2012 ReportMedicines in DevelopmentVaccinespresented by america’s biopharmaceuticalresearch companies                     ...
Medicines in Development for Vaccines  Allergy  Product Name                           Sponsor                            ...
Medicines in Development for Vaccines Cancer Product Name                  Sponsor                           Indication   ...
Medicines in Development for VaccinesCancerProduct Name                    Sponsor                            Indication  ...
Medicines in Development for Vaccines Cancer Product Name                      Sponsor                     Indication     ...
Medicines in Development for VaccinesCancerProduct Name                  Sponsor                    Indication            ...
Medicines in Development for Vaccines Cancer Product Name                     Sponsor                       Indication    ...
Medicines in Development for VaccinesCancerProduct Name                       Sponsor                           Indication...
Medicines in Development for Vaccines Cancer Product Name                      Sponsor                     Indication     ...
Medicines in Development for Vaccines Cancer Product Name                  Sponsor                  Indication            ...
Medicines in Development for Vaccines Cancer Product Name                     Sponsor                                 Indi...
Medicines in Development for Vaccines Infectious Diseases Product Name                      Sponsor                       ...
Medicines in Development for Vaccines Infectious Diseases Product Name                      Sponsor                       ...
Medicines in Development for Vaccines Infectious Diseases Product Name                      Sponsor                       ...
Medicines in Development for Vaccines Infectious Diseases Product Name                    Sponsor                         ...
Medicines in Development for Vaccines Infectious Diseases Product Name                   Sponsor                          ...
Medicines in Development for Vaccines Infectious Diseases Product Name                     Sponsor                        ...
Medicines in Development for Vaccines Infectious Diseases Product Name                     Sponsor                        ...
Medicines in Development for Vaccines Infectious Diseases Product Name                      Sponsor                       ...
Medicines in Development for Vaccines Infectious Diseases Product Name                     Sponsor                        ...
Medicines in Development for Vaccines Infectious Diseases Product Name                        Sponsor                     ...
Medicines in Development for Vaccines Infectious Diseases Product Name                      Sponsor                       ...
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

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For many years, vaccines have been used to successfully prevent diseases such as
smallpox, measles, polio and other infectious diseases. A 2007 study by the U.S. Centers for Disease Control and Prevention (CDC) found that cases of vaccine-preventable diseases had reached an all-time low in the United States. The study found that hospitalizations and deaths from nine infectious diseases had declined by more than 90 percent and nearly 90 percent for another four diseases.

These findings illustrate the major contribution that vaccines have made in saving countless lives around the world. In the past several years, many successful new vaccines have been developed, including one against human papillomavirus (HPV) infections that can lead to cervical cancer, one to guard against preexposure to the anthrax virus, and a vaccine to prevent pneumococcal infections in high-risk populations.

But vaccines are not only for preventing infectious diseases. In 2010, a new cancer vaccine for the treatment of prostate cancer was approved in the United States, and many more are in development.

Today, biopharmaceutical research companies are developing 295 vaccines. Potential vaccines in development include:
• A recombinant vaccine against malaria.
• A vaccine that protects infants against meningococcal disease, a leading cause
of meningitis.
• A genetically-modified vaccine designed for the treatment of pancreatic cancer.

Although many new promising vaccines are being researched today, the vaccine development process is not an easy one. As with the development of all drugs, vaccines must survive many years of thorough testing before they can be approved for use by the general public. Advances in other scientific fields, such as genomics, are becoming increasingly useful in the development of new vaccines. With the continued efforts of researchers, it is likely that we may have many more vaccines to protect against life-threatening diseases in the near future.

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PhRMA Report 2012: Vaccines in Development

  1. 1. 2012 ReportMedicines in DevelopmentVaccinespresented by america’s biopharmaceuticalresearch companies Nearly 300 Vaccines Are in Development; Research Focuses on Prevention and TreatmentVaccines 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 wasmore than one category. approved in the United States, and many more are in development.
  2. 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. 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) 849-7885Medicines in Development Vaccines 2012 3
  4. 4. Medicines in Development for VaccinesCancerProduct Name Sponsor Indication Development Statuscancer vaccine Immunovaccine ovarian cancer Phase I Halifax, Canada (902) 492-1819cancer vaccine Activartis Biotech glioblastoma (first-line therapy) Phase II(autologous dendritic cell Vienna, Austria www.activartis.comvaccine) -------------------------------------------------- ------------------------------------------- metastatic renal cancer in clinical trials www.activartis.comcancer vaccine Bayer HealthCare Pharmaceuticals follicular lymphoma (prevention of Phase I(autologous idiotype vaccine) Wayne, NJ relapse) (888) 842-2937cancer vaccine Cytokine PharmaSciences cancer Phase I(fibrocyte vaccine) King of Prussia, PA (610) 687-1776cancer vaccine MabVax Therapeutics sarcoma Phase II(mAb vaccine) San Diego, CA (858) 259-9405 -------------------------------------------------- ------------------------------------------- breast cancer Phase I (858) 259-9405CB-10-01 Cosmo Pharmaceuticals malignant melanoma Phase II Lainate, Italy www.cosmopharmaceuticals. comCDX-1401 Celldex Therapeutics solid tumors expressing the Phase I/II Needham, MA NY-ESO-1 protein (781) 433-0771CG201 CG Therapeutics solid tumors Phase II Seattle, WA (206) 336-5604CLL MaxCyte chronic lymphocytic leukemia (CLL) Phase I/IIimmunotherapeutic Gaithersburg, MD (301) 944-1700CRS-207 Aduro BioTech metastatic pancreatic cancer Phase II Berkeley, CA (combination therapy) (510) 848-4400CV-301 BN ImmunoTherapeutics metastatic breast cancer Phase II(immunotherapeutic vaccine) (Bavarian Nordic) (650) 681-4660 Mountain View, CACVac™ Prima Biomed ovarian cancer Phase II/IIIcancer vaccine Sydney, Australia www.primabiomed.com.auMUC-14 Medicines in Development Vaccines 2012
  5. 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) 674-4400Medicines in Development Vaccines 2012 5
  6. 6. Medicines in Development for VaccinesCancerProduct Name Sponsor Indication Development StatusGI-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), NSCLCGI-6207 GlobeImmune metastatic cancer Phase I(therapeutic vaccine) Louisville, CO (303) 625-2700GI-6301 GlobeImmune solid tumors Phase I(brachyury peptide vaccine) Louisville, CO (303) 625-2700GRNVAC1 Geron acute myeloid leukemia (AML) Phase II(telomerase-based cancer Menlo Park, CA (650) 473-7700vaccine) -------------------------------------------------- ------------------------------------------- prostate cancer Phase I/II (650) 473-7700GSK2241658A GlaxoSmithKline metastatic melanoma Phase I(NY-ESO-1 antigen-specific Rsch. Triangle Park, NC (888) 825-5249cancer 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 Iimmunotherapeutic vaccine Lincolnshire, IL (847) 478-0500GVAX® Colorectal BioSante Pharmaceuticals colorectal cancer Phase Iimmunotherapeutic vaccine Lincolnshire, IL (847) 478-0500GVAX® Leukemia BioSante Pharmaceuticals AML, chronic myeloid leukemia Phase IIimmunotherapeutic vaccine Lincolnshire, IL (CML) (847) 478-0500(Orphan Drug)GVAX® Myeloma BioSante Pharmaceuticals multiple myeloma Phase IIimmunotherapeutic vaccine Lincolnshire, IL (847) 478-0500GVAX® Pancreatic BioSante Pharmaceuticals pancreatic cancer Phase IIimmunotherapeutic vaccine Lincolnshire, IL (847) 478-0500(Orphan Drug)GVAX® Prostate BioSante Pharmaceuticals prostate cancer Phase IIIimmunotherapeutic vaccine Lincolnshire, IL (Fast Track) (847) 478-05006 Medicines in Development Vaccines 2012
  7. 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) 524-5400Medicines in Development Vaccines 2012 7
  8. 8. Medicines in Development for VaccinesCancerProduct Name Sponsor Indication Development StatusJVRS-100 Colby Pharmaceutical leukemia Phase I(lipid-DNA complex vaccine) San Jose, CA (650) 333-3152Lucanix® NovaRx NSCLC Phase IIIbelagenpumatucel-L San Diego, CA (Fast Track) (858) 552-8600(cell-based therapeutic vaccine) -------------------------------------------------- ------------------------------------------- glioma Phase I (858) 552-8600LungVax® AVAX Technologies NSCLC Phase I/IIautologous cell vaccine Philadelphia, PA (215) 241-9760M-200 prophage cancer vaccine Agenus metastatic melanoma Phase III(Orphan Drug) Lexington, MA (Fast Track) (781) 674-4400melanoma DNA vaccine Ichor Medical Systems malignant melanoma Phase I San Diego, CA (858) 550-2022 Memorial Sloan-Kettering Cancer Center New York, NYMVA-BN® Breast BN ImmunoTherapeutics breast cancer Phase IHER-2/neu-based modified (Bavarian Nordic) (650) 681-4660vaccinia ankara (MVA) vaccine Mountain View, CAMVA-BN®-PRO BN ImmunoTherapeutics prostate cancer Phase I/II (Bavarian Nordic) (650) 681-4660 Mountain View, CAMVax® AVAX Technologies malignant melanoma Phase IIIautologous cell vaccine Philadelphia, PA (215) 241-9760NeuVax™ Galena Biopharma early-stage breast cancer Phase IIIE75 cancer vaccine Lake Oswego, OR (prevention of relapse) (855) 855-4253 -------------------------------------------------- ------------------------------------------- prostate cancer Phase I/II (855) 855-4253Oncophage® Agenus renal cell carcinoma Phase IIvitespen Lexington, MA (Fast Track) (781) 674-4400(Orphan Drug)OncoVAX® Vaccinogen stage III colorectal cancer Phase IIcolorectal cancer vaccine Frederick, MD (combination therapy) (301) 668-8400 -------------------------------------------------- ------------------------------------------- colorectal cancer Phase I/II (Fast Track) (301) 668-8400ONT-10 Oncothyreon solid tumors Phase I Seattle, WA (206) 801-21008 Medicines in Development Vaccines 2012
  9. 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) 789-2800Medicines in Development Vaccines 2012 9
  10. 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. 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) 847-1111Medicines in Development Vaccines 2012 11
  12. 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, MA12 Medicines in Development Vaccines 2012
  13. 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, MDMedicines in Development Vaccines 2012 13
  14. 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. 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) 871-7000Medicines in Development Vaccines 2012 15
  16. 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) 871-700016 Medicines in Development Vaccines 2012
  17. 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) 871-7000Medicines in Development Vaccines 2012 17
  18. 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) 398-000018 Medicines in Development Vaccines 2012
  19. 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) 302-4000Medicines in Development Vaccines 2012 19
  20. 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) 607-500020 Medicines in Development Vaccines 2012
  21. 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) 871-7000Medicines in Development Vaccines 2012 21
  22. 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

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