2016 shareholder meeting presentation final

21
2016 ANNUAL MEETING OF STOCKHOLDERS July 14, 2016

Upload: galenabio

Post on 14-Feb-2017

5.189 views

Category:

Investor Relations


0 download

TRANSCRIPT

  • 2016 ANNUAL MEETING OF STOCKHOLDERS

    July 14, 2016

  • FORWARD LOOKING STATEMENT

    This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future expectations, plans and prospects for the development and commercialization of the Company's product candidates, including patient enrollment in our clinical trials, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in the Companys most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. The Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.

    2

  • DEVELOPMENT PIPELINE

    Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA

    Immunotherapy: Breast Cancer

    NeuVax (nelipepimut-S) Node-positiveHER2 IHC 1+/2+

    NeuVax + Herceptin Node-positive or node negative/triple negative HER2 IHC 1+/2+

    NeuVax + Herceptin High risk, node-positive or negative, HER2 IHC 3+

    NeuVax Ductal Carcinoma in Situ (DCIS)

    Immunotherapy: Gastric Cancer

    NeuVax Gastric, HER2 IHC 1+/2+/3+

    Immunotherapy: Gynecological Cancer

    GALE-301 Ovarian & Endometrial

    GALE-301 + GALE-302 Ovarian & Breast

    Hematology

    GALE-401 (Anagrelide CR) MPN-related thrombocytosis

    *NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech.

    Ongoing Planned

    VADIS

    3

    2b

    StoppedPRESENT

  • PRESENT CURRENT STATUS

    IDMC recommend the trial stop for futility Study drug and all procedures have stopped

    Investigation ongoing Compiled team with addition of outside experts and the Company

    remains blinded to the data Operational elements under review include: Database and data analysis (programming) Randomization Manufacturing and packaging elements such as filling, labeling and

    kit assembly Biology and immunology Anticipated timeline: up to 3 months or longer

    4

  • T-Cell

    Activating Receptors Inhibitory Receptors

    CD28

    OX40

    GITR

    CD122

    CD27

    CD360

    HVEM

    CD137

    CTLA-4

    PD-1

    TIM-3

    BTLA

    VISTA

    LAG-3

    IMMUNO-ONCOLOGY:UNLOCKING THE POWER OF THE T-CELL

    5

    Checkpoint inhibitors

    Indirect Immune Modulators

    Co-stimulators

    Immune Inhibitory Enzymes

    CAR TTechnology

    TCRTechnology

  • T-Cell

    Activating Receptors Inhibitory Receptors

    CD28

    OX40

    GITR

    CD122

    CD27

    CD360

    HVEM

    CD137

    CTLA-4

    PD-1

    TIM-3

    BTLA

    VISTA

    LAG-3

    LACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERS

    6

    Checkpoint inhibitors

    Indirect Immune Modulators

    Co-stimulators

    Immune Inhibitory Enzymes

  • T-Cell

    CD28OX40

    GITR

    CD122

    CD27

    CD360

    HVEM

    CD137

    CTLA-4

    PD-1

    TIM-3

    BTLA

    VISTA

    LAG-3

    Activating Receptors Inhibitory Receptors

    OUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSION

    7

    T cells

    Checkpoint inhibitors

    Indirect Immune Modulators

    Co-stimulators

    Immune Inhibitory Enzymes

    T cells

    T cells

    T cells

    T cells

    T cells

    T cells

    T cells

    T cells

    T cells

    GALE-301

  • NOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORS

    8

    RECEIVES PRIMARY TREATMENT

    Surgery Chemotherapy and/or Radiation

    Disease freesurvivor

    Breast: HER2, 1+/2+25% recurrence rate in 3 yrs

    No FDA Approved targeted therapies

    Breast: HER2, 3+ High Risk20% recurrence rate

    DECLAREDTO PREVENT RECURRENCE / METASTATIC DISEASE

    Breast: Ductal Carcinoma in Situ8-10% progression to invasive

    Ovarian Cancer~50% recurrence rate in 1 yr

    No FDA Approved targeted therapies

    Watch & Wait, or

    Repetitive therapies

    TOLD

  • NEUVAX: DEVELOPMENT COLLABORATIONS

    Phase Treatment HER2 Status Indication Trial StatusProtocol Defined

    # of PatientsCollaborations

    3Single agent

    PRESENTStudy

    1+, 2+BREAST

    Node PositiveHLA A2+, A3+

    STOPPED 700(enrolled 758)

    2bCombination

    with trastuzumab

    1+, 2+

    BREAST Node Positive or High Risk Node Negative

    HLA A2+, A3+, A24+, A26+

    EnrollingU.S. only

    33 centers300

    2Combination

    with trastuzumab

    3+ high risk

    BREASTNode PositiveHLA A2+, A3+

    EnrollingU.S. only

    28 centers100

    2 Single agentVADIS Study1+,

    2+,3+

    BREASTDuctal Carcinoma in

    Situ (DCIS)HLA A2+

    RecruitingU.S. only4 centers

    48

    2 Single agent 1+, 2+,3+GASTRIC

    HLA A2+, A3+Planned

    India Only 50

    9

  • Targeting Folate Binding Protein

    GALE-301 & GALE-302

  • GALE-301 & GALE-302:CURRENT CLINICAL DEVELOPMENT

    11

    Phase Treatment Cancer Type TargetIndicationCurrent Status

    # of Enrolled Patients

    1/2a GALE-301Ovarian,

    EndometrialHLA A2+

    Ovarian Enrolled 51

    1b GALE-301 & GALE-302Ovarian, Breast

    HLA A2+Ovarian /

    Breast Enrolled 39

  • GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY

    Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2015 12

    Phase 1/2a trial ongoing Phase 1: Determined optimal dose and

    demonstrated safety and potent immune response

    Phase 2a Preliminary data:

    At 16 months median follow-up:

    Overall recurrence rate was 44.8% in the VG versus 54.5% in the CG (p=0.58),

    Recurrence rate of 23.5% in patients who received booster inoculations.

    Two year DFS estimate in 1000 mcg dose group is 73.5% vaccine vs. 38.1% control (p=.03)

    GALE-301 plus GM-CSF is well tolerated and elicits a strong in vivo immune response with primarily Grade 1 and Grade 2 toxicities

    Estimated 24 months Disease Free Survival by Dosing Cohort

    Chart1

    0.3103448276

    0.5

    *p=0.17

    % of Subjects

    Recurrence

    Demographics

    Enroll DateDOBAge at EnrollCohortDosageBooster CohortBooster DoseTumor Size (cm)GradeCytology# pos nodedStatusStatus CommentDate offRecurrence TypeLast VaxVax Date

    NV005V15/24/127/10/6250Group 1100mcg E39 + 250mcg GM-CSF13poorlypositivenaCompletePt recurred with primary cancer11/7/13TreatedV612/4/12

    NV033V23/29/126/19/5161Group 1100mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF8poorlypositive1

    NV015V39/21/126/22/5656Group 1100mcg E39 + 250mcg GM-CSF3poorlypositive0CompletePt recurred with primary cancer12/18/13TreatedV62/4/13

    NV009V411/27/123/13/4271Group 2500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF5.5poorlyunknownnaCompletePt recurred with primary cancer3/18/14Treated

    NV025V511/29/127/18/5656Group 2500mcg E39 + 250mcg GM-CSF6.5poorlypositive0CompletePt recurred with primary cancer2/7/13EarlyV32/5/13

    NV032V612/3/121/11/5360Group 2500mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 250mcg GM-CSF6poorlypositive1

    NV030V71/24/132/20/4073Group 3500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF15moderatenegative0

    NV016V82/11/139/28/5557Group 31000mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3.5well-differentiatedpositive

    NV054V93/4/138/2/3875Group 31000mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 125mcg GM-CSFcannot be determinedpoorlyunknown

    NV060V105/2/132/23/5261OBD500mcg E39 + 250mcg GM-CSF1.7moderateunknown0Off TreatmentIntercurrent Illness8/16/13(patient hospitalized for NSTEMI and subsequent CABG)

    NV061V115/23/137/23/5261OBD500mcg E39 + 250mcg GM-CSF7.3poorlypositive0CompletePt recurred with primary cancer7/10/13EarlyV27/9/13

    NV062V125/30/139/23/6449OBD500mcg E39 + 250mcg GM-CSF3poorlyunknown1CompletePt recurred with primary cancer3/7/14Treated

    NV070V137/11/137/21/4568OBD500mcg E39 + 250mcg GM-CSF4.5poorlynegative0CompletePt recurred with primary cancer12/23/13TreatedV611/18/13

    NV064V146/3/136/14/3974OBD500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3poorlyunknown4

    NV065V156/4/135/11/4271OBD500mcg E39 + 250mcg GM-CSF8moderatepositive3CompletePt recurred with primary cancer11/14/13TreatedV610/1/13

    NV100V1612/30/134/6/5163OBD500mcg E39 + 250mcg GM-CSF7poorlypositivena

    NV101V172/3/147/16/5955OBD500mcg E39 + 250mcg GM-CSF11.5moderatenegative3

    NV102V182/24/1410/12/7340OBD1000mcg E39 + 250mcg GM-CSFperitoneal carcinomatosispoorlyunknown13

    NV103V192/27/148/29/4766OBD1000mcg E39 + 250mcg GM-CSF9well-differentiatednegative0

    NV104V203/24/145/28/7539OBD1000mcg E39 + 250mcg GM-CSF10poorlyunknown0

    NV105V215/5/144/29/5361OBD1000mcg E39 + 250mcg GM-CSF8poorlypositive19Off StudyWithdrawn5/8/14

    NV106V224/25/142/26/6252OBD1000mcg E39 + 250mcg GM-CSF6poorlyatypical cells0

    NV107V235/19/1410/5/4767OBD1000mcg E39 + 250mcg GM-CSF10poorlypositivena

    NV108V246/3/149/29/5955OBD1000mcg E39 + 250mcg GM-CSF8.5poorlypositivena

    NV109V256/16/146/25/3876OBD1000mcg E39 + 250mcg GM-CSF3.5poorlyunknown0

    NV0279/13/121/11/5063controlNApoorlyatypical cells3CompletePt recurred with primary cancer8/22/13

    NV0315/5/124/10/5656control4poorlypositive4CompletePt recurred with primary cancer11/28/12

    WR02312/5/117/22/6942control9poorly0CompletePt has completed 18 months on trial12/19/13

    NV0083/23/126/10/7042control10poorlypositiveNACompletePt recurred with primary cancer11/1/12

    NV0189/19/1210/25/5359control14poorlypositivenaCompletePt recurred with primary cancer6/4/14

    NV0363/23/128/10/4666control15poorlypositiveNACompletePt recurred with primary cancer10/26/12

    NV0201/8/132/23/7439control10well-differentiatedunknownNAOff StudyWithdrawn: Pt refuses participation in control group1/9/13

    NV0291/24/135/3/4271control11poorlyunknownnaOff StudyWithdrawn: screen failure1/25/13

    NV0012/12/1311/4/5854control7.5poorlyatypical cellsnaCompletePt recurred with primary cancer6/13/14

    NV0232/14/1310/11/5062controlnot measurablepoorlypositive1CompletePt recurred with primary cancer8/16/13

    NV0131/23/133/15/6647control8well-differentiatedunknown0

    NV0112/28/132/17/5063control5poorlyunknownnaCompletePt recurred with primary cancer10/14/13

    NV0636/25/139/8/3776control5.2poorlypositivena

    NV0666/26/136/13/6152control9.5poorlypositivenaCompletePt recurred with primary cancer11/14/13

    NV0676/25/139/27/5162control8poorlypositivena

    NV0687/3/135/9/5954control8poorlypositive0

    NV0982/10/145/8/5163control10poorlynegative0

    NV0992/6/147/4/5361control12poorlypositive0

    NV0973/27/144/4/6153control1.5poorlypositive0

    NV0964/8/142/1/4866control3.5poorlypositive0CompletePt recurred with primary cancer6/13/14

    NV0955/8/143/8/4965control5moderateunknown1

    NV0946/4/143/4/2886control5moderateunknown2

    AgeSizePoorly graded, mod, wellCytologyNodesStage IIIStage IIStage IStage IV

    Vac6119,4,212 pos2.515334

    Cont5918,2,212 pos0.916666666711335

    pvalue10.33672648630.73,0.67, 10.770.2308385170.56110.714

    Demographics

    VaccinatedControl

    n2522

    Age (mean)6159p=1

    Nodes30.92p=0.23

    Poor Grade1918p=0.73

    Mod Grade42p=0.67

    Well Differentiated22p=1

    Stage I33p=1

    Stage II33p=1

    Stage III1511p=0.56

    Stage IV45p=0.714

    Laura:diffuse cannot be determined

    Path_Stage

    Study IDSyncronous 1* Malignancies1* SiteFIGOTNMMetastasis LocationHistologyEpithelial1Epithelial2Epithelial3Endometrial1

    NV005V1NoOvarianIIIC3cNxM1transverse 2nd sigmoid colonOvarianAdenocarcinoma

    NV0033V2NoOvarianIIIC3bN1MxOvarianPapillary Serous Carcinoma

    NV015V3NoOvarianIIIC3cNxMxOvarianEndometrioid CystoadenocarcinomaMixed Epithelial TumorPapillary Serous Carcinoma

    NV009V4NoOvarianIIIC3cNxM0OvarianSerous Cystoadenocarcinoma

    NV025V5NoOvarianIC1cN0MxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV032V6NoOvarianIIIC3cN1M0OvarianSerous Cystoadenocarcinoma

    NV030V7NoOvarianIIA1aN0M0OvarianEndometrioid Cystoadenocarcinoma

    NV016V8NoOvarianIIIA3aNxM1Gall BladderOvarianSerous Cystoadenocarcinoma

    NV054V9NoOvarianIIB2bNxMxOvarianMixed Epithelial Tumor

    NV060V10NoEndometrialIV4N0M1PulmonaryEndometrialEndometriod Adenocarcinoma

    NV061V11NoOvarianIIIC3CNxMxOvarianSerous Cystoadenocarcinoma

    NV062V12NoPeritonealIIIC3cN1MxPrimary PeritonealSerous CystoadenocarcinomaClear Cell Cystoadenocarcinoma

    NV070V13NoEndometrialIIIC11aN1M0EndometrialCarcinosarcoma

    NV064V14NoFallopian TubeIIIC1aN1MxFallopian tubeSerous Cystoadenocarcinoma

    NV065V15NoOvarianIIIC3CN1MxOvarianSerous Cystoadenocarcinoma

    NV100V16NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma

    NV101V17NoEndometrialIVB4N2M1PulmonaryEndometrialEndometrioid Adenocarcinoma

    NV102V18NoPeritonealIV4N2(13)M1LO, RO, liver parenchyma, splenic serosa, peripancreatic LN, pericecal adispose tissue, anterior abdominal wall fascia & subcutaneous tissue, uterine serosa, omentumPrimary PeritonealSerous Cystoadenocarcinoma

    NV103V19NoOvarianIC1cN0MxOvarianEndometrioid Cystoadenocarcinoma

    NV104V20NoOvarianIIIC3cN0M0OvarianSerous Cystoadenocarcinoma

    NV105V21NoOvarianIV4N2M1SpleenOvarianSerous Cystoadenocarcinoma

    NV106V22NoOvarianIICTxNxMxOvarianClear cell cystoadenocarcinoma

    NV107V23NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma

    NV108V24NoOvarianIIIC3cNxMxOvarian

    NV109V25NoEndometrialIA1aN0MxEndometrialEndometrioid Adenocarcinoma

    NV008NoOvarianIIIC3bNxMxOvarianCarcinosarcoma

    NV018NoOvarianIIIB3bN0MxOvarianSerous Cystoadenocarcinoma

    NV020NoOvarianIA1aNxMxOvarianMucinous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV027NoEndometrialIVB3bN2M1IntraperitonealEndometrialEndometrioid Adenocarcinoma

    NV031NoOvarianIV4NxM1skin implants in abdominal wall where intraperitoneal port would be placedOvarianSerous Cystoadenocarcinoma

    NV036NoOvarianIIIC3cNxMxOvarianCarcinosarcoma

    WR023NoOvarianIC1cNxMxOvarianSerous CystoadenocarcinomaEndometrioid Cystoadenocarcinoma

    NV029NoOvarianIIIC3cNxM0OvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV023NoOvarianIV3cN1M1Cardiophrenic LNOvarianSerous Cystoadenocarcinoma

    NV013NoOvarianIIC2cN0M0OvarianSexcord Stromal

    NV001NoOvarianIA1aNxMxOvarianClear cell cystoadenocarcinoma

    NV011NoOvarianIV4NxM1lungsOvarianSerous Cystoadenocarcinoma

    NV063NoOvarianIIIC2cNxMxOvarianSerous Cystoadenocarcinoma

    NV066NoOvarianIIIB3bNxM0OvarianClear cell cystoadenocarcinoma

    NV067NoOvarianIIIC3cNxMxovarianSerous Cystoadenocarcinoma

    NV068NoOvarianIIC2cN0MxOvarianSerous Cystoadenocarcinoma

    NV098NoOvarianIIIB3bNxMxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV099NoOvarianIIIC3cN0MxOvarianSerous Cystoadenocarcinoma

    NV097NoOvarianIIIB3bNxMxOvarianSerous Cystoadenocarcinoma

    NV096NoOvarianIIB2bN0MxOvarianSerous Cystoadenocarcinoma

    NV095NoEndometrialIV4N1M1Hernia and omentumEndometrialEndometrioid Adenocarcinoma

    NV094NoEndometrialIIIC3bN2MxEndometrialEndometrioid Adenocarcinoma

    DTH

    R0 E39RO NSSR6 E39R6 NSSR0 E39RO NSSR6 E39R6 NSSR0R6

    NV005V113.50480n242414147.145833333315.8214285714

    NV033V24000median20130

    NV015V37.509.50mean7.14583333332.1915.82142857145.5357142857

    NV009V440230Stdev8.363324654415.7182000619

    NV025V500Count2414

    NV032V6162.52622.5Sqrt4.89897948563.7416573868

    NV030V718.50250SEM1.70715649644.2008656692

    NV016V8210390

    NV054V91701100.0723360654

    NV060V1000

    NV061V1117.50

    NV062V1215000

    NV070V13020015

    NV064V1418301520

    NV065V1519.5000

    NV100V160000

    NV101V17002520

    NV102V1800

    NV103V1900

    NV104V2000

    NV105V2100

    NV106V2200

    NV107V2300

    NV108V2400

    joyceog wendynew wendy

    NV030V72523.518.5

    NV016V822.52621

    NV054V923.52717

    Laura:off study

    Laura:off study

    Laura:off treatment

    DTH

    1.7071564964

    4.20086566924.2008656692

    Orthogonal Mean (mm)

    E39 DTH Response (mm)

    Local Reaction

    R0R1R2R3R4R5B1

    NV015V33884.515077.550105Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6B1

    NV005V152.5101.5106171200210.5n1515141212125

    NV033V228143.5137154.514165median42.56982.59495100.7597.5

    NV009V41483.5120.512861127.5103.5mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25

    NV25V50087

    NV032V6759103134.510011491.5

    NV030V749113190136102126135

    NV016V842.578.579147.51219875.5Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6Booster 1

    NV054V951.592.5112.58897.5112103.5median42.56982.59495100.7597.25

    NV060V1073.59846.5

    NV061V117062.5

    NV062V127059.581.594111.510374.5

    NV070V13456963.564.576.545

    NV064V146845.572.57274.574

    NV065V15113.584.582.5105.56258.5

    NV100V163547.570.58675.598.5

    NV101V173864.593.586.59596

    NV102V184085.55869

    NV103V1954505672.564.5

    NV104V20264265106

    NV105V21did not present

    NV106V2233.545.5

    NV107V2382

    NV108V2417

    0.00388804070.05145904570.30687968230.44061529060.63902523620.72097308930

    Mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25

    Stdev26.169163127930.399267691736.368705620933.46755452538.274603042939.816129593722.4805471464

    Count2321191715146

    Sqrt4.79583152334.5825756954.35889894354.12310562563.87298334623.74165738682.4494897428

    SEM5.4566477166.63366406048.34355328998.11707425529.882460011210.64130824349.1776449412

    0.02345634050.5131632142

    0.04717082220.7605079717

    Laura:recurrence/off study

    Laura:no dose reduction

    Laura:off study

    Laura:OFF TX

    Local Reaction

    5.4566477165.456647716

    6.63366406046.6336640604

    8.34355328998.3435532899

    8.11707425528.1170742552

    9.88246001129.8824600112

    10.641308243410.6413082434

    9.17764494129.1776449412

    *

    Orthogonal Mean (mm)

    E39 Local Reaction

    Max Toxicity

    Max ToxicityLocal GradeSystemic Grade

    NV015V3VAX#11Induration0No adverse eventLocalSystemic0123401234

    NV015V3VAX#21Erythema0No adverse eventNV015V3110%96%4%0%0%9%56.5%26.1%4.30%4.30%

    NV015V3VAX#21PruritusNV005V112red numbers are for graph purposes only

    NV015V3VAX#21IndurationNV033V211

    NV015V3VAX#31Erythema0No adverse eventNV009V411

    NV015V3VAX#31PruritusNV025V511

    NV015V3VAX#31IndurationNV032V611

    NV015V3VAX#41Induration1FatigueNV030V712

    NV015V3VAX#41Pruritus1MalaiseNV016V811

    NV015V3VAX#41ErythemaNV054V912

    NV015V3VAX#51Erythema0No adverse eventNV060V1013possibly related

    NV015V3VAX#51PruritusNV061V1110

    NV015V3VAX#51IndurationNV062V1211

    NV015V3VAX#61Erythema0No adverse eventNV070V1312

    NV015V3VAX#61PruritusNV064V1412

    NV015V3VAX#61IndurationNV065V1522

    NV005V1VAX#11Induration1HeadacheNV100V1611

    NV005V1VAX#11FlushingNV101V1711

    NV005V1VAX#21Erythema1FlushingNV102V1814possibly related

    NV005V1VAX#21PruritusNV103V1911

    NV005V1VAX#21IndurationNV104V2011

    NV005V1VAX#31Erythema1NauseaNV16V8 had a grade 3 SAE for low WBC, but the attribution is unlikely related, so it isn't includedNV106V2211

    NV005V1VAX#31Pruritus1FlushingNV107V2310

    NV005V1VAX#31IndurationNV108V2411

    NV005V1VAX#41Erythema1Arthralgias

    NV005V1VAX#41Pruritus2Joint Effusion

    NV005V1VAX#41Induration

    NV005V1VAX#51Erythema1Arthralgias

    NV005V1VAX#51Pruritus1Joint Effusion

    NV005V1VAX#51IndurationGradeLocalSystemic

    NV005V1VAX#61Erythema1Arthralgias000.00%28.7%

    NV005V1VAX#61Pruritus12296%1356.5%

    NV005V1VAX#61Induration214%626.1%

    NV033V2VAX#11Induration1Fatigue300%14.3%

    NV033V2VAX#11Erythema400%14.3%

    NV033V2VAX#11Pruritus2323

    NV033V2VAX#21Erythema1Flushing

    NV033V2VAX#21Pruritus

    NV033V2VAX#21Induration

    NV033V2VAX#31Erythema1Headache

    NV033V2VAX#31Pruritus1Dizziness

    NV033V2VAX#31Induration

    NV033V2VAX#41Erythema0No adverse event

    NV033V2VAX#41Pruritus

    NV033V2VAX#41Induration

    NV033V2VAX#51Erythema0No adverse event

    NV033V2VAX#51Pruritus

    NV033V2VAX#51Induration

    NV033V2VAX#61Erythema0No adverse event

    NV033V2VAX#61Pruritus

    NV033V2VAX#61Induration

    NV009V4VAX#11Pruritus0No adverse event

    NV009V4VAX#11Induration

    NV009V4VAX#21Erythema1Arthralgias

    NV009V4VAX#21Pruritus

    NV009V4VAX#21Induration

    NV009V4VAX#31Erythema1Bone Pain

    NV009V4VAX#31Induration1Fatigue

    NV009V4VAX#31Pruritus1Headache

    NV009V4VAX#41Erythema0No adverse event

    NV009V4VAX#41Pruritus

    NV009V4VAX#41Induration

    NV009V4VAX#51Erythema1Bone Pain

    NV009V4VAX#51Induration1Headache

    NV009V4VAX#61Erythema1Headache

    NV009V4VAX#61Pruritus

    NV009V4VAX#61Induration

    NV009V4Booster#11Erythema1Arthralgias

    NV009V4Booster#11Pruritus1Back Pain

    NV009V4Booster#11Induration1Fatigue

    NV025V5VAX#11Erythema1Diarrhea

    NV025V5VAX#11GI pain

    NV025V5VAX#21Erythema0No adverse event

    NV025V5VAX#21Pruritus

    NV025V5VAX#2

    NV025V5VAX#31Erythema0No adverse event

    NV025V5VAX#31Pruritus

    NV025V5VAX#31Induration

    NV032V6VAX#11Erythema1Back Pain

    NV032V6VAX#11Pruritus1Diarrhea

    NV032V6VAX#11Induration

    NV032V6VAX#21Erythema1Back Pain

    NV032V6VAX#21Pruritus

    NV032V6VAX#21Induration

    NV032V6VAX#31Erythema0No adverse event

    NV032V6VAX#31Pruritus

    NV032V6VAX#31Induration

    NV032V6VAX#41Erythema1Fatigue

    NV032V6VAX#41Induration1Headache

    NV032V6VAX#41Nausea

    NV032V6VAX#51Erythema0No adverse event

    NV032V6VAX#51Induration

    NV032V6VAX#51Bruising

    NV032V6VAX#61Erythema0No adverse event

    NV032V6VAX#61Induration

    NV032V6Booster#11Erythema1Bone Pain

    NV032V6Booster#11Pruritus

    NV032V6Booster#11Induration

    NV030V7VAX#11Erythema0No adverse event

    NV030V7VAX#11Induration

    NV030V7VAX#11Bruising

    NV030V7VAX#21Erythema0No adverse event

    NV030V7VAX#21Pruritus

    NV030V7VAX#21Induration

    NV030V7VAX#21Burning

    NV030V7VAX#31Erythema0No adverse event

    NV030V7VAX#31Pruritus

    NV030V7VAX#31Induration

    NV030V7VAX#41Erythema0No adverse event

    NV030V7VAX#41Pruritus

    NV030V7VAX#41Induration

    NV030V7VAX#51Erythema0No adverse event

    NV030V7VAX#51Pruritus

    NV030V7VAX#51Induration

    NV030V7VAX#61Erythema0No adverse event

    NV030V7VAX#61Pruritus

    NV030V7VAX#61Induration

    NV030V7Booster#11Erythema1Neuropathy

    NV030V7Booster#11Pruritus1Arthralgias

    NV030V7Booster#11Induration1Headache

    NV030V7Booster#11Malaise

    NV030V7Booster#12Maculo-papular rash

    NV016V8VAX#11Induration1Headache

    NV016V8VAX#21Induration1Headache

    NV016V8VAX#21Pruritus

    NV016V8VAX#31Induration1Headache

    NV016V8VAX#31Pruritus

    NV016V8VAX#31Induration

    NV016V8VAX#41Erythema1Headache

    NV016V8VAX#41Pruritus1Nausea

    NV016V8VAX#41Induration1Neuropathy

    NV016V8VAX#41Dizziness

    NV016V8VAX#41Insomnia

    NV016V8VAX#51Erythema0No adverse event

    NV016V8VAX#51Pruritus

    NV016V8VAX#51Induration

    NV016V8VAX#61Erythema0No adverse event

    NV016V8VAX#61Pruritus

    NV016V8VAX#61Induration

    NV016V8Booster#11Erythema1Neuropathy

    NV016V8Booster#11Pruritus

    NV016V8Booster#11Induration

    NV054V9VAX#11Erythema0No adverse event

    NV054V9VAX#11Induration

    NV054V9VAX#11Bruising

    NV054V9VAX#21Erythema0No adverse event

    NV054V9VAX#21Pruritus

    NV054V9VAX#21Induration

    NV054V9VAX#31Erythema2Neuropathy

    NV054V9VAX#31Pruritus

    NV054V9VAX#31Induration

    NV054V9VAX#41Erythema2Neuropathy

    NV054V9VAX#41Pruritus

    NV054V9VAX#41Induration

    NV054V9VAX#51Erythema2Neuropathy

    NV054V9VAX#51Pruritus

    NV054V9VAX#51Induration

    NV054V9VAX#61Erythema0No adverse event

    NV054V9VAX#61Pruritus

    NV054V9VAX#61Induration

    NV054V9Booster#11Erythema0No adverse event

    NV054V9Booster#11Pruritus

    NV054V9Booster#11Induration

    NV060V10VAX#11Erythema1Arthralgias

    NV060V10VAX#11Induration2Fatigue

    NV060V10VAX#11Pruritus2Headache

    NV060V10VAX#11Malaise

    NV060V10VAX#11Dizziness

    NV060V10VAX#21Induration1Arthralgias

    NV060V10VAX#21Pruritus1Fatigue

    NV060V10VAX#21Erythema2Headache

    NV060V10VAX#21Nausea

    NV060V10VAX#31Erythema1Arthralgias

    NV060V10VAX#31Pruritus1Fatigue

    NV060V10VAX#31Induration1Headache

    NV060V10VAX#31Myalgias

    NV060V103Cardiac disorder

    NV061V11VAX#11Pruritus0No adverse event

    NV061V11VAX#11Induration

    NV061V11VAX#21Erythema0No adverse event

    NV061V11VAX#21Induration

    NV061V11VAX#21Pruritus

    NV062V12VAX#11Induration1Bone Pain

    NV062V12VAX#11Fatigue

    NV062V12VAX#11Malaise

    NV062V12VAX#11Myalgias

    NV062V12VAX#11Nausea

    NV062V12VAX#21Erythema0No adverse event

    NV062V12VAX#21Induration

    NV062V12VAX#21Pruritus

    NV062V12VAX#31Erythema0No adverse event

    NV062V12VAX#31Induration

    NV062V12VAX#31Pruritus

    NV062V12VAX#41Erythema1Headache

    NV062V12VAX#41Induration1Malaise

    NV062V12VAX#41Pruritus

    NV062V12VAX#51Erythema1Headache

    NV062V12VAX#51Pruritus1Malaise

    NV062V12VAX#51Induration

    NV062V12VAX#61Erythema1Fatigue

    NV062V12VAX#61Pruritus

    NV062V12VAX#61Induration

    NV070V13VAX#11Erythema1Fatigue

    NV070V13VAX#11Induration1Headache

    NV070V13VAX#11Nausea

    NV070V13VAX#21Erythema1Fatigue

    NV070V13VAX#21Pruritus

    NV070V13VAX#21Induration

    NV070V13VAX#21Pain

    NV070V13VAX#31Erythema1Arthralgias

    NV070V13VAX#31Pruritus2Fatigue

    NV070V13VAX#31Induration1Headache

    NV070V13VAX#31Pain at site

    NV070V13VAX#41Erythema1Arthralgias

    NV070V13VAX#41Pruritus1Fatigue

    NV070V13VAX#41Induration1Headache

    NV070V13VAX#41Pain at site

    NV070V13VAX#51Erythema1Arthralgias

    NV070V13VAX#51Pruritus2Fatigue

    NV070V13VAX#51Induration1Headache

    NV070V13VAX#51Pain at site

    NV070V13VAX#61Erythema1Arthralgias

    NV070V13VAX#61Pruritus2Fatigue

    NV070V13VAX#61Induration1Headache

    NV070V13VAX#61Pain at site

    NV064V14VAX#11Erythema0No adverse event

    NV064V14VAX#11Induration

    NV064V14VAX#11Pruritus

    NV064V14Delayed2DUR: Urticarial lesion (Left buttock)

    NV064V14VAX#21Erythema0No adverse event

    NV064V14VAX#21Induration

    NV064V14VAX#21Pruritus

    NV064V14VAX#21Bruising

    NV064V14VAX#31Erythema0No adverse event

    NV064V14VAX#31Induration

    NV064V14VAX#31Pruritus

    NV064V14VAX#41Erythema0No adverse event

    NV064V14VAX#41Pruritus

    NV064V14VAX#41Induration

    NV064V14VAX#51Erythema0No adverse event

    NV064V14VAX#51Pruritus

    NV064V14VAX#51Induration

    NV064V14VAX#61Erythema0No adverse event

    NV064V14VAX#61Pruritus

    NV064V14VAX#61Induration

    NV064V14Delayed2DUR: Urticarial lesion (Left buttock)

    NV064V14Booster#11Erythema1Headache

    NV064V14Booster#11Induration

    NV065V15VAX#11Erythema1Fatigue

    NV065V15VAX#11Pruritus

    NV065V15VAX#11Induration

    NV065V15VAX#21Erythema1Fatigue

    NV065V15VAX#21Pruritus

    NV065V15VAX#21Induration

    NV065V15VAX#31Erythema1Fatigue

    NV065V15VAX#31Pruritus

    NV065V15VAX#31Induration

    NV065V15VAX#42Erythema2Fatigue

    NV065V15VAX#42Pruritus2Headache

    NV065V15VAX#51Erythema1Arthralgias

    NV065V15VAX#51Pruritus1Chills

    NV065V15VAX#51Induration1Fatigue

    NV065V15VAX#51Headache

    NV065V15VAX#61Erythema1Arthralgias

    NV065V15VAX#61Pruritus1Fatigue

    NV065V15VAX#61Induration1Headache

    NV0100V16VAX#11Erythema1Back Pain

    NV0100V16VAX#11Pruritus1Malaise

    NV0100V16VAX#11Induration

    NV0100V16VAX#21Induration1Fatigue

    NV100V16VAX#31Erythema1Malaise

    NV100V16VAX#31Pruritus

    NV100V16VAX#31Induration

    NV100V16VAX#41Erythema1Abdominal pain

    NV100V16VAX#41Pruritus

    NV100V16VAX#41Induration

    NV100V16VAX#51Erythema0No adverse event

    NV100V16VAX#51Induration

    NV100V16VAX#61Erythema0No adverse event

    NV100V16VAX#61Induration

    NV0101V17VAX#11Pruritus0No adverse event

    NV0101V17VAX#11Induration

    NV0101V17VAX#21Pruritus0No adverse event

    NV0101V17VAX#21Induration

    NV0101V17VAX#31Erythema1Neuropathy

    NV0101V17VAX#31Pruritus

    NV0101V17VAX#31Induration

    NV0101V17VAX#31Pain at site

    NV0101V17VAX#41Erythema0No adverse event

    NV0101V17VAX#41Pruritus

    NV0101V17VAX#41Induration

    NV0101V17VAX#51Erythema0No adverse event

    NV0101V17VAX#51Induration

    NV0101V17VAX#61Erythema0No adverse event

    NV0101V17VAX#61Pruritus

    NV0101V17VAX#61Erythema

    NV102V18VAX#11Induration2Fatigue

    NV102V18VAX#12Fever

    NV102V18VAX#12Headache

    NV102V18VAX#12Malaise

    NV102V18VAX#21Erythema1Fatigue

    NV102V18VAX#21Pruritus1Fever

    NV102V18VAX#21Induration1Malaise

    NV102V18VAX#24Sepsispossiblydelayed

    NV102V18VAX#31Erythema1Fatigue

    NV102V18VAX#31Induration

    NV102V18VAX#24Cellulitispossiblydelayed

    NV102V18VAX#41Erythema0No adverse event

    NV102V18VAX#41Pruritus

    NV102V18VAX#41Induration

    NV103V19VAX#11Erythema0No adverse event

    NV103V19VAX#11Induration

    NV103V19VAX#21Erythema0No adverse event

    NV103V19VAX#21Induration

    NV103V19VAX#21Discomfort

    NV103V19VAX#31Erythema0No adverse event

    NV103V19VAX#31Induration

    NV103V19VAX#41Erythema1Chills

    NV103V19VAX#41Induration

    NV103V19VAX#51Erythema0No adverse event

    NV103V19VAX#51Pruritus

    NV103V19VAX#51Induration

    NV104V20VAX#11Induration1Chills

    NV104V20VAX#11Neuropathy

    NV104V20VAX#11Nausea

    NV104V20VAX#21Erythema0No adverse event

    NV104V20VAX#21Pruritus

    NV104V20VAX#21Induration

    NV104V20VAX#31Erythema0No adverse event

    NV104V20VAX#31Induration

    NV104V20VAX#41Erythema1Chills

    NV104V20VAX#41Pruritus1Headache

    NV104V20VAX#41Induration

    NV106V22VAX#11Induration0No adverse event

    NV106V22VAX#21Induration1Bone Pain

    NV106V22VAX#21Fatigue

    NV107V23VAX#11Erythema0No adverse event

    NV107V23VAX#11Induration

    NV108V24VAX#11Induration1Headache

    NV108V24VAX#11Bruising

    Laura:delayed

    Laura:possibly related

    Laura:possibly related

    Max Toxicity

    % of Subjects

    E39 Maximum Toxicity

    Recurrence

    VaccineControl

    Number of Recurrences911

    Total patient2922

    % recurred31.0%50.0%

    Recurrence

    % of Subjects

    Recurrence

    Chart1

    0.3103448276

    0.5

    *p=0.17

    % of Subjects

    Recurrence

    Demographics

    Enroll DateDOBAge at EnrollCohortDosageBooster CohortBooster DoseTumor Size (cm)GradeCytology# pos nodedStatusStatus CommentDate offRecurrence TypeLast VaxVax Date

    NV005V15/24/127/10/6250Group 1100mcg E39 + 250mcg GM-CSF13poorlypositivenaCompletePt recurred with primary cancer11/7/13TreatedV612/4/12

    NV033V23/29/126/19/5161Group 1100mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF8poorlypositive1

    NV015V39/21/126/22/5656Group 1100mcg E39 + 250mcg GM-CSF3poorlypositive0CompletePt recurred with primary cancer12/18/13TreatedV62/4/13

    NV009V411/27/123/13/4271Group 2500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF5.5poorlyunknownnaCompletePt recurred with primary cancer3/18/14Treated

    NV025V511/29/127/18/5656Group 2500mcg E39 + 250mcg GM-CSF6.5poorlypositive0CompletePt recurred with primary cancer2/7/13EarlyV32/5/13

    NV032V612/3/121/11/5360Group 2500mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 250mcg GM-CSF6poorlypositive1

    NV030V71/24/132/20/4073Group 3500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF15moderatenegative0

    NV016V82/11/139/28/5557Group 31000mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3.5well-differentiatedpositive

    NV054V93/4/138/2/3875Group 31000mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 125mcg GM-CSFcannot be determinedpoorlyunknown

    NV060V105/2/132/23/5261OBD500mcg E39 + 250mcg GM-CSF1.7moderateunknown0Off TreatmentIntercurrent Illness8/16/13(patient hospitalized for NSTEMI and subsequent CABG)

    NV061V115/23/137/23/5261OBD500mcg E39 + 250mcg GM-CSF7.3poorlypositive0CompletePt recurred with primary cancer7/10/13EarlyV27/9/13

    NV062V125/30/139/23/6449OBD500mcg E39 + 250mcg GM-CSF3poorlyunknown1CompletePt recurred with primary cancer3/7/14Treated

    NV070V137/11/137/21/4568OBD500mcg E39 + 250mcg GM-CSF4.5poorlynegative0CompletePt recurred with primary cancer12/23/13TreatedV611/18/13

    NV064V146/3/136/14/3974OBD500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3poorlyunknown4

    NV065V156/4/135/11/4271OBD500mcg E39 + 250mcg GM-CSF8moderatepositive3CompletePt recurred with primary cancer11/14/13TreatedV610/1/13

    NV100V1612/30/134/6/5163OBD500mcg E39 + 250mcg GM-CSF7poorlypositivena

    NV101V172/3/147/16/5955OBD500mcg E39 + 250mcg GM-CSF11.5moderatenegative3

    NV102V182/24/1410/12/7340OBD1000mcg E39 + 250mcg GM-CSFperitoneal carcinomatosispoorlyunknown13

    NV103V192/27/148/29/4766OBD1000mcg E39 + 250mcg GM-CSF9well-differentiatednegative0

    NV104V203/24/145/28/7539OBD1000mcg E39 + 250mcg GM-CSF10poorlyunknown0

    NV105V215/5/144/29/5361OBD1000mcg E39 + 250mcg GM-CSF8poorlypositive19Off StudyWithdrawn5/8/14

    NV106V224/25/142/26/6252OBD1000mcg E39 + 250mcg GM-CSF6poorlyatypical cells0

    NV107V235/19/1410/5/4767OBD1000mcg E39 + 250mcg GM-CSF10poorlypositivena

    NV108V246/3/149/29/5955OBD1000mcg E39 + 250mcg GM-CSF8.5poorlypositivena

    NV109V256/16/146/25/3876OBD1000mcg E39 + 250mcg GM-CSF3.5poorlyunknown0

    NV0279/13/121/11/5063controlNApoorlyatypical cells3CompletePt recurred with primary cancer8/22/13

    NV0315/5/124/10/5656control4poorlypositive4CompletePt recurred with primary cancer11/28/12

    WR02312/5/117/22/6942control9poorly0CompletePt has completed 18 months on trial12/19/13

    NV0083/23/126/10/7042control10poorlypositiveNACompletePt recurred with primary cancer11/1/12

    NV0189/19/1210/25/5359control14poorlypositivenaCompletePt recurred with primary cancer6/4/14

    NV0363/23/128/10/4666control15poorlypositiveNACompletePt recurred with primary cancer10/26/12

    NV0201/8/132/23/7439control10well-differentiatedunknownNAOff StudyWithdrawn: Pt refuses participation in control group1/9/13

    NV0291/24/135/3/4271control11poorlyunknownnaOff StudyWithdrawn: screen failure1/25/13

    NV0012/12/1311/4/5854control7.5poorlyatypical cellsnaCompletePt recurred with primary cancer6/13/14

    NV0232/14/1310/11/5062controlnot measurablepoorlypositive1CompletePt recurred with primary cancer8/16/13

    NV0131/23/133/15/6647control8well-differentiatedunknown0

    NV0112/28/132/17/5063control5poorlyunknownnaCompletePt recurred with primary cancer10/14/13

    NV0636/25/139/8/3776control5.2poorlypositivena

    NV0666/26/136/13/6152control9.5poorlypositivenaCompletePt recurred with primary cancer11/14/13

    NV0676/25/139/27/5162control8poorlypositivena

    NV0687/3/135/9/5954control8poorlypositive0

    NV0982/10/145/8/5163control10poorlynegative0

    NV0992/6/147/4/5361control12poorlypositive0

    NV0973/27/144/4/6153control1.5poorlypositive0

    NV0964/8/142/1/4866control3.5poorlypositive0CompletePt recurred with primary cancer6/13/14

    NV0955/8/143/8/4965control5moderateunknown1

    NV0946/4/143/4/2886control5moderateunknown2

    AgeSizePoorly graded, mod, wellCytologyNodesStage IIIStage IIStage IStage IV

    Vac6119,4,212 pos2.515334

    Cont5918,2,212 pos0.916666666711335

    pvalue10.33672648630.73,0.67, 10.770.2308385170.56110.714

    Demographics

    VaccinatedControl

    n2522

    Age (mean)6159p=1

    Nodes30.92p=0.23

    Poor Grade1918p=0.73

    Mod Grade42p=0.67

    Well Differentiated22p=1

    Stage I33p=1

    Stage II33p=1

    Stage III1511p=0.56

    Stage IV45p=0.714

    Laura:diffuse cannot be determined

    Path_Stage

    Study IDSyncronous 1* Malignancies1* SiteFIGOTNMMetastasis LocationHistologyEpithelial1Epithelial2Epithelial3Endometrial1

    NV005V1NoOvarianIIIC3cNxM1transverse 2nd sigmoid colonOvarianAdenocarcinoma

    NV0033V2NoOvarianIIIC3bN1MxOvarianPapillary Serous Carcinoma

    NV015V3NoOvarianIIIC3cNxMxOvarianEndometrioid CystoadenocarcinomaMixed Epithelial TumorPapillary Serous Carcinoma

    NV009V4NoOvarianIIIC3cNxM0OvarianSerous Cystoadenocarcinoma

    NV025V5NoOvarianIC1cN0MxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV032V6NoOvarianIIIC3cN1M0OvarianSerous Cystoadenocarcinoma

    NV030V7NoOvarianIIA1aN0M0OvarianEndometrioid Cystoadenocarcinoma

    NV016V8NoOvarianIIIA3aNxM1Gall BladderOvarianSerous Cystoadenocarcinoma

    NV054V9NoOvarianIIB2bNxMxOvarianMixed Epithelial Tumor

    NV060V10NoEndometrialIV4N0M1PulmonaryEndometrialEndometriod Adenocarcinoma

    NV061V11NoOvarianIIIC3CNxMxOvarianSerous Cystoadenocarcinoma

    NV062V12NoPeritonealIIIC3cN1MxPrimary PeritonealSerous CystoadenocarcinomaClear Cell Cystoadenocarcinoma

    NV070V13NoEndometrialIIIC11aN1M0EndometrialCarcinosarcoma

    NV064V14NoFallopian TubeIIIC1aN1MxFallopian tubeSerous Cystoadenocarcinoma

    NV065V15NoOvarianIIIC3CN1MxOvarianSerous Cystoadenocarcinoma

    NV100V16NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma

    NV101V17NoEndometrialIVB4N2M1PulmonaryEndometrialEndometrioid Adenocarcinoma

    NV102V18NoPeritonealIV4N2(13)M1LO, RO, liver parenchyma, splenic serosa, peripancreatic LN, pericecal adispose tissue, anterior abdominal wall fascia & subcutaneous tissue, uterine serosa, omentumPrimary PeritonealSerous Cystoadenocarcinoma

    NV103V19NoOvarianIC1cN0MxOvarianEndometrioid Cystoadenocarcinoma

    NV104V20NoOvarianIIIC3cN0M0OvarianSerous Cystoadenocarcinoma

    NV105V21NoOvarianIV4N2M1SpleenOvarianSerous Cystoadenocarcinoma

    NV106V22NoOvarianIICTxNxMxOvarianClear cell cystoadenocarcinoma

    NV107V23NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma

    NV108V24NoOvarianIIIC3cNxMxOvarian

    NV109V25NoEndometrialIA1aN0MxEndometrialEndometrioid Adenocarcinoma

    NV008NoOvarianIIIC3bNxMxOvarianCarcinosarcoma

    NV018NoOvarianIIIB3bN0MxOvarianSerous Cystoadenocarcinoma

    NV020NoOvarianIA1aNxMxOvarianMucinous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV027NoEndometrialIVB3bN2M1IntraperitonealEndometrialEndometrioid Adenocarcinoma

    NV031NoOvarianIV4NxM1skin implants in abdominal wall where intraperitoneal port would be placedOvarianSerous Cystoadenocarcinoma

    NV036NoOvarianIIIC3cNxMxOvarianCarcinosarcoma

    WR023NoOvarianIC1cNxMxOvarianSerous CystoadenocarcinomaEndometrioid Cystoadenocarcinoma

    NV029NoOvarianIIIC3cNxM0OvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV023NoOvarianIV3cN1M1Cardiophrenic LNOvarianSerous Cystoadenocarcinoma

    NV013NoOvarianIIC2cN0M0OvarianSexcord Stromal

    NV001NoOvarianIA1aNxMxOvarianClear cell cystoadenocarcinoma

    NV011NoOvarianIV4NxM1lungsOvarianSerous Cystoadenocarcinoma

    NV063NoOvarianIIIC2cNxMxOvarianSerous Cystoadenocarcinoma

    NV066NoOvarianIIIB3bNxM0OvarianClear cell cystoadenocarcinoma

    NV067NoOvarianIIIC3cNxMxovarianSerous Cystoadenocarcinoma

    NV068NoOvarianIIC2cN0MxOvarianSerous Cystoadenocarcinoma

    NV098NoOvarianIIIB3bNxMxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV099NoOvarianIIIC3cN0MxOvarianSerous Cystoadenocarcinoma

    NV097NoOvarianIIIB3bNxMxOvarianSerous Cystoadenocarcinoma

    NV096NoOvarianIIB2bN0MxOvarianSerous Cystoadenocarcinoma

    NV095NoEndometrialIV4N1M1Hernia and omentumEndometrialEndometrioid Adenocarcinoma

    NV094NoEndometrialIIIC3bN2MxEndometrialEndometrioid Adenocarcinoma

    DTH

    R0 E39RO NSSR6 E39R6 NSSR0 E39RO NSSR6 E39R6 NSSR0R6

    NV005V113.50480n242414147.145833333315.8214285714

    NV033V24000median20130

    NV015V37.509.50mean7.14583333332.1915.82142857145.5357142857

    NV009V440230Stdev8.363324654415.7182000619

    NV025V500Count2414

    NV032V6162.52622.5Sqrt4.89897948563.7416573868

    NV030V718.50250SEM1.70715649644.2008656692

    NV016V8210390

    NV054V91701100.0723360654

    NV060V1000

    NV061V1117.50

    NV062V1215000

    NV070V13020015

    NV064V1418301520

    NV065V1519.5000

    NV100V160000

    NV101V17002520

    NV102V1800

    NV103V1900

    NV104V2000

    NV105V2100

    NV106V2200

    NV107V2300

    NV108V2400

    joyceog wendynew wendy

    NV030V72523.518.5

    NV016V822.52621

    NV054V923.52717

    Laura:off study

    Laura:off study

    Laura:off treatment

    DTH

    1.7071564964

    4.20086566924.2008656692

    Orthogonal Mean (mm)

    E39 DTH Response (mm)

    Local Reaction

    R0R1R2R3R4R5B1

    NV015V33884.515077.550105Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6B1

    NV005V152.5101.5106171200210.5n1515141212125

    NV033V228143.5137154.514165median42.56982.59495100.7597.5

    NV009V41483.5120.512861127.5103.5mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25

    NV25V50087

    NV032V6759103134.510011491.5

    NV030V749113190136102126135

    NV016V842.578.579147.51219875.5Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6Booster 1

    NV054V951.592.5112.58897.5112103.5median42.56982.59495100.7597.25

    NV060V1073.59846.5

    NV061V117062.5

    NV062V127059.581.594111.510374.5

    NV070V13456963.564.576.545

    NV064V146845.572.57274.574

    NV065V15113.584.582.5105.56258.5

    NV100V163547.570.58675.598.5

    NV101V173864.593.586.59596

    NV102V184085.55869

    NV103V1954505672.564.5

    NV104V20264265106

    NV105V21did not present

    NV106V2233.545.5

    NV107V2382

    NV108V2417

    0.00388804070.05145904570.30687968230.44061529060.63902523620.72097308930

    Mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25

    Stdev26.169163127930.399267691736.368705620933.46755452538.274603042939.816129593722.4805471464

    Count2321191715146

    Sqrt4.79583152334.5825756954.35889894354.12310562563.87298334623.74165738682.4494897428

    SEM5.4566477166.63366406048.34355328998.11707425529.882460011210.64130824349.1776449412

    0.02345634050.5131632142

    0.04717082220.7605079717

    Laura:recurrence/off study

    Laura:no dose reduction

    Laura:off study

    Laura:OFF TX

    Local Reaction

    5.4566477165.456647716

    6.63366406046.6336640604

    8.34355328998.3435532899

    8.11707425528.1170742552

    9.88246001129.8824600112

    10.641308243410.6413082434

    9.17764494129.1776449412

    *

    Orthogonal Mean (mm)

    E39 Local Reaction

    Max Toxicity

    Max ToxicityLocal GradeSystemic Grade

    NV015V3VAX#11Induration0No adverse eventLocalSystemic0123401234

    NV015V3VAX#21Erythema0No adverse eventNV015V3110%96%4%0%0%9%56.5%26.1%4.30%4.30%

    NV015V3VAX#21PruritusNV005V112red numbers are for graph purposes only

    NV015V3VAX#21IndurationNV033V211

    NV015V3VAX#31Erythema0No adverse eventNV009V411

    NV015V3VAX#31PruritusNV025V511

    NV015V3VAX#31IndurationNV032V611

    NV015V3VAX#41Induration1FatigueNV030V712

    NV015V3VAX#41Pruritus1MalaiseNV016V811

    NV015V3VAX#41ErythemaNV054V912

    NV015V3VAX#51Erythema0No adverse eventNV060V1013possibly related

    NV015V3VAX#51PruritusNV061V1110

    NV015V3VAX#51IndurationNV062V1211

    NV015V3VAX#61Erythema0No adverse eventNV070V1312

    NV015V3VAX#61PruritusNV064V1412

    NV015V3VAX#61IndurationNV065V1522

    NV005V1VAX#11Induration1HeadacheNV100V1611

    NV005V1VAX#11FlushingNV101V1711

    NV005V1VAX#21Erythema1FlushingNV102V1814possibly related

    NV005V1VAX#21PruritusNV103V1911

    NV005V1VAX#21IndurationNV104V2011

    NV005V1VAX#31Erythema1NauseaNV16V8 had a grade 3 SAE for low WBC, but the attribution is unlikely related, so it isn't includedNV106V2211

    NV005V1VAX#31Pruritus1FlushingNV107V2310

    NV005V1VAX#31IndurationNV108V2411

    NV005V1VAX#41Erythema1Arthralgias

    NV005V1VAX#41Pruritus2Joint Effusion

    NV005V1VAX#41Induration

    NV005V1VAX#51Erythema1Arthralgias

    NV005V1VAX#51Pruritus1Joint Effusion

    NV005V1VAX#51IndurationGradeLocalSystemic

    NV005V1VAX#61Erythema1Arthralgias000.00%28.7%

    NV005V1VAX#61Pruritus12296%1356.5%

    NV005V1VAX#61Induration214%626.1%

    NV033V2VAX#11Induration1Fatigue300%14.3%

    NV033V2VAX#11Erythema400%14.3%

    NV033V2VAX#11Pruritus2323

    NV033V2VAX#21Erythema1Flushing

    NV033V2VAX#21Pruritus

    NV033V2VAX#21Induration

    NV033V2VAX#31Erythema1Headache

    NV033V2VAX#31Pruritus1Dizziness

    NV033V2VAX#31Induration

    NV033V2VAX#41Erythema0No adverse event

    NV033V2VAX#41Pruritus

    NV033V2VAX#41Induration

    NV033V2VAX#51Erythema0No adverse event

    NV033V2VAX#51Pruritus

    NV033V2VAX#51Induration

    NV033V2VAX#61Erythema0No adverse event

    NV033V2VAX#61Pruritus

    NV033V2VAX#61Induration

    NV009V4VAX#11Pruritus0No adverse event

    NV009V4VAX#11Induration

    NV009V4VAX#21Erythema1Arthralgias

    NV009V4VAX#21Pruritus

    NV009V4VAX#21Induration

    NV009V4VAX#31Erythema1Bone Pain

    NV009V4VAX#31Induration1Fatigue

    NV009V4VAX#31Pruritus1Headache

    NV009V4VAX#41Erythema0No adverse event

    NV009V4VAX#41Pruritus

    NV009V4VAX#41Induration

    NV009V4VAX#51Erythema1Bone Pain

    NV009V4VAX#51Induration1Headache

    NV009V4VAX#61Erythema1Headache

    NV009V4VAX#61Pruritus

    NV009V4VAX#61Induration

    NV009V4Booster#11Erythema1Arthralgias

    NV009V4Booster#11Pruritus1Back Pain

    NV009V4Booster#11Induration1Fatigue

    NV025V5VAX#11Erythema1Diarrhea

    NV025V5VAX#11GI pain

    NV025V5VAX#21Erythema0No adverse event

    NV025V5VAX#21Pruritus

    NV025V5VAX#2

    NV025V5VAX#31Erythema0No adverse event

    NV025V5VAX#31Pruritus

    NV025V5VAX#31Induration

    NV032V6VAX#11Erythema1Back Pain

    NV032V6VAX#11Pruritus1Diarrhea

    NV032V6VAX#11Induration

    NV032V6VAX#21Erythema1Back Pain

    NV032V6VAX#21Pruritus

    NV032V6VAX#21Induration

    NV032V6VAX#31Erythema0No adverse event

    NV032V6VAX#31Pruritus

    NV032V6VAX#31Induration

    NV032V6VAX#41Erythema1Fatigue

    NV032V6VAX#41Induration1Headache

    NV032V6VAX#41Nausea

    NV032V6VAX#51Erythema0No adverse event

    NV032V6VAX#51Induration

    NV032V6VAX#51Bruising

    NV032V6VAX#61Erythema0No adverse event

    NV032V6VAX#61Induration

    NV032V6Booster#11Erythema1Bone Pain

    NV032V6Booster#11Pruritus

    NV032V6Booster#11Induration

    NV030V7VAX#11Erythema0No adverse event

    NV030V7VAX#11Induration

    NV030V7VAX#11Bruising

    NV030V7VAX#21Erythema0No adverse event

    NV030V7VAX#21Pruritus

    NV030V7VAX#21Induration

    NV030V7VAX#21Burning

    NV030V7VAX#31Erythema0No adverse event

    NV030V7VAX#31Pruritus

    NV030V7VAX#31Induration

    NV030V7VAX#41Erythema0No adverse event

    NV030V7VAX#41Pruritus

    NV030V7VAX#41Induration

    NV030V7VAX#51Erythema0No adverse event

    NV030V7VAX#51Pruritus

    NV030V7VAX#51Induration

    NV030V7VAX#61Erythema0No adverse event

    NV030V7VAX#61Pruritus

    NV030V7VAX#61Induration

    NV030V7Booster#11Erythema1Neuropathy

    NV030V7Booster#11Pruritus1Arthralgias

    NV030V7Booster#11Induration1Headache

    NV030V7Booster#11Malaise

    NV030V7Booster#12Maculo-papular rash

    NV016V8VAX#11Induration1Headache

    NV016V8VAX#21Induration1Headache

    NV016V8VAX#21Pruritus

    NV016V8VAX#31Induration1Headache

    NV016V8VAX#31Pruritus

    NV016V8VAX#31Induration

    NV016V8VAX#41Erythema1Headache

    NV016V8VAX#41Pruritus1Nausea

    NV016V8VAX#41Induration1Neuropathy

    NV016V8VAX#41Dizziness

    NV016V8VAX#41Insomnia

    NV016V8VAX#51Erythema0No adverse event

    NV016V8VAX#51Pruritus

    NV016V8VAX#51Induration

    NV016V8VAX#61Erythema0No adverse event

    NV016V8VAX#61Pruritus

    NV016V8VAX#61Induration

    NV016V8Booster#11Erythema1Neuropathy

    NV016V8Booster#11Pruritus

    NV016V8Booster#11Induration

    NV054V9VAX#11Erythema0No adverse event

    NV054V9VAX#11Induration

    NV054V9VAX#11Bruising

    NV054V9VAX#21Erythema0No adverse event

    NV054V9VAX#21Pruritus

    NV054V9VAX#21Induration

    NV054V9VAX#31Erythema2Neuropathy

    NV054V9VAX#31Pruritus

    NV054V9VAX#31Induration

    NV054V9VAX#41Erythema2Neuropathy

    NV054V9VAX#41Pruritus

    NV054V9VAX#41Induration

    NV054V9VAX#51Erythema2Neuropathy

    NV054V9VAX#51Pruritus

    NV054V9VAX#51Induration

    NV054V9VAX#61Erythema0No adverse event

    NV054V9VAX#61Pruritus

    NV054V9VAX#61Induration

    NV054V9Booster#11Erythema0No adverse event

    NV054V9Booster#11Pruritus

    NV054V9Booster#11Induration

    NV060V10VAX#11Erythema1Arthralgias

    NV060V10VAX#11Induration2Fatigue

    NV060V10VAX#11Pruritus2Headache

    NV060V10VAX#11Malaise

    NV060V10VAX#11Dizziness

    NV060V10VAX#21Induration1Arthralgias

    NV060V10VAX#21Pruritus1Fatigue

    NV060V10VAX#21Erythema2Headache

    NV060V10VAX#21Nausea

    NV060V10VAX#31Erythema1Arthralgias

    NV060V10VAX#31Pruritus1Fatigue

    NV060V10VAX#31Induration1Headache

    NV060V10VAX#31Myalgias

    NV060V103Cardiac disorder

    NV061V11VAX#11Pruritus0No adverse event

    NV061V11VAX#11Induration

    NV061V11VAX#21Erythema0No adverse event

    NV061V11VAX#21Induration

    NV061V11VAX#21Pruritus

    NV062V12VAX#11Induration1Bone Pain

    NV062V12VAX#11Fatigue

    NV062V12VAX#11Malaise

    NV062V12VAX#11Myalgias

    NV062V12VAX#11Nausea

    NV062V12VAX#21Erythema0No adverse event

    NV062V12VAX#21Induration

    NV062V12VAX#21Pruritus

    NV062V12VAX#31Erythema0No adverse event

    NV062V12VAX#31Induration

    NV062V12VAX#31Pruritus

    NV062V12VAX#41Erythema1Headache

    NV062V12VAX#41Induration1Malaise

    NV062V12VAX#41Pruritus

    NV062V12VAX#51Erythema1Headache

    NV062V12VAX#51Pruritus1Malaise

    NV062V12VAX#51Induration

    NV062V12VAX#61Erythema1Fatigue

    NV062V12VAX#61Pruritus

    NV062V12VAX#61Induration

    NV070V13VAX#11Erythema1Fatigue

    NV070V13VAX#11Induration1Headache

    NV070V13VAX#11Nausea

    NV070V13VAX#21Erythema1Fatigue

    NV070V13VAX#21Pruritus

    NV070V13VAX#21Induration

    NV070V13VAX#21Pain

    NV070V13VAX#31Erythema1Arthralgias

    NV070V13VAX#31Pruritus2Fatigue

    NV070V13VAX#31Induration1Headache

    NV070V13VAX#31Pain at site

    NV070V13VAX#41Erythema1Arthralgias

    NV070V13VAX#41Pruritus1Fatigue

    NV070V13VAX#41Induration1Headache

    NV070V13VAX#41Pain at site

    NV070V13VAX#51Erythema1Arthralgias

    NV070V13VAX#51Pruritus2Fatigue

    NV070V13VAX#51Induration1Headache

    NV070V13VAX#51Pain at site

    NV070V13VAX#61Erythema1Arthralgias

    NV070V13VAX#61Pruritus2Fatigue

    NV070V13VAX#61Induration1Headache

    NV070V13VAX#61Pain at site

    NV064V14VAX#11Erythema0No adverse event

    NV064V14VAX#11Induration

    NV064V14VAX#11Pruritus

    NV064V14Delayed2DUR: Urticarial lesion (Left buttock)

    NV064V14VAX#21Erythema0No adverse event

    NV064V14VAX#21Induration

    NV064V14VAX#21Pruritus

    NV064V14VAX#21Bruising

    NV064V14VAX#31Erythema0No adverse event

    NV064V14VAX#31Induration

    NV064V14VAX#31Pruritus

    NV064V14VAX#41Erythema0No adverse event

    NV064V14VAX#41Pruritus

    NV064V14VAX#41Induration

    NV064V14VAX#51Erythema0No adverse event

    NV064V14VAX#51Pruritus

    NV064V14VAX#51Induration

    NV064V14VAX#61Erythema0No adverse event

    NV064V14VAX#61Pruritus

    NV064V14VAX#61Induration

    NV064V14Delayed2DUR: Urticarial lesion (Left buttock)

    NV064V14Booster#11Erythema1Headache

    NV064V14Booster#11Induration

    NV065V15VAX#11Erythema1Fatigue

    NV065V15VAX#11Pruritus

    NV065V15VAX#11Induration

    NV065V15VAX#21Erythema1Fatigue

    NV065V15VAX#21Pruritus

    NV065V15VAX#21Induration

    NV065V15VAX#31Erythema1Fatigue

    NV065V15VAX#31Pruritus

    NV065V15VAX#31Induration

    NV065V15VAX#42Erythema2Fatigue

    NV065V15VAX#42Pruritus2Headache

    NV065V15VAX#51Erythema1Arthralgias

    NV065V15VAX#51Pruritus1Chills

    NV065V15VAX#51Induration1Fatigue

    NV065V15VAX#51Headache

    NV065V15VAX#61Erythema1Arthralgias

    NV065V15VAX#61Pruritus1Fatigue

    NV065V15VAX#61Induration1Headache

    NV0100V16VAX#11Erythema1Back Pain

    NV0100V16VAX#11Pruritus1Malaise

    NV0100V16VAX#11Induration

    NV0100V16VAX#21Induration1Fatigue

    NV100V16VAX#31Erythema1Malaise

    NV100V16VAX#31Pruritus

    NV100V16VAX#31Induration

    NV100V16VAX#41Erythema1Abdominal pain

    NV100V16VAX#41Pruritus

    NV100V16VAX#41Induration

    NV100V16VAX#51Erythema0No adverse event

    NV100V16VAX#51Induration

    NV100V16VAX#61Erythema0No adverse event

    NV100V16VAX#61Induration

    NV0101V17VAX#11Pruritus0No adverse event

    NV0101V17VAX#11Induration

    NV0101V17VAX#21Pruritus0No adverse event

    NV0101V17VAX#21Induration

    NV0101V17VAX#31Erythema1Neuropathy

    NV0101V17VAX#31Pruritus

    NV0101V17VAX#31Induration

    NV0101V17VAX#31Pain at site

    NV0101V17VAX#41Erythema0No adverse event

    NV0101V17VAX#41Pruritus

    NV0101V17VAX#41Induration

    NV0101V17VAX#51Erythema0No adverse event

    NV0101V17VAX#51Induration

    NV0101V17VAX#61Erythema0No adverse event

    NV0101V17VAX#61Pruritus

    NV0101V17VAX#61Erythema

    NV102V18VAX#11Induration2Fatigue

    NV102V18VAX#12Fever

    NV102V18VAX#12Headache

    NV102V18VAX#12Malaise

    NV102V18VAX#21Erythema1Fatigue

    NV102V18VAX#21Pruritus1Fever

    NV102V18VAX#21Induration1Malaise

    NV102V18VAX#24Sepsispossiblydelayed

    NV102V18VAX#31Erythema1Fatigue

    NV102V18VAX#31Induration

    NV102V18VAX#24Cellulitispossiblydelayed

    NV102V18VAX#41Erythema0No adverse event

    NV102V18VAX#41Pruritus

    NV102V18VAX#41Induration

    NV103V19VAX#11Erythema0No adverse event

    NV103V19VAX#11Induration

    NV103V19VAX#21Erythema0No adverse event

    NV103V19VAX#21Induration

    NV103V19VAX#21Discomfort

    NV103V19VAX#31Erythema0No adverse event

    NV103V19VAX#31Induration

    NV103V19VAX#41Erythema1Chills

    NV103V19VAX#41Induration

    NV103V19VAX#51Erythema0No adverse event

    NV103V19VAX#51Pruritus

    NV103V19VAX#51Induration

    NV104V20VAX#11Induration1Chills

    NV104V20VAX#11Neuropathy

    NV104V20VAX#11Nausea

    NV104V20VAX#21Erythema0No adverse event

    NV104V20VAX#21Pruritus

    NV104V20VAX#21Induration

    NV104V20VAX#31Erythema0No adverse event

    NV104V20VAX#31Induration

    NV104V20VAX#41Erythema1Chills

    NV104V20VAX#41Pruritus1Headache

    NV104V20VAX#41Induration

    NV106V22VAX#11Induration0No adverse event

    NV106V22VAX#21Induration1Bone Pain

    NV106V22VAX#21Fatigue

    NV107V23VAX#11Erythema0No adverse event

    NV107V23VAX#11Induration

    NV108V24VAX#11Induration1Headache

    NV108V24VAX#11Bruising

    Laura:delayed

    Laura:possibly related

    Laura:possibly related

    Max Toxicity

    % of Subjects

    E39 Maximum Toxicity

    Recurrence

    VaccineControl

    Number of Recurrences911

    Total patient2922

    % recurred31.0%50.0%

    Recurrence

    % of Subjects

    Recurrence

    Chart1

    0.3103448276

    0.5

    *p=0.17

    % of Subjects

    Recurrence

    Demographics

    Enroll DateDOBAge at EnrollCohortDosageBooster CohortBooster DoseTumor Size (cm)GradeCytology# pos nodedStatusStatus CommentDate offRecurrence TypeLast VaxVax Date

    NV005V15/24/127/10/6250Group 1100mcg E39 + 250mcg GM-CSF13poorlypositivenaCompletePt recurred with primary cancer11/7/13TreatedV612/4/12

    NV033V23/29/126/19/5161Group 1100mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF8poorlypositive1

    NV015V39/21/126/22/5656Group 1100mcg E39 + 250mcg GM-CSF3poorlypositive0CompletePt recurred with primary cancer12/18/13TreatedV62/4/13

    NV009V411/27/123/13/4271Group 2500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF5.5poorlyunknownnaCompletePt recurred with primary cancer3/18/14Treated

    NV025V511/29/127/18/5656Group 2500mcg E39 + 250mcg GM-CSF6.5poorlypositive0CompletePt recurred with primary cancer2/7/13EarlyV32/5/13

    NV032V612/3/121/11/5360Group 2500mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 250mcg GM-CSF6poorlypositive1

    NV030V71/24/132/20/4073Group 3500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF15moderatenegative0

    NV016V82/11/139/28/5557Group 31000mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3.5well-differentiatedpositive

    NV054V93/4/138/2/3875Group 31000mcg E39 + 250mcg GM-CSFArm 1500mcg E39 + 125mcg GM-CSFcannot be determinedpoorlyunknown

    NV060V105/2/132/23/5261OBD500mcg E39 + 250mcg GM-CSF1.7moderateunknown0Off TreatmentIntercurrent Illness8/16/13(patient hospitalized for NSTEMI and subsequent CABG)

    NV061V115/23/137/23/5261OBD500mcg E39 + 250mcg GM-CSF7.3poorlypositive0CompletePt recurred with primary cancer7/10/13EarlyV27/9/13

    NV062V125/30/139/23/6449OBD500mcg E39 + 250mcg GM-CSF3poorlyunknown1CompletePt recurred with primary cancer3/7/14Treated

    NV070V137/11/137/21/4568OBD500mcg E39 + 250mcg GM-CSF4.5poorlynegative0CompletePt recurred with primary cancer12/23/13TreatedV611/18/13

    NV064V146/3/136/14/3974OBD500mcg E39 + 250mcg GM-CSFArm 2500mcg J65 + 250mcg GM-CSF3poorlyunknown4

    NV065V156/4/135/11/4271OBD500mcg E39 + 250mcg GM-CSF8moderatepositive3CompletePt recurred with primary cancer11/14/13TreatedV610/1/13

    NV100V1612/30/134/6/5163OBD500mcg E39 + 250mcg GM-CSF7poorlypositivena

    NV101V172/3/147/16/5955OBD500mcg E39 + 250mcg GM-CSF11.5moderatenegative3

    NV102V182/24/1410/12/7340OBD1000mcg E39 + 250mcg GM-CSFperitoneal carcinomatosispoorlyunknown13

    NV103V192/27/148/29/4766OBD1000mcg E39 + 250mcg GM-CSF9well-differentiatednegative0

    NV104V203/24/145/28/7539OBD1000mcg E39 + 250mcg GM-CSF10poorlyunknown0

    NV105V215/5/144/29/5361OBD1000mcg E39 + 250mcg GM-CSF8poorlypositive19Off StudyWithdrawn5/8/14

    NV106V224/25/142/26/6252OBD1000mcg E39 + 250mcg GM-CSF6poorlyatypical cells0

    NV107V235/19/1410/5/4767OBD1000mcg E39 + 250mcg GM-CSF10poorlypositivena

    NV108V246/3/149/29/5955OBD1000mcg E39 + 250mcg GM-CSF8.5poorlypositivena

    NV109V256/16/146/25/3876OBD1000mcg E39 + 250mcg GM-CSF3.5poorlyunknown0

    NV0279/13/121/11/5063controlNApoorlyatypical cells3CompletePt recurred with primary cancer8/22/13

    NV0315/5/124/10/5656control4poorlypositive4CompletePt recurred with primary cancer11/28/12

    WR02312/5/117/22/6942control9poorly0CompletePt has completed 18 months on trial12/19/13

    NV0083/23/126/10/7042control10poorlypositiveNACompletePt recurred with primary cancer11/1/12

    NV0189/19/1210/25/5359control14poorlypositivenaCompletePt recurred with primary cancer6/4/14

    NV0363/23/128/10/4666control15poorlypositiveNACompletePt recurred with primary cancer10/26/12

    NV0201/8/132/23/7439control10well-differentiatedunknownNAOff StudyWithdrawn: Pt refuses participation in control group1/9/13

    NV0291/24/135/3/4271control11poorlyunknownnaOff StudyWithdrawn: screen failure1/25/13

    NV0012/12/1311/4/5854control7.5poorlyatypical cellsnaCompletePt recurred with primary cancer6/13/14

    NV0232/14/1310/11/5062controlnot measurablepoorlypositive1CompletePt recurred with primary cancer8/16/13

    NV0131/23/133/15/6647control8well-differentiatedunknown0

    NV0112/28/132/17/5063control5poorlyunknownnaCompletePt recurred with primary cancer10/14/13

    NV0636/25/139/8/3776control5.2poorlypositivena

    NV0666/26/136/13/6152control9.5poorlypositivenaCompletePt recurred with primary cancer11/14/13

    NV0676/25/139/27/5162control8poorlypositivena

    NV0687/3/135/9/5954control8poorlypositive0

    NV0982/10/145/8/5163control10poorlynegative0

    NV0992/6/147/4/5361control12poorlypositive0

    NV0973/27/144/4/6153control1.5poorlypositive0

    NV0964/8/142/1/4866control3.5poorlypositive0CompletePt recurred with primary cancer6/13/14

    NV0955/8/143/8/4965control5moderateunknown1

    NV0946/4/143/4/2886control5moderateunknown2

    AgeSizePoorly graded, mod, wellCytologyNodesStage IIIStage IIStage IStage IV

    Vac6119,4,212 pos2.515334

    Cont5918,2,212 pos0.916666666711335

    pvalue10.33672648630.73,0.67, 10.770.2308385170.56110.714

    Demographics

    VaccinatedControl

    n2522

    Age (mean)6159p=1

    Nodes30.92p=0.23

    Poor Grade1918p=0.73

    Mod Grade42p=0.67

    Well Differentiated22p=1

    Stage I33p=1

    Stage II33p=1

    Stage III1511p=0.56

    Stage IV45p=0.714

    Laura:diffuse cannot be determined

    Path_Stage

    Study IDSyncronous 1* Malignancies1* SiteFIGOTNMMetastasis LocationHistologyEpithelial1Epithelial2Epithelial3Endometrial1

    NV005V1NoOvarianIIIC3cNxM1transverse 2nd sigmoid colonOvarianAdenocarcinoma

    NV0033V2NoOvarianIIIC3bN1MxOvarianPapillary Serous Carcinoma

    NV015V3NoOvarianIIIC3cNxMxOvarianEndometrioid CystoadenocarcinomaMixed Epithelial TumorPapillary Serous Carcinoma

    NV009V4NoOvarianIIIC3cNxM0OvarianSerous Cystoadenocarcinoma

    NV025V5NoOvarianIC1cN0MxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV032V6NoOvarianIIIC3cN1M0OvarianSerous Cystoadenocarcinoma

    NV030V7NoOvarianIIA1aN0M0OvarianEndometrioid Cystoadenocarcinoma

    NV016V8NoOvarianIIIA3aNxM1Gall BladderOvarianSerous Cystoadenocarcinoma

    NV054V9NoOvarianIIB2bNxMxOvarianMixed Epithelial Tumor

    NV060V10NoEndometrialIV4N0M1PulmonaryEndometrialEndometriod Adenocarcinoma

    NV061V11NoOvarianIIIC3CNxMxOvarianSerous Cystoadenocarcinoma

    NV062V12NoPeritonealIIIC3cN1MxPrimary PeritonealSerous CystoadenocarcinomaClear Cell Cystoadenocarcinoma

    NV070V13NoEndometrialIIIC11aN1M0EndometrialCarcinosarcoma

    NV064V14NoFallopian TubeIIIC1aN1MxFallopian tubeSerous Cystoadenocarcinoma

    NV065V15NoOvarianIIIC3CN1MxOvarianSerous Cystoadenocarcinoma

    NV100V16NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma

    NV101V17NoEndometrialIVB4N2M1PulmonaryEndometrialEndometrioid Adenocarcinoma

    NV102V18NoPeritonealIV4N2(13)M1LO, RO, liver parenchyma, splenic serosa, peripancreatic LN, pericecal adispose tissue, anterior abdominal wall fascia & subcutaneous tissue, uterine serosa, omentumPrimary PeritonealSerous Cystoadenocarcinoma

    NV103V19NoOvarianIC1cN0MxOvarianEndometrioid Cystoadenocarcinoma

    NV104V20NoOvarianIIIC3cN0M0OvarianSerous Cystoadenocarcinoma

    NV105V21NoOvarianIV4N2M1SpleenOvarianSerous Cystoadenocarcinoma

    NV106V22NoOvarianIICTxNxMxOvarianClear cell cystoadenocarcinoma

    NV107V23NoOvarianIIIC3cNxMxOvarianSerous Cystoadenocarcinoma

    NV108V24NoOvarianIIIC3cNxMxOvarian

    NV109V25NoEndometrialIA1aN0MxEndometrialEndometrioid Adenocarcinoma

    NV008NoOvarianIIIC3bNxMxOvarianCarcinosarcoma

    NV018NoOvarianIIIB3bN0MxOvarianSerous Cystoadenocarcinoma

    NV020NoOvarianIA1aNxMxOvarianMucinous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV027NoEndometrialIVB3bN2M1IntraperitonealEndometrialEndometrioid Adenocarcinoma

    NV031NoOvarianIV4NxM1skin implants in abdominal wall where intraperitoneal port would be placedOvarianSerous Cystoadenocarcinoma

    NV036NoOvarianIIIC3cNxMxOvarianCarcinosarcoma

    WR023NoOvarianIC1cNxMxOvarianSerous CystoadenocarcinomaEndometrioid Cystoadenocarcinoma

    NV029NoOvarianIIIC3cNxM0OvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV023NoOvarianIV3cN1M1Cardiophrenic LNOvarianSerous Cystoadenocarcinoma

    NV013NoOvarianIIC2cN0M0OvarianSexcord Stromal

    NV001NoOvarianIA1aNxMxOvarianClear cell cystoadenocarcinoma

    NV011NoOvarianIV4NxM1lungsOvarianSerous Cystoadenocarcinoma

    NV063NoOvarianIIIC2cNxMxOvarianSerous Cystoadenocarcinoma

    NV066NoOvarianIIIB3bNxM0OvarianClear cell cystoadenocarcinoma

    NV067NoOvarianIIIC3cNxMxovarianSerous Cystoadenocarcinoma

    NV068NoOvarianIIC2cN0MxOvarianSerous Cystoadenocarcinoma

    NV098NoOvarianIIIB3bNxMxOvarianSerous CystoadenocarcinomaEndometrioid CystoadenocarcinomaMixed Epithelial Tumor

    NV099NoOvarianIIIC3cN0MxOvarianSerous Cystoadenocarcinoma

    NV097NoOvarianIIIB3bNxMxOvarianSerous Cystoadenocarcinoma

    NV096NoOvarianIIB2bN0MxOvarianSerous Cystoadenocarcinoma

    NV095NoEndometrialIV4N1M1Hernia and omentumEndometrialEndometrioid Adenocarcinoma

    NV094NoEndometrialIIIC3bN2MxEndometrialEndometrioid Adenocarcinoma

    DTH

    R0 E39RO NSSR6 E39R6 NSSR0 E39RO NSSR6 E39R6 NSSR0R6

    NV005V113.50480n242414147.145833333315.8214285714

    NV033V24000median20130

    NV015V37.509.50mean7.14583333332.1915.82142857145.5357142857

    NV009V440230Stdev8.363324654415.7182000619

    NV025V500Count2414

    NV032V6162.52622.5Sqrt4.89897948563.7416573868

    NV030V718.50250SEM1.70715649644.2008656692

    NV016V8210390

    NV054V91701100.0723360654

    NV060V1000

    NV061V1117.50

    NV062V1215000

    NV070V13020015

    NV064V1418301520

    NV065V1519.5000

    NV100V160000

    NV101V17002520

    NV102V1800

    NV103V1900

    NV104V2000

    NV105V2100

    NV106V2200

    NV107V2300

    NV108V2400

    joyceog wendynew wendy

    NV030V72523.518.5

    NV016V822.52621

    NV054V923.52717

    Laura:off study

    Laura:off study

    Laura:off treatment

    DTH

    1.7071564964

    4.20086566924.2008656692

    Orthogonal Mean (mm)

    E39 DTH Response (mm)

    Local Reaction

    R0R1R2R3R4R5B1

    NV015V33884.515077.550105Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6B1

    NV005V152.5101.5106171200210.5n1515141212125

    NV033V228143.5137154.514165median42.56982.59495100.7597.5

    NV009V41483.5120.512861127.5103.5mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25

    NV25V50087

    NV032V6759103134.510011491.5

    NV030V749113190136102126135

    NV016V842.578.579147.51219875.5Vax 1Vax 2Vax 3Vax 4Vax 5Vax 6Booster 1

    NV054V951.592.5112.58897.5112103.5median42.56982.59495100.7597.25

    NV060V1073.59846.5

    NV061V117062.5

    NV062V127059.581.594111.510374.5

    NV070V13456963.564.576.545

    NV064V146845.572.57274.574

    NV065V15113.584.582.5105.56258.5

    NV100V163547.570.58675.598.5

    NV101V173864.593.586.59596

    NV102V184085.55869

    NV103V1954505672.564.5

    NV104V20264265106

    NV105V21did not present

    NV106V2233.545.5

    NV107V2382

    NV108V2417

    0.00388804070.05145904570.30687968230.44061529060.63902523620.72097308930

    Mean45.565217391371.904761904893.3947368421105.470588235395.4666666667102.357142857197.25

    Stdev26.169163127930.399267691736.368705620933.46755452538.274603042939.816129593722.4805471464

    Count2321191715146

    Sqrt4.79583152334.5825756954.35889894354.12310562563.87298334623.74165738682.4494897428

    SEM5.4566477166.63366406048.34355328998.11707425529.882460011210.64130824349.1776449412

    0.02345634050.5131632142

    0.04717082220.7605079717

    Laura:recurrence/off study

    Laura:no dose reduction

    Laura:off study

    Laura:OFF TX

    Local Reaction

    5.4566477165.456647716

    6.63366406046.6336640604

    8.34355328998.3435532899

    8.11707425528.1170742552

    9.88246001129.8824600112

    10.641308243410.6413082434

    9.17764494129.1776449412

    *

    Orthogonal Mean (mm)

    E39 Local Reaction

    Max Toxicity

    Max ToxicityLocal GradeSystemic Grade

    NV015V3VAX#11Induration0No adverse eventLocalSystemic0123401234

    NV015V3VAX#21Erythema0No adverse eventNV015V3110%96%4%0%0%9%56.5%26.1%4.30%4.30%

    NV015V3VAX#21PruritusNV005V112red numbers are for graph purposes only

    NV015V3VAX#21IndurationNV033V211

    NV015V3VAX#31Erythema0No adverse eventNV009V411

    NV015V3VAX#31PruritusNV025V511

    NV015V3VAX#31IndurationNV032V611

    NV015V3VAX#41Induration1FatigueNV030V712

    NV015V3VAX#41Pruritus1MalaiseNV016V811

    NV015V3VAX#41ErythemaNV054V912

    NV015V3VAX#51Erythema0No adverse eventNV060V1013possibly related

    NV015V3VAX#51PruritusNV061V1110

    NV015V3VAX#51IndurationNV062V1211

    NV015V3VAX#61Erythema0No adverse eventNV070V1312

    NV015V3VAX#61PruritusNV064V1412

    NV015V3VAX#61IndurationNV065V1522

    NV005V1VAX#11Induration1HeadacheNV100V1611

    NV005V1VAX#11FlushingNV101V1711

    NV005V1VAX#21Erythema1FlushingNV102V1814possibly related

    NV005V1VAX#21PruritusNV103V1911

    NV005V1VAX#21IndurationNV104V2011

    NV005V1VAX#31Erythema1NauseaNV16V8 had a grade 3 SAE for low WBC, but the attribution is unlikely related, so it isn't includedNV106V2211

    NV005V1VAX#31Pruritus1FlushingNV107V2310

    NV005V1VAX#31IndurationNV108V2411

    NV005V1VAX#41Erythema1Arthralgias

    NV005V1VAX#41Pruritus2Joint Effusion

    NV005V1VAX#41Induration

    NV005V1VAX#51Erythema1Arthralgias

    NV005V1VAX#51Pruritus1Joint Effusion

    NV005V1VAX#51IndurationGradeLocalSystemic

    NV005V1VAX#61Erythema1Arthralgias000.00%28.7%

    NV005V1VAX#61Pruritus12296%1356.5%

    NV005V1VAX#61Induration214%626.1%

    NV033V2VAX#11Induration1Fatigue300%14.3%

    NV033V2VAX#11Erythema400%14.3%

    NV033V2VAX#11Pruritus2323

    NV033V2VAX#21Erythema1Flushing

    NV033V2VAX#21Pruritus

    NV033V2VAX#21Induration

    NV033V2VAX#31Erythema1Headache

    NV033V2VAX#31Pruritus1Dizziness

    NV033V2VAX#31Induration

    NV033V2VAX#41Erythema0No adverse event

    NV033V2VAX#41Pruritus

    NV033V2VAX#41Induration

    NV033V2VAX#51Erythema0No adverse event

    NV033V2VAX#51Pruritus

    NV033V2VAX#51Induration

    NV033V2VAX#61Erythema0No adverse event

    NV033V2VAX#61Pruritus

    NV033V2VAX#61Induration

    NV009V4VAX#11Pruritus0No adverse event

    NV009V4VAX#11Induration

    NV009V4VAX#21Erythema1Arthralgias

    NV009V4VAX#21Pruritus

    NV009V4VAX#21Induration

    NV009V4VAX#31Erythema1Bone Pain

    NV009V4VAX#31Induration1Fatigue

    NV009V4VAX#31Pruritus1Headache

    NV009V4VAX#41Erythema0No adverse event

    NV009V4VAX#41Pruritus

    NV009V4VAX#41Induration

    NV009V4VAX#51Erythema1Bone Pain

    NV009V4VAX#51Induration1Headache

    NV009V4VAX#61Erythema1Headache

    NV009V4VAX#61Pruritus

    NV009V4VAX#61Induration

    NV009V4Booster#11Erythema1Arthralgias

    NV009V4Booster#11Pruritus1Back Pain

    NV009V4Booster#11Induration1Fatigue

    NV025V5VAX#11Erythema1Diarrhea

    NV025V5VAX#11GI pain

    NV025V5VAX#21Erythema0No adverse event

    NV025V5VAX#21Pruritus

    NV025V5VAX#2

    NV025V5VAX#31Erythema0No adverse event

    NV025V5VAX#31Pruritus

    NV025V5VAX#31Induration

    NV032V6VAX#11Erythema1Back Pain

    NV032V6VAX#11Pruritus1Diarrhea

    NV032V6VAX#11Induration

    NV032V6VAX#21Erythema1Back Pain

    NV032V6VAX#21Pruritus

    NV032V6VAX#21Induration

    NV032V6VAX#31Erythema0No adverse event

    NV032V6VAX#31Pruritus

    NV032V6VAX#31Induration

    NV032V6VAX#41Erythema1Fatigue

    NV032V6VAX#41Induration1Headache

    NV032V6VAX#41Nausea

    NV032V6VAX#51Erythema0No adverse event

    NV032V6VAX#51Induration

    NV032V6VAX#51Bruising

    NV032V6VAX#61Erythema0No adverse event

    NV032V6VAX#61Induration

    NV032V6Booster#11Erythema1Bone Pain

    NV032V6Booster#11Pruritus

    NV032V6Booster#11Induration

    NV030V7VAX#11Erythema0No adverse event

    NV030V7VAX#11Induration

    NV030V7VAX#11Bruising

    NV030V7VAX#21Erythema0No adverse event

    NV030V7VAX#21Pruritus

    NV030V7VAX#21Induration

    NV030V7VAX#21Burning

    NV030V7VAX#31Erythema0No adverse event

    NV030V7VAX#31Pruritus

    NV030V7VAX#31Induration

    NV030V7VAX#41Erythema0No adverse event

    NV030V7VAX#41Pruritus

    NV030V7VAX#41Induration

    NV030V7VAX#51Erythema0No adverse event

    NV030V7VAX#51Pruritus

    NV030V7VAX#51Induration

    NV030V7VAX#61Erythema0No adverse event

    NV030V7VAX#61Pruritus

    NV030V7VAX#61Induration

    NV030V7Booster#11Erythema1Neuropathy

    NV030V7Booster#11Pruritus1Arthralgias

    NV030V7Booster#11Induration1Headache

    NV030V7Booster#11Malaise

    NV030V7Booster#12Maculo-papular rash

    NV016V8VAX#11Induration1Headache

    NV016V8VAX#21Induration1Headache

    NV016V8VAX#21Pruritus

    NV016V8VAX#31Induration1Headache

    NV016V8VAX#31Pruritus

    NV016V8VAX#31Induration

    NV016V8VAX#41Erythema1Headache

    NV016V8VAX#41Pruritus1Nausea

    NV016V8VAX#41Induration1Neuropathy

    NV016V8VAX#41Dizziness

    NV016V8VAX#41Insomnia

    NV016V8VAX#51Erythema0No adverse event

    NV016V8VAX#51Pruritus

    NV016V8VAX#51Induration

    NV016V8VAX#61Erythema0No adverse event

    NV016V8VAX#61Pruritus

    NV016V8VAX#61Induration

    NV016V8Booster#11Erythema1Neuropathy

    NV016V8Booster#11Pruritus

    NV016V8Booster#11Induration

    NV054V9VAX#11Erythema0No adverse event

    NV054V9VAX#11Induration

    NV054V9VAX#11Bruising

    NV054V9VAX#21Erythema0No adverse event

    NV054V9VAX#21Pruritus

    NV054V9VAX#21Induration

    NV054V9VAX#31Erythema2Neuropathy

    NV054V9VAX#31Pruritus

    NV054V9VAX#31Induration

    NV054V9VAX#41Erythema2Neuropathy

    NV054V9VAX#41Pruritus

    NV054V9VAX#41Induration

    NV054V9VAX#51Erythema2Neuropathy

    NV054V9VAX#51Pruritus

    NV054V9VAX#51Induration

    NV054V9VAX#61Erythema0No adverse event

    NV054V9VAX#61Pruritus

    NV054V9VAX#61Induration

    NV054V9Booster#11Erythema0No adverse event

    NV054V9Booster#11Pruritus

    NV054V9Booster#11Induration

    NV060V10VAX#11Erythema1Arthralgias

    NV060V10VAX#11Induration2Fatigue

    NV060V10VAX#11Pruritus2Headache

    NV060V10VAX#11Malaise

    NV060V10VAX#11Dizziness

    NV060V10VAX#21Induration1Arthralgias

    NV060V10VAX#21Pruritus1Fatigue

    NV060V10VAX#21Erythema2Headache

    NV060V10VAX#21Nausea

    NV060V10VAX#31Erythema1Arthralgias

    NV060V10VAX#31Pruritus1Fatigue

    NV060V10VAX#31Induration1Headache

    NV060V10VAX#31Myalgias

    NV060V103Cardiac disorder

    NV061V11VAX#11Pruritus0No adverse event

    NV061V11VAX#11Induration

    NV061V11VAX#21Erythema0No adverse event

    NV061V11VAX#21Induration

    NV061V11VAX#21Pruritus

    NV062V12VAX#11Induration1Bone Pain

    NV062V12VAX#11Fatigue

    NV062V12VAX#11Malaise

    NV062V12VAX#11Myalgias

    NV062V12VAX#11Nausea

    NV062V12VAX#21Erythema0No adverse event

    NV062V12VAX#21Induration

    NV062V12VAX#21Pruritus

    NV062V12VAX#31Erythema0No adverse event

    NV062V12VAX#31Induration

    NV062V12VAX#31Pruritus

    NV062V12VAX#41Erythema1Headache

    NV062V12VAX#41Induration1Malaise

    NV062V12VAX#41Pruritus

    NV062V12VAX#51Erythema1Headache

    NV062V12VAX#51Pruritus1Malaise

    NV062V12VAX#51Induration

    NV062V12VAX#61Erythema1Fatigue

    NV062V12VAX#61Pruritus

    NV062V12VAX#61Induration

    NV070V13VAX#11Erythema1Fatigue

    NV070V13VAX#11Induration1Headache

    NV070V13VAX#11Nausea

    NV070V13VAX#21Erythema1Fatigue

    NV070V13VAX#21Pruritus

    NV070V13VAX#21Induration

    NV070V13VAX#21Pain

    NV070V13VAX#31Erythema1Arthralgias

    NV070V13VAX#31Pruritus2Fatigue

    NV070V13VAX#31Induration1Headache

    NV070V13VAX#31Pain at site

    NV070V13VAX#41Erythema1Arthralgias

    NV070V13VAX#41Pruritus1Fatigue

    NV070V13VAX#41Induration1Headache

    NV070V13VAX#41Pain at site

    NV070V13VAX#51Erythema1Arthralgias

    NV070V13VAX#51Pruritus2Fatigue

    NV070V13VAX#51Induration1Headache

    NV070V13VAX#51Pain at site

    NV070V13VAX#61Erythema1Arthralgias

    NV070V13VAX#61Pruritus2Fatigue

    NV070V13VAX#61Induration1Headache

    NV070V13VAX#61Pain at site

    NV064V14VAX#11Erythema0No adverse event

    NV064V14VAX#11Induration

    NV064V14VAX#11Pruritus

    NV064V14Delayed2DUR: Urticarial lesion (Left buttock)

    NV064V14VAX#21Erythema0No adverse event

    NV064V14VAX#21Induration

    NV064V14VAX#21Pruritus

    NV064V14VAX#21Bruising

    NV064V14VAX#31Erythema0No adverse event

    NV064V14VAX#31Induration

    NV064V14VAX#31Pruritus

    NV064V14VAX#41Erythema0No adverse event

    NV064V14VAX#41Pruritus

    NV064V14VAX#41Induration

    NV064V14VAX#51Erythema0No adverse event

    NV064V14VAX#51Pruritus

    NV064V14VAX#51Induration

    NV064V14VAX#61Erythema0No adverse event

    NV064V14VAX#61Pruritus

    NV064V14VAX#61Induration

    NV064V14Delayed2DUR: Urticarial lesion (Left buttock)

    NV064V14Booster#11Erythema1Headache

    NV064V14Booster#11Induration

    NV065V15VAX#11Erythema1Fatigue

    NV065V15VAX#11Pruritus

    NV065V15VAX#11Induration

    NV065V15VAX#21Erythema1Fatigue

    NV065V15VAX#21Pruritus

    NV065V15VAX#21Induration

    NV065V15VAX#31Erythema1Fatigue

    NV065V15VAX#31Pruritus

    NV065V15VAX#31Induration

    NV065V15VAX#42Erythema2Fatigue

    NV065V15VAX#42Pruritus2Headache

    NV065V15VAX#51Erythema1Arthralgias

    NV065V15VAX#51Pruritus1Chills

    NV065V15VAX#51Induration1Fatigue

    NV065V15VAX#51Headache

    NV065V15VAX#61Erythema1Arthralgias

    NV065V15VAX#61Pruritus1Fatigue

    NV065V15VAX#61Induration1Headache

    NV0100V16VAX#11Erythema1Back Pain

    NV0100V16VAX#11Pruritus1Malaise

    NV0100V16VAX#11Induration

    NV0100V16VAX#21Induration1Fatigue

    NV100V16VAX#31Erythema1Malaise

    NV100V16VAX#31Pruritus

    NV100V16VAX#31Induration

    NV100V16VAX#41Erythema1Abdominal pain

    NV100V16VAX#41Pruritus

    NV100V16VAX#41Induration

    NV100V16VAX#51Erythema0No adverse event

    NV100V16VAX#51Induration

    NV100V16VAX#61Erythema0No adverse event

    NV100V16VAX#61Induration

    NV0101V17VAX#11Pruritus0No adverse event

    NV0101V17VAX#11Induration

    NV0101V17VAX#21Pruritus0No adverse event

    NV0101V17VAX#21Induration

    NV0101V17VAX#31Erythema1Neuropathy

    NV0101V17VAX#31Pruritus

    NV0101V17VAX#31Induration

    NV0101V17VAX#31Pain at site

    NV0101V17VAX#41Erythema0No adverse event

    NV0101V17VAX#41Pruritus

    NV0101V17VAX#41Induration

    NV0101V17VAX#51Erythema0No adverse event

    NV0101V17VAX#51Induration

    NV0101V17VAX#61Erythema0No adverse event

    NV0101V17VAX#61Pruritus

    NV0101V17VAX#61Erythema

    NV102V18VAX#11Induration2Fatigue

    NV102V18VAX#12Fever

    NV102V18VAX#12Headache

    NV102V18VAX#12Malaise

    NV102V18VAX#21Erythema1Fatigue

    NV102V18VAX#21Pruritus1Fever

    NV102V18VAX#21Induration1Malaise

    NV102V18VAX#24Sepsispossiblydelayed

    NV102V18VAX#31Erythema1Fatigue

    NV102V18VAX#31Induration

    NV102V18VAX#24Cellulitispossiblydelayed

    NV102V18VAX#41Erythema0No adverse event

    NV102V18VAX#41Pruritus

    NV102V18VAX#41Induration

    NV103V19VAX#11Erythema0No adverse event

    NV103V19VAX#11Induration

    NV103V19VAX#21Erythema0No adverse event

    NV103V19VAX#21Induration

    NV103V19VAX#21Discomfort

    NV103V19VAX#31Erythema0No adverse event

    NV103V19VAX#31Induration

    NV103V19VAX#41Erythema1Chills

    NV103V19VAX#41Induration

    NV103V19VAX#51Erythema0No adverse event

    NV103V19VAX#51Pruritus

    NV103V19VAX#51Induration

    NV104V20VAX#11Induration1Chills

    NV104V20VAX#11Neuropathy

    NV104V20VAX#11Nausea

    NV104V20VAX#21Erythema0No adverse event

    NV104V20VAX#21Pruritus

    NV104V20VAX#21Induration

    NV104V20VAX#31Erythema0No adverse event

    NV104V20VAX#31Induration

    NV104V20VAX#41Erythema1Chills

    NV104V20VAX#41Pruritus1Headache

    NV104V20VAX#41Induration

    NV106V22VAX#11Induration0No adverse event

    NV106V22VAX#21Induration1Bone Pain

    NV106V22VAX#21Fatigue

    NV107V23VAX#11Erythema0No adverse event

    NV107V23VAX#11Induration

    NV108V24VAX#11Induration1Headache

    NV108V24VAX#11Bruising

    Laura:delayed

    Laura:possibly related

    Laura:possibly related

    Max Toxicity

    % of Subjects

    E39 Maximum Toxicity

    Recurrence

    VaccineControl

    Number of Recurrences911

    Total patient2922

    % recurred31.0%50.0%

    Recurrence

    % of Subjects

    Recurrence

  • GALE-401

    Anagrelide CR

  • GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR)

    Anagrelide

    Active ingredient Reduces the elevated platelet count and the risk of thrombosis in patients with

    myeloproliferative neoplasms (MPNs) MPNs are hematological malignancies in which the bone marrow cells develop and function

    abnormally

    Immediate Release

    Approved for the treatment of patients with thrombocythemia, secondary to MPNs IR formulation can cause unacceptable side effects believed to be Cmax-related and has largely

    limited the use due to early treatment withdrawal

    GALE-401

    Controlled Release (CR) formulation may decrease the frequency or severity of side effects Phase 2, Proof-of-Concept Trial Results

    Well tolerated with primarily Grade 1 and 2 toxicities Efficacy compares favorably to historical anagrelide IR

    14

  • ESSENTIAL THROMBOCYTHEMIA (ET):CURRENT STANDARD OF CARE

    15

    Generally first line therapy for ET Cytotoxic Myelosuppressive drug (reduces

    other blood cells as well) Increased risk of developing acute leukemia

    after long term; avoided in younger patients About 25% of patients are

    intolerant/refractory

    Limited third line use Non cytotoxic drug Not used in most patients because requires

    injection and has flu like symptoms Used mostly in pregnant women

    Generally second line Non cytotoxic drug Decreases platelets formation Not associated with increased risk of

    leukemia Side effects: palpitations, headaches About one-third are intolerant to Anagrelide

    Hydroxyurea and/or Anagrelide Treatment Failure

    Sources: Leukemia and Lymphoma Society: Essential Thrombocythemia Facts Cervantes, F. Hematology 2011; 215-221

    Hydroxyurea

    Anagrelide IR

    Interferon alpha

    Unmet Need

  • CORPORATE OVERVIEW

    16

  • FINANCIAL OVERVIEW

    Cash Position (as of June 30, 2016) $19.6 million

    Debt Financing (May 10, 2016) + $24 million (restricted cash)

    Litigation Settlement (July 1, 2016) - $2.3 million

    Projected Quarterly Burn $9 - $11 million

    Shares Outstanding (as of March 31, 2016) 182 million

    Market Cap (as of July 12, 2016) ~$75 million

    17

    July 2016 Financing $11.7 million (net proceeds)

    Common Stock Issued 28,000,000 shares

  • 2016 MILESTONES

    18

    PROGRAM MILESTONEPROJECTED

    DATE

    NeuVax(nelipepimut-S)

    PRESENT: Achieve 70 Qualifying DFS Events Fast Track Designation PRESENT: Interim analysis Stopped

    Initiate DCIS trial Q2

    Combo H&N 1+/2+ Interim safety data Q4

    GALE-301GALE-302

    Present 301/302 booster data Present GALE-301 Phase 2a two year data Orphan Drug Designation Present GALE-301 Biomarker & Dosing Data Q4

    GALE-401 (anagrelide CR)

    Present combined safety data Confirmation of 505(b)2 pathway 2H

    Publish final Phase 2 report Q4

  • LEADERSHIP TEAM

    19

    Mark W. Schwartz, Ph.D., President & CEOApthera, Bayhill Therapeutics, Calyx Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics

    Bijan Nejadnik, M.D., Executive Vice President, Chief Medical Officer Jazz Pharmaceuticals, Johnson & Johnson, Stanford, Johns Hopkins, UC Davis

    Remy Bernarda, SVP, Investor Relations & Corporate CommunicationsIR Sense, Hana Biosciences, Knight Equity Markets, Bear Stearns, Goldman Sachs

    Gavin Choy, Pharm.D., SVP, Clinical Sciences & OperationsOtsuka, Astex, SuperGen, Hana Biosciences, Gilead, Stanford University Medical Center, Department of Veteran Affairs

    Tom Knapp, Esq., Interim General Counsel Sucampo, Exemplar Law Partners, NorthWestern Energy, Paul Hastings, The Boeing Company

    Joe Lasaga, VP, Business Development & Alliance ManagementNektar Therapeutics, Rigel

    Pat Murphy, VP, Regulatory Affairs & ComplianceNektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen

  • WHY WERE HERE

    20Source: San Antonio Express E75 vaccine's final tests start in S.A. By Don Finley, January 22, 2012; Photo credit: Kin Man Hui/San Antonio Express-News/ZUMAPress

    I've had several friends who've had (breast cancer) and thenit came back and they had to go through treatment again. So this would be wonderful, not to have to come back.

    First NeuVax Phase 3 patient

  • THANK YOU

    2016 ANNUAL MEETING OF STOCKHOLDERSFORWARD LOOKING STATEMENTDEVELOPMENT PIPELINEPRESENT CURRENT STATUSIMMUNO-ONCOLOGY:UNLOCKING THE POWER OF THE T-CELLLACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERSOUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSIONNOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORSNEUVAX: DEVELOPMENT COLLABORATIONSGALE-301 & GALE-302GALE-301 & GALE-302:CURRENT CLINICAL DEVELOPMENT GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACYGALE-401GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR)ESSENTIAL THROMBOCYTHEMIA (ET):CURRENT STANDARD OF CARECORPORATE OVERVIEWFINANCIAL OVERVIEW2016 MILESTONESLEADERSHIP TEAMWHY WERE HERETHANK YOU