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2012 Report
Medicines in Development



Vaccines
presented by america’s biopharmaceutical
research companies




                                               Nearly 300 Vaccines Are in Development;
                                               Research Focuses on Prevention and Treatment




Vaccines in Development*


                        170




                                               For many years, vaccines have been used            Today, biopharmaceutical research companies
                                               to successfully prevent diseases such as           are developing 295 vaccines. Potential vac-
                                               smallpox, measles, polio and other infectious      cines in development include:
                                               diseases. A 2007 study by the U.S. Centers for     	 •  recombinant vaccine against malaria.
                                                                                                      A
               102
                                               Disease Control and Prevention (CDC) found
                                               that cases of vaccine-preventable diseases         	 •  vaccine that protects infants against
                                                                                                      A
                                               had reached an all-time low in the United              meningococcal disease, a leading cause
                                                                                                      of meningitis.
                                               States. The study found that hospitalizations
                                               and deaths from nine infectious diseases had       	 •  genetically-modified vaccine designed
                                                                                                      A
                                               declined by more than 90 percent and nearly            for the treatment of pancreatic cancer.
                                               90 percent for another four diseases.              Although many new promising vaccines are
                                                                                                  being researched today, the vaccine devel-
                                               These findings illustrate the major contribution
                                                                                                  opment process is not an easy one. As with
                                               that vaccines have made in saving countless
                                                                                                  the development of all drugs, vaccines must
                                               lives around the world. In the past several
                                                                                                  survive many years of thorough testing before
                                               years, many successful new vaccines have
                                                                                                  they can be approved for use by the general
                                               been developed, including one against human
       12                                                                                         public. Advances in other scientific fields,
                                    8          papillomavirus (HPV) infections that can lead
                                          7
                                                                                                  such as genomics, are becoming increasingly
                                               to cervical cancer, one to guard against pre-
                                                                                                  useful in the development of new vaccines.
                                               exposure to the anthrax virus, and a vaccine to
                                                                                                  With the continued efforts of researchers, it is
        gy




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                                               prevent pneumococcal infections in high-risk
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                                                                                                  likely that we may have many more vaccines
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                                               populations.
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                                                                                                  to protect against life-threatening diseases in
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                                               But vaccines are not only for preventing infec-    the near future.
                       ur
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                                               tious diseases. In 2010, a new cancer vaccine
* Some vaccines are listed in                  for the treatment of prostate cancer was
more than one category.                        approved in the United States, and many more
                                               are in development.
Medicines in Development for Vaccines



  Allergy
  Product Name                           Sponsor                                      Indication                                           Development Status*

  cat allergy vaccine                    Greer Laboratories                           perennnial allergic rhinitis due to                  Phase I
  sublingual                             Lenoir, NC                                   cat hair                                             (800) 419-7302

  food allergy epicutaneous              DBV Technologies                             peanut hypersensitivity                              Phase I
  immunotherapy                          Bagneux, France                              (Fast Track)                                         www.dbv-technologies.com

  grass pollen allergy                   ALK Abello                                   seasonal allergic rhinitis                           Phase III
  vaccine tablet                         Horsholm, Denmark                                                                                 (800) 672-6372
  (immunotherapy)                        Merck
                                         Whitehouse Station, NJ

  grass pollen extract                   Stallergenes                                 seasonal allergic rhinitis                           Phase III
  sublingual vaccine                     Norwell, MA                                                                                       (781) 878-0018

  house dust mite allergy                Greer Laboratories                           allergic rhinitis                                    Phase I
  sublingual vaccine                     Lenoir, NC                                                                                        (800) 419-7302

  house dust mite allergy                ALK Abello                                   allergic asthma                                      Phase II
  vaccine tablet                         Horsholm, Denmark                                                                                 (800) 672-6372
                                         Merck
                                         Whitehouse Station, NJ

  peanut allergy vaccine                 Allertein Therapeutics                       peanut hypersensitivity                              Phase I
                                         Fairfield, CT

  Pollinex® Quattro                      Allergy Therapeutics                         prevention of grass pollen                           Phase III
  injectable MPL allergy vaccine         West Sussex, United Kingdom                  hypersensitivity, prevention of                      www.allergytherapeutics.com
                                                                                      ragweed hypersensitivity
                                                                                      --------------------------------------------------   -------------------------------------------
                                                                                      prevention of tree pollen                            Phase II
                                                                                      hypersensitivity                                     www.allergytherapeutics.com

  QGE031                                 Novartis Pharmaceuticals                     allergic diseases                                    Phase I
  (anti-IgE antibody)                    East Hanover, NJ                                                                                  (888) 669-6682

  ragweed allergy immunotherapy          Stallergenes                                 seasonal allergic rhinitis                           Phase I
  vaccine                                Norwell, MA                                                                                       (781) 878-0018

  ragweed allergy vaccine                Greer Laboratories                           seasonal allergic rhinitis                           Phase III
  sublingual                             Lenoir, NC                                                                                        (800) 419-7302

  ragweed allergy vaccine                ALK Abello                                   seasonal allergic rhinitis                           Phase III
  sublingual tablet                      Horsholm, Denmark                                                                                 (800) 672-6372
                                         Merck
                                         Whitehouse Station, NJ



* For more information about a specific medicine in this report, please call the telephone number listed.




2                                                                                                          Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Cancer
 Product Name                  Sponsor                           Indication                                           Development Status

 abagovomab                    Menarini                          ovarian cancer                                       Phase III
 (anti-idiotype mAb vaccine)   Florence, Italy                                                                        www.menarini.com

 ADXS-HPV                      Advaxis                           recurrent cervical cancer, cervical                  Phase II
 (live, attenuated Listeria    Princeton, NJ                     intraepithelial neoplasia                            (609) 452-9813
 monocytogenes [Lm]-based
 vaccine)

 AE37                          Antigen Express                   breast cancer                                        Phase II
 (peptide vaccine)             Worcester, MA                                                                          (508) 852-8783
                                                                 --------------------------------------------------   -------------------------------------------
                                                                 ovarian cancer (combination                          Phase I
                                                                 therapy), prostate cancer                            (508) 852-8783

 AGS-003                       Argos Therapeutics                kidney cancer (combination therapy),                 Phase II
 (personalized dendritic       Durham, NC                        metastatic kidney cancer                             (919) 287-6300
 cell-based immunotherapy)                                       (monotherapy)

 AlloStim™                     Novo Energies                     hematological malignancies,                          Phase I/II
 immunotherapeutic vaccine     Montreal, Canada                  solid tumors                                         (514) 840-3697

 anti-GnRH vaccine             Novartis Vaccines  Diagnostics   prostate cancer                                      Phase I/II
                               Cambridge, MA                                                                          (617) 871-7000
                               Pepscan Therapeutics
                               Lelystad, Netherlands

 astuprotimut-R                GlaxoSmithKline                   malignant melanoma, non-small-cell                   Phase III
 (MAGE-A3 recombinant          Rsch. Triangle Park, NC           lung cancer (NSCLC)                                  (888) 825-5249
 antigen-specific cancer                                         --------------------------------------------------   -------------------------------------------
 immunotherapy)                                                  bladder cancer                                       Phase II
                                                                                                                      (888) 825-5249

 AVX-701                       AlphaVax                          prevention of advanced or metastatic                 Phase I/II
                               Rsch. Triangle Park, NC           CEA-expressing colorectal cancer                     (919) 595-0400

 B7-2/GM-CSF                   NuVax Therapeutics                cancer                                               Phase I
 cancer gene therapy vaccine   Tustin, CA                                                                             (714) 505-4461

 BiovaxID®                     Biovest International             indolent follicular lymphoma                         Phase III
 B-cell lymphoma vaccine       Tampa, FL                         (Fast Track)                                         (813) 864-2558
 (personalized lymphoma                                          --------------------------------------------------   -------------------------------------------
 vaccine)                                                        mantle-cell lymphoma                                 Phase II
                                                                                                                      (813) 864-2558

 BPX-101                       Bellicum Pharmaceuticals          prostate cancer                                      Phase I/II
 (dendritic cell vaccine)      Houston, TX                                                                            www.bellicum.com

 breast cancer vaccine         Quantum Immunologics              breast cancer                                        Phase I/II
 (dendritic cell vaccine)      Tampa, FL                                                                              (813) 849-7885




Medicines in Development Vaccines 2012                                                                                                                          3
Medicines in Development for Vaccines



Cancer
Product Name                    Sponsor                            Indication                                           Development Status

cancer vaccine                  Immunovaccine                      ovarian cancer                                       Phase I
                                Halifax, Canada                                                                         (902) 492-1819

cancer vaccine                  Activartis Biotech                 glioblastoma (first-line therapy)                    Phase II
(autologous dendritic cell      Vienna, Austria                                                                         www.activartis.com
vaccine)                                                           --------------------------------------------------   -------------------------------------------
                                                                   metastatic renal cancer                              in clinical trials
                                                                                                                        www.activartis.com

cancer vaccine                  Bayer HealthCare Pharmaceuticals   follicular lymphoma (prevention of                   Phase I
(autologous idiotype vaccine)   Wayne, NJ                          relapse)                                             (888) 842-2937

cancer vaccine                  Cytokine PharmaSciences            cancer                                               Phase I
(fibrocyte vaccine)             King of Prussia, PA                                                                     (610) 687-1776

cancer vaccine                  MabVax Therapeutics                sarcoma                                              Phase II
(mAb vaccine)                   San Diego, CA                                                                           (858) 259-9405
                                                                   --------------------------------------------------   -------------------------------------------
                                                                   breast cancer                                        Phase I
                                                                                                                        (858) 259-9405

CB-10-01                        Cosmo Pharmaceuticals              malignant melanoma                                   Phase II
                                Lainate, Italy                                                                          www.cosmopharmaceuticals.
                                                                                                                        com

CDX-1401                        Celldex Therapeutics               solid tumors expressing the                          Phase I/II
                                Needham, MA                        NY-ESO-1 protein                                     (781) 433-0771

CG201                           CG Therapeutics                    solid tumors                                         Phase II
                                Seattle, WA                                                                             (206) 336-5604

CLL                             MaxCyte                            chronic lymphocytic leukemia (CLL)                   Phase I/II
immunotherapeutic               Gaithersburg, MD                                                                        (301) 944-1700

CRS-207                         Aduro BioTech                      metastatic pancreatic cancer                         Phase II
                                Berkeley, CA                       (combination therapy)                                (510) 848-4400

CV-301                          BN ImmunoTherapeutics              metastatic breast cancer                             Phase II
(immunotherapeutic vaccine)     (Bavarian Nordic)                                                                       (650) 681-4660
                                Mountain View, CA

CVac™                           Prima Biomed                       ovarian cancer                                       Phase II/III
cancer vaccine                  Sydney, Australia                                                                       www.primabiomed.com.au
MUC-1




4                                                                                       Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Cancer
 Product Name                      Sponsor                     Indication                                           Development Status

 DCVax®-Brain                      Northwest Biotherapeutics   glioblastoma                                         Phase II
 dendritic cell-based vaccine      Bethesda, MD                                                                     (240) 497-9024
 (Orphan Drug)

 DCVax®-Ovarian                    Northwest Biotherapeutics   ovarian cancer, peritoneal cancer                    Phase I
 dendritic cell-based vaccine      Bethesda, MD                                                                     (240) 497-9024

 DCVax®-Prostate                   Northwest BioTherapeutics   prostate cancer                                      Phase III
 dendritic cell-based vaccine      Bethesda, MD                                                                     (240) 497-9024

 dendritic cell cancer vaccine     EMD Serono                  malignant melanoma                                   Phase I
                                   Rockland, MA                                                                     (800) 283-8088

 DN24-02                           Dendreon                    HER2-positive urogenital cancer                      Phase II
 (lapuleucel-T)                    Seattle, WA                 (adjuvant therapy)                                   (877) 256-4545
 (dendritic cell vaccine)                                      --------------------------------------------------   -------------------------------------------
                                                               breast cancer, colorectal cancer,                    Phase I completed
                                                               ovarian cancer                                       (877) 256-445

 DPX-0907                          Immunovaccine               breast cancer, ovarian cancer,                       Phase I
                                   Halifax, Canada             prostate cancer                                      (902) 492-1819

 EC17                              Endocyte                    kidney cancer                                        Phase I
                                   West Lafayette, IN          (combination therapy)                                www.endocyte.com

 ETBX-011                          Etubics                     solid tumors                                         Phase I
 (adenovirus vector vaccine)       Seattle, WA                                                                      (206) 838-5110

 FANG™ vaccine                     Gradalis                    malignant melanoma, ovarian cancer                   Phase II
 (autologous tumor cell vaccine)   Carrollton, TX                                                                   (214) 442-8100

 FBP vaccine                       Galena Biopharma            endometrial cancer, ovarian cancer                   Phase I/II
 (folate-binding protein           Lake Oswego, OR                                                                  (855) 855-4253
 E39 vaccine)                                                  --------------------------------------------------   -------------------------------------------
                                                               breast cancer                                        Phase I
                                                                                                                    (855) 855-4253

 G-100 prophage cancer vaccine     Agenus                      newly-diagnosed glioma                               Phase II
 (Orphan Drug)                     Lexington, MA                                                                    (781) 674-4400

 G-200 prophage cancer vaccine     Agenus                      recurrent glioma                                     Phase II
 (Orphan Drug)                     Lexington, MA                                                                    (781) 674-4400




Medicines in Development Vaccines 2012                                                                                                                        5
Medicines in Development for Vaccines



Cancer
Product Name                  Sponsor                    Indication                                           Development Status

GI-4000                       GlobeImmune                colorectal cancer, pancreatic cancer                 Phase II
(therapeutic vaccine)         Louisville, CO                                                                  (303) 625-2700
                                                         --------------------------------------------------   -------------------------------------------
                                                         colorectal cancer (first-line therapy),              Phase I
                                                         colorectal cancer (second-line                       (303) 625-2700
                                                         therapy), NSCLC

GI-6207                       GlobeImmune                metastatic cancer                                    Phase I
(therapeutic vaccine)         Louisville, CO                                                                  (303) 625-2700

GI-6301                       GlobeImmune                solid tumors                                         Phase I
(brachyury peptide vaccine)   Louisville, CO                                                                  (303) 625-2700

GRNVAC1                       Geron                      acute myeloid leukemia (AML)                         Phase II
(telomerase-based cancer      Menlo Park, CA                                                                  (650) 473-7700
vaccine)                                                 --------------------------------------------------   -------------------------------------------
                                                         prostate cancer                                      Phase I/II
                                                                                                              (650) 473-7700

GSK2241658A                   GlaxoSmithKline            metastatic melanoma                                  Phase I
(NY-ESO-1 antigen-specific    Rsch. Triangle Park, NC                                                         (888) 825-5249
cancer immunotherapeutic)

GV1001                        KAEL-GemVax                pancreatic cancer                                    Phase I
(hTERT RNA vaccine)           Seoul, South Korea                                                              www.kaelgemvax.com
(Orphan Drug)

GVAX® Breast                  BioSante Pharmaceuticals   breast cancer                                        Phase I
immunotherapeutic vaccine     Lincolnshire, IL                                                                (847) 478-0500

GVAX® Colorectal              BioSante Pharmaceuticals   colorectal cancer                                    Phase I
immunotherapeutic vaccine     Lincolnshire, IL                                                                (847) 478-0500

GVAX® Leukemia                BioSante Pharmaceuticals   AML, chronic myeloid leukemia                        Phase II
immunotherapeutic vaccine     Lincolnshire, IL           (CML)                                                (847) 478-0500
(Orphan Drug)

GVAX® Myeloma                 BioSante Pharmaceuticals   multiple myeloma                                     Phase II
immunotherapeutic vaccine     Lincolnshire, IL                                                                (847) 478-0500

GVAX® Pancreatic              BioSante Pharmaceuticals   pancreatic cancer                                    Phase II
immunotherapeutic vaccine     Lincolnshire, IL                                                                (847) 478-0500
(Orphan Drug)

GVAX® Prostate                BioSante Pharmaceuticals   prostate cancer                                      Phase III
immunotherapeutic vaccine     Lincolnshire, IL           (Fast Track)                                         (847) 478-0500




6                                                                             Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Cancer
 Product Name                     Sponsor                       Indication                                           Development Status

 HS-110                           Heat Biologics                NSCLC (combination therapy)                          Phase II
                                  Chapel Hill, NC                                                                    (919) 240-7133

 hTERT vaccine                    Merck                         cancer                                               Phase I
 (human telomerase reverse        Whitehouse Station, NJ                                                             (800) 672-6372
 transcriptase cancer vaccine)    Vical                                                                              (858) 646-1100
                                  San Diego, CA

 HyperAcute® Lung                 NewLink Genetics              NSCLC                                                Phase II
 lung cancer immunotherapy        Ames, IA                                                                           (515) 296-5555

 HyperAcute® Melanoma             NewLink Genetics              malignant melanoma                                   Phase II
 lung cancer immunotherapy        Ames, IA                                                                           (515) 296-5555

 HyperAcute® Pancreas             NewLink Genetics              pancreatic cancer                                    Phase III
 algenpantucel-L                  Ames, IA                      (Fast Track)                                         (515) 296-5555
 (Orphan Drug)

 ICT-107                          ImmunoCellular Therapeutics   glioblastoma                                         Phase II
 (autologous dendritic-cell       Woodland Hills, CA                                                                 (818) 992-2907
 vaccine)
 (Orphan Drug)

 IDM-2101                         Biotech Synergy               NSCLC                                                Phase II
 (multi-epitope cancer vaccine)   San Diego, CA                                                                      (858) 459-6689

 IMA901                           immatics biotechnologies      kidney cancer                                        Phase III
 (multiple tumor-associated       Tuebingen, Germany                                                                 www.immatics.com
 peptides cancer vaccine)

 IMCgp100                         Immunocore                    malignant melanoma                                   Phase 0
                                  Oxon, United Kingdom                                                               www.immunocore.com

 IMF-001                          ImmunoFrontier                solid tumors                                         Phase I
 (protein vaccine)                Tokyo, Japan                                                                       www.immunofrontier.com

 IMT-1012                         Immunotope                    breast cancer, ovarian cancer                        Phase I
 (multi-peptide antigen           Doylestown, PA                                                                     (215) 253-4180
 immunotherapeutics vaccine)

 ISF35                            Memgen                        CLL (monotherapy),                                   Phase II
 (recombinant immunotherapy)      San Diego, CA                 non-Hodgkin’s lymphoma                               (858) 524-5400
                                                                --------------------------------------------------   -------------------------------------------
                                                                CLL (combination therapy)                            Phase I
                                                                                                                     (858) 524-5400




Medicines in Development Vaccines 2012                                                                                                                         7
Medicines in Development for Vaccines



Cancer
Product Name                       Sponsor                           Indication                                           Development Status

JVRS-100                           Colby Pharmaceutical              leukemia                                             Phase I
(lipid-DNA complex vaccine)        San Jose, CA                                                                           (650) 333-3152

Lucanix®                           NovaRx                            NSCLC                                                Phase III
belagenpumatucel-L                 San Diego, CA                     (Fast Track)                                         (858) 552-8600
(cell-based therapeutic vaccine)                                     --------------------------------------------------   -------------------------------------------
                                                                     glioma                                               Phase I
                                                                                                                          (858) 552-8600

LungVax®                           AVAX Technologies                 NSCLC                                                Phase I/II
autologous cell vaccine            Philadelphia, PA                                                                       (215) 241-9760

M-200 prophage cancer vaccine      Agenus                            metastatic melanoma                                  Phase III
(Orphan Drug)                      Lexington, MA                     (Fast Track)                                         (781) 674-4400

melanoma DNA vaccine               Ichor Medical Systems             malignant melanoma                                   Phase I
                                   San Diego, CA                                                                          (858) 550-2022
                                   Memorial Sloan-Kettering Cancer
                                   Center
                                   New York, NY

MVA-BN® Breast                     BN ImmunoTherapeutics             breast cancer                                        Phase I
HER-2/neu-based modified           (Bavarian Nordic)                                                                      (650) 681-4660
vaccinia ankara (MVA) vaccine      Mountain View, CA

MVA-BN®-PRO                        BN ImmunoTherapeutics             prostate cancer                                      Phase I/II
                                   (Bavarian Nordic)                                                                      (650) 681-4660
                                   Mountain View, CA

MVax®                              AVAX Technologies                 malignant melanoma                                   Phase III
autologous cell vaccine            Philadelphia, PA                                                                       (215) 241-9760

NeuVax™                            Galena Biopharma                  early-stage breast cancer                            Phase III
E75 cancer vaccine                 Lake Oswego, OR                   (prevention of relapse)                              (855) 855-4253
                                                                     --------------------------------------------------   -------------------------------------------
                                                                     prostate cancer                                      Phase I/II
                                                                                                                          (855) 855-4253

Oncophage®                         Agenus                            renal cell carcinoma                                 Phase II
vitespen                           Lexington, MA                     (Fast Track)                                         (781) 674-4400
(Orphan Drug)

OncoVAX®                           Vaccinogen                        stage III colorectal cancer                          Phase II
colorectal cancer vaccine          Frederick, MD                     (combination therapy)                                (301) 668-8400
                                                                     --------------------------------------------------   -------------------------------------------
                                                                     colorectal cancer                                    Phase I/II
                                                                     (Fast Track)                                         (301) 668-8400

ONT-10                             Oncothyreon                       solid tumors                                         Phase I
                                   Seattle, WA                                                                            (206) 801-2100




8                                                                                         Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Cancer
 Product Name                      Sponsor                     Indication                                           Development Status

 OPT-822                           Optimer Pharmaceuticals     breast cancer                                        Phase II
                                   San Diego, CA                                                                    (858) 909-0736

 oral peptide cancer vaccine       Immunitor                   cancer                                               Phase I/II
                                   Vancouver, Canada

 oregovomab                        Quest PharmaTech            ovarian cancer                                       Phase I/II
 (Orphan Drug)                     Edmonton, Canada                                                                 (780) 448-1400

 OVax®                             AVAX Technologies           ovarian cancer                                       Phase I/II
 autologous tumor cell vaccine     Philadelphia, PA                                                                 (215) 241-9760
 (Orphan Drug)

 POL-103A                          Polynoma                    malignant melanoma                                   Phase II
 (polyvalent shed-antigen          San Diego, CA                                                                    (858) 205-2501
 vaccine)
 (Orphan Drug)

 polyclonal antibody stimulator    Cancer Advances             gastric cancer, pancreatic cancer                    Phase III
 (Orphan Drug)                     Durham. NC                  (see also other)                                     (919) 361-2162
                                                               --------------------------------------------------   -------------------------------------------
                                                               colorectal cancer                                    Phase II
                                                                                                                    (919) 361-2162

 PRAME                             GlaxoSmithKline             metastatic melanoma, NSCLC                           Phase I
 antigen-specific cancer           Rsch. Triangle Park, NC                                                          (888) 825-5249
 immunotherapeutic

 Prostvac™                         BN ImmunoTherapeutics       metastatic prostate cancer                           Phase III
 prostate cancer vaccine           (Bavarian Nordic)           (Fast Track)                                         (650) 681-4660
                                   Mountain View, CA

 Provenge®                         Dendreon                    recurrent early-stage prostate cancer                Phase III
 sipuleucel-T                      Seattle, WA                                                                      (877) 256-4545
                                                               --------------------------------------------------   -------------------------------------------
                                                               early-stage prostate cancer                          Phase II
                                                               (neoadjuvant therapy)                                (877) 256-4545

 PSMA VRP therapeutic vaccine      Progenics Pharmaceuticals   prostate cancer                                      Phase I
                                   Tarrytown, NY                                                                    (914) 789-2800

 PT107                             Pique Therapeutics          NSCLC                                                Phase II
 (allogeneic tumor cell vaccine)   Durham, NC                                                                       (919) 806-4395

 recombinant soluble PSMA          Progenics Pharmaceuticals   prostate cancer                                      Phase I
 protein vaccine                   Tarrytown, NY                                                                    (914) 789-2800




Medicines in Development Vaccines 2012                                                                                                                        9
Medicines in Development for Vaccines



 Cancer
 Product Name                  Sponsor                  Indication                                           Development Status

 REIC gene therapy             Momotaro-Gene            prostate cancer                                      Phase I
                               Okayama, Japan                                                                www.mt-gene.com

 Reximmune-C®                  Epeius Biotechnologies   breast cancer                                        Phase I/II
 personalized cancer vaccine   San Marino, CA                                                                (626) 441-6695

 rindopepimut                  Celldex Therapeutics     glioblastoma (first-line therapy)                    Phase III
 (Orphan Drug)                 Needham, MA              (Fast Track)                                         (781) 433-0771
                                                        --------------------------------------------------   -------------------------------------------
                                                        glioblastoma (combination therapy,                   Phase II
                                                        second-line therapy)                                 (781) 433-0771
                                                        (Fast Track)

 SL-701                        Stemline Therapeutics    glioma                                               Phase I/II
 (dendritic cell vaccine)      New York, NY                                                                  (212) 831-1111

 Stimuvax®                     EMD Serono               NSCLC (Fast Track)                                   Phase III
 emepepimut-S                  Rockland, MA                                                                  (800) 283-8088
                               Oncothyreon              --------------------------------------------------   (206) 769-9219
                               Seattle, WA              prostate cancer                                      -------------------------------------------
                                                                                                             Phase II
                                                                                                             (800) 283-8088
                                                                                                             (206) 769-9219

 TAG vaccine                   Gradalis                 solid tumors                                         Phase I
                               Carrollton, TX                                                                (214) 442-8100

 TeloB-Vax                     Adamis Pharmaceuticals   prostate cancer                                      Phase I
 telomerase cancer vaccine     San Diego, CA                                                                 www.adamispharma.com

 tipapkinogene sovacivec       Transgene                cervical intraepithelial neoplasia                   Phase II
                               Rockville, MD                                                                 (301) 816-5421

 TroVax®                       Oxford BioMedica         hormone refractory prostate cancer                   Phase II
 tumor-associated antigen      Oxford, United Kingdom                                                        www.oxfordbiomedica.co.uk
 vaccine

 TVI-Brain-1                   TVAX Biomedical          glioma                                               Phase II
 (cellular immunotherapy       Lenexa, KS                                                                    (913) 492-2221
 vaccine)

 TVI-Kidney-1                  TVAX Biomedical          renal cell carcinoma                                 in clinical trials
 (cellular immunotherapy       Lenexa, KS                                                                    (913) 492-2221
 vaccine)

 V503                          Merck                    prevention of cervical cancer,                       Phase III
 (virus-like particle [VLP]    Whitehouse Station, NJ   prevention of vulvovaginal cancer                    (800) 672-6372
 vaccine)                                               (see also infectious diseases)




10                                                                           Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Cancer
 Product Name                     Sponsor                                 Indication                                           Development Status

 V505                             Merck                                   prevention of cervical cancer                        Phase II completed
                                  Whitehouse Station, NJ                  (see also infectious diseases)                       (800) 672-6372

 V930/V932                        Merck                                   cancer                                               Phase I
 (plasmid DNA cancer vaccine)     Whitehouse Station, NJ                                                                       (800) 672-6372
                                  Vical                                                                                        (858) 646-1100
                                  San Diego, CA

 V935                             Geron                                   solid tumors                                         Phase I
 (telomerase inhibitor vaccine)   Menlo Park, CA                                                                               (650) 473-7700
                                  Merck                                                                                        (800) 672-6372
                                  Whitehouse Station, NJ

 verpasep caltespen               Akela Pharma                            cervical intraepithelial neoplasia                   Phase I completed
                                  Austin, TX                                                                                   (512) 834-0449

 VGX-3100                         Inovio Pharmaceuticals                  cervical intraepithelial neoplasia                   Phase II
                                  Blue Bell, PA                           (see also infectious diseases)                       (877) 446-6846

 WT1 antigen specific cancer      GlaxoSmithKline                         AML                                                  Phase II
 immunotherapeutic                Rsch. Triangle Park, NC                                                                      (888) 825-5249
                                                                          --------------------------------------------------   -------------------------------------------
                                                                          breast cancer                                        Phase I
                                                                                                                               (888) 825-5249


 Infectious Diseases
 Product Name                     Sponsor                                 Indication                                           Development Status

 ACAM-Cdiff                       sanofi pasteur                          Clostridium difficile infections                     Phase II
 (toxoid vaccine)                 Swiftwater, PA                                                                               (800) 822-2463

 ACE527                           ACE Biosciences                         prevention of traveler’s diarrhea                    Phase II
 (oral pentavalent vaccine)       Odense, Denmark                         caused by Escherichia coli infections                www.acebiosciences.com
                                  TD Vaccines                                                                                  www.tdvaccines.com
                                  Skorping, Denmark

 Ad26.ENVA.01                     Crucell                                 prevention of HIV infection                          Phase I
 HIV-1 recombinant vaccine        Leiden, Netherlands                                                                          www.crucell.com

 ADVAX                            Aaron Diamond AIDS Research             HIV infection prevention                             Phase I completed
 (DNA vaccine)                    Center                                                                                       (212) 448-5000
                                  New York, NY                                                                                 (212) 847-1111
                                  International AIDS Vaccine Initiative   --------------------------------------------------   -------------------------------------------
                                  New York, NY                            HIV infection prevention                             Phase I completed
                                  Ichor Medical Systems                   (new delivery system)                                (212) 448-5000
                                  San Diego, CA                                                                                (212) 847-1111



Medicines in Development Vaccines 2012                                                                                                                                   11
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                      Sponsor                           Indication                             Development Status

 Aflunov™                          Novartis Vaccines  Diagnostics   prevention of influenza A virus H5N1   Phase II
 influenza A virus H5N1 vaccine    Cambridge, MA                     subtype (pre-pandemic)                 (617) 871-7000

 AG-707                            Agenus                            treatment of herpes simplex virus      Phase I completed
 (herpes simplex vaccine)          Lexington, MA                     infections                             (781) 674-4400

 AGS-004                           Argos Therapeutics                HIV-1 infection                        Phase II
 (personalized dendritic           Durham, NC                                                               (919) 287-6300
 cell-based immunotherapy)

 anthrax transdermal vaccine       Intercell USA                     anthrax                                Phase I
                                   Gaithersburg, MD                                                         (301) 556-4500

 ANZ-521                           Aduro BioTech                     treatment of hepatitis C               Phase I
 (recombinant vaccine)             Berkeley, CA                                                             (510) 848-4400

 AV-7909                           Emergent BioSolutions             anthrax                                Phase I
 (anthrax vaccine adsorbed with    Rockville, MD                                                            (301) 795-1800
 adjuvant)

 AVX-101                           AlphaVax                          prevention of HIV-1 infection          Phase I completed
 (monovalent HIV vaccine)          Rsch. Triangle Park, NC                                                  (919) 595-0400

 AVX-502                           AlphaVax                          prevention of influenza virus          Phase I/II
                                   Rsch. Triangle Park, NC           infections in the elderly              (919) 595-0400

 BioThrax®                         Emergent BioSolutions             anthrax (post-exposure prevention)     Phase III
 anthrax vaccine adsorbed          Rockville, MD                     (Fast Track)                           (301) 795-1800

 botulinum toxin recombinant       DynPort Vaccine Company           botulism                               Phase II
 vaccine                           Frederick, MD                                                            (301) 607-5000

 chikungunya virus vaccine         Inviragen                         chikungunya virus infections           Phase II
                                   Fort Collins, CO                                                         (970) 672-4918

 CholeraGarde®                     Vaccine Technologies              cholera                                Phase II
 cholera vaccine live attenuated   Boston, MA                                                               (617) 358-5011

 ChronVac-C®                       Inovio Pharmaceuticals            treatment of hepatitis C               Phase II
 hepatitis C DNA vaccine           Blue Bell, PA                                                            (877) 446-6846
                                   ChronTech Pharma
                                   Huddinge, Sweden

 cytomegalovirus vaccine           AlphaVax                          prevention of cytomegalovirus          Phase I
 (AVX-601)                         Rsch. Triangle Park, NC           infections                             (617) 871-7000
                                   Novartis Vaccines  Diagnostics
                                   Cambridge, MA




12                                                                                     Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                      Sponsor                              Indication                             Development Status

 DCVax-001                         Celldex Therapeutics                 prevention and treatment of HIV        Phase I
 (recombinant protein vaccine)     Needham, MA                          infection                              (781) 433-0771

 dengue DNA vaccine                U.S. Naval Medical Research Center   prevention of dengue fever             Phase I
                                   Silver Spring, MD                                                           (858) 646-1100
                                   Vical
                                   San Diego, CA

 dengue fever vaccine              GlaxoSmithKline                      prevention of dengue fever             Phase II completed
                                   Rsch. Triangle Park, NC                                                     (888) 825-5249

 dengue fever vaccine              sanofi pasteur                       prevention of mild to severe dengue    Phase III
                                   Swiftwater, PA                       fever                                  (800) 822-2463
                                                                        (Fast Track)

 DENVax™                           Inviragen                            dengue                                 Phase I
 tetravalent hybrid dengue virus   Fort Collins, CO                                                            (970) 672-4918
 vaccine

 DermaVir™ Patch                   Genetic Immunity                     treatment of HIV-1 infection           Phase II
 DNA topical patch vaccine         McLean, VA                                                                  (703) 879-6803

 DTP-HepB-Polio-Hib                Merck                                diphtheria, tetanus, pertussis,        Phase III
 hexavalent vaccine                Whitehouse Station, NJ               hepatitis B, poliomyelitis,            (800) 672-6372
                                   sanofi pasteur                       Haemophilus influenzae type b          (800) 822-2463
                                   Swiftwater, PA                       (infants)

 DV-601                            Dynavax                              treatment of hepatitis B               Phase I
 (therapeutic vaccine)             Berkeley, CA                                                                (510) 848-5100

 Ebola vaccine                     Crucell                              prevention of Ebola virus infections   Phase I
                                   Leiden, Netherlands                                                         www.crucell.com
                                   Vaccine Research Center (NIAID)
                                   Bethesda, MD

 Ebola virus vaccine               GenPhar                              Ebola virus infections                 in clinical trials
                                   Mt. Pleasant, SC                                                            (843) 884-0120

 EP1043                            VaxOnco                              prevention of HIV-1 infections         Phase I
 (recombinant protein vaccine)     Seoul, South Korea                                                          www.vaxonco.com
                                   National Institute of Allergy and
                                   Infectious Diseases
                                   Bethesda, MD

 EP1090                            VaxOnco                              prevention and treatment of HIV-1      Phase I/II
 (DNA vaccine)                     Seoul, South Korea                   infections                             www.vaxonco.com
                                   National Institute of Allergy and
                                   Infectious Diseases
                                   Bethesda, MD




Medicines in Development Vaccines 2012                                                                                              13
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                      Sponsor                           Indication                             Development Status

 EP1300                            VaxOnco                           prevention of malaria                  Phase I
 (DNA vaccine)                     Seoul, South Korea                                                       www.vaxonco.com
                                   National Institutes of Health
                                   Bethesda, MD

 ETEC vaccine                      Vaccine Technologies              prevention of cholera, Escherichia     Phase I
                                   Boston, MA                        coli infections                        (617) 358-5011

 FluBlok®                          Protein Sciences                  prevention of influenza virus          application submitted
 influenza virus vaccine           Meridian, CT                      infections (adults and children)       (800) 488-7099
                                                                     (Fast Track)

 FluLaval™                         GlaxoSmithKline                   prevention of influenza virus          Phase III completed
 influenza virus vaccine           Rsch. Triangle Park, NC           infections                             (888) 825-5249
                                                                     (pediatric)

 Fluvirin®                         Novartis Vaccines  Diagnostics   prevention of influenza A virus H1N1   Phase II/III completed
 influenza A virus H1N1 vaccine    Cambridge, MA                     subtype (pediatric)                    (617) 871-7000

 Fluzone® QIV IM                   sanofi pasteur                    influenza virus infections             Phase III
 quadrivalent inactivated influ-   Swiftwater, PA                                                           (800) 822-2463
 enza vaccine

 GelVac™                           Nanotherapeutics                  influenza virus infections             Phase I
 H5N1 influenza virus vaccine      Alachua, FL                                                              (386) 462-9663
 intranasal

 GI-5005                           GlobeImmune                       hepatitis C (combination therapy)      Phase II
 (therapeutic vaccine)             Louisville, CO                                                           (303) 625-2700

 GSK1437173A                       GlaxoSmithKline                   prevention of varicella zoster virus   Phase III
 (varicella zoster vaccine)        Rsch. Triangle Park, NC           infections                             (888) 825-5249

 GSK1492903A                       GlaxoSmithKline                   prevention of cytomegalovirus          Phase I
 (recombinant glycoprotein         Rsch. Triangle Park, NC           infections                             (888) 825-5249
 vaccine)

 GSK2189242A                       GlaxoSmithKline                   prevention of pneumococcal             Phase II
 (Streptococcus pneumoniae         Rsch. Triangle Park, NC           infections                             (888) 825-5249
 recombinant conjugated
 vaccine)

 GSK2254232A                       GlaxoSmithKline                   prevention of Haemophilus              Phase I completed
 (Haemophilus influenzae,          Rsch. Triangle Park, NC           infections, prevention of              (888) 825-5249
 pneumococcal recombinant                                            pneumococcal infections
 vaccine)




14                                                                                   Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                    Sponsor                           Indication                                           Development Status

 GSK2254233A                     GlaxoSmithKline                   prevention of Haemophilus                            Phase I completed
 (Haemophilus influenzae,        Rsch. Triangle Park, NC           infections, prevention of                            (888) 825-5249
 pneumococcal recombinant                                          pneumococcal infections
 vaccine)

 GSK2282512A                     GlaxoSmithKline                   prevention of influenza virus                        application submitted
 (influenza virus vaccine)       Rsch. Triangle Park, NC           infections (adults, adolescents and                  (888) 825-5249
                                                                   children)

 GSK2321138A                     GlaxoSmithKline                   prevention of influenza virus                        application submitted
 (influenza virus vaccine)       Rsch. Triangle Park, NC           infections (adults, adolescents and                  (888) 825-5249
                                                                   children)

 GSK2340273A                     GlaxoSmithKline                   prevention of influenza A virus                      Phase II
 (influenza A virus              Rsch. Triangle Park, NC           H1N1 subtype (children and infants)                  (888) 825-5249
 H1N1 vaccine)

 GSK2340274A                     GlaxoSmithKline                   prevention of influenza A virus H1N1                 Phase II
 (influenza A virus vaccine)     Rsch. Triangle Park, NC           subtype (children and infants)                       (888) 825-5249
                                                                   --------------------------------------------------   -------------------------------------------
                                                                   influenza A virus H5N1 subtype                       Phase I
                                                                                                                        (888) 825-5249

 GSK2392102A                     GlaxoSmithKline                   staphylococcal infections                            Phase I
 (Staphylococcus aureus          Rsch. Triangle Park, NC                                                                (888) 825-5249
 vaccine)

 GSK2830930A                     GlaxoSmithKline                   pneumococcal infections                              Phase I
 (pneumococcal vaccine)          Rsch. Triangle Park, NC                                                                (888) 825-5249

 H5N1 influenza virus vaccine    Novavax                           prevention of influenza A virus H5N1                 Phase II
 (recombinant)                   Rockville, MD                     subtype                                              (240) 268-2000

 H5N1 influenza virus vaccine    Vaxart                            prevention of influenza A virus H5N1                 Phase I
                                 San Francisco, CA                 subtype                                              (415) 437-0132

 H5N1 pandemic influenza virus   GlaxoSmithKline                   prevention of influenza A virus H5N1                 application submitted
 vaccine                         Rsch. Triangle Park, NC           subtype                                              (888) 825-5249
                                                                   --------------------------------------------------   -------------------------------------------
                                                                   prevention of influenza A virus H5N1                 Phase III
                                                                   subtype (children and adolescents)                   (888) 825-5249

 HBV-002                         Hawaii Biotech                    prevention of West Nile virus                        Phase I completed
 (recombinant subunit vaccine)   Aiea, HI                          infection                                            (808) 486-5333

 Helicobacter pylori vaccine     Novartis Vaccines  Diagnostics   helicobacter infections                              Phase I
                                 Cambridge, MA                                                                          (617) 871-7000




Medicines in Development Vaccines 2012                                                                                                                            15
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                   Sponsor                           Indication                           Development Status

 hepatitis B DNA vaccine        Pfizer                            hepatitis B                          Phase I
                                New York, NY                                                           (860) 732-5156

 hepatitis B vaccine            Emergent BioSolutions             hepatitis B                          Phase II
                                Rockville, MD                                                          (301) 795-1800

 hepatitis C vaccine            Okairos                           prevention of hepatitis C            Phase I/II
                                Rome, Italy                                                            www.okairos.il

 hepatitis C vaccine            Novartis Vaccines  Diagnostics   treatment of hepatitis C             Phase I/II
 (HCV/MF59)                     Cambridge, MA                                                          (617) 871-7000

 Heplisav™                      Dynavax                           prevention of hepatitis B            Phase III
 hepatitis B vaccine 1018-ISS   Berkeley, CA                                                           (510) 848-5100
 conjugate

 herpes simplex DNA vaccine     Pfizer                            treatment of herpes simplex virus    Phase I
                                New York, NY                      infections                           (860) 732-5156

 herpes simplex vaccine         AuRx                              prevention and treatment of herpes   Phase I/II
                                Elkridge, MD                                                           (410) 796-759

 Hexaxim®                       sanofi pasteur                    diptheria, tetanus, pertussis,       application submitted
 DTP-HepB-Polio-Hib vaccine     Swiftwater, PA                    hepatitis B, poliomyelitis,          (800) 822-2463
                                                                  Haemophilus influenzae type b
                                                                  (infants)

 HIVAX™                         GeneCure Biotechnologies          HIV-1 infection                      Phase I
 replication-defective HIV-1    Norcross, GA                                                           (770) 263-7508
 vaccine

 HIV recombinant vaccine        GlaxoSmithKline                   treatment of HIV infection           Phase II
 (gag/pol/nef)                  Rsch. Triangle Park, NC                                                (888) 825-5249

 HIV recombinant vaccine        GlaxoSmithKline                   prevention of HIV-1 infection        Phase I completed
 (gp120/NefTat/AS02A)           Rsch. Triangle Park, NC                                                (888) 825-5249

 HIV vaccine                    GeoVax Labs                       prevention of HIV infection          Phase II
                                Smyrna, GA                                                             (678) 384-7220

 HIV vaccine                    GeoVax Labs                       treatment of HIV infection           Phase I/II
                                Smyrna, GA                                                             (678) 384-7220

 HIV vaccine                    Novartis Vaccines  Diagnostics   HIV infection                        Phase I
                                Cambridge, MA                                                          (617) 871-7000




16                                                                                  Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                     Sponsor                           Indication                              Development Status

 HIV vaccine                      Opal Therapeutics                 HIV infection                           Phase I
                                  Palo Alto, CA                                                             (617) 726-2000
                                  Massachusetts General Hospital
                                  Boston, MA

 HIV vaccine                      Profectus Biosciences             prevention of HIV infection             Phase I
 (MAG pDNA)                       Baltimore, MD                                                             (866) 938-8559

 HIV vaccine                      Profectus Biosciences             prevention of HIV infection             Phase I
 (rVSV)                           Baltimore, MD                                                             (866) 938-8559

 Imvamune®                        BM ImmunoTherapeutics             smallpox                                Phase II
 smallpox vaccine                 (Bavarian Nordic)                                                         (650) 681-4660
                                  Mountain View, CA

 influenza A virus H1N1 vaccine   CEL-SCI                           prevention and treatment of influenza   Phase I
                                  Vienna, VA                        A virus H1N1 subtype                    (703) 506-9460

 influenza A virus H1N1 vaccine   iBio                              prevention of influenza A virus H1N1    Phase I
                                  Newark, DE                        subtype                                 www.ibioinc.com
                                  Fraunhofer USA Center for
                                  Molecular Biotechnology
                                  Newark, DE

 influenza A virus H5N1           GlaxoSmithKline                   prevention of influenza A virus H5N1    Phase I
 cell culture-based vaccine       Rsch. Triangle Park, NC           subtype (pandemic use)                  (888) 825-5249

 influenza A virus H5N1 vaccine   Baxter Healthcare                 prevention of influenza A virus H5N1    Phase I
                                  Deerfield, IL                     subtype                                 (800) 422-9837

 influenza A virus vaccine H1N1   Medicago USA                      prevention of influenza A virus H1N1    Phase I
                                  Durham, NC                        subtype                                 (919) 313-9670

 influenza A virus vaccine H5N1   iBio                              prevention of influenza A virus H5N1    Phase I
                                  Newark, DE                        subtype                                 www.ibioinc.com

 influenza A virus vaccine H9N2   Baxter Healthcare                 prevention of influenza A virus H9N2    Phase I/II
                                  Deerfield, IL                     subtype                                 (800) 422-9837

 influenza virus DNA vaccine      Vical                             prevention of influenza A virus H1N1    Phase I completed
                                  San Diego, CA                     subtype                                 (858) 646-1100

 influenza virus vaccine          Dynavax                           prevention of influenza virus           Phase I
                                  Berkeley, CA                      infections                              (510) 848-5100

 influenza virus vaccine          Novartis Vaccines  Diagnostics   influenza virus infections              Phase III
 (Fluad)                          Cambridge, MA                     (children and elderly)                  (617) 871-7000




Medicines in Development Vaccines 2012                                                                                           17
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                     Sponsor                              Indication                               Development Status

 influenza virus vaccine          Vaxin                                influenza virus infections               Phase I
 intranasal                       Birmingham, AL                                                                (205) 413-8238

 Influvac® TC                     Abbott Laboratories                  prevention of influenza virus            Phase I
 cell culture-derived influenza   Abbott Park, IL                      infections                               (847) 937-6100
 vaccine

 INO-3510                         Inovio Pharmaceuticals               influenza A virus H1N1 subtype,          Phase I
 (DNA vaccine)                    Blue Bell, PA                        influenza A virus H5N1 subtype           (877) 466-6846

 Ixiaro®                          Intercell                            prevention of Japanese encephalitis      Phase III
 Japanese encephalitis vaccine    Vienna, Austria                      (pediatric)                              (617) 871-7000
                                  Novartis Vaccines  Diagnostics
                                  Cambridge, MA

 Ii-Key hybrid peptide vaccine    Antigen Express                      influenza A virus H1N1 subtype           Phase I
                                  Worcester, MA                                                                 (508) 852-8783

 LIQ-001                          Liquidia Technologies                influenza virus infections               Phase I
                                  Rsch. Triangle Park, NC                                                       (919) 328-4400

 Lyme disease vaccine             Bayer HealthCare Pharmaceuticals     prevention of Lyme disease               Phase I/II
                                  Wayne, NJ                                                                     (888) 842-2937

 malaria DNA vaccine              U.S. Naval Medical Research Center   malaria                                  Phase I/II
                                  Silver Spring, MD                                                             (858) 646-1100
                                  Vical
                                  San Diego, CA

 malaria vaccine                  GenVec                               malaria                                  Phase I/II
                                  Gaithersburg, MD                                                              (877) 943-6832
                                  U.S. Naval Medical Research Center
                                  Silver Spring, MD

 malaria vaccine                  Sanaria                              malaria                                  Phase I/II
                                  Rockville, MD                                                                 (301) 770-3222

 malaria vaccine                  Crucell                              malaria                                  Phase I
 (recombinant)                    Leiden, Netherlands                                                           www.crucell.com

 malaria vaccine                  Crucell                              prevention of malaria                    Phase I/II
 (recombinant combination         Leiden, Netherlands                                                           www.crucell.com
 vaccine)                         GlaxoSmithKline                                                               (888) 825-5249
                                  Rsch. Triangle Park, NC

 Marburg virus DNA vaccine        GenPhar                              Marburg virus disease                    in clinical trials
                                  Mt. Pleasant, SC                                                              (843) 884-0120

 MEDI-534                         MedImmune                            prevention of parainfluenza and          Phase I
 (RSV/PIV-3 vaccine)              Gaithersburg, MD                     respiratory syncytial virus infections   (301) 398-0000



18                                                                                      Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                      Sponsor                           Indication                             Development Status

 MEDI-550                          MedImmune                         prevention of pandemic influenza       Phase I
 (pandemic influenza virus         Gaithersburg, MD                  (H5N1 subtype)                         (301) 398-0000
 vaccine)

 MEDI-559                          MedImmune                         prevention of respiratory syncytial    Phase I
 (RSV vaccine)                     Gaithersburg, MD                  virus infections (pediatric)           (301) 398-0000

 MenABCWY                          Novartis Vaccine  Diagnostics    prevention of meningococcal groups     Phase II
 (multivalent conjugate vaccine)   Cambridge, MA                     A, B, C, Y and W-135 infections        (617) 871-7000
                                                                     (adolescents)

 MenHibrix®                        GlaxoSmithKline                   prevention of Neisseria meningitidis   application submitted
 Hib-MenCY-TT conjugated           Rsch. Triangle Park, NC           groups C and Y infections and          (888) 825-5249
 vaccine                                                             Haemophilus influenzae type B

 Meninge ACYW                      sanofi pasteur                    meningococcal infections               Phase II
 (second-generation                Swiftwater, PA                                                           (800) 822-2463
 meningococcal conjugate infant
 vaccine)

 meningococcal vaccine group B     Novartis Vaccines  Diagnostics   meningococcal group B infections       Phase II
 quadrivalent recombinant          Cambridge, MA                                                            (617) 871-7000
 vaccine (4CMenB)

 Menveo® Infants                   Novartis Vaccines  Diagnostics   prevention of meningococcal A, C, Y    application submitted
 meningococcal vaccine groups      Cambridge, MA                     and W-135 infections (infants)         (617) 871-7000
 ACYW-135 conjugate vaccine

 MMR vaccine                       GlaxoSmithKline                   prevention of measles, mumps and       Phase II
 (live attenuated trivalent        Rsch. Triangle Park, NC           rubella                                (888) 825-5249
 vaccine)

 Mosquirix™                        GlaxoSmithKline                   malaria                                Phase III
 malaria recombinant vaccine       Rsch. Triangle Park, NC                                                  (888) 825-5249

 MVA-BN® HIV                       BN ImmunoTherapeutics             prevention and treatment of HIV-1      Phase I/II completed
 HIV multiantigen vaccine          (Bavarian Nordic)                 infection                              (650) 681-4660
                                   Mountain View, CA

 MVA-BN® Polytope                  BN ImmunoTherapeutics             prevention of HIV infection            Phase I
 HIV vaccine                       (Bavarin Nordic)                                                         (650) 681-4660
                                   Mountain View, CA

 NB-1008                           NanoBio                           prevention of influenza virus          Phase I
 (intranasal vaccine)              Ann Arbor, MI                     infections                             (734) 302-4000




Medicines in Development Vaccines 2012                                                                                              19
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                     Sponsor                           Indication                                           Development Status

 NDV-3                            NovaDigm Therapeutics             prevention of candidiasis, prevention                Phase I
 (recombinant protein vaccine)    Grand Forks, ND                   of staphylococcal (MRSA) infections                  (701) 757-5161

 Nimenrix™                        GlaxoSmithKline                   prevention of meningococcal groups                   Phase III
 MenACWY-TT conjugated            Rsch. Triangle Park, NC           A, C, Y and W-135 infections                         (888) 825-5249
 vaccine                                                            (children)
                                                                    --------------------------------------------------   -------------------------------------------
                                                                    prevention of meningococcal groups                   Phase II
                                                                    A, C, Y and W-135 infections                         (888) 825-5249
                                                                    (adults, adolescents, infants)

 NmVac                            JN-International Medical          prevention of meningococcal groups                   Phase I
 (meningococcal vaccine groups    Omaha, NE                         A, C, Y, and W-135 infections                        (402) 884-3477
 ACWY conjugate vaccine)

 norovirus bivalent vaccine       LigoCyte Pharmaceuticals          norovirus infections                                 Phase I
                                  Bozeman, MT                                                                            (406) 585-2733

 norovirus monovalent vaccine     LigoCyte Pharmaceuticals          norovirus infections                                 Phase I/II
                                  Bozeman, MT                                                                            (406) 585-2733

 Optaflu®                         Novartis Vaccines  Diagnostics   prevention of influenza virus                        application submitted
 influenza virus vaccine          Cambridge, MA                     infections                                           (617) 871-7000

 PanBlok™                         Protein Sciences                  prevention of influenza A virus H5N1                 Phase I/II
 influenza A virus H5N1 vaccine   Meriden, CT                       subtype (pandemic)                                   (800) 488-7099

 parvovirus B19 vaccine           Meridian Biosciences              parvovirus infections                                Phase I/II
                                  Cincinnati, OH                                                                         (513) 271-3700

 PENNVAX™-B                       Inovio Pharmaceuticals            prevention and treatment of HIV                      Phase I
 DNA vaccine (clade B)            Blue Bell, PA                     infection                                            (267) 440-4200

 PENNVAX™-G                       Inovio Pharmaceuticals            prevention of HIV infection                          Phase I
 DNA vaccine (clade A, C, D)      Blue Bell, PA                                                                          (267) 440-4200

 PER.C-flu vaccine                Crucell                           prevention of influenza virus                        Phase II
                                  Leiden, Netherlands               infections                                           www.crucell.com

 PF-05212366                      Pfizer                            adolescent meningitis                                Phase II
 (MnB rLP2086)                    New York, NY                                                                           (860) 732-5156
                                                                    --------------------------------------------------   -------------------------------------------
                                                                    infant meningitis                                    Phase I
                                                                                                                         (860) 732-5156

 PF-06290510                      Pfizer                            staphylococcal infections                            Phase II
 (4-antigen Staphylococcus        New York, NY                                                                           (860) 732-5156
 aureus vaccine)

 plague vaccine injectable        DynPort Vaccine                   Yersinia infections                                  Phase II
                                  Frederick, MD                                                                          (301) 607-5000

20                                                                                       Medicines in Development Vaccines 2012
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                        Sponsor                           Indication                             Development Status

 Preflucel™                          Baxter Healthcare                 prevention of influenza virus          Phase III
 seasonal influenza virus vaccine    Deerfield, IL                     infections                             (800) 422-9837

 Pseudomonas aeruginosa              sanofi pasteur                    prevention of ventilator-associated    Phase I
 antibody fragment product           Swiftwater, PA                    pneumonia                              (800) 822-2463

 PXVX-0103                           PaxVax                            prevention of influenza A virus        Phase I
 (H5N1 influenza vaccine)            Menlo Park, CA                    H5N1 infections                        www.paxvax.com

 Q-LAIV Flu                          MedImmune                         seasonal influenza                     application submitted
 (MEDI-3250 vaccine)                 Gaithersburg, MD                                                         (301) 398-0000

 Quadracel®                          sanofi pasteur                    diphtheria, tetanus, pertussis and     Phase III
 diphtheria and tetanus toxoids      Swiftwater, PA                    polio vaccine (in children 4-6 years   (800) 822-2463
 and acellular pertussis vaccine                                       of age)
 adsorbed combined with
 inactivated poliomyelitis vaccine

 rabies VRVg                         sanofi pasteur                    prevention of rabies infection         Phase II
 (purified vero rabies vaccine)      Swiftwater, PA                                                           (800) 822-2463

 respiratory syncytial virus VLP     Novavax                           prevention of respiratory syncytial    Phase I
 vaccine                             Rockville, MD                     virus (RSV) infections                 (240) 268-2000

 RiVax™                              Soligenix                         prevention of ricin poisoning          Phase I
 ricin vaccine                       Princeton, NJ                                                            (609) 538-8200
 (Orphan Drug)

 rotavirus vaccine                   sanofi pasteur                    prevention of rotavirus infections     Phase I
 (live attenuated tetravalent oral   Swiftwater, PA                                                           (800) 822-2463
 vaccine)

 rotavirus vaccine I321              Bharat Biotech                    prevention of rotavirus infections     Phase I
                                     Hyderabad, India                                                         www.bharatbiotech.com

 rPA-102                             Emergent BioSolutions             anthrax                                Phase II
 (recombinant protective antigen     Rockville, MD                     (Fast Track)                           (301) 795-1800
 anthrax vaccine)

 Shigella vaccine                    Emergent BioSolutions             Shigella infections                    Phase I
                                     Rockville, MD                                                            (301) 795-1800

 SparVax™                            PharmAthene                       anthrax                                Phase II completed
 recombinant protective antigen      Annapolis, MD                     (pre- and post-exposure prevention)    (410) 269-2600
 (rPA) anthrax vaccine

 Staphylococcus aureus vaccine       Novartis Vaccines  Diagnostics   staphylococcal infections              Phase I
                                     Cambridge, MA                                                            (617) 871-7000




Medicines in Development Vaccines 2012                                                                                                21
Medicines in Development for Vaccines



 Infectious Diseases
 Product Name                      Sponsor                              Indication                               Development Status

 Staphylococcus aureus vaccine     GlaxoSmithKline                      Gram-positive infections,                Phase I/II
 conjugate pentavalent             Rsch. Triangle Park, NC              staphylococcal infections                (888) 825-5249

 streptococcal B vaccine           Emergent BioSolutions                streptococcal infections                 Phase I
                                   Rockville, MD                                                                 (301) 795-1800

 streptococcal B vaccine           Novartis Vaccines  Diagnostics      prevention of streptococcal infections   Phase II
 conjugate                         Cambridge, MA                                                                 (617) 871-7000

 Streptococcus pneumoniae          sanofi pasteur                       meningitis and penumonia                 Phase I
 vaccine                           Swiftwater, PA                                                                (800) 822-2463

 TCN-032                           Theraclone Sciences                  influenza A virus infections             Phase I
 (mAb vaccine)                     Seattle, WA                                                                   (206) 805-1600

 TG-4040                           Transgene                            hepatitis C                              Phase II
 (vector-based therapeutic         Rockville, MD                                                                 (301) 816-5421
 vaccine)

 TransVax™                         Astellas Pharma US                   prevention of cytomegalovirus            Phase II
 cytomegalovirus DNA vaccine       Deerfield, IL                        infections                               (800) 695-4321
 (Orphan Drug)                     Vical                                                                         (858) 646-1100
                                   San Diego, CA

 tuberculosis recombinant          sanofi pasteur                       prevention of tuberculosis               Phase I
 subunit vaccine                   Swiftwater, PA                                                                (800) 822-2463

 tuberculosis vaccine              Aerus Global TB Vaccine Foundation   prevention of tuberculosis               Phase I
                                   Rockville, MD                                                                 www.crucell.com
                                   Crucell
                                   Leiden, Netherlands

 tularemia vaccine                 DynPort Vaccine                      prevention of tularemia                  Phase I
                                   Frederick, MD                                                                 (301) 607-5000

 TUTI-16                           Thymon                               HIV-1 infection                          Phase I/II
 (synthetic lipopeptide vaccine)   Short Hills, NJ                                                               (973) 467-9558

 Typhella™                         Emergent BioSolutions                prevention of typhoid                    Phase II completed
 typhoid vaccine oral              Rockville, MD                                                                 (301) 795-1800

 typhoid vaccine                   Novartis Vaccines Institute for      prevention of typhoid                    Phase II
                                   Global Health                                                                 (888) 669-6682
                                   Siena, Italy

 V114                              Merck                                prevention of pneumococcal               Phase II
 (pneumococcal 15 valent           Whitehouse Station, NJ               infections (infants)                     (800) 672-6372
 conjugate vaccine)




22                                                                                        Medicines in Development Vaccines 2012
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development
PhRMA Report 2012: Vaccines in Development

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PhRMA Report 2012: Vaccines in Development

  • 1. 2012 Report Medicines in Development Vaccines presented by america’s biopharmaceutical research companies Nearly 300 Vaccines Are in Development; Research Focuses on Prevention and Treatment Vaccines in Development* 170 For many years, vaccines have been used Today, biopharmaceutical research companies to successfully prevent diseases such as are developing 295 vaccines. Potential vac- smallpox, measles, polio and other infectious cines in development include: diseases. A 2007 study by the U.S. Centers for • recombinant vaccine against malaria. A 102 Disease Control and Prevention (CDC) found that cases of vaccine-preventable diseases • vaccine that protects infants against A had reached an all-time low in the United meningococcal disease, a leading cause of meningitis. States. The study found that hospitalizations and deaths from nine infectious diseases had • genetically-modified vaccine designed A declined by more than 90 percent and nearly for the treatment of pancreatic cancer. 90 percent for another four diseases. Although many new promising vaccines are being researched today, the vaccine devel- These findings illustrate the major contribution opment process is not an easy one. As with that vaccines have made in saving countless the development of all drugs, vaccines must lives around the world. In the past several survive many years of thorough testing before years, many successful new vaccines have they can be approved for use by the general been developed, including one against human 12 public. Advances in other scientific fields, 8 papillomavirus (HPV) infections that can lead 7 such as genomics, are becoming increasingly to cervical cancer, one to guard against pre- useful in the development of new vaccines. exposure to the anthrax virus, and a vaccine to With the continued efforts of researchers, it is gy es r s er he er prevent pneumococcal infections in high-risk nc ler as rd Ot likely that we may have many more vaccines Ca ise Al so populations. Di sD to protect against life-threatening diseases in gic u tio olo ec But vaccines are not only for preventing infec- the near future. ur Inf Ne tious diseases. In 2010, a new cancer vaccine * Some vaccines are listed in for the treatment of prostate cancer was more than one category. approved in the United States, and many more are in development.
  • 2. Medicines in Development for Vaccines Allergy Product Name Sponsor Indication Development Status* cat allergy vaccine Greer Laboratories perennnial allergic rhinitis due to Phase I sublingual Lenoir, NC cat hair (800) 419-7302 food allergy epicutaneous DBV Technologies peanut hypersensitivity Phase I immunotherapy Bagneux, France (Fast Track) www.dbv-technologies.com grass pollen allergy ALK Abello seasonal allergic rhinitis Phase III vaccine tablet Horsholm, Denmark (800) 672-6372 (immunotherapy) Merck Whitehouse Station, NJ grass pollen extract Stallergenes seasonal allergic rhinitis Phase III sublingual vaccine Norwell, MA (781) 878-0018 house dust mite allergy Greer Laboratories allergic rhinitis Phase I sublingual vaccine Lenoir, NC (800) 419-7302 house dust mite allergy ALK Abello allergic asthma Phase II vaccine tablet Horsholm, Denmark (800) 672-6372 Merck Whitehouse Station, NJ peanut allergy vaccine Allertein Therapeutics peanut hypersensitivity Phase I Fairfield, CT Pollinex® Quattro Allergy Therapeutics prevention of grass pollen Phase III injectable MPL allergy vaccine West Sussex, United Kingdom hypersensitivity, prevention of www.allergytherapeutics.com ragweed hypersensitivity -------------------------------------------------- ------------------------------------------- prevention of tree pollen Phase II hypersensitivity www.allergytherapeutics.com QGE031 Novartis Pharmaceuticals allergic diseases Phase I (anti-IgE antibody) East Hanover, NJ (888) 669-6682 ragweed allergy immunotherapy Stallergenes seasonal allergic rhinitis Phase I vaccine Norwell, MA (781) 878-0018 ragweed allergy vaccine Greer Laboratories seasonal allergic rhinitis Phase III sublingual Lenoir, NC (800) 419-7302 ragweed allergy vaccine ALK Abello seasonal allergic rhinitis Phase III sublingual tablet Horsholm, Denmark (800) 672-6372 Merck Whitehouse Station, NJ * For more information about a specific medicine in this report, please call the telephone number listed. 2 Medicines in Development Vaccines 2012
  • 3. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status abagovomab Menarini ovarian cancer Phase III (anti-idiotype mAb vaccine) Florence, Italy www.menarini.com ADXS-HPV Advaxis recurrent cervical cancer, cervical Phase II (live, attenuated Listeria Princeton, NJ intraepithelial neoplasia (609) 452-9813 monocytogenes [Lm]-based vaccine) AE37 Antigen Express breast cancer Phase II (peptide vaccine) Worcester, MA (508) 852-8783 -------------------------------------------------- ------------------------------------------- ovarian cancer (combination Phase I therapy), prostate cancer (508) 852-8783 AGS-003 Argos Therapeutics kidney cancer (combination therapy), Phase II (personalized dendritic Durham, NC metastatic kidney cancer (919) 287-6300 cell-based immunotherapy) (monotherapy) AlloStim™ Novo Energies hematological malignancies, Phase I/II immunotherapeutic vaccine Montreal, Canada solid tumors (514) 840-3697 anti-GnRH vaccine Novartis Vaccines Diagnostics prostate cancer Phase I/II Cambridge, MA (617) 871-7000 Pepscan Therapeutics Lelystad, Netherlands astuprotimut-R GlaxoSmithKline malignant melanoma, non-small-cell Phase III (MAGE-A3 recombinant Rsch. Triangle Park, NC lung cancer (NSCLC) (888) 825-5249 antigen-specific cancer -------------------------------------------------- ------------------------------------------- immunotherapy) bladder cancer Phase II (888) 825-5249 AVX-701 AlphaVax prevention of advanced or metastatic Phase I/II Rsch. Triangle Park, NC CEA-expressing colorectal cancer (919) 595-0400 B7-2/GM-CSF NuVax Therapeutics cancer Phase I cancer gene therapy vaccine Tustin, CA (714) 505-4461 BiovaxID® Biovest International indolent follicular lymphoma Phase III B-cell lymphoma vaccine Tampa, FL (Fast Track) (813) 864-2558 (personalized lymphoma -------------------------------------------------- ------------------------------------------- vaccine) mantle-cell lymphoma Phase II (813) 864-2558 BPX-101 Bellicum Pharmaceuticals prostate cancer Phase I/II (dendritic cell vaccine) Houston, TX www.bellicum.com breast cancer vaccine Quantum Immunologics breast cancer Phase I/II (dendritic cell vaccine) Tampa, FL (813) 849-7885 Medicines in Development Vaccines 2012 3
  • 4. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status cancer vaccine Immunovaccine ovarian cancer Phase I Halifax, Canada (902) 492-1819 cancer vaccine Activartis Biotech glioblastoma (first-line therapy) Phase II (autologous dendritic cell Vienna, Austria www.activartis.com vaccine) -------------------------------------------------- ------------------------------------------- metastatic renal cancer in clinical trials www.activartis.com cancer vaccine Bayer HealthCare Pharmaceuticals follicular lymphoma (prevention of Phase I (autologous idiotype vaccine) Wayne, NJ relapse) (888) 842-2937 cancer vaccine Cytokine PharmaSciences cancer Phase I (fibrocyte vaccine) King of Prussia, PA (610) 687-1776 cancer vaccine MabVax Therapeutics sarcoma Phase II (mAb vaccine) San Diego, CA (858) 259-9405 -------------------------------------------------- ------------------------------------------- breast cancer Phase I (858) 259-9405 CB-10-01 Cosmo Pharmaceuticals malignant melanoma Phase II Lainate, Italy www.cosmopharmaceuticals. com CDX-1401 Celldex Therapeutics solid tumors expressing the Phase I/II Needham, MA NY-ESO-1 protein (781) 433-0771 CG201 CG Therapeutics solid tumors Phase II Seattle, WA (206) 336-5604 CLL MaxCyte chronic lymphocytic leukemia (CLL) Phase I/II immunotherapeutic Gaithersburg, MD (301) 944-1700 CRS-207 Aduro BioTech metastatic pancreatic cancer Phase II Berkeley, CA (combination therapy) (510) 848-4400 CV-301 BN ImmunoTherapeutics metastatic breast cancer Phase II (immunotherapeutic vaccine) (Bavarian Nordic) (650) 681-4660 Mountain View, CA CVac™ Prima Biomed ovarian cancer Phase II/III cancer vaccine Sydney, Australia www.primabiomed.com.au MUC-1 4 Medicines in Development Vaccines 2012
  • 5. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status DCVax®-Brain Northwest Biotherapeutics glioblastoma Phase II dendritic cell-based vaccine Bethesda, MD (240) 497-9024 (Orphan Drug) DCVax®-Ovarian Northwest Biotherapeutics ovarian cancer, peritoneal cancer Phase I dendritic cell-based vaccine Bethesda, MD (240) 497-9024 DCVax®-Prostate Northwest BioTherapeutics prostate cancer Phase III dendritic cell-based vaccine Bethesda, MD (240) 497-9024 dendritic cell cancer vaccine EMD Serono malignant melanoma Phase I Rockland, MA (800) 283-8088 DN24-02 Dendreon HER2-positive urogenital cancer Phase II (lapuleucel-T) Seattle, WA (adjuvant therapy) (877) 256-4545 (dendritic cell vaccine) -------------------------------------------------- ------------------------------------------- breast cancer, colorectal cancer, Phase I completed ovarian cancer (877) 256-445 DPX-0907 Immunovaccine breast cancer, ovarian cancer, Phase I Halifax, Canada prostate cancer (902) 492-1819 EC17 Endocyte kidney cancer Phase I West Lafayette, IN (combination therapy) www.endocyte.com ETBX-011 Etubics solid tumors Phase I (adenovirus vector vaccine) Seattle, WA (206) 838-5110 FANG™ vaccine Gradalis malignant melanoma, ovarian cancer Phase II (autologous tumor cell vaccine) Carrollton, TX (214) 442-8100 FBP vaccine Galena Biopharma endometrial cancer, ovarian cancer Phase I/II (folate-binding protein Lake Oswego, OR (855) 855-4253 E39 vaccine) -------------------------------------------------- ------------------------------------------- breast cancer Phase I (855) 855-4253 G-100 prophage cancer vaccine Agenus newly-diagnosed glioma Phase II (Orphan Drug) Lexington, MA (781) 674-4400 G-200 prophage cancer vaccine Agenus recurrent glioma Phase II (Orphan Drug) Lexington, MA (781) 674-4400 Medicines in Development Vaccines 2012 5
  • 6. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status GI-4000 GlobeImmune colorectal cancer, pancreatic cancer Phase II (therapeutic vaccine) Louisville, CO (303) 625-2700 -------------------------------------------------- ------------------------------------------- colorectal cancer (first-line therapy), Phase I colorectal cancer (second-line (303) 625-2700 therapy), NSCLC GI-6207 GlobeImmune metastatic cancer Phase I (therapeutic vaccine) Louisville, CO (303) 625-2700 GI-6301 GlobeImmune solid tumors Phase I (brachyury peptide vaccine) Louisville, CO (303) 625-2700 GRNVAC1 Geron acute myeloid leukemia (AML) Phase II (telomerase-based cancer Menlo Park, CA (650) 473-7700 vaccine) -------------------------------------------------- ------------------------------------------- prostate cancer Phase I/II (650) 473-7700 GSK2241658A GlaxoSmithKline metastatic melanoma Phase I (NY-ESO-1 antigen-specific Rsch. Triangle Park, NC (888) 825-5249 cancer immunotherapeutic) GV1001 KAEL-GemVax pancreatic cancer Phase I (hTERT RNA vaccine) Seoul, South Korea www.kaelgemvax.com (Orphan Drug) GVAX® Breast BioSante Pharmaceuticals breast cancer Phase I immunotherapeutic vaccine Lincolnshire, IL (847) 478-0500 GVAX® Colorectal BioSante Pharmaceuticals colorectal cancer Phase I immunotherapeutic vaccine Lincolnshire, IL (847) 478-0500 GVAX® Leukemia BioSante Pharmaceuticals AML, chronic myeloid leukemia Phase II immunotherapeutic vaccine Lincolnshire, IL (CML) (847) 478-0500 (Orphan Drug) GVAX® Myeloma BioSante Pharmaceuticals multiple myeloma Phase II immunotherapeutic vaccine Lincolnshire, IL (847) 478-0500 GVAX® Pancreatic BioSante Pharmaceuticals pancreatic cancer Phase II immunotherapeutic vaccine Lincolnshire, IL (847) 478-0500 (Orphan Drug) GVAX® Prostate BioSante Pharmaceuticals prostate cancer Phase III immunotherapeutic vaccine Lincolnshire, IL (Fast Track) (847) 478-0500 6 Medicines in Development Vaccines 2012
  • 7. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status HS-110 Heat Biologics NSCLC (combination therapy) Phase II Chapel Hill, NC (919) 240-7133 hTERT vaccine Merck cancer Phase I (human telomerase reverse Whitehouse Station, NJ (800) 672-6372 transcriptase cancer vaccine) Vical (858) 646-1100 San Diego, CA HyperAcute® Lung NewLink Genetics NSCLC Phase II lung cancer immunotherapy Ames, IA (515) 296-5555 HyperAcute® Melanoma NewLink Genetics malignant melanoma Phase II lung cancer immunotherapy Ames, IA (515) 296-5555 HyperAcute® Pancreas NewLink Genetics pancreatic cancer Phase III algenpantucel-L Ames, IA (Fast Track) (515) 296-5555 (Orphan Drug) ICT-107 ImmunoCellular Therapeutics glioblastoma Phase II (autologous dendritic-cell Woodland Hills, CA (818) 992-2907 vaccine) (Orphan Drug) IDM-2101 Biotech Synergy NSCLC Phase II (multi-epitope cancer vaccine) San Diego, CA (858) 459-6689 IMA901 immatics biotechnologies kidney cancer Phase III (multiple tumor-associated Tuebingen, Germany www.immatics.com peptides cancer vaccine) IMCgp100 Immunocore malignant melanoma Phase 0 Oxon, United Kingdom www.immunocore.com IMF-001 ImmunoFrontier solid tumors Phase I (protein vaccine) Tokyo, Japan www.immunofrontier.com IMT-1012 Immunotope breast cancer, ovarian cancer Phase I (multi-peptide antigen Doylestown, PA (215) 253-4180 immunotherapeutics vaccine) ISF35 Memgen CLL (monotherapy), Phase II (recombinant immunotherapy) San Diego, CA non-Hodgkin’s lymphoma (858) 524-5400 -------------------------------------------------- ------------------------------------------- CLL (combination therapy) Phase I (858) 524-5400 Medicines in Development Vaccines 2012 7
  • 8. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status JVRS-100 Colby Pharmaceutical leukemia Phase I (lipid-DNA complex vaccine) San Jose, CA (650) 333-3152 Lucanix® NovaRx NSCLC Phase III belagenpumatucel-L San Diego, CA (Fast Track) (858) 552-8600 (cell-based therapeutic vaccine) -------------------------------------------------- ------------------------------------------- glioma Phase I (858) 552-8600 LungVax® AVAX Technologies NSCLC Phase I/II autologous cell vaccine Philadelphia, PA (215) 241-9760 M-200 prophage cancer vaccine Agenus metastatic melanoma Phase III (Orphan Drug) Lexington, MA (Fast Track) (781) 674-4400 melanoma DNA vaccine Ichor Medical Systems malignant melanoma Phase I San Diego, CA (858) 550-2022 Memorial Sloan-Kettering Cancer Center New York, NY MVA-BN® Breast BN ImmunoTherapeutics breast cancer Phase I HER-2/neu-based modified (Bavarian Nordic) (650) 681-4660 vaccinia ankara (MVA) vaccine Mountain View, CA MVA-BN®-PRO BN ImmunoTherapeutics prostate cancer Phase I/II (Bavarian Nordic) (650) 681-4660 Mountain View, CA MVax® AVAX Technologies malignant melanoma Phase III autologous cell vaccine Philadelphia, PA (215) 241-9760 NeuVax™ Galena Biopharma early-stage breast cancer Phase III E75 cancer vaccine Lake Oswego, OR (prevention of relapse) (855) 855-4253 -------------------------------------------------- ------------------------------------------- prostate cancer Phase I/II (855) 855-4253 Oncophage® Agenus renal cell carcinoma Phase II vitespen Lexington, MA (Fast Track) (781) 674-4400 (Orphan Drug) OncoVAX® Vaccinogen stage III colorectal cancer Phase II colorectal cancer vaccine Frederick, MD (combination therapy) (301) 668-8400 -------------------------------------------------- ------------------------------------------- colorectal cancer Phase I/II (Fast Track) (301) 668-8400 ONT-10 Oncothyreon solid tumors Phase I Seattle, WA (206) 801-2100 8 Medicines in Development Vaccines 2012
  • 9. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status OPT-822 Optimer Pharmaceuticals breast cancer Phase II San Diego, CA (858) 909-0736 oral peptide cancer vaccine Immunitor cancer Phase I/II Vancouver, Canada oregovomab Quest PharmaTech ovarian cancer Phase I/II (Orphan Drug) Edmonton, Canada (780) 448-1400 OVax® AVAX Technologies ovarian cancer Phase I/II autologous tumor cell vaccine Philadelphia, PA (215) 241-9760 (Orphan Drug) POL-103A Polynoma malignant melanoma Phase II (polyvalent shed-antigen San Diego, CA (858) 205-2501 vaccine) (Orphan Drug) polyclonal antibody stimulator Cancer Advances gastric cancer, pancreatic cancer Phase III (Orphan Drug) Durham. NC (see also other) (919) 361-2162 -------------------------------------------------- ------------------------------------------- colorectal cancer Phase II (919) 361-2162 PRAME GlaxoSmithKline metastatic melanoma, NSCLC Phase I antigen-specific cancer Rsch. Triangle Park, NC (888) 825-5249 immunotherapeutic Prostvac™ BN ImmunoTherapeutics metastatic prostate cancer Phase III prostate cancer vaccine (Bavarian Nordic) (Fast Track) (650) 681-4660 Mountain View, CA Provenge® Dendreon recurrent early-stage prostate cancer Phase III sipuleucel-T Seattle, WA (877) 256-4545 -------------------------------------------------- ------------------------------------------- early-stage prostate cancer Phase II (neoadjuvant therapy) (877) 256-4545 PSMA VRP therapeutic vaccine Progenics Pharmaceuticals prostate cancer Phase I Tarrytown, NY (914) 789-2800 PT107 Pique Therapeutics NSCLC Phase II (allogeneic tumor cell vaccine) Durham, NC (919) 806-4395 recombinant soluble PSMA Progenics Pharmaceuticals prostate cancer Phase I protein vaccine Tarrytown, NY (914) 789-2800 Medicines in Development Vaccines 2012 9
  • 10. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status REIC gene therapy Momotaro-Gene prostate cancer Phase I Okayama, Japan www.mt-gene.com Reximmune-C® Epeius Biotechnologies breast cancer Phase I/II personalized cancer vaccine San Marino, CA (626) 441-6695 rindopepimut Celldex Therapeutics glioblastoma (first-line therapy) Phase III (Orphan Drug) Needham, MA (Fast Track) (781) 433-0771 -------------------------------------------------- ------------------------------------------- glioblastoma (combination therapy, Phase II second-line therapy) (781) 433-0771 (Fast Track) SL-701 Stemline Therapeutics glioma Phase I/II (dendritic cell vaccine) New York, NY (212) 831-1111 Stimuvax® EMD Serono NSCLC (Fast Track) Phase III emepepimut-S Rockland, MA (800) 283-8088 Oncothyreon -------------------------------------------------- (206) 769-9219 Seattle, WA prostate cancer ------------------------------------------- Phase II (800) 283-8088 (206) 769-9219 TAG vaccine Gradalis solid tumors Phase I Carrollton, TX (214) 442-8100 TeloB-Vax Adamis Pharmaceuticals prostate cancer Phase I telomerase cancer vaccine San Diego, CA www.adamispharma.com tipapkinogene sovacivec Transgene cervical intraepithelial neoplasia Phase II Rockville, MD (301) 816-5421 TroVax® Oxford BioMedica hormone refractory prostate cancer Phase II tumor-associated antigen Oxford, United Kingdom www.oxfordbiomedica.co.uk vaccine TVI-Brain-1 TVAX Biomedical glioma Phase II (cellular immunotherapy Lenexa, KS (913) 492-2221 vaccine) TVI-Kidney-1 TVAX Biomedical renal cell carcinoma in clinical trials (cellular immunotherapy Lenexa, KS (913) 492-2221 vaccine) V503 Merck prevention of cervical cancer, Phase III (virus-like particle [VLP] Whitehouse Station, NJ prevention of vulvovaginal cancer (800) 672-6372 vaccine) (see also infectious diseases) 10 Medicines in Development Vaccines 2012
  • 11. Medicines in Development for Vaccines Cancer Product Name Sponsor Indication Development Status V505 Merck prevention of cervical cancer Phase II completed Whitehouse Station, NJ (see also infectious diseases) (800) 672-6372 V930/V932 Merck cancer Phase I (plasmid DNA cancer vaccine) Whitehouse Station, NJ (800) 672-6372 Vical (858) 646-1100 San Diego, CA V935 Geron solid tumors Phase I (telomerase inhibitor vaccine) Menlo Park, CA (650) 473-7700 Merck (800) 672-6372 Whitehouse Station, NJ verpasep caltespen Akela Pharma cervical intraepithelial neoplasia Phase I completed Austin, TX (512) 834-0449 VGX-3100 Inovio Pharmaceuticals cervical intraepithelial neoplasia Phase II Blue Bell, PA (see also infectious diseases) (877) 446-6846 WT1 antigen specific cancer GlaxoSmithKline AML Phase II immunotherapeutic Rsch. Triangle Park, NC (888) 825-5249 -------------------------------------------------- ------------------------------------------- breast cancer Phase I (888) 825-5249 Infectious Diseases Product Name Sponsor Indication Development Status ACAM-Cdiff sanofi pasteur Clostridium difficile infections Phase II (toxoid vaccine) Swiftwater, PA (800) 822-2463 ACE527 ACE Biosciences prevention of traveler’s diarrhea Phase II (oral pentavalent vaccine) Odense, Denmark caused by Escherichia coli infections www.acebiosciences.com TD Vaccines www.tdvaccines.com Skorping, Denmark Ad26.ENVA.01 Crucell prevention of HIV infection Phase I HIV-1 recombinant vaccine Leiden, Netherlands www.crucell.com ADVAX Aaron Diamond AIDS Research HIV infection prevention Phase I completed (DNA vaccine) Center (212) 448-5000 New York, NY (212) 847-1111 International AIDS Vaccine Initiative -------------------------------------------------- ------------------------------------------- New York, NY HIV infection prevention Phase I completed Ichor Medical Systems (new delivery system) (212) 448-5000 San Diego, CA (212) 847-1111 Medicines in Development Vaccines 2012 11
  • 12. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status Aflunov™ Novartis Vaccines Diagnostics prevention of influenza A virus H5N1 Phase II influenza A virus H5N1 vaccine Cambridge, MA subtype (pre-pandemic) (617) 871-7000 AG-707 Agenus treatment of herpes simplex virus Phase I completed (herpes simplex vaccine) Lexington, MA infections (781) 674-4400 AGS-004 Argos Therapeutics HIV-1 infection Phase II (personalized dendritic Durham, NC (919) 287-6300 cell-based immunotherapy) anthrax transdermal vaccine Intercell USA anthrax Phase I Gaithersburg, MD (301) 556-4500 ANZ-521 Aduro BioTech treatment of hepatitis C Phase I (recombinant vaccine) Berkeley, CA (510) 848-4400 AV-7909 Emergent BioSolutions anthrax Phase I (anthrax vaccine adsorbed with Rockville, MD (301) 795-1800 adjuvant) AVX-101 AlphaVax prevention of HIV-1 infection Phase I completed (monovalent HIV vaccine) Rsch. Triangle Park, NC (919) 595-0400 AVX-502 AlphaVax prevention of influenza virus Phase I/II Rsch. Triangle Park, NC infections in the elderly (919) 595-0400 BioThrax® Emergent BioSolutions anthrax (post-exposure prevention) Phase III anthrax vaccine adsorbed Rockville, MD (Fast Track) (301) 795-1800 botulinum toxin recombinant DynPort Vaccine Company botulism Phase II vaccine Frederick, MD (301) 607-5000 chikungunya virus vaccine Inviragen chikungunya virus infections Phase II Fort Collins, CO (970) 672-4918 CholeraGarde® Vaccine Technologies cholera Phase II cholera vaccine live attenuated Boston, MA (617) 358-5011 ChronVac-C® Inovio Pharmaceuticals treatment of hepatitis C Phase II hepatitis C DNA vaccine Blue Bell, PA (877) 446-6846 ChronTech Pharma Huddinge, Sweden cytomegalovirus vaccine AlphaVax prevention of cytomegalovirus Phase I (AVX-601) Rsch. Triangle Park, NC infections (617) 871-7000 Novartis Vaccines Diagnostics Cambridge, MA 12 Medicines in Development Vaccines 2012
  • 13. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status DCVax-001 Celldex Therapeutics prevention and treatment of HIV Phase I (recombinant protein vaccine) Needham, MA infection (781) 433-0771 dengue DNA vaccine U.S. Naval Medical Research Center prevention of dengue fever Phase I Silver Spring, MD (858) 646-1100 Vical San Diego, CA dengue fever vaccine GlaxoSmithKline prevention of dengue fever Phase II completed Rsch. Triangle Park, NC (888) 825-5249 dengue fever vaccine sanofi pasteur prevention of mild to severe dengue Phase III Swiftwater, PA fever (800) 822-2463 (Fast Track) DENVax™ Inviragen dengue Phase I tetravalent hybrid dengue virus Fort Collins, CO (970) 672-4918 vaccine DermaVir™ Patch Genetic Immunity treatment of HIV-1 infection Phase II DNA topical patch vaccine McLean, VA (703) 879-6803 DTP-HepB-Polio-Hib Merck diphtheria, tetanus, pertussis, Phase III hexavalent vaccine Whitehouse Station, NJ hepatitis B, poliomyelitis, (800) 672-6372 sanofi pasteur Haemophilus influenzae type b (800) 822-2463 Swiftwater, PA (infants) DV-601 Dynavax treatment of hepatitis B Phase I (therapeutic vaccine) Berkeley, CA (510) 848-5100 Ebola vaccine Crucell prevention of Ebola virus infections Phase I Leiden, Netherlands www.crucell.com Vaccine Research Center (NIAID) Bethesda, MD Ebola virus vaccine GenPhar Ebola virus infections in clinical trials Mt. Pleasant, SC (843) 884-0120 EP1043 VaxOnco prevention of HIV-1 infections Phase I (recombinant protein vaccine) Seoul, South Korea www.vaxonco.com National Institute of Allergy and Infectious Diseases Bethesda, MD EP1090 VaxOnco prevention and treatment of HIV-1 Phase I/II (DNA vaccine) Seoul, South Korea infections www.vaxonco.com National Institute of Allergy and Infectious Diseases Bethesda, MD Medicines in Development Vaccines 2012 13
  • 14. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status EP1300 VaxOnco prevention of malaria Phase I (DNA vaccine) Seoul, South Korea www.vaxonco.com National Institutes of Health Bethesda, MD ETEC vaccine Vaccine Technologies prevention of cholera, Escherichia Phase I Boston, MA coli infections (617) 358-5011 FluBlok® Protein Sciences prevention of influenza virus application submitted influenza virus vaccine Meridian, CT infections (adults and children) (800) 488-7099 (Fast Track) FluLaval™ GlaxoSmithKline prevention of influenza virus Phase III completed influenza virus vaccine Rsch. Triangle Park, NC infections (888) 825-5249 (pediatric) Fluvirin® Novartis Vaccines Diagnostics prevention of influenza A virus H1N1 Phase II/III completed influenza A virus H1N1 vaccine Cambridge, MA subtype (pediatric) (617) 871-7000 Fluzone® QIV IM sanofi pasteur influenza virus infections Phase III quadrivalent inactivated influ- Swiftwater, PA (800) 822-2463 enza vaccine GelVac™ Nanotherapeutics influenza virus infections Phase I H5N1 influenza virus vaccine Alachua, FL (386) 462-9663 intranasal GI-5005 GlobeImmune hepatitis C (combination therapy) Phase II (therapeutic vaccine) Louisville, CO (303) 625-2700 GSK1437173A GlaxoSmithKline prevention of varicella zoster virus Phase III (varicella zoster vaccine) Rsch. Triangle Park, NC infections (888) 825-5249 GSK1492903A GlaxoSmithKline prevention of cytomegalovirus Phase I (recombinant glycoprotein Rsch. Triangle Park, NC infections (888) 825-5249 vaccine) GSK2189242A GlaxoSmithKline prevention of pneumococcal Phase II (Streptococcus pneumoniae Rsch. Triangle Park, NC infections (888) 825-5249 recombinant conjugated vaccine) GSK2254232A GlaxoSmithKline prevention of Haemophilus Phase I completed (Haemophilus influenzae, Rsch. Triangle Park, NC infections, prevention of (888) 825-5249 pneumococcal recombinant pneumococcal infections vaccine) 14 Medicines in Development Vaccines 2012
  • 15. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status GSK2254233A GlaxoSmithKline prevention of Haemophilus Phase I completed (Haemophilus influenzae, Rsch. Triangle Park, NC infections, prevention of (888) 825-5249 pneumococcal recombinant pneumococcal infections vaccine) GSK2282512A GlaxoSmithKline prevention of influenza virus application submitted (influenza virus vaccine) Rsch. Triangle Park, NC infections (adults, adolescents and (888) 825-5249 children) GSK2321138A GlaxoSmithKline prevention of influenza virus application submitted (influenza virus vaccine) Rsch. Triangle Park, NC infections (adults, adolescents and (888) 825-5249 children) GSK2340273A GlaxoSmithKline prevention of influenza A virus Phase II (influenza A virus Rsch. Triangle Park, NC H1N1 subtype (children and infants) (888) 825-5249 H1N1 vaccine) GSK2340274A GlaxoSmithKline prevention of influenza A virus H1N1 Phase II (influenza A virus vaccine) Rsch. Triangle Park, NC subtype (children and infants) (888) 825-5249 -------------------------------------------------- ------------------------------------------- influenza A virus H5N1 subtype Phase I (888) 825-5249 GSK2392102A GlaxoSmithKline staphylococcal infections Phase I (Staphylococcus aureus Rsch. Triangle Park, NC (888) 825-5249 vaccine) GSK2830930A GlaxoSmithKline pneumococcal infections Phase I (pneumococcal vaccine) Rsch. Triangle Park, NC (888) 825-5249 H5N1 influenza virus vaccine Novavax prevention of influenza A virus H5N1 Phase II (recombinant) Rockville, MD subtype (240) 268-2000 H5N1 influenza virus vaccine Vaxart prevention of influenza A virus H5N1 Phase I San Francisco, CA subtype (415) 437-0132 H5N1 pandemic influenza virus GlaxoSmithKline prevention of influenza A virus H5N1 application submitted vaccine Rsch. Triangle Park, NC subtype (888) 825-5249 -------------------------------------------------- ------------------------------------------- prevention of influenza A virus H5N1 Phase III subtype (children and adolescents) (888) 825-5249 HBV-002 Hawaii Biotech prevention of West Nile virus Phase I completed (recombinant subunit vaccine) Aiea, HI infection (808) 486-5333 Helicobacter pylori vaccine Novartis Vaccines Diagnostics helicobacter infections Phase I Cambridge, MA (617) 871-7000 Medicines in Development Vaccines 2012 15
  • 16. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status hepatitis B DNA vaccine Pfizer hepatitis B Phase I New York, NY (860) 732-5156 hepatitis B vaccine Emergent BioSolutions hepatitis B Phase II Rockville, MD (301) 795-1800 hepatitis C vaccine Okairos prevention of hepatitis C Phase I/II Rome, Italy www.okairos.il hepatitis C vaccine Novartis Vaccines Diagnostics treatment of hepatitis C Phase I/II (HCV/MF59) Cambridge, MA (617) 871-7000 Heplisav™ Dynavax prevention of hepatitis B Phase III hepatitis B vaccine 1018-ISS Berkeley, CA (510) 848-5100 conjugate herpes simplex DNA vaccine Pfizer treatment of herpes simplex virus Phase I New York, NY infections (860) 732-5156 herpes simplex vaccine AuRx prevention and treatment of herpes Phase I/II Elkridge, MD (410) 796-759 Hexaxim® sanofi pasteur diptheria, tetanus, pertussis, application submitted DTP-HepB-Polio-Hib vaccine Swiftwater, PA hepatitis B, poliomyelitis, (800) 822-2463 Haemophilus influenzae type b (infants) HIVAX™ GeneCure Biotechnologies HIV-1 infection Phase I replication-defective HIV-1 Norcross, GA (770) 263-7508 vaccine HIV recombinant vaccine GlaxoSmithKline treatment of HIV infection Phase II (gag/pol/nef) Rsch. Triangle Park, NC (888) 825-5249 HIV recombinant vaccine GlaxoSmithKline prevention of HIV-1 infection Phase I completed (gp120/NefTat/AS02A) Rsch. Triangle Park, NC (888) 825-5249 HIV vaccine GeoVax Labs prevention of HIV infection Phase II Smyrna, GA (678) 384-7220 HIV vaccine GeoVax Labs treatment of HIV infection Phase I/II Smyrna, GA (678) 384-7220 HIV vaccine Novartis Vaccines Diagnostics HIV infection Phase I Cambridge, MA (617) 871-7000 16 Medicines in Development Vaccines 2012
  • 17. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status HIV vaccine Opal Therapeutics HIV infection Phase I Palo Alto, CA (617) 726-2000 Massachusetts General Hospital Boston, MA HIV vaccine Profectus Biosciences prevention of HIV infection Phase I (MAG pDNA) Baltimore, MD (866) 938-8559 HIV vaccine Profectus Biosciences prevention of HIV infection Phase I (rVSV) Baltimore, MD (866) 938-8559 Imvamune® BM ImmunoTherapeutics smallpox Phase II smallpox vaccine (Bavarian Nordic) (650) 681-4660 Mountain View, CA influenza A virus H1N1 vaccine CEL-SCI prevention and treatment of influenza Phase I Vienna, VA A virus H1N1 subtype (703) 506-9460 influenza A virus H1N1 vaccine iBio prevention of influenza A virus H1N1 Phase I Newark, DE subtype www.ibioinc.com Fraunhofer USA Center for Molecular Biotechnology Newark, DE influenza A virus H5N1 GlaxoSmithKline prevention of influenza A virus H5N1 Phase I cell culture-based vaccine Rsch. Triangle Park, NC subtype (pandemic use) (888) 825-5249 influenza A virus H5N1 vaccine Baxter Healthcare prevention of influenza A virus H5N1 Phase I Deerfield, IL subtype (800) 422-9837 influenza A virus vaccine H1N1 Medicago USA prevention of influenza A virus H1N1 Phase I Durham, NC subtype (919) 313-9670 influenza A virus vaccine H5N1 iBio prevention of influenza A virus H5N1 Phase I Newark, DE subtype www.ibioinc.com influenza A virus vaccine H9N2 Baxter Healthcare prevention of influenza A virus H9N2 Phase I/II Deerfield, IL subtype (800) 422-9837 influenza virus DNA vaccine Vical prevention of influenza A virus H1N1 Phase I completed San Diego, CA subtype (858) 646-1100 influenza virus vaccine Dynavax prevention of influenza virus Phase I Berkeley, CA infections (510) 848-5100 influenza virus vaccine Novartis Vaccines Diagnostics influenza virus infections Phase III (Fluad) Cambridge, MA (children and elderly) (617) 871-7000 Medicines in Development Vaccines 2012 17
  • 18. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status influenza virus vaccine Vaxin influenza virus infections Phase I intranasal Birmingham, AL (205) 413-8238 Influvac® TC Abbott Laboratories prevention of influenza virus Phase I cell culture-derived influenza Abbott Park, IL infections (847) 937-6100 vaccine INO-3510 Inovio Pharmaceuticals influenza A virus H1N1 subtype, Phase I (DNA vaccine) Blue Bell, PA influenza A virus H5N1 subtype (877) 466-6846 Ixiaro® Intercell prevention of Japanese encephalitis Phase III Japanese encephalitis vaccine Vienna, Austria (pediatric) (617) 871-7000 Novartis Vaccines Diagnostics Cambridge, MA Ii-Key hybrid peptide vaccine Antigen Express influenza A virus H1N1 subtype Phase I Worcester, MA (508) 852-8783 LIQ-001 Liquidia Technologies influenza virus infections Phase I Rsch. Triangle Park, NC (919) 328-4400 Lyme disease vaccine Bayer HealthCare Pharmaceuticals prevention of Lyme disease Phase I/II Wayne, NJ (888) 842-2937 malaria DNA vaccine U.S. Naval Medical Research Center malaria Phase I/II Silver Spring, MD (858) 646-1100 Vical San Diego, CA malaria vaccine GenVec malaria Phase I/II Gaithersburg, MD (877) 943-6832 U.S. Naval Medical Research Center Silver Spring, MD malaria vaccine Sanaria malaria Phase I/II Rockville, MD (301) 770-3222 malaria vaccine Crucell malaria Phase I (recombinant) Leiden, Netherlands www.crucell.com malaria vaccine Crucell prevention of malaria Phase I/II (recombinant combination Leiden, Netherlands www.crucell.com vaccine) GlaxoSmithKline (888) 825-5249 Rsch. Triangle Park, NC Marburg virus DNA vaccine GenPhar Marburg virus disease in clinical trials Mt. Pleasant, SC (843) 884-0120 MEDI-534 MedImmune prevention of parainfluenza and Phase I (RSV/PIV-3 vaccine) Gaithersburg, MD respiratory syncytial virus infections (301) 398-0000 18 Medicines in Development Vaccines 2012
  • 19. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status MEDI-550 MedImmune prevention of pandemic influenza Phase I (pandemic influenza virus Gaithersburg, MD (H5N1 subtype) (301) 398-0000 vaccine) MEDI-559 MedImmune prevention of respiratory syncytial Phase I (RSV vaccine) Gaithersburg, MD virus infections (pediatric) (301) 398-0000 MenABCWY Novartis Vaccine Diagnostics prevention of meningococcal groups Phase II (multivalent conjugate vaccine) Cambridge, MA A, B, C, Y and W-135 infections (617) 871-7000 (adolescents) MenHibrix® GlaxoSmithKline prevention of Neisseria meningitidis application submitted Hib-MenCY-TT conjugated Rsch. Triangle Park, NC groups C and Y infections and (888) 825-5249 vaccine Haemophilus influenzae type B Meninge ACYW sanofi pasteur meningococcal infections Phase II (second-generation Swiftwater, PA (800) 822-2463 meningococcal conjugate infant vaccine) meningococcal vaccine group B Novartis Vaccines Diagnostics meningococcal group B infections Phase II quadrivalent recombinant Cambridge, MA (617) 871-7000 vaccine (4CMenB) Menveo® Infants Novartis Vaccines Diagnostics prevention of meningococcal A, C, Y application submitted meningococcal vaccine groups Cambridge, MA and W-135 infections (infants) (617) 871-7000 ACYW-135 conjugate vaccine MMR vaccine GlaxoSmithKline prevention of measles, mumps and Phase II (live attenuated trivalent Rsch. Triangle Park, NC rubella (888) 825-5249 vaccine) Mosquirix™ GlaxoSmithKline malaria Phase III malaria recombinant vaccine Rsch. Triangle Park, NC (888) 825-5249 MVA-BN® HIV BN ImmunoTherapeutics prevention and treatment of HIV-1 Phase I/II completed HIV multiantigen vaccine (Bavarian Nordic) infection (650) 681-4660 Mountain View, CA MVA-BN® Polytope BN ImmunoTherapeutics prevention of HIV infection Phase I HIV vaccine (Bavarin Nordic) (650) 681-4660 Mountain View, CA NB-1008 NanoBio prevention of influenza virus Phase I (intranasal vaccine) Ann Arbor, MI infections (734) 302-4000 Medicines in Development Vaccines 2012 19
  • 20. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status NDV-3 NovaDigm Therapeutics prevention of candidiasis, prevention Phase I (recombinant protein vaccine) Grand Forks, ND of staphylococcal (MRSA) infections (701) 757-5161 Nimenrix™ GlaxoSmithKline prevention of meningococcal groups Phase III MenACWY-TT conjugated Rsch. Triangle Park, NC A, C, Y and W-135 infections (888) 825-5249 vaccine (children) -------------------------------------------------- ------------------------------------------- prevention of meningococcal groups Phase II A, C, Y and W-135 infections (888) 825-5249 (adults, adolescents, infants) NmVac JN-International Medical prevention of meningococcal groups Phase I (meningococcal vaccine groups Omaha, NE A, C, Y, and W-135 infections (402) 884-3477 ACWY conjugate vaccine) norovirus bivalent vaccine LigoCyte Pharmaceuticals norovirus infections Phase I Bozeman, MT (406) 585-2733 norovirus monovalent vaccine LigoCyte Pharmaceuticals norovirus infections Phase I/II Bozeman, MT (406) 585-2733 Optaflu® Novartis Vaccines Diagnostics prevention of influenza virus application submitted influenza virus vaccine Cambridge, MA infections (617) 871-7000 PanBlok™ Protein Sciences prevention of influenza A virus H5N1 Phase I/II influenza A virus H5N1 vaccine Meriden, CT subtype (pandemic) (800) 488-7099 parvovirus B19 vaccine Meridian Biosciences parvovirus infections Phase I/II Cincinnati, OH (513) 271-3700 PENNVAX™-B Inovio Pharmaceuticals prevention and treatment of HIV Phase I DNA vaccine (clade B) Blue Bell, PA infection (267) 440-4200 PENNVAX™-G Inovio Pharmaceuticals prevention of HIV infection Phase I DNA vaccine (clade A, C, D) Blue Bell, PA (267) 440-4200 PER.C-flu vaccine Crucell prevention of influenza virus Phase II Leiden, Netherlands infections www.crucell.com PF-05212366 Pfizer adolescent meningitis Phase II (MnB rLP2086) New York, NY (860) 732-5156 -------------------------------------------------- ------------------------------------------- infant meningitis Phase I (860) 732-5156 PF-06290510 Pfizer staphylococcal infections Phase II (4-antigen Staphylococcus New York, NY (860) 732-5156 aureus vaccine) plague vaccine injectable DynPort Vaccine Yersinia infections Phase II Frederick, MD (301) 607-5000 20 Medicines in Development Vaccines 2012
  • 21. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status Preflucel™ Baxter Healthcare prevention of influenza virus Phase III seasonal influenza virus vaccine Deerfield, IL infections (800) 422-9837 Pseudomonas aeruginosa sanofi pasteur prevention of ventilator-associated Phase I antibody fragment product Swiftwater, PA pneumonia (800) 822-2463 PXVX-0103 PaxVax prevention of influenza A virus Phase I (H5N1 influenza vaccine) Menlo Park, CA H5N1 infections www.paxvax.com Q-LAIV Flu MedImmune seasonal influenza application submitted (MEDI-3250 vaccine) Gaithersburg, MD (301) 398-0000 Quadracel® sanofi pasteur diphtheria, tetanus, pertussis and Phase III diphtheria and tetanus toxoids Swiftwater, PA polio vaccine (in children 4-6 years (800) 822-2463 and acellular pertussis vaccine of age) adsorbed combined with inactivated poliomyelitis vaccine rabies VRVg sanofi pasteur prevention of rabies infection Phase II (purified vero rabies vaccine) Swiftwater, PA (800) 822-2463 respiratory syncytial virus VLP Novavax prevention of respiratory syncytial Phase I vaccine Rockville, MD virus (RSV) infections (240) 268-2000 RiVax™ Soligenix prevention of ricin poisoning Phase I ricin vaccine Princeton, NJ (609) 538-8200 (Orphan Drug) rotavirus vaccine sanofi pasteur prevention of rotavirus infections Phase I (live attenuated tetravalent oral Swiftwater, PA (800) 822-2463 vaccine) rotavirus vaccine I321 Bharat Biotech prevention of rotavirus infections Phase I Hyderabad, India www.bharatbiotech.com rPA-102 Emergent BioSolutions anthrax Phase II (recombinant protective antigen Rockville, MD (Fast Track) (301) 795-1800 anthrax vaccine) Shigella vaccine Emergent BioSolutions Shigella infections Phase I Rockville, MD (301) 795-1800 SparVax™ PharmAthene anthrax Phase II completed recombinant protective antigen Annapolis, MD (pre- and post-exposure prevention) (410) 269-2600 (rPA) anthrax vaccine Staphylococcus aureus vaccine Novartis Vaccines Diagnostics staphylococcal infections Phase I Cambridge, MA (617) 871-7000 Medicines in Development Vaccines 2012 21
  • 22. Medicines in Development for Vaccines Infectious Diseases Product Name Sponsor Indication Development Status Staphylococcus aureus vaccine GlaxoSmithKline Gram-positive infections, Phase I/II conjugate pentavalent Rsch. Triangle Park, NC staphylococcal infections (888) 825-5249 streptococcal B vaccine Emergent BioSolutions streptococcal infections Phase I Rockville, MD (301) 795-1800 streptococcal B vaccine Novartis Vaccines Diagnostics prevention of streptococcal infections Phase II conjugate Cambridge, MA (617) 871-7000 Streptococcus pneumoniae sanofi pasteur meningitis and penumonia Phase I vaccine Swiftwater, PA (800) 822-2463 TCN-032 Theraclone Sciences influenza A virus infections Phase I (mAb vaccine) Seattle, WA (206) 805-1600 TG-4040 Transgene hepatitis C Phase II (vector-based therapeutic Rockville, MD (301) 816-5421 vaccine) TransVax™ Astellas Pharma US prevention of cytomegalovirus Phase II cytomegalovirus DNA vaccine Deerfield, IL infections (800) 695-4321 (Orphan Drug) Vical (858) 646-1100 San Diego, CA tuberculosis recombinant sanofi pasteur prevention of tuberculosis Phase I subunit vaccine Swiftwater, PA (800) 822-2463 tuberculosis vaccine Aerus Global TB Vaccine Foundation prevention of tuberculosis Phase I Rockville, MD www.crucell.com Crucell Leiden, Netherlands tularemia vaccine DynPort Vaccine prevention of tularemia Phase I Frederick, MD (301) 607-5000 TUTI-16 Thymon HIV-1 infection Phase I/II (synthetic lipopeptide vaccine) Short Hills, NJ (973) 467-9558 Typhella™ Emergent BioSolutions prevention of typhoid Phase II completed typhoid vaccine oral Rockville, MD (301) 795-1800 typhoid vaccine Novartis Vaccines Institute for prevention of typhoid Phase II Global Health (888) 669-6682 Siena, Italy V114 Merck prevention of pneumococcal Phase II (pneumococcal 15 valent Whitehouse Station, NJ infections (infants) (800) 672-6372 conjugate vaccine) 22 Medicines in Development Vaccines 2012