormalstemcellsCSC
primed
T
cells
recognizeCSCsCSC
primed
T
cells
recognize
Cancerdaughtercells(tumor)
Secondproduct:ICT121
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October 2010 21
ICT121:OfftheshelfCancerStemCellVaccine
PeptidebasedvaccinetargetingCD133antigenpresentonCSCs
Applicableformultiplesolidtumors
INDtobefiledin1H,2011
Maybe
applicable
to
brain,
pancreatic,
lung,
colon,
renal,
melanoma,andbreastcancers
Onlycompanydevelopinganactiveimmunotherapy
platformtargeting
CSCs
PotentialBlockBusterProduct.
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October 2010 23
StrongIP
Position
25+PatentsandPatentApplications.
7Issued
18+Pending
IssuedPatentscovercompositionofmatter,therapeutictreatmentsanddiagnosticsrelatedtomonoclonalantibodies
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October 2010 24
ValueCreationinNext12Months
Clinical
InitiatePhaseIIclinicaltrialsforICT107(Q4)
PeerreviewedpublicationofphaseItrialinamajor
journal
InitiatePhaseIclinicaltrialforanofftheshelfvaccine
Business
Development PotentialpartneringofICT107vaccineoroneofthe
antibodycandidates
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October 2010 25
ExperiencedManagement
Team
ManishSingh,PhD,PresidentandCEO
CaliforniaTechnologyVentures,CellGenesys,ChironViagene,GeneticTherapyInc(Novartis)
JohnYu,MD,ChairmanandCSO
Neurosurgeonat
Cedars
Sinai
Medical
Center,
Mass
General
Hospital,HarvardMedicalSchool
JimBender,PhD,MPH,VPofClinicalDevelopment
IDM
Pharma,
Baxter
Healthcare C.KirkPeacock,CPA,CFO
CytRx,DigitalMed,Ants.com
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October 2010 26
KeyOpinion
Leaders
KeithBlack,MD,HeadofScientificAdvisoryBoard
HeadofNeurosurgery,CedarsSinaiMedicalCenter
GeorgePeoples,MD,MemberofScientificAdvisoryBoard
Directorof
Cancer
Vaccines,
US
Military
Cancer
Institute
RobertMartuza,MD,MemberBoardofDirectors
ProfessorofNeurosurgery,HarvardMedicalSchool,and
Chiefof
Neurosurgery,
Massachusetts
General
Hospital
SherieMorrison,PhD,MemberofScientificAdvisoryBoard
Chair,DeptofMicrobiology,ImmunologyandMolecular
Genetics,UCLA
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October 2010 2727
StrongFinancial
Position
and
Capitalization
Cash: $7.7Million(June30th,2010)
Currentburnrate: $1.15M/quarter(Q2,2010)
Outstandingdebt: $0
Sharesoutstanding: 21.6
million
Currentshareprice: $1.00
Currentmarketcap: $22million
Warrantsoutstanding 3.4million
Optionsoutstanding: 11.3million;averageweightedaverageexercisepriceof$0.92
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October 2010 28
ImmunoCellular Therapeutics AdvancingPromisingCancer
Stem
Cell
Therapeutics
BuildingNextGenerationVaccineTargetingCancer
Stem
Cells
to
prevent
recurrence Bestclinicaldataforglioblastoma outofall
publishedclinicaltrialsover30years
PhaseII
trial
to
start
in
Q4,
2010
Additionalclinicaltrialsinnext3yearsinrecurrent
brain
cancers,
pancreatic,
and
ovarian
cancers Experiencedmanagementteamwithprovendrug
developmentexperience