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2017 Vaccines in Development

Allergies

Drug Name

Organization

Indication

Development Phase

allergy immunotherapeutic vaccine

United Therapeutics Hauppauge, NY

IgE-mediated allergy response

Phase I

AR101

(oral immunotherapy)

Aimmune Therapeutics Brisbane, CA

peanut allergy (treatment)

(Fast Track)

Phase III

ASP-0892

(immunotherapeutic plasmid based DNA vaccine)

Astellas Pharma US Northbrook, IL Immunomic Therapeutics Rockville, MD

peanut allergy (treatment)

(Fast Track)

Phase I

HAL-MPE1

(subcutaneous immunotherapy)

HAL Allergy Leiden, Netherlands

peanut allergy (treatment)

Phase I

injectable MPL allergy vaccine

Allergy Therapeutics West Sussex, United Kingdom

seasonal allergic rhinitis due to either ragweed, grass or tree pollen (prevention)

Phase III

ragweed mix vaccine

Woodmont Pharmaceuticals Atlanta, GA

seasonal allergic rhinitis and allergic conjunctivitis due to ragweed

Phase I

SAR439794

Immune Design

peanut allergy (treatment)

Phase I

(peanut allergy vaccine)

Seattle, WA

Sanofi

Bridgewater, NJ

Allergies

Drug Name

Organization

Indication

Development Phase

STAGR320

(sublingual desensitization immunotherapy)

Stallergenes Greer London, United Kingdom

house dust mite allergic rhinitis

Phase III

Viaskin® Milk epicutaneous immunotherapy

DBV Technologies

milk allergy (treatment) (pediatric) (Fast Track)

Phase II

Summit, NJ

Viaskin® Peanut epicutaneous immunotherapy

DBV Technologies

peanut allergy (treatment) (pediatric) (Fast Track)

Phase III

Summit, NJ

Alzheimer's Disease Drug Name

Organization

Indication

Development Phase

ACI-24

(liposomal therapeutic anti-Abeta vaccine)

AC Immune Lusanne, Switzerland

Alzheimer’s disease-like characteristics in patients with Down syndrome (treatment)

Phase I

ACI-35

AC Immune Lusanne, Switzerland Janssen Research & Development Raritan, NJ

Alzheimer’s disease in patients with Down syndrome (treatment)

Phase I

(anti-pTau vaccine)

 

CAD106

Novartis Pharmaceuticals East Hanover, NJ

Alzheimer's disease (treatment)

Phase II/III

(VLP immunotherapy vaccine)

UB-311

United Neuroscience Hauppauge, NY

Alzheimer's disease (treatment)

Phase II

(anti-amyloid endobody vaccine)

Autoimmune Diseases Drug Name

Organization

Indication

Development Phase

CrohnsVaxCrohn's disease vaccine

Immune Response BioPharma Atlantic City, NJ

Diamyd®/GABA autoimmune diabetes vaccine/ gamma-aminobutyric acid (GABA)

Diamyd Medical Stockholm, Sweden University of Alabama Birmingham, AL

type 1 diabetes (treatment) (pediatric)

Phase I

DV-100

DiaVacs La Jolla, CA

type 1 diabetes (treatment)

Phase I completed

(autologous dendritic cell immunotherapy vaccine)

IFN-Kinoid (inactivated immunogenic interferon alpha-based vaccine)

Neovacs

systemic lupus erythematosus

Phase II

Paris, France

(Fast Track)

NeuroVaxmultiple sclerosis vaccine

ORPHAN DRUG

Immune Response BioPharma Atlantic City, NJ

multiple sclerosis (Fast Track)

Phase II

Nexvax2®

ImmusanT

celiac disease (treatment)

Phase I

peptide-based vaccine

Cambridge, MA

RAVAXrheumatoid arthritis vaccine

Immune Response BioPharma Atlantic City, NJ

rheumatoid arthritis

Phase III

Zorcell

Immune Response BioPharma

psoriasis

Phase II

psoriasis vaccine

Atlantic City, NJ

Cancer

Drug Name

Organization

Indication

Development Phase

adagloxad simolenin (cancer immunotherapy)

OBI Pharma

metastatic breast

Phase II/III

Taipei, Taiwan

ADXS-DUAL (cancer immunotherapy)

Advaxis Princeton, NJ Bristol Myers-Squibb Princeton, NJ

cervical

Phase II

(with nivolumab)

ADXS-HER2

Advaxis

HER2-expressing metastatic solid tumors

Phase II

(cancer immunotherapy)

Princeton, NJ

ADXS-PSA (cancer immunotherapy)

Advaxis

metastatic castration-resistant prostate (monotherapy)

Phase I/II

Princeton, NJ

 

metastatic prostate (with pembrolizumab)

Phase I/II

AE37

Antigen Express

newly-diagnosed breast, metastatic triple negative breast (with pembrolizumab)

Phase II

(HER-2/neu li-key hybrid cancer vaccine)

Wellesley, MA

 

metastatic prostate (monotherapy)

Phase I

 

AlloStim® T-cell therapy-device combination

Immunovative Therapies Jerusalem, Israel

metastatic colorectal

Phase II

Cancer

Drug Name

Organization

Indication

Development Phase

AST-VAC1

(dendritic cell vaccine)

Asterias Biotherapeutics Fremont, CA Immunomic Therapeutics Rockville, MD

acute myeloid leukemia (AML)

Phase II

AutoSynVaxautologous synthetic vaccine

Agenus

cancer (prevention)

Phase I

Lexington, MA

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) (cancer immunotherapy)

Advaxis

high-risk locally advanced cervical

Phase III

Princeton, NJ

(Fast Track)

ORPHAN DRUG

 

metastatic cervical, metastatic head and neck (with durvalumab)

Phase II

metastatic anal (monotherapy)

Phase II

 

BB-MPI-03

Benovus Bio

AML, multiple myeloma, myelodysplastic syndromes

Phase I

(RNA-derived cancer vaccine)

Atlanta, GA

Cancer

Drug Name

Organization

Indication

Development Phase

BI 1361849 (mRNA cancer vaccine)

Boehringer Ingelheim Pharmaceuticals Ridgefield, CT

non-small cell lung cancer (NSCLC)

Phase II

BriaVaxSV-BR-1 GM cancer vaccine

BriaCell Therapeutics Berkeley, CA

breast

Phase I/II

CMB305

Immune Design

soft tissue sarcoma, NY-ESO-1 solid tumors (adult and elderly)

Phase II

(prime-boost immunotherapy)

Seattle, WA

ORPHAN DRUG

CMP-001

(virus-like particle cancer vaccine)

Checkmate Pharmaceuticals Cambridge, MA

malignant melanoma (with pembrolizumab)

Phase I

colorectal cancer vaccine (therapeutic cancer vaccine)

Targeted Diagnostics & Therapeutics Exton, PA Viral Gene Philadelphia, PA

colorectal

Phase I

CRS-207

Aduro Biotech

gastric (combination therapy), mesothelioma (combination therapy)

Phase II

(Listeria monocytogenes cancer vaccine)

Berkeley, CA

ORPHAN DRUG

ovarian (combination therapy)

Phase I/I

 

CV301

Bavarian Nordic

NSCLC (with nivolumab)

Phase II

(CEA/MUC-1 targeted immunotherapy)

Morrisville, NC

Cancer

Drug Name

Organization

Indication

Development Phase

DCVax®-Direct personalized immune therapy

Northwest Biotherapeutics Bethesda, MD

solid tumors

Phase I/II

DCVax®-L personalized immune therapy ORPHAN DRUG

Northwest Biotherapeutics Bethesda, MD

newly-diagnosed glioblastoma

Phase III

DCVax®-Prostate personalized immune therapy

Northwest Biotherapeutics Bethesda, MD

prostate

Phase II completed

DPV-001

UbiVac

definitely-treated stage III NSCLC

Phase II

(tumor-derived, autophagosome- enriched cancer vaccine)

Portland, OR

 

advanced prostate

Phase I

 

DPX E7 (peptide cancer vaccine)

Immunovaccine

human papillomavirus (HPV)-related anal, cervical, head and neck

Phase I/II

Halifax, Canada

DPX Survivac (peptide cancer vaccine)

Immunovaccine

ovarian (combination therapy)

Phase I

Halifax, Canada

(Fast Track)

ORPHAN DRUG

Cancer

Drug Name

Organization

Indication

Development Phase

DSP-7888

Boston Biomedical

glioblastoma (combination therapy)

Phase II

(peptide cancer vaccine)

Cambridge, MA

ORPHAN DRUG

 

hematologic malignancies, solid tumors

Phase I

Elenagen™ p62 anti-cancer DNA Vaccine

CureLab Oncology

solid tumors

Phase I/II

Canton, MA

EP-101

EpiThany

breast

Phase I

(multi-antigen vaccine)

Seattle, WA

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

ERC1671

Epitopoietic Research Pasadena, CA

glioblastoma

Phase II

(allogeneic/autologous cell vaccine)

ORPHAN DRUG

Cancer

Drug Name

Organization

Indication

Development Phase

ETBX-011

Etubics Seattle, WA NantCell Culver City, CA

colorectal, pancreatic

Phase I/II

(Ad5 CEA cancer vaccine)

ETBX-021

Etubics Seattle, WA NantCell Culver City, CA

breast

Phase I

(Ad5 HER2/neu cancer vaccine)

GALE-301

Galena Biopharma San Ramon, CA

endometrial, ovarian (prevention of recurrence)

Phase II completed

(folate binding protein E39-targeted peptide vaccine)

ORPHAN DRUG

GALE-301 + GALE-302 (immunogenic peptide vaccine combination)

ORPHAN DRUG

Galena Biopharma San Ramon, CA

breast, ovarian

Phase I completed

 

galinpepimut-S (WT1 cancer vaccine)

Sellas Life Sciences New York, NY

AML (Fast Track), chronic myeloid leukemia (CML), mesothelioma (Fast Track), multiple myeloma, ovarian (with nivolumab)

Phase II

ORPHAN DRUG

GBM-LAMP-Vax (DNA immunotherapeutic vaccine)

Immunomic Therapeutics Rockville, MD

newly-diagnosed glioblastoma

Phase II

Cancer

Drug Name

Organization

Indication

Development Phase

GI-4000

GlobeImmune Louisville, CO NantCell Culver City, CA

pancreatic (combination therapy)

Phase II

(mutated Ras cancer vaccine)

GI-6207

GlobeImmune Louisville, CO NantCell Culver City, CA

medullary thyroid cancer

Phase II

(CEA inhibitor cancer vaccine)

GI-6301

GlobeImmune Louisville, CO NantCell Culver City, CA

chordoma

Phase II

(brachyury peptide cancer vaccine)

advanced cancer

Phase I

 

GL 0817

Gliknik

head and neck, squamous cell

Phase II

(MAGE-A3 vaccine)

Baltimore, MD

ORPHAN DRUG

GRN 1201 (peptide cancer vaccine)

BrightPath Biotherapeutics Kurume, Japan

NSCLC (combination therapy), melanoma

Phase II

ICT-107

(dendritic cell vaccine)

ORPHAN DRUG

ImmunoCellular Therapeutics Calabasas, CA

newly-diagnosed glioblastoma

Phase III

Cancer

Drug Name

Organization

Indication

Development Phase

(dendritic cell vaccine)

ImmunoCellular Therapeutics Calabasas, CA

IMT1012

Immunotope

breast, ovarian

Phase I

(multi-peptide antigen cancer vaccine)

Doylestown, PA

INO-1400

(hTERT DNA cancer vaccine)

Inovio Pharmaceuticals Plymouth Meeting, PA

breast, lung, pancreatic

Phase I

INO-3106

Inovio Pharmaceuticals Plymouth Meeting, PA

precancerous lesions and malignancies

Phase I

(E6, E7 DNA cancer vaccine)

INO-5150

Inovio Pharmaceuticals Plymouth Meeting, PA

prostate

Phase I

(PSA, PSMA DNA cancer vaccine)

INT230-6

Intensity Therapeutics Westport, CT

cancer

Phase I/II

(cisplatin based cancer vaccine)

JNJ-64041757 (ADU-214) (Listeria monocytogenes immunotherapy)

Aduro Biotech Berkeley, CA Janssen Research & Development Raritan, NJ

NSCLC

Phase I

JNJ-64041809 (ADU-741) (Listeria monocytogenes immunotherapy)

Aduro Biotech Berkeley, CA Janssen Research & Development Raritan, NJ

prostate

Phase I

Cancer

Drug Name

Organization

Indication

Development Phase

KiroVAX-001

Kiromic

hematological malignancies

Phase I/II

(TAPA-pulsed dendritic cell vaccine)

Houston, TX

KiroVAX-002

Kiromic

hematological malignancies

Phase I/II

(TAPA-pulsed dendritic cell vaccine)

Houston, TX

KiroVAX-003

Kiromic

solid tumors

Phase I/II

(TAPA-pulsed dendritic cell vaccine)

Houston, TX

KiroVAX-004

Kiromic

solid tumors

Phase I/II

(TAPA-pulsed dendritic cell vaccine)

Houston, TX

LV305

Immune Design

breast, malignant melanoma, NSCLC, ovarian, sarcoma

Phase I

(RNA cancer vaccine)

Seattle, WA

ORPHAN DRUG

MEDI0457 (INO-3112) (DNA cancer vaccine)

Inovio Pharmaceuticals Plymouth Meeting, PA MedImmune Gaithersburg, MD

head and neck (HPV type 16/18) (with durvalumab)

Phase I/II

   

MUC-1 CD40L dendritic cell vaccine

MicroVAX

solid tumors

Phase I

Manassas, VA

MVA-BN brachyury vaccine (cancer immunotherapy)

Bavarian Nordic

solid tumors

Phase I

Morrisville, NC

Cancer

Drug Name

Organization

Indication

Development Phase

MVA p53 vaccine (modified vaccinia virus ankara vaccine expressing p53)

Tara Immuno-Oncology New York, NY

solid tumors

Phase I

MVI-118

Madison Vaccines

metastatic prostate

Phase I

(AR plasmind DNA vaccine)

Madison, WI

MVI-816

Madison Vaccines

biochemically recurrent prostate

Phase II

(plasmid DNA vaccine)

Madison, WI

 

metastatic castration-resistant prostate (with pembrolizumab)

Phase I

NEO-PV-01

Bristol-Myers Squibb Princeton, NJ Neon Therapeutics Cambridge, MA

bladder, melanoma, NSCLC (with nivolumab)

Phase I

(personalized neoantigen vaccine)

NeuVax® nelipepimut S (peptide cancer vaccine)

Galena Biopharma San Ramon, CA

triple negative HER2-positive breast (with trastuzumab), HER2-positive breast (with trastuzumab), ductal carcinoma in situ of breast

(Fast Track)

Phase II

 
 

gastric

Phase I completed

 

Cancer

Drug Name

Organization

Indication

Development Phase

Oncoquest™-CLL chronic lymphocytic leukemia vaccine

XEME Biopharma

chronic lymphocytic leukemia

Phase II

Lombard, IL

Oncoquest-L® personalized cancer vaccine

XEME Biopharma

non-Hodgkin lymphoma

Phase I completed

Lombard, IL

OncoVAX® personalized colorectal cancer vaccine

Vaccinogen

colorectal (Fast Track)

Phase III

Baltimore, MD

OSE-2101

OSE Immunotherapeutics Nantes, France

NSCLC

Phase III

(neo-epitopes cancer vaccine)

ORPHAN DRUG

ovapuldencel-T

AiVita Biomedical

ovarian

Phase II

Irvine, CA

PAN-301-1

Panacea Pharmaceuticals Gaithersburg, MD

prostate

Phase I

(nanoparticle-based cancer vaccine)

PDS0101

PDS Biotechnology North Brunswick, NJ

HPV-related cancer

Phase I

(cancer immunotherapy)

PEPIDH1M

Annias Immunotherapeutics Chapel Hill, NC

glioblastoma

Phase I/II

(dendritic cell cancer vaccine)

Cancer

Drug Name

Organization

Indication

Development Phase

PF-06753512

Pfizer New York, NY

prostate

Phase I

(cancer immunotherapy)

pLADD (personalized LADD immunotherapy vaccine)

Aduro Biotech

microsatellite stable colorectal

Phase I

Berkeley, CA

polyclonal antibody stimulator (fusion peptide)

Cancer Advances

gastric, pancreatic (see also other)

Phase III

Durham, NC

ORPHAN DRUG

 

colorectal

Phase II

 

Prophageheat shock protein vaccine

Agenus

newly-diagnosed glioblastoma

Phase II

Lexington, MA

ORPHAN DRUG

ProscaVaxPSA/IL-2/GM-CSF vaccine

OncBioMune Pharmaceuticals Baton Rouge, LA

prostate cancer

Phase I

PROSTVAC rilimogene galvacirepvec- rilimogene glafolivec

Bavarian Nordic Morrisville, NC Bristol-Myers Squibb Princeton, NJ

prostate cancer (combination

Phase II

therapy) (Fast Track)

PSMA VRP (viral vector vaccine)

AlphaVax

prostate

Phase I

Durham, NC

Cancer

Drug Name

Organization

Indication

Development Phase

PT 107 (allogeneic B7.1/HLA-A1 transfected tumor cell vaccine)

Pique Therapeutics

NSCLC

Phase II

Durham, NC

PVX-410

OncoPep North Andover, MA

smoldering multiple myeloma

Phase II

(multi-peptide cancer vaccine)

ORPHAN DRUG

REIC gene therapy vaccine

Momotaro-Gene

localized prostate

Phase I/II

Okayama, Japan

RG6180

Genentech South San Francisco, CA

cancer

Phase I

(personalized mRNA cancer vaccine)

rocapuldencel-T (dendritic cell vaccine)

Argos Therapeutics

renal cell (Fast Track)

Phase III

Durham, NC

seviprotimut-L (polyvalent antigen vaccine)

Polynoma San Diego, CA

melanoma

Phase III

ORPHAN DRUG

SL-701

(alpha-type 1 dendritic cell-based vaccine)

ORPHAN DRUG

Stemline Therapeutics New York, NY

glioblastoma (adults)

Phase II

stapuldencel-T (autologous dendritic cell vaccine)

SOTIO Prague, Czech Republic

prostate

Phase III

Cancer

Drug Name

Organization

Indication

Development Phase

SurVaxM peptide mimic vaccine

MimiVax

glioblastoma

Phase II

Rochester, NY

 

multiple myeloma

Phase I

 

tergenpumatucel-L + indoximod + chemotherapy (tumor cell vaccine)

NewLink Genetics

NSCLC (combination therapy)

Phase I

Ames, IA

TG4010

(MVA-MUC1-IL2 cancer vaccine)

Transgene Paris, France Bristol-Myers Squibb Princeton, NJ

NSCLC (with nivolumab)

Phase II

TLPLDC (tumor lysate particle loaded dendritic cell vaccine)

Cancer Insight San Antonio, TX Elios Therapeutics Austin, TX

melanoma

Phase II/III

 

ovarian

Phase I/II

 

TPIV 100/110 (HER2/neu peptide vaccine)

TapImmune

HER2/neu-positive breast

Phase I

Jacksonville, FL

TPIV 200 (folate receptor-alpha peptide vaccine)

ORPHAN DRUG

TapImmune

platinum-sensitive ovarian (Fast Track), platinum-resistant ovarian combination therapy), triple negative breast

Phase II

Jacksonville, FL

Cancer

Drug Name

Organization

Indication

Development Phase

TV-Brain-1

TVAX Biomedical

glioblastoma

Phase II

(personalized cancer cell vaccine and killer T-cell therapy)

Olathe, KS

TV-Kidney-1

TVAX Biomedical

renal cell

Phase II

(personalized cancer cell vaccine and killer T-cell therapy)

Olathe, KS

TVGV-1 vaccine (fusion protein vaccine)

TheVax Cape Canaveral, FL

HPV-related cancers

Phase II

VGX-3100

Inovio Pharmaceuticals Plymouth Meeting, PA

cervical dysplasia (HPV type 16/18)

Phase III

(therapeutic DNA vaccine)

 

vuval neoplasia (HPV type 16/18)

Phase II

viagenpumatucel-L (HS-110) (allogeneic vaccine)

Heat Biologics

NSCLC (with nivolumab)

Phase II

Durham, NC

Cancer

Drug Name

Organization

Indication

Development Phase

Vigil

Gradalis

advanced ovarian

Phase III

Dallas, TX

genetically-modified autologous tumor cell vaccine

advanced breast Phase II/III www.gradalisinc.com
advanced breast
Phase II/III
www.gradalisinc.com

Ewing's sarcoma (adults, children, elderly), advanced NSCLC, advanced, melanoma, gynecological

Phase I

WT2725

Sunovion Pharmaceuticals Marlborough, MA

hematological malignancies, solid tumors

Phase I

(peptide cancer vaccine)

Infectious Diseases Drug Name

Organization

Indication

Development Phase

Adacel+ tetanus, diphtheria, acellular pertussis (Tdap) booster vaccine

Sanofi Pasteur

Tdap booster (prevention)

Phase II

Swiftwater, PA

Afluria Quadrivalent® influenza vaccine

Seqirus

influenza (prevention) (6-59 months of age)

Phase III completed

Cambridge, MA

AGS-004

(autologous dendritic cell vaccine)

Argos Therapeutics Durham, NC University of North Carolina Chapel Hill, NC

HIV-1 infections (combination therapy)

Phase I

Infectious Diseases Drug Name

Organization

Indication

Development Phase

AGS-v (protein-based vaccine)

Imutex London, United Kingdom National Institute of Allergy and Infectious Diseases Bethesda, MD

mosquito-transmitted viral infections (prevention)

Phase I

antifungal multivalent oral vaccine

Immunitor

fungal infections (prevention and treatment)

Phase I/II

Vancouver, Canada

antimicrobial oral vaccine

Immunitor

bacterial infections (treatment)

Phase I/II

Vancouver, Canada

ASP0113

Astellas Northbrook, IL Vical San Diego, CA

cytomegalovirus (CMV) infections in transplant patients (prevention)

Phase III

(bivalent plasmid DNA-based vaccine)

ORPHAN DRUG

 

AV0328

Alopexx Vaccine

Phase I/II

(conjugated oligosaccharide vaccine against dPNAG [deacetylated polymeric- N-acetyl glucosamine])

Concord, MA

PNAG-expressing bacterial infections (prevention and treatment)

www.alopexx.com

Chikungunya vaccine (virus-like particle vaccine)

PaxVax Redwood City, CA

Chikungunya infections (prevention)

Phase II

Clostridium difficile toxoid vaccine

Sanofi Pasteur

Clostridium difficile infections

Phase III

Swiftwater, PA

(prevention) (Fast Track)

Infectious Diseases Drug Name

Organization

Indication

Development Phase

CodaVax® influenza A virus H1N1 vaccine

Codagenix

multi-season influenza (prevention)

Phase I

Farmingdale, NY

deltaFLU-LAIV (influenza virus delta NS1 vaccine)

Vivaldi Biosciences Fort Collins, CO

influenza (prevention)

Phase II

Dengvaxia® dengue tetravalent vaccine

Sanofi Pasteur

dengue (prevention)

Phase II

Swiftwater, PA

(Fast Track)

DNA-C (DNA HIV vaccine)

EuroVacc Amsterdam, Netherlands National Institute of Allergy and Infectious Diseases Rockville, MD

HIV infections (prevention) (combination with other HIV vaccines)

Phase I/II

Ebola recombinant viral vector vaccine

GlaxoSmithKline Research Triangle Park, NC

Ebola virus infections (prevention)

Phase II

Ebola virus vaccine (Ad26 EBOV vaccine)

Janssen Vaccines & Prevention Leiden, Netherlands

Ebola virus infections (prevention)

Phase III

Ebola virus vaccine + Matrix-M

Novavax

Ebola virus infections (prevention)

Phase I

Gaithersburg, MD

Fluarix® Quadrivalent influenza vaccine

GlaxoSmithKline Research Triangle Park, NC

seasonal influenza subtypes A and B (prevention) (6-35 months of age)

application submitted

Infectious Diseases Drug Name

Organization

Indication

Development Phase

Flucelvax®

Seqirus

influenza (prevention) (6-<48 months of age)

Phase I/II completed

influenza vaccine

Cambridge, MA

FluNhancerecombinant influenza vaccine

Protein Sciences

influenza (prevention)

Phase II

Meriden, CT

Fluzone® QIV HD quadrivalent inactivated influenza vaccine - high dose

Sanofi Pasteur

influenza (prevention) (elderly)

Phase III

Swiftwater, PA

GEN-003

Genocea Biosciences Cambridge, MA

herpes simplex virus (HSV) infections (treatment)

Phase II

(protein subunit T cell-enabled vaccine

GLS-5300

GeneOne Life Science Seoul, South Korea Inovio Pharmaceuticals Plymouth Meeting, PA

Middle East respiratory syndrome (MERS) (prevention), coronavirus infections (prevention)

Phase I

(DNA vaccine)

GLS-5700

GeneOne Life Science Seoul, South Korea Inovio Pharmaceuticals Plymouth Meeting, PA

Zika virus infections (prevention)

Phase I

(DNA-based synthetic vaccine)

Infectious Diseases Drug Name

Organization

Indication

Development Phase

GOVX-B11

GeoVax Labs

HIV infections (prevention)

Phase II

(clade-B DNA HIV vaccine)

Smyrna, GA

 

HIV infections (treatment)

Phase I

 

GS-4774

GlobeImmune

hepatitis C (treatment) (treatment naïve and virally suppressed)

Phase II

(T-cell immunity stimulator vaccine)

Louisville, CO

haemophilus recombinant vaccine

GlaxoSmithKline Research Triangle Park, NC

reduction of the frequency of COPD exacerbations associated with non-typeable haemophilus influenza and moreaxella catarrhalis

Phase II

HBV-002

Hawaii Biotech

West Nile virus infections (prevention)

Phase I

(recombinant subunit vaccine)

Honolulu, HI

hepatitis C vaccine (recombinant viral vector vaccine)

GlaxoSmithKline Research Triangle Park, NC

hepatitis C (prevention)

Phase II

HEPLISAV-B

Dynavax Technologies Berkeley, CA

hepatitis B (prevention)

application submitted

HBsAg-1018 vaccine

HepTcell

Altimmune

hepatitis B (treatment)

Phase I

peptide vaccine

Gaithersburg, MD

Infectious Diseases Drug Name

Organization

Indication

Development Phase

HIV recombinant proteins vaccine

GlaxoSmithKline Research Triangle Park, NC

HIV infections (prevention)

Phase II

HIV vaccine (Ad26 Mos HIV trivalent vaccine)

Janssen Vaccines and Prevention Leiden, Netherlands

HIV infections (prevention)

Phase II

HIV vaccine (Ad26 Mos HIV vaccine)

Janssen Vaccines and Prevention Leiden, Netherlands

HIV infections (prevention)

Phase II

HIV vaccine (MVA mosaic HIV vaccine)

Janssen Vaccines and Prevention Leiden, Netherlands

HIV infections (prevention)

Phase I/II

HIV vaccine (prime-boost vaccine)

Sanofi Pasteur

HIV infections (prevention)

Phase II

Swiftwater, NJ

HIV vaccine Ad4-Clade C

PaxVax Redwood City, CA

HIV infections (prevention)

Phase I

HIV vaccine Ad4-mGag

PaxVax Redwood City, CA

HIV infections (prevention)

Phase I

HIVAXreplication-defective HIV vaccine

GeneCure Biotechnologies Norcross, GA

HIV-1 infections (treatment)

Phase I

HSV529

Sanofi Pasteur

HSV-type 2 infections (prevention)

Phase I

(herpes simplex virus type 2 vaccine)

Swiftwater, PA

Infectious Diseases Drug Name

Organization

Indication

Development Phase

HTNV/PUUV DNA vaccine

Ichor Medical Systems San Diego, CA United States Army Medical Research and Materiel Command Fort Detrick, MD

hemorrhagic fever caused by hantaan virus and puumala virus (prevention)

Phase II

www.ichorms.com

IHV001

Profectus Biosciences Baltimore, MD

HIV infections (prevention)

Phase I

(subunit HIV vaccine)

Imvamune®

Bavarian Nordic

smallpox (prevention) (liquid-frozen)

Phase III

smallpox vaccine

Morrisville, NC

 

smallpox (prevention) (freeze-dried)

Phase II

Infanrix Hexa® combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated polio- myelitis, and adsorbed conjugated Haemophilus influenzae type b vaccine

 

diphtheria, haemophilus, hepatitis B, pertussis, polio, tetanus (prevention)

Phase III

GlaxoSmithKline Research Triangle Park, NC

influenza A virus vaccine H1N1 (Ii-key hybrid cancer vaccine)

Antigen Express

influenza (prevention)

Phase I

Wellesley, MA

influenza A virus vaccine H5N1 (Ii-key hybrid cancer vaccine)

Antigen Express

influenza (prevention)

Phase I

Wellesley, MA

Infectious Diseases Drug Name

Organization

Indication

Development Phase

influenza A virus H5N1 vaccine

Seqirus

influenza (prevention) (adults, elderly)

Phase III

Cambridge, MA

influenza A virus H5N8 vaccine

Seqirus

influenza (prevention)

Phase I

Cambridge, MA

influenza A virus H7N9 vaccine

EpiVax

influenza (prevention)

Phase I

Providence, RI

influenza H3N2 vaccine (intranasal)

FluGen

influenza (prevention)

Phase I

Madison, WI

influenza virus vaccine quadrivalent (plant-based VLP vaccine)

Medicago

seasonal influenza (prevention)

Phase III

Durham, NC

 

seasonal influenza (prevention) (elderly)

Phase II

influenza virus vaccine quadrivalent (aQIV-aQIV)

Seqirus

influenza (prevention)

Phase III

Cambridge, MA

(multi-antigen vaccine)

Inovio Pharmaceuticals Plymouth Meeting, PA

INO-4212

Inovio Pharmaceuticals Plymouth Meeting, PA

Ebola virus infections (prevention)

Phase I

(polyvalent DNA based vaccine)

Infectious Diseases Drug Name

Organization

Indication

Development Phase

(multi-antigen DNA vaccine)

Inovio Pharmaceuticals Plymouth Meeting, PA

ITV-1

Immunotech Laboratories Monrovia, CA

HIV infections (treatment)

Phase II

(inactivated pepsin fraction vaccine)

JNJ-61187165

Janssen Vaccines and Prevention Leiden, Netherlands

respiratory syncytial virus (RSV) infections (prevention)

Phase I completed

(RSV vaccine)

JNJ-61187191

Janssen Vaccines and Prevention Leiden, Netherlands

RSV infections (prevention)

Phase I completed

(RSV vaccine)

JNJ-63871860

Janssen Vaccines and Prevention Leiden, Netherlands

Escherichia coli infections (prevention)

Phase II completed

(multivalent glycoprotein conjugate vaccine)

JNJ-64400141

Janssen Vaccines and Prevention Leiden, Netherlands

RSV infections (prevention) (elderly)

Phase I

(RSV vaccine)

M-001

BiondVax Ness Ziona, Israel National Institute of Allergy and Infectious Diseases Bethesda, MD

influenza (prevention)

Phase II

(universal influenza vaccine)

malaria next generation vaccine (recombinant)

GlaxoSmithKline Research Triangle Park, NC

malaria (prevention) (plasmodium falciparum)

Phase II

Infectious Diseases Drug Name

Organization

Indication

Development Phase

MEDI8897/SP0232 MedImmune

RSV infections (prevention)

Phase II/III

(monoclonal antibody vaccine)

Gaithersburg, MD

(infants)

Sanofi Pasteur

Swiftwater, PA

Men ABCWY vaccine

GlaxoSmithKline Research Triangle Park, NC

meningococcal A,B,C,W and Y disease (prevention) (adolescents)

Phase II

Men Quad TT (second-generation meningococcal ACYW conjugate vaccine)

Sanofi Pasteur

meningococcal A,C,W,Y disease (prevention) (adults, children, elderly)

Phase III

Swiftwater, PA

MER4101

Mercia Pharma New York, NY

influenza (prevention) (elderly)

Phase I

(MAS-1-adjuvanted seasonal inactivated influenza vaccine)

MMR vaccine

GlaxoSmithKline Research Triangle Park, NC

measles, mumps, rubella (prevention) (pediatric)

Phase III

mRNA-1325

Moderna Therapeutics Cambridge, MA

Zika virus infections (prevention)

Phase I/II

(messenger RNA vaccine)

(messenger RNA vaccine)

Moderna Therapeutics Cambridge, MA

Chikungunya virus infections (prevention)

mRNA-1440

Moderna Therapeutics Cambridge, MA

influenza (prevention)

Phase I

(influenza virus H10N8 messenger RNA vaccine)

Infectious Diseases Drug Name

Organization

Indication

Development Phase

mRNA-1851

(influenza virus H7N9 messenger RNA vaccine)

Moderna Therapeutics Cambridge, MA

influenza (prevention)

Phase I

mRNA MRK-1777 (messenger RNA vaccine)

Merck Kenilworth, NJ Moderna Therapeutics Cambridge, MA

infections (prevention)

Phase I

MVA-BN Filo (monovalent vaccine)

Bavarian Nordic Morrisville, NC Janssen Vaccines and Prevention Leiden, Netherlands

Ebola virus infections (prevention)

Phase III

MVA-BN Filo (multivalent vaccine)

Bavarian Nordic Morrisville, NC Janssen Vaccines and Prevention Leiden, Netherlands

Ebola virus infections (prevention), Marburg virus infections (prevention) (adults, elderly)

Phase II

MVA-BN RSV (recombinant RSV vaccine)

Bavarian Nordic

RSV infections (prevention) (adults, elderly)

Phase II

Morrisville, NC

Na-APR-1

Sabin Vaccine Institute Washington, DC

hookworm infections (prevention)

Phase I completed

(hookworm monovalent vaccine)

Nanofluseasonal influenza nanoparticle vaccine

Novavax

seasonal influenza (prevention) (elderly)

Phase I

Gaithersburg, MD

Infectious Diseases Drug Name

Organization

Indication

Development Phase

NasoVAXrecombinant influenza vaccine (intranasal)

Altimmune

seasonal influenza (prevention), pandemic influenza (prevention)

Phase II

Gaithersburg, MD

NB-1008

NanoBio Ann Arbor, MI

seasonal influenza (prevention)

Phase I

(influenza intranasal vaccine)

NDV-3

(alum-adjuvanted recombinant protein vaccine)

NovaDigm Therapeutics Brookline, MA

recurrent vulvovaginal candidiasis (prevention)

Phase I/II

NmVac-4 A/C/Y/W-135 DT (meningococcal conjugate vaccine)

JN-International Medical Oakland, Nebraska

meningococcal A,C,W,Y disease

Phase II completed

NuThraxanthrax vaccine adsorbed with CPG 7909 adjuvant

Emergent BioSolutions Gaithersburg, MD

anthrax (pre-exposure prevention)

(Fast Track)

Phase II

PanBlok influenza virus vaccine

Protein Sciences

pandemic influenza (prevention)

Phase II

Meriden, CT

PBSVaxHIV-MAG DNA vaccine

Profectus Biosciences Baltimore, MD

HIV infections (treatment)

Phase I

 

HIV infections (prevention)

Phase I

Infectious Diseases Drug Name

Organization

Indication

Development Phase

PENNVAX®-GP Clade A, B, C, D HIV DNA vaccine

Inovio Pharmaceuticals Plymouth Meeting, PA

HIV infection

Phase I

(prevention)

Pepvax cytomegalovirus peptide vaccine

Helocyte New York, NY

CMV infections in patients under- going stem cell transplantation (prevention)

Phase II

PF-06290510

Pfizer New York, NY