2017 Vaccines in Development

Allergies
Drug Name Organization Indication Development Phase

allergy immunotherapeutic United Therapeutics IgE-mediated allergy response Phase I

vaccine Hauppauge, NY www.unitedbiomedical.com

AR101 Aimmune Therapeutics peanut allergy (treatment) Phase III

(oral immunotherapy) Brisbane, CA (Fast Track) www.aimmune.com

ASP-0892 Astellas Pharma US peanut allergy (treatment) Phase I

(immunotherapeutic plasmid Northbrook, IL (Fast Track) www.immunomix.com
based DNA vaccine) Immunomic Therapeutics
Rockville, MD

HAL-MPE1 HAL Allergy peanut allergy (treatment) Phase I

(subcutaneous immunotherapy) Leiden, Netherlands www.hal-allergy.com

injectable MPL allergy vaccine Allergy Therapeutics seasonal allergic rhinitis due to Phase III
West Sussex, United Kingdom either ragweed, grass or tree pollen www.allergytherapeutics.com
(prevention)

ragweed mix vaccine Woodmont Pharmaceuticals seasonal allergic rhinitis and allergic Phase I
Atlanta, GA conjunctivitis due to ragweed

SAR439794 Immune Design peanut allergy (treatment) Phase I

(peanut allergy vaccine) Seattle, WA www.immunedesign.com
Sanofi
Bridgewater, NJ

Medicines in Development: Vaccines | 2017 1

Allergies
Drug Name Organization Indication Development Phase

STAGR320 Stallergenes Greer house dust mite allergic rhinitis Phase III
(sublingual desensitization London, United Kingdom www.stallergenesgreer.com
immunotherapy)

Viaskin® Milk DBV Technologies milk allergy (treatment) Phase II

epicutaneous immunotherapy Summit, NJ (pediatric) (Fast Track) www.dbv-technologies.com

Viaskin® Peanut DBV Technologies peanut allergy (treatment) Phase III

epicutaneous immunotherapy Summit, NJ (pediatric) (Fast Track) www.dbv-technologies.com

Alzheimer's Disease
Drug Name Organization Indication Development Phase

ACI-24 AC Immune Alzheimer’s disease-like characteristics Phase I

(liposomal therapeutic Lusanne, Switzerland in patients with Down syndrome www.acimmune.com
anti-Abeta vaccine) (treatment)

ACI-35 AC Immune Alzheimer’s disease in patients Phase I

(anti-pTau vaccine) Lusanne, Switzerland with Down syndrome (treatment) www.acimmune.com
Janssen Research & Development www.janssen.com
Raritan, NJ

CAD106 Novartis Pharmaceuticals Alzheimer's disease (treatment) Phase II/III

(VLP immunotherapy vaccine) East Hanover, NJ www.novartis.com

UB-311 United Neuroscience Alzheimer's disease (treatment) Phase II

(anti-amyloid endobody vaccine) Hauppauge, NY www.unitedneuroscience.com

Medicines in Development: Vaccines | 2017 2

Autoimmune Diseases
Drug Name Organization Indication Development Phase

CrohnsVax™ Immune Response BioPharma Crohn's disease Phase I

Crohn's disease vaccine Atlantic City, NJ www.immuneresponsebiopharma.com

Diamyd®/GABA Diamyd Medical type 1 diabetes (treatment) Phase I

autoimmune diabetes vaccine/ Stockholm, Sweden (pediatric) www.diamyd.com
gamma-aminobutyric acid (GABA) University of Alabama
Birmingham, AL

DV-100 DiaVacs type 1 diabetes (treatment) Phase I completed

(autologous dendritic cell La Jolla, CA www.diavacs.com
immunotherapy vaccine)

IFN-Kinoid Neovacs systemic lupus erythematosus Phase II

(inactivated immunogenic Paris, France (Fast Track) www.neovacs.fr
interferon alpha-based vaccine)

NeuroVax™ Immune Response BioPharma multiple sclerosis (Fast Track) Phase II

multiple sclerosis vaccine Atlantic City, NJ www.immuneresponsebiopharma.com
ORPHAN DRUG

Nexvax2® ImmusanT celiac disease (treatment) Phase I

peptide-based vaccine Cambridge, MA www.immusant.com

RAVAX™ Immune Response BioPharma rheumatoid arthritis Phase III

rheumatoid arthritis vaccine Atlantic City, NJ www.immuneresponsebiopharma.com

Zorcell™ Immune Response BioPharma psoriasis Phase II

psoriasis vaccine Atlantic City, NJ www.immuneresponsebiopharma.com

Medicines in Development: Vaccines | 2017 3

Cancer
Drug Name Organization Indication Development Phase

adagloxad simolenin OBI Pharma metastatic breast Phase II/III

(cancer immunotherapy) Taipei, Taiwan www.obipharma.com

ADXS-DUAL Advaxis cervical Phase II

(cancer immunotherapy) Princeton, NJ (with nivolumab) www.advaxis.com
Bristol Myers-Squibb
Princeton, NJ

ADXS-HER2 Advaxis HER2-expressing metastatic Phase II

(cancer immunotherapy) Princeton, NJ solid tumors www.advaxis.com

ADXS-PSA Advaxis metastatic castration-resistant Phase I/II

(cancer immunotherapy) Princeton, NJ prostate (monotherapy) www.advaxis.com

metastatic prostate Phase I/II

(with pembrolizumab) www.advaxis.com

AE37 Antigen Express newly-diagnosed breast, metastatic Phase II

(HER-2/neu li-key hybrid cancer Wellesley, MA triple negative breast www.antigenexpress.com
vaccine) (with pembrolizumab)

metastatic prostate (monotherapy) Phase I

www.antigenexpress.com

AlloStim® Immunovative Therapies metastatic colorectal Phase II

T-cell therapy-device combination Jerusalem, Israel www.immunovative.com

Medicines in Development: Vaccines | 2017 4

Cancer
Drug Name Organization Indication Development Phase

AST-VAC1 Asterias Biotherapeutics acute myeloid leukemia (AML) Phase II

(dendritic cell vaccine) Fremont, CA www.asteriasbiotherapeutics.com
Immunomic Therapeutics www.immunomix.com
Rockville, MD

AutoSynVax™ Agenus cancer (prevention) Phase I

autologous synthetic vaccine Lexington, MA www.agenusbio.com

AVX701 AlphaVax CEA-expressing colon Phase I/II

(alphavirus VRP cancer vaccine) Durham, NC www.alphavax.com

AVX901 AlphaVax HER2-expressing breast Phase I

(alphavirus VRP cancer vaccine) Durham, NC www.alphavax.com

axalimogene filolisbac (AXAL) Advaxis high-risk locally advanced cervical Phase III
(cancer immunotherapy) Princeton, NJ (Fast Track) www.advaxis.com
ORPHAN DRUG

metastatic cervical, metastatic Phase II

head and neck (with durvalumab) www.advaxis.com

metastatic anal (monotherapy) Phase II

www.advaxis.com

BB-MPI-03 Benovus Bio AML, multiple myeloma, Phase I

(RNA-derived cancer vaccine) Atlanta, GA myelodysplastic syndromes www.benovousbio.com

Medicines in Development: Vaccines | 2017 5

Cancer
Drug Name Organization Indication Development Phase

BI 1361849 Boehringer Ingelheim Pharmaceuticals non-small cell lung cancer (NSCLC) Phase II
(mRNA cancer vaccine) Ridgefield, CT www.boehringer-ingelheim.com

BriaVax™ BriaCell Therapeutics breast Phase I/II

SV-BR-1 GM cancer vaccine Berkeley, CA www.briacell.com

CMB305 Immune Design soft tissue sarcoma, NY-ESO-1 solid Phase II

(prime-boost immunotherapy) Seattle, WA tumors (adult and elderly) www.immunedesign.com
ORPHAN DRUG

CMP-001 Checkmate Pharmaceuticals malignant melanoma Phase I

(virus-like particle cancer vaccine) Cambridge, MA (with pembrolizumab) www.checkmatepharma.com

colorectal cancer vaccine Targeted Diagnostics & Therapeutics colorectal Phase I

(therapeutic cancer vaccine) Exton, PA www.viralgeneinc.com
Viral Gene
Philadelphia, PA

CRS-207 Aduro Biotech gastric (combination therapy), Phase II

(Listeria monocytogenes Berkeley, CA mesothelioma (combination therapy) www.aduro.com
cancer vaccine)
ORPHAN DRUG
ovarian (combination therapy) Phase I/I
www.aduro.com

CV301 Bavarian Nordic NSCLC (with nivolumab) Phase II

(CEA/MUC-1 targeted Morrisville, NC www.bavarian-nordic.com
immunotherapy)

Medicines in Development: Vaccines | 2017 6

Cancer
Drug Name Organization Indication Development Phase

DCVax®-Direct Northwest Biotherapeutics solid tumors Phase I/II

personalized immune therapy Bethesda, MD www.nwbio.com

DCVax®-L Northwest Biotherapeutics newly-diagnosed glioblastoma Phase III

personalized immune therapy Bethesda, MD www.nwbio.com
ORPHAN DRUG

DCVax®-Prostate Northwest Biotherapeutics prostate Phase II completed

personalized immune therapy Bethesda, MD www.nwbio.com

DPV-001 UbiVac definitely-treated stage III NSCLC Phase II

(tumor-derived, autophagosome- Portland, OR www.ubivac.com
enriched cancer vaccine)

advanced prostate Phase I

www.ubivac.com

DPX E7 Immunovaccine human papillomavirus (HPV)-related Phase I/II

(peptide cancer vaccine) Halifax, Canada anal, cervical, head and neck www.imvaccine.com

DPX Survivac Immunovaccine ovarian (combination therapy) Phase I

(peptide cancer vaccine) Halifax, Canada (Fast Track) www.imvaccine.com
ORPHAN DRUG

Medicines in Development: Vaccines | 2017 7

Cancer
Drug Name Organization Indication Development Phase

DSP-7888 Boston Biomedical glioblastoma (combination therapy) Phase II

(peptide cancer vaccine) Cambridge, MA www.bostonbiomedical.com
ORPHAN DRUG

hematologic malignancies, Phase I

solid tumors www.bostonbiomedical.com

Elenagen™ CureLab Oncology solid tumors Phase I/II

p62 anti-cancer DNA Vaccine Canton, MA www.curelaboncology.com

EP-101 EpiThany breast Phase I

(multi-antigen vaccine) Seattle, WA www.epithany.com

EP-201 EpiThany ovarian Phase II

(single-antigen vaccine - IGFBP-2) Seattle, WA www.epithany.com

EP-301 EpiThany breast Phase I

(single-antigen vaccine - HER2-ICD) Seattle, WA www.epithany.com

EP-302 EpiThany breast Phase II

(multi-antigen vaccine) Seattle, WA www.epithany.com

ERC1671 Epitopoietic Research glioblastoma Phase II

(allogeneic/autologous cell vaccine) Pasadena, CA www.erc-immunotherapy.com
ORPHAN DRUG

Medicines in Development: Vaccines | 2017 8

Cancer
Drug Name Organization Indication Development Phase

ETBX-011 Etubics colorectal, pancreatic Phase I/II

(Ad5 CEA cancer vaccine) Seattle, WA www.etubics.com
NantCell
Culver City, CA

ETBX-021 Etubics breast Phase I

(Ad5 HER2/neu cancer vaccine) Seattle, WA www.etubics.com
NantCell
Culver City, CA

GALE-301 Galena Biopharma endometrial, ovarian Phase II completed

(folate binding protein E39-targeted San Ramon, CA (prevention of recurrence) www.galenabiopharma.com
peptide vaccine)
ORPHAN DRUG

GALE-301 + GALE-302 Galena Biopharma breast, ovarian Phase I completed

(immunogenic peptide vaccine San Ramon, CA www.galenabiopharma.com
combination)
ORPHAN DRUG

galinpepimut-S Sellas Life Sciences AML (Fast Track), chronic myeloid Phase II
(WT1 cancer vaccine) New York, NY leukemia (CML), mesothelioma www.sellaslifesciences.com
ORPHAN DRUG (Fast Track), multiple myeloma,
ovarian (with nivolumab)

GBM-LAMP-Vax Immunomic Therapeutics newly-diagnosed glioblastoma Phase II

(DNA immunotherapeutic vaccine) Rockville, MD www.immunomix.com

Medicines in Development: Vaccines | 2017 9

Cancer
Drug Name Organization Indication Development Phase

GI-4000 GlobeImmune pancreatic (combination therapy) Phase II

(mutated Ras cancer vaccine) Louisville, CO www.globeimmune.com
NantCell
Culver City, CA

GI-6207 GlobeImmune medullary thyroid cancer Phase II

(CEA inhibitor cancer vaccine) Louisville, CO www.globeimmune.com
NantCell
Culver City, CA

GI-6301 GlobeImmune chordoma Phase II

(brachyury peptide cancer vaccine) Louisville, CO www.globeimmune.com
NantCell
Culver City, CA
advanced cancer Phase I
www.globeimmune.com

GL 0817 Gliknik head and neck, squamous cell Phase II

(MAGE-A3 vaccine) Baltimore, MD www.gliknik.com
ORPHAN DRUG

GRN 1201 BrightPath Biotherapeutics NSCLC (combination therapy), Phase II

(peptide cancer vaccine) Kurume, Japan melanoma www.brightpathbio.com

ICT-107 ImmunoCellular Therapeutics newly-diagnosed glioblastoma Phase III

(dendritic cell vaccine) Calabasas, CA www.imuc.com
ORPHAN DRUG

Medicines in Development: Vaccines | 2017 10

Cancer
Drug Name Organization Indication Development Phase

ICT-121 ImmunoCellular Therapeutics recurrent glioblastoma Phase I

(dendritic cell vaccine) Calabasas, CA www.imuc.com

IMT1012 Immunotope breast, ovarian Phase I

(multi-peptide antigen Doylestown, PA www.immunotope.com
cancer vaccine)

INO-1400 Inovio Pharmaceuticals breast, lung, pancreatic Phase I

(hTERT DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com

INO-3106 Inovio Pharmaceuticals precancerous lesions and Phase I

(E6, E7 DNA cancer vaccine) Plymouth Meeting, PA malignancies www.inovio.com

INO-5150 Inovio Pharmaceuticals prostate Phase I

(PSA, PSMA DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com

INT230-6 Intensity Therapeutics cancer Phase I/II

(cisplatin based cancer vaccine) Westport, CT www.intensitytherapeutics.com

JNJ-64041757 (ADU-214) Aduro Biotech NSCLC Phase I

(Listeria monocytogenes Berkeley, CA www.aduro.com
immunotherapy) Janssen Research & Development www.janssen.com
Raritan, NJ

JNJ-64041809 (ADU-741) Aduro Biotech prostate Phase I

(Listeria monocytogenes Berkeley, CA www.aduro.com
immunotherapy) Janssen Research & Development www.janssen.com
Raritan, NJ

Medicines in Development: Vaccines | 2017 11

Cancer
Drug Name Organization Indication Development Phase

KiroVAX-001 Kiromic hematological malignancies Phase I/II

(TAPA-pulsed dendritic cell vaccine) Houston, TX www.kiromic.com

KiroVAX-002 Kiromic hematological malignancies Phase I/II

(TAPA-pulsed dendritic cell vaccine) Houston, TX www.kiromic.com

KiroVAX-003 Kiromic solid tumors Phase I/II

(TAPA-pulsed dendritic cell vaccine) Houston, TX www.kiromic.com

KiroVAX-004 Kiromic solid tumors Phase I/II

(TAPA-pulsed dendritic cell vaccine) Houston, TX www.kiromic.com

LV305 Immune Design breast, malignant melanoma, Phase I

(RNA cancer vaccine) Seattle, WA NSCLC, ovarian, sarcoma www.immunedesign.com
ORPHAN DRUG

MEDI0457 (INO-3112) Inovio Pharmaceuticals head and neck (HPV type 16/18) Phase I/II
(DNA cancer vaccine) Plymouth Meeting, PA (with durvalumab) www.inovio.com
MedImmune www.medimmune.com
Gaithersburg, MD

MUC-1 CD40L dendritic cell vaccine MicroVAX solid tumors Phase I

Manassas, VA

MVA-BN brachyury vaccine Bavarian Nordic solid tumors Phase I

(cancer immunotherapy) Morrisville, NC www.bavarian-nordic.com

Medicines in Development: Vaccines | 2017 12

Cancer
Drug Name Organization Indication Development Phase

MVA p53 vaccine Tara Immuno-Oncology solid tumors Phase I

(modified vaccinia virus ankara New York, NY
vaccine expressing p53)

MVI-118 Madison Vaccines metastatic prostate Phase I

(AR plasmind DNA vaccine) Madison, WI www.madisonvaccinesinc.com

MVI-816 Madison Vaccines biochemically recurrent prostate Phase II

(plasmid DNA vaccine) Madison, WI www.madisonvaccinesinc.com

metastatic castration-resistant Phase I

prostate (with pembrolizumab) www.madisonvaccinesinc.com

NEO-PV-01 Bristol-Myers Squibb bladder, melanoma, NSCLC Phase I

(personalized neoantigen vaccine) Princeton, NJ (with nivolumab) www.neontherapeutics.com
Neon Therapeutics
Cambridge, MA

NeuVax® Galena Biopharma triple negative HER2-positive breast Phase II

nelipepimut S San Ramon, CA (with trastuzumab), HER2-positive www.galenabiopharma.com
(peptide cancer vaccine) breast (with trastuzumab), ductal
carcinoma in situ of breast
(Fast Track)

gastric Phase I completed

www.galenabiopharma.com

Medicines in Development: Vaccines | 2017 13

Cancer
Drug Name Organization Indication Development Phase

Oncoquest™-CLL XEME Biopharma chronic lymphocytic leukemia Phase II

chronic lymphocytic leukemia vaccine Lombard, IL www.xemebiopharma.com

Oncoquest-L® XEME Biopharma non-Hodgkin lymphoma Phase I completed

personalized cancer vaccine Lombard, IL www.xemebiopharma.com

OncoVAX® Vaccinogen colorectal (Fast Track) Phase III

personalized colorectal Baltimore, MD www.vaccinogeninc.com
cancer vaccine

OSE-2101 OSE Immunotherapeutics NSCLC Phase III

(neo-epitopes cancer vaccine) Nantes, France www.ose-immuno.com
ORPHAN DRUG

ovapuldencel-T AiVita Biomedical ovarian Phase II

Irvine, CA www.aivitabiomedical.com

PAN-301-1 Panacea Pharmaceuticals prostate Phase I

(nanoparticle-based cancer vaccine) Gaithersburg, MD www.panaceapharma.com

PDS0101 PDS Biotechnology HPV-related cancer Phase I

(cancer immunotherapy) North Brunswick, NJ www.pdsbiotech.com

PEPIDH1M Annias Immunotherapeutics glioblastoma Phase I/II

(dendritic cell cancer vaccine) Chapel Hill, NC www.anniasimmuno.com

Medicines in Development: Vaccines | 2017 14

Cancer
Drug Name Organization Indication Development Phase

PF-06753512 Pfizer prostate Phase I

(cancer immunotherapy) New York, NY www.pfizer.com

pLADD Aduro Biotech microsatellite stable colorectal Phase I

(personalized LADD Berkeley, CA www.aduro.com
immunotherapy vaccine)

polyclonal antibody stimulator Cancer Advances gastric, pancreatic Phase III

(fusion peptide) Durham, NC (see also other) www.canceradvancesinc.com
ORPHAN DRUG

colorectal Phase II
www.canceradvancesinc.com

Prophage™ Agenus newly-diagnosed glioblastoma Phase II

heat shock protein vaccine Lexington, MA www.agenusbio.com
ORPHAN DRUG

ProscaVax™ OncBioMune Pharmaceuticals prostate cancer Phase I

PSA/IL-2/GM-CSF vaccine Baton Rouge, LA www.oncbiomune.com

PROSTVAC Bavarian Nordic prostate cancer (combination Phase II

rilimogene galvacirepvec- Morrisville, NC therapy) (Fast Track) www.bavarian-nordic.com
rilimogene glafolivec Bristol-Myers Squibb www.bms.com
Princeton, NJ

PSMA VRP AlphaVax prostate Phase I

(viral vector vaccine) Durham, NC www.alphavax.com

Medicines in Development: Vaccines | 2017 15

Cancer
Drug Name Organization Indication Development Phase

PT 107 Pique Therapeutics NSCLC Phase II

(allogeneic B7.1/HLA-A1 transfected Durham, NC www.piquetherapeutics.com
tumor cell vaccine)

PVX-410 OncoPep smoldering multiple myeloma Phase II

(multi-peptide cancer vaccine) North Andover, MA www.oncopep.com
ORPHAN DRUG

REIC gene therapy vaccine Momotaro-Gene localized prostate Phase I/II

Okayama, Japan www.mt-gene.com

RG6180 Genentech cancer Phase I

(personalized mRNA cancer vaccine) South San Francisco, CA www.gene.com

rocapuldencel-T Argos Therapeutics renal cell (Fast Track) Phase III

(dendritic cell vaccine) Durham, NC www.argostherapeutics.com

seviprotimut-L Polynoma melanoma Phase III

(polyvalent antigen vaccine) San Diego, CA www.polynoma.com
ORPHAN DRUG

SL-701 Stemline Therapeutics glioblastoma (adults) Phase II

(alpha-type 1 dendritic New York, NY www.stemline.com
cell-based vaccine)
ORPHAN DRUG

stapuldencel-T SOTIO prostate Phase III

(autologous dendritic cell vaccine) Prague, Czech Republic www.sotio.com

Medicines in Development: Vaccines | 2017 16

Cancer
Drug Name Organization Indication Development Phase

SurVaxM MimiVax glioblastoma Phase II

peptide mimic vaccine Rochester, NY www.mimivax.com

multiple myeloma Phase I

www.mimivax.com

tergenpumatucel-L + indoximod + NewLink Genetics NSCLC (combination therapy) Phase I

chemotherapy Ames, IA www.newlinkgenetics.com
(tumor cell vaccine)

TG4010 Transgene NSCLC (with nivolumab) Phase II

(MVA-MUC1-IL2 cancer vaccine) Paris, France www.transgene.fr
Bristol-Myers Squibb
Princeton, NJ

TLPLDC Cancer Insight melanoma Phase II/III

(tumor lysate particle loaded San Antonio, TX www.cancerinsight.com
dendritic cell vaccine) Elios Therapeutics
Austin, TX
ovarian Phase I/II
www.cancerinsight.com

TPIV 100/110 TapImmune HER2/neu-positive breast Phase I

(HER2/neu peptide vaccine) Jacksonville, FL www.tapimmune.com

TPIV 200 TapImmune platinum-sensitive ovarian (Fast Track), Phase II

(folate receptor-alpha peptide Jacksonville, FL platinum-resistant ovarian www.tapimmune.com
vaccine) combination therapy), triple
ORPHAN DRUG negative breast

Medicines in Development: Vaccines | 2017 17

Cancer
Drug Name Organization Indication Development Phase

TV-Brain-1 TVAX Biomedical glioblastoma Phase II

(personalized cancer cell vaccine Olathe, KS www.tvaxbiomedical.com
and killer T-cell therapy)

TV-Kidney-1 TVAX Biomedical renal cell Phase II

(personalized cancer cell vaccine Olathe, KS www.tvaxbiomedical.com
and killer T-cell therapy)

TVGV-1 vaccine TheVax HPV-related cancers Phase II

(fusion protein vaccine) Cape Canaveral, FL www.thevaxgenetics.com

VGX-3100 Inovio Pharmaceuticals cervical dysplasia (HPV type 16/18) Phase III
(therapeutic DNA vaccine) Plymouth Meeting, PA www.inovio.com

vuval neoplasia Phase II

(HPV type 16/18) www.inovio.com

viagenpumatucel-L (HS-110) Heat Biologics NSCLC (with nivolumab) Phase II

(allogeneic vaccine) Durham, NC www.heatbio.com

Medicines in Development: Vaccines | 2017 18

Cancer
Drug Name Organization Indication Development Phase

Vigil™ Gradalis advanced ovarian Phase III

genetically-modified autologous Dallas, TX www.gradalisinc.com
tumor cell vaccine

advanced breast Phase II/III

www.gradalisinc.com

Ewing's sarcoma (adults, children, Phase I

elderly), advanced NSCLC, www.gradalisinc.com
advanced, melanoma, gynecological

WT2725 Sunovion Pharmaceuticals hematological malignancies, Phase I

(peptide cancer vaccine) Marlborough, MA solid tumors www.sunovion.com

Infectious Diseases
Drug Name Organization Indication Development Phase

Adacel+ Sanofi Pasteur Tdap booster (prevention) Phase II

tetanus, diphtheria, acellular Swiftwater, PA www.sanofi.com
pertussis (Tdap) booster vaccine

Afluria Quadrivalent® Seqirus influenza (prevention) Phase III completed

influenza vaccine Cambridge, MA (6-59 months of age) www.seqirus.com

AGS-004 Argos Therapeutics HIV-1 infections (combination Phase I

(autologous dendritic cell vaccine) Durham, NC therapy) www.argostherapeutics.com
University of North Carolina
Chapel Hill, NC

Medicines in Development: Vaccines | 2017 19

Infectious Diseases
Drug Name Organization Indication Development Phase

AGS-v Imutex mosquito-transmitted viral Phase I

(protein-based vaccine) London, United Kingdom infections (prevention) www.imutex.com
National Institute of Allergy
and Infectious Diseases
Bethesda, MD

antifungal multivalent oral vaccine Immunitor fungal infections Phase I/II

Vancouver, Canada (prevention and treatment) www.immunitor.com

antimicrobial oral vaccine Immunitor bacterial infections (treatment) Phase I/II

Vancouver, Canada www.immunitor.com

ASP0113 Astellas cytomegalovirus (CMV) infections Phase III

(bivalent plasmid DNA-based vaccine) Northbrook, IL in transplant patients (prevention) www.vical.com
ORPHAN DRUG Vical
San Diego, CA

AV0328 Alopexx Vaccine PNAG-expressing bacterial infections Phase I/II

(conjugated oligosaccharide vaccine Concord, MA (prevention and treatment) www.alopexx.com
against dPNAG [deacetylated polymeric-
N-acetyl glucosamine])

Chikungunya vaccine PaxVax Chikungunya infections (prevention) Phase II

(virus-like particle vaccine) Redwood City, CA www.paxvax.com

Clostridium difficile toxoid vaccine Sanofi Pasteur Clostridium difficile infections Phase III
Swiftwater, PA (prevention) (Fast Track) www.sanofi.com

Medicines in Development: Vaccines | 2017 20

Infectious Diseases
Drug Name Organization Indication Development Phase

CodaVax® Codagenix multi-season influenza (prevention) Phase I

influenza A virus H1N1 vaccine Farmingdale, NY www.codagenix.com

deltaFLU-LAIV Vivaldi Biosciences influenza (prevention) Phase II

(influenza virus delta NS1 vaccine) Fort Collins, CO www.vivaldibiosciences.com

Dengvaxia® Sanofi Pasteur dengue (prevention) Phase II

dengue tetravalent vaccine Swiftwater, PA (Fast Track) www.sanofi.com

DNA-C EuroVacc HIV infections (prevention) Phase I/II

(DNA HIV vaccine) Amsterdam, Netherlands (combination with other HIV vaccines)
National Institute of Allergy and
Infectious Diseases
Rockville, MD

Ebola recombinant viral vector GlaxoSmithKline Ebola virus infections (prevention) Phase II
vaccine Research Triangle Park, NC www.gsk.com

Ebola virus vaccine Janssen Vaccines & Prevention Ebola virus infections Phase III
(Ad26 EBOV vaccine) Leiden, Netherlands (prevention) www.janssen.com

Ebola virus vaccine + Matrix-M™ Novavax Ebola virus infections (prevention) Phase I
Gaithersburg, MD www.novavax.com

Fluarix® Quadrivalent GlaxoSmithKline seasonal influenza subtypes A and B application submitted

influenza vaccine Research Triangle Park, NC (prevention) (6-35 months of age) www.gsk.com

Medicines in Development: Vaccines | 2017 21

Infectious Diseases
Drug Name Organization Indication Development Phase

Flucelvax® Seqirus influenza (prevention) Phase I/II completed

influenza vaccine Cambridge, MA (6-<48 months of age) www.seqirus.com

FluNhance™ Protein Sciences influenza (prevention) Phase II

recombinant influenza vaccine Meriden, CT www.proteinsciences.com

Fluzone® QIV HD Sanofi Pasteur influenza (prevention) Phase III

quadrivalent inactivated influenza Swiftwater, PA (elderly) www.sanofi.com
vaccine - high dose

GEN-003 Genocea Biosciences herpes simplex virus (HSV) infections Phase II

(protein subunit T cell-enabled Cambridge, MA (treatment) www.genocea.com
vaccine

GLS-5300 GeneOne Life Science Middle East respiratory syndrome Phase I

(DNA vaccine) Seoul, South Korea (MERS) (prevention), coronavirus www.inovio.com
Inovio Pharmaceuticals infections (prevention)
Plymouth Meeting, PA

GLS-5700 GeneOne Life Science Zika virus infections (prevention) Phase I

(DNA-based synthetic vaccine) Seoul, South Korea www.inovio.com
Inovio Pharmaceuticals
Plymouth Meeting, PA

Medicines in Development: Vaccines | 2017 22

Infectious Diseases
Drug Name Organization Indication Development Phase

GOVX-B11 GeoVax Labs HIV infections (prevention) Phase II

(clade-B DNA HIV vaccine) Smyrna, GA www.geovax.com

HIV infections (treatment) Phase I

www.geovax.com

GS-4774 GlobeImmune hepatitis C (treatment) Phase II

(T-cell immunity stimulator Louisville, CO (treatment naïve and virally www.globeimmune.com
vaccine) suppressed)

haemophilus recombinant vaccine GlaxoSmithKline reduction of the frequency of COPD Phase II

Research Triangle Park, NC exacerbations associated with www.gsk.com
non-typeable haemophilus influenza
and moreaxella catarrhalis

HBV-002 Hawaii Biotech West Nile virus infections Phase I

(recombinant subunit vaccine) Honolulu, HI (prevention) www.hibiotech.com

hepatitis C vaccine GlaxoSmithKline hepatitis C (prevention) Phase II

(recombinant viral vector vaccine) Research Triangle Park, NC www.gsk.com

HEPLISAV-B Dynavax Technologies hepatitis B (prevention) application submitted

HBsAg-1018 vaccine Berkeley, CA www.dynavax.com

HepTcell Altimmune hepatitis B (treatment) Phase I

peptide vaccine Gaithersburg, MD www.altimmune.com

Medicines in Development: Vaccines | 2017 23

Infectious Diseases
Drug Name Organization Indication Development Phase

HIV recombinant proteins vaccine GlaxoSmithKline HIV infections (prevention) Phase II

Research Triangle Park, NC www.gsk.com

HIV vaccine Janssen Vaccines and Prevention HIV infections (prevention) Phase II
(Ad26 Mos HIV trivalent vaccine) Leiden, Netherlands www.janssen.com

HIV vaccine Janssen Vaccines and Prevention HIV infections (prevention) Phase II
(Ad26 Mos HIV vaccine) Leiden, Netherlands www.janssen.com

HIV vaccine Janssen Vaccines and Prevention HIV infections (prevention) Phase I/II
(MVA mosaic HIV vaccine) Leiden, Netherlands www.janssen.comm

HIV vaccine Sanofi Pasteur HIV infections (prevention) Phase II

(prime-boost vaccine) Swiftwater, NJ www.sanofi.com

HIV vaccine Ad4-Clade C PaxVax HIV infections (prevention) Phase I

Redwood City, CA www.paxvax.com

HIV vaccine Ad4-mGag PaxVax HIV infections (prevention) Phase I

Redwood City, CA www.paxvax.com

HIVAX™ GeneCure Biotechnologies HIV-1 infections (treatment) Phase I

replication-defective HIV vaccine Norcross, GA www.genecure.com

HSV529 Sanofi Pasteur HSV-type 2 infections Phase I

(herpes simplex virus type 2 vaccine) Swiftwater, PA (prevention) www.sanofi.com

Medicines in Development: Vaccines | 2017 24

Infectious Diseases
Drug Name Organization Indication Development Phase

HTNV/PUUV DNA vaccine Ichor Medical Systems hemorrhagic fever caused by Phase II
San Diego, CA hantaan virus and puumala virus www.ichorms.com
United States Army Medical Research (prevention)
and Materiel Command
Fort Detrick, MD

IHV001 Profectus Biosciences HIV infections (prevention) Phase I

(subunit HIV vaccine) Baltimore, MD www.profectusbiosciences.com

Imvamune® Bavarian Nordic smallpox (prevention) Phase III

smallpox vaccine Morrisville, NC (liquid-frozen) www.bavarian-nordic.com

smallpox (prevention) Phase II

(freeze-dried) www.bavarian-nordic.com

Infanrix Hexa® GlaxoSmithKline diphtheria, haemophilus, hepatitis B, Phase III

combined diphtheria and tetanus Research Triangle Park, NC pertussis, polio, tetanus www.gsk.com
toxoids, acellular pertussis, hepatitis (prevention)
B (recombinant), inactivated polio-
myelitis, and adsorbed conjugated
Haemophilus influenzae type b
vaccine

influenza A virus vaccine H1N1 Antigen Express influenza (prevention) Phase I

(Ii-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com

influenza A virus vaccine H5N1 Antigen Express influenza (prevention) Phase I

(Ii-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com

Medicines in Development: Vaccines | 2017 25

Infectious Diseases
Drug Name Organization Indication Development Phase

influenza A virus H5N1 vaccine Seqirus influenza (prevention) Phase III

Cambridge, MA (adults, elderly) www.seqirus.com

influenza A virus H5N8 vaccine Seqirus influenza (prevention) Phase I

Cambridge, MA www.seqirus.com

influenza A virus H7N9 vaccine EpiVax influenza (prevention) Phase I

Providence, RI www.epivax.com

influenza H3N2 vaccine FluGen influenza (prevention) Phase I

(intranasal) Madison, WI www.flugen.com

influenza virus vaccine quadrivalent Medicago seasonal influenza (prevention) Phase III
(plant-based VLP vaccine) Durham, NC www.medicago.com

seasonal influenza (prevention) Phase II

(elderly) www.medicago.com

influenza virus vaccine quadrivalent Seqirus influenza (prevention) Phase III

(aQIV-aQIV) Cambridge, MA www.seqirus.com

INO-1800 Inovio Pharmaceuticals hepatitis B (treatment) Phase I

(multi-antigen vaccine) Plymouth Meeting, PA www.inovio.com

INO-4212 Inovio Pharmaceuticals Ebola virus infections (prevention) Phase I

(polyvalent DNA based vaccine) Plymouth Meeting, PA www.inovio.com

Medicines in Development: Vaccines | 2017 26

Infectious Diseases
Drug Name Organization Indication Development Phase

INO-8000 Inovio Pharmaceuticals hepatitis C (treatment) Phase I

(multi-antigen DNA vaccine) Plymouth Meeting, PA www.inovio.com

ITV-1 Immunotech Laboratories HIV infections (treatment) Phase II

(inactivated pepsin fraction vaccine) Monrovia, CA www.immunotechlab.com

JNJ-61187165 Janssen Vaccines and Prevention respiratory syncytial virus (RSV) Phase I completed
(RSV vaccine) Leiden, Netherlands infections (prevention) www.janssen.com

JNJ-61187191 Janssen Vaccines and Prevention RSV infections (prevention) Phase I completed
(RSV vaccine) Leiden, Netherlands www.janssen.com

JNJ-63871860 Janssen Vaccines and Prevention Escherichia coli infections Phase II completed
(multivalent glycoprotein Leiden, Netherlands (prevention) www.janssen.com
conjugate vaccine)

JNJ-64400141 Janssen Vaccines and Prevention RSV infections (prevention) Phase I

(RSV vaccine) Leiden, Netherlands (elderly) www.janssen.com

M-001 BiondVax influenza (prevention) Phase II

(universal influenza vaccine) Ness Ziona, Israel www.biondvax.com
National Institute of Allergy
and Infectious Diseases
Bethesda, MD

malaria next generation vaccine GlaxoSmithKline malaria (prevention) Phase II

(recombinant) Research Triangle Park, NC (plasmodium falciparum) www.gsk.com

Medicines in Development: Vaccines | 2017 27

Infectious Diseases
Drug Name Organization Indication Development Phase

MEDI8897/SP0232 MedImmune RSV infections (prevention) Phase II/III

(monoclonal antibody vaccine) Gaithersburg, MD (infants) www.medimmune.com
Sanofi Pasteur www.sanofi.com
Swiftwater, PA

Men ABCWY vaccine GlaxoSmithKline meningococcal A,B,C,W and Y disease Phase II

Research Triangle Park, NC (prevention) (adolescents) www.gsk.com

Men Quad TT Sanofi Pasteur meningococcal A,C,W,Y disease Phase III

(second-generation meningococcal Swiftwater, PA (prevention) (adults, children, elderly) www.sanofi.com
ACYW conjugate vaccine)

MER4101 Mercia Pharma influenza (prevention) Phase I

(MAS-1-adjuvanted seasonal New York, NY (elderly) www.merciapharma.com
inactivated influenza vaccine)

MMR vaccine GlaxoSmithKline measles, mumps, rubella (prevention) Phase III

Research Triangle Park, NC (pediatric) www.gsk.com

mRNA-1325 Moderna Therapeutics Zika virus infections (prevention) Phase I/II

(messenger RNA vaccine) Cambridge, MA www.modernatx.com

mRNA-1388 Moderna Therapeutics Chikungunya virus infections Phase I

(messenger RNA vaccine) Cambridge, MA (prevention) www.modernatx.com

mRNA-1440 Moderna Therapeutics influenza (prevention) Phase I

(influenza virus H10N8 messenger Cambridge, MA www.modernatx.com
RNA vaccine)

Medicines in Development: Vaccines | 2017 28

Infectious Diseases
Drug Name Organization Indication Development Phase

mRNA-1851 Moderna Therapeutics influenza (prevention) Phase I

(influenza virus H7N9 messenger Cambridge, MA www.modernatx.com
RNA vaccine)

mRNA MRK-1777 Merck infections (prevention) Phase I

(messenger RNA vaccine) Kenilworth, NJ www.modernatx.com
Moderna Therapeutics
Cambridge, MA

MVA-BN Filo Bavarian Nordic Ebola virus infections (prevention) Phase III
(monovalent vaccine) Morrisville, NC www.bavarian-nordic.com
Janssen Vaccines and Prevention
Leiden, Netherlands

MVA-BN Filo Bavarian Nordic Ebola virus infections (prevention), Phase II

(multivalent vaccine) Morrisville, NC Marburg virus infections (prevention) www.bavarian-nordic.com
Janssen Vaccines and Prevention (adults, elderly)
Leiden, Netherlands

MVA-BN RSV Bavarian Nordic RSV infections (prevention) Phase II

(recombinant RSV vaccine) Morrisville, NC (adults, elderly) www.bavarian-nordic.com

Na-APR-1 Sabin Vaccine Institute hookworm infections (prevention) Phase I completed

(hookworm monovalent vaccine) Washington, DC www.sabin.org

Nanoflu™ Novavax seasonal influenza (prevention) Phase I

seasonal influenza nanoparticle Gaithersburg, MD (elderly) www.novavax.com
vaccine

Medicines in Development: Vaccines | 2017 29

Infectious Diseases
Drug Name Organization Indication Development Phase

NasoVAX™ Altimmune seasonal influenza (prevention), Phase II

recombinant influenza vaccine Gaithersburg, MD pandemic influenza (prevention) www.altimmune.com
(intranasal)

NB-1008 NanoBio seasonal influenza (prevention) Phase I

(influenza intranasal vaccine) Ann Arbor, MI www.nanobio.com

NDV-3 NovaDigm Therapeutics recurrent vulvovaginal candidiasis Phase I/II

(alum-adjuvanted recombinant Brookline, MA (prevention) www.novadigm.net
protein vaccine)

NmVac-4 A/C/Y/W-135 DT JN-International Medical meningococcal A,C,W,Y disease Phase II completed

(meningococcal conjugate vaccine) Oakland, Nebraska www.jn-vaccines.com

NuThrax™ Emergent BioSolutions anthrax (pre-exposure prevention) Phase II

anthrax vaccine adsorbed with Gaithersburg, MD (Fast Track) www.emergentbiosolutions.com
CPG 7909 adjuvant

PanBlok Protein Sciences pandemic influenza (prevention) Phase II

influenza virus vaccine Meriden, CT www.proteinsciences.com

PBSVax™ Profectus Biosciences HIV infections (treatment) Phase I

HIV-MAG DNA vaccine Baltimore, MD www.profectusbiosciences.com

HIV infections (prevention) Phase I

www.profectusbiosciences.com

Medicines in Development: Vaccines | 2017 30

Infectious Diseases
Drug Name Organization Indication Development Phase

PENNVAX®-GP Inovio Pharmaceuticals HIV infection Phase I

Clade A, B, C, D HIV DNA vaccine Plymouth Meeting, PA (prevention) www.inovio.com

Pepvax Helocyte CMV infections in patients under- Phase II

cytomegalovirus peptide vaccine New York, NY going stem cell transplantation www.helocyte.com
(prevention)

PF-06290510 Pfizer invasive Staphylococcus aureus Phase II

(4-antigen Staphylococcus aureus New York, NY infections in surgical populations www.pfizer.com
vaccine) (prevention) (Fast Track)

PF-06425090 Pfizer primary clostridium difficile infection Phase III

(adjuvant-formulated modified vaccine) New York, NY (prevention) (Fast Track) www.pfizer.com
vaccine) (adults, elderly)

PF-06482077 Pfizer invasive and non-invasive Phase I

(pneumococcal vaccine) New York, NY pneumococcal infections www.pfizer.com

PF-06760805 Pfizer invasive Group B Streptococcus Phase I

(multivalent vaccine) New York, NY infections (prevention) www.pfizer.com

PF-06886992 Pfizer serogroups ABCWY meningococcal Phase I

New York, NY infections (prevention) www.pfizer.com

PfSPZ-Cvac Sanaria Falciparum malaria (prevention) Phase I

(live unattenuated malaria vaccine Rockville, MD www.sanaria.com
plus chloroquine)

Medicines in Development: Vaccines | 2017 31

Infectious Diseases
Drug Name Organization Indication Development Phase

PfSPZ-GA1 Sanaria Falciparum malaria (prevention) Phase II

(live attenuated malaria vaccine) Rockville, MD (Fast Track) www.sanaria.com

plague injectable vaccine DynPort Vaccine Yersinia infections (prevention) Phase II

ORPHAN DRUG Falls Church, VA www.csra.com/dvc

PR5i (V419) Merck DTP-HepB-polio-Hib infections application submitted

(pediatric hexavalent Kenilworth, NJ (prevention) (infants) www.merck.com
combination vaccine) Sanofi Pasteur www.sanofi.com
Swiftwater, PA

pre-pandemic Avian influenza Vaxart avian influenza (treatment) Phase I

vaccine (oral tablet) South San Francisco, CA www.vaxart.com

Px563L Pfenex anthrax (prevention) Phase I

(recombinant protective San Diego, CA www.pfenex.com
antigen vaccine)

PXVX0047 PaxVax adenovirus infections Phase I

(adenovirus type 4 and Redwood City, CA (prevention) www.paxvax.com
type 7 vaccine)

Rabies VRVg Sanofi Pasteur rabies (prevention) Phase II

(purified vero rabies vaccine) Swiftwater, PA www.sanofi.com

Remune® Immune Response BioPharma HIV-1 infections (adult and pediatrics) application submitted
GP120-depleted HIV-1 vaccine Atlantic City, NJ (treatment) www.immuneresponsebiopharma.com
ORPHAN DRUG

Medicines in Development: Vaccines | 2017 32

Infectious Diseases
Drug Name Organization Indication Development Phase

RemuneX® Immune Response BioPharma HIV-1 infections (treatment) Phase III

HIV combination vaccine Atlantic City, NJ www.immuneresponsebiopharma.com

rotavirus vaccine PATH rotavirus infections (prevention) Phase II

Seattle, WA www.path.org
SK Chemicals
Gyeonggi-do, Korea

RSV F protein vaccine Novavax RSV infections (prevention) Phase III

Gaithersburg, MD (maternal immunization) (Fast Track) www.novovax.com

RSV infections (prevention) Phase II

(elderly) (Fast Track) www.novavax.com

RSV infections (prevention) Phase I

(6 months-5 years of age) (Fast Track) www.novavax.com

RSV recombinant vaccine GlaxoSmithKline RSV (prevention) Phase II

Research Triangle Park, NC (maternal immunization) www.gsk.com

RSV vaccine GlaxoSmithKline RSV infections (prevention) Phase II

(replication-defective recombinant Research Triangle Park, NC www.gsk.com
vaccine)

RSV vaccine Sanofi Pasteur RSV infections in infants (prevention) Phase I

Swiftwater, PA www.sanofi.com

Medicines in Development: Vaccines | 2017 33

Infectious Diseases
Drug Name Organization Indication Development Phase

S. pneumococcal next-generation GlaxoSmithKline streptococcus pneumonia disease Phase II

vaccine Research Triangle Park, NC (prevention) (infants) www.gsk.com

Shan 6 Sanofi Pasteur hepatitis B, diphtheria, tetanus, Phase II

(DTP-HepB-Polio-Hib pediatric Swiftwater, PA pertussis (DTP), haemophilus infections, www.sanofi.com
hexavalent vaccine) poliomyelitis (prevention)

Shigella conjugated and outer GlaxoSmithKline Shigella diarrhea (prevention) Phase II

membrane vaccine Research Triangle Park, NC www.gsk.com

Shigella vaccine LimmaTech Biologics Shigella infections (prevention) Phase II

(Flexyn2a) Schlieren, Switzerland (Fast Track) www.lmtbio.com

STEBVax Integrated Biotherapeutics toxic shock syndrome from Phase I

recombinant detoxified SEB vaccine Rockville, MD Staphylococcus enterotoxin B www.integratedbiotherapeutics.com
exposure (prevention)

Streptococcal B conjugated vaccine GlaxoSmithKline Streptococcal B infections Phase II

Research Triangle Park, NC (prevention) www.gsk.com
(maternal immunization)

TAK-003 Takeda Pharmaceuticals dengue (prevention) Phase III

(dengue vaccine) Deerfield, IL www.takeda.com

TAK-021 Takeda Pharmaceuticals enterovirus A infections Phase I

(EV71 enterovirus A vaccine) Deerfield, IL (prevention) www.takeda.com

Medicines in Development: Vaccines | 2017 34

Infectious Diseases
Drug Name Organization Indication Development Phase

TAK-195 Takeda Pharmaceuticals poliomyelitis (prevention) Phase I

(sabin-strain inactivated polio Deerfield, IL www.takeda.com
vaccine)

TAK-214 Takeda Pharmaceuticals norovirus infections (prevention) Phase II

(norovirus vaccine) Deerfield, IL (adults, elderly) www.takeda.com

TDENV GlaxoSmithKline dengue (prevention) Phase I/II

(tetravalent dengue virus vaccine) Research Triangle Park, NC www.gsk.com
U.S. Army Medical Research
and Materiel Command
Fort Detrick, MD

Triplex Helocyte CMV infections in patients under- Phase II

cytomegalovirus peptide vaccine New York, NY going stem cell transplantation www.helocyte.com
(prevention)

tuberculosis recombinant Sanofi Pasteur tuberculosis (prevention) Phase II

subunit vaccine Swiftwater, PA www.sanofi.com

tuberculosis recombinant vaccine GlaxoSmithKline tuberculosis (prevention) Phase II

Research Triangle Park, NC www.gsk.com

UTI vaccine Sequoia Sciences reduction of recurrent urinary tract Phase I

St. Louis, MO infections caused by multi-drug www.sequoiasciences.com
resistant bacteria (Fast Track)

Medicines in Development: Vaccines | 2017 35

Infectious Diseases
Drug Name Organization Indication Development Phase

V114 Merck pneumococcal infections (prevention) Phase II

(pneumoconjugate 15-valent vaccine) Kenilworth, NJ (adults, children, elderly) www.merck.com

V160 Merck CMV infections (treatment) Phase I completed

(CMV vaccine) Kenilworth, NJ www.merck.com

V180 Merck dengue (prevention) Phase I completed

(tetravalent subunit vaccine) Kenilworth, NJ www.merck.com

V212 Merck herpes zoster (prevention) Phase III

(inactivated VZV vaccine) Kenilworth, NJ www.merck.com

V920 Merck Ebola virus infections (prevention) Phase III

(Ebola vaccine) Kenilworth, NJ www.merck.com

Vaxchora® PaxVax cholera (prevention) (pediatric) Phase III

cholera vaccine, live, oral Redwood City, CA www.paxvax.com

VaxiGrip® QIV IM Sanofi Pasteur

quadrivalent inactivated Swiftwater, PA influenza (prevention) Phase III
influenza vaccine (6-35 months of age) www.sanofi.com

VBI-1501A VBI Vaccines CMV infections (prevention) Phase I

Cambridge, MA www.vbivaccines.com

Medicines in Development: Vaccines | 2017 36

Infectious Diseases
Drug Name Organization Indication Development Phase

VCL-HB01 Vical HSV-2 infections (treatment) Phase II

(naked plasmid DNA vaccine) San Diego, CA www.vical.com

VesiculoVax™ Profectus Biosciences Ebola/Marburg virus infections Phase I

Ebola virus vaccine Baltimore, MD (prevention) www.profectusbiosciences.com

VLA15-101 Valneva Lyme disease (prevention) Phase I

(hexavalent protein subunit vaccine) Lyon, France (Fast Track) www.valneva.com

VLA-84 Valneva Clostridium difficile infections Phase II

(recombinant fusion protein vaccine) Lyon, France (prevention) www.valneva.com

VXA-A1.1-H1 (H1N1) Vaxart influenza (prevention) Phase II

(oral influenza vaccine) South San Francisco, CA www.vaxart.com

VXA-G1.1-NN Vaxart norovirus infections (prevention) Phase I

(oral norovirus vaccine) South San Francisco, CA www.vaxart.com

VXA-RSV-f Vaxart RSV infections (prevention) Phase I

(oral RSV vaccine) South San Francisco, CA www.vaxart.com

Zika virus vaccine Sanofi Pasteur Zika virus infections (prevention) Phase I
(inactivated Zika vaccine) Swiftwater, PA www.sanofi.com

Medicines in Development: Vaccines | 2017 37

Other Diseases
Drug Name Organization Indication Development Phase

polyclonal antibody stimulator Cancer Advances gastro-esophageal reflux disease Phase II

(fusion peptide) Durham, NC (see also cancer) www.canceradvancesinc.com

RiVax® + TVax Soligenix ricin poisoning Phase I

heat stable recombinant Princeton, NJ (pre-exposure prevention) www.soligenix.com
subunit vaccine
ORPHAN DRUG

SELA-070 Selecta Biosciences tobacco use disorder and Phase I

(immune stimulation Watertown, MA relapse prevention www.selectabio.com
2nd-generation vaccine)

SELA-212 Selecta Biosciences gout (treatment) Phase II

pegsiticase/synthetic vaccine Watertown, MA www.selectabio.com
particle-rapamycin)

TA-CD vaccine Celtic Pharma cocaine use disorder Phase II

Bermuda
National Institute on Drug Abuse
Rockville, MD

The content of this report has been obtained through public, government and industry sources, and the Springer "Adis Insight” database based on the latest
information. Report current as of October 23, 2017. The medicines in this listing include medicines being developed by U.S.-based companies conducting trials in the
United States and abroad, PhRMA-member companies conducting trials in the United States and abroad, and foreign companies conducting clinical trials in the United
States. Some products may not be in active clinical trials. The information may not be comprehensive. For more, specific information about a particular product,
contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA's website, www.phrma.org.

Medicines in Development: Vaccines | 2017 38

Definitions

Application Submitted—An application for marketing has been submitted by the company to the U.S. Food and Drug Administration (FDA).

Fast Track—Upon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a
serious condition and fill an unmet medical need. When considering a biopharmaceutical company’s request for Fast Track designation for an investigational drug or
biologic, the FDA evaluates whether it will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress
from a less severe condition to a more serious one, and whether a condition can be adequately addressed by available therapy. With Fast Track designation, early and
frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to
quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.

Orphan Designation—Upon request by a sponsor, the FDA can grant special status (“orphan status”) to a drug or biologic to treat a rare disease or condition.
In order to receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or
condition that affects usually fewer than 200,000 people in the United States.

Phase I—Researchers test the investigational drug or biologic in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate
its initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects.

Phase II—The investigational drug or biologic is given to volunteer patients, usually between 100 and 500, to determine whether it is effective, identify an
optimal dose, and to further evaluate its short-term safety.

Phase III—The investigational drug or biologic is given to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients
(but sometimes many more), to generate statistically significant evidence to confirm its safety and effectiveness. Phase III studies are the longest studies
and usually take place in multiple sites around the world.

Medicines in Development: Vaccines | 2017 39