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NEGLECTED DISEASE PRODUCT PIPELINE

Candidates by sub-disease

This page presents in-depth, candidate-level information on the R&D product pipeline for a subset of neglected diseases as at October 2015. It covers diseases that are grouped up in G-FINDER and in the main pipeline table (e.g. kinetoplastid infections), and breaks this down to show the pipeline candidates for each individual sub-disease (e.g. Chagas’ disease, leishmaniasis and sleeping sickness). The information is sorted in descending order by number of products per category.

Select the hyperlinked diseases in the list at the top of the page (or the product tiles below) to go directly to the relevant section of the pipeline. To return back to the top of the page, simply select the floating ‘Back to top’ icon in the bottom right-hand corner of your browser window. To return to the overview page at any time, there is a link provided at the top of the page.

Kinetoplastids

Chagas' disease

21
products in
the pipeline
chagas vaccine
chagas diagnostics_OL_RGB
chagas drugs_OL_RGB
Vaccines
(13 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
ASP-2 Kyushu University
Cruzipain National Administration of Laboratories and Institutes of Health (ANLIS)
Ministry of Health of Argentina
GP82 Universidade Federal de São Paulo
Live attenuated Trypanisoma cruzi Instituto de Patología Experimental-CONICET
Universidad Nacional de Salta Argentina
Live Trypanosoma rangeli Servicio Nacional de Chagas Córdoba Argentina
MASP University of Texas at El Paso
Tc24 Sabin Vaccine Institute
Tc52 Universidad de Buenos Aires
Helmholtz Centre for Infection Research, Germany
TcG1 Sabin Vaccine Institute
University of Texas Medical Branch
TcG2 Sabin Vaccine Institute
University of Texas Medical Branch
TcG4 Sabin Vaccine Institute
University of Texas Medical Branch
TcVac2 University of Texas Medical Branch
TSA-1 Sabin Vaccine Institute
Diagnostics
(5 candidates)
Product/Candidate name Key developers/partners Early development Late development
Chunap (Chagas urine nanoparticle test) Johns Hopkins University
LAMP Test Foundation for Innovative New Diagnostics (FIND)
INGEBI/CONICET
London School of Hygiene and Tropical Medicine
Pontificia Universidad Javeriana and Universidad de los Andes
Eiken Chemical Co
24-kDa fusion protein ELISA Instituto Nacional de Laboratorios de Salud
Universitat de Barcelona
Universidade Federal de Goiás
University of Giessen
Electrochemical impedance spectroscopy Oswaldo Cruz Foundation
Universidade Federal de Pernambuco
PATH Chagas Immunochromatographic Strip Test (ICS) PATH
Drugs
(3 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
E1224/benznidazole (combination treatment) Drugs for Neglected Diseases initiative (DNDi)
Eisai
Nitroimidazole Drugs for Neglected Diseases initiative (DNDi)
University of Auckland
TB Alliance
Monash University
Epichem
Murdoch University
Federal University of Ouro Preto (UFOP) Brazil
Institut Pasteur Korea (IPK) South Korea
Oxachagas Drugs for Neglected Diseases initiative (DNDi)
Anacor Pharmaceuticals Inc
SCYNEXIS Inc
Murdoch University
Wuxi AppTech
Sandexis
Laboratory of Microbiology Parasitology and Hygiene (LMPH), University of Antwerp

Leishmaniasis

16
products in
the pipeline
leish drugs_OL_RGB
leish vaccine_OL_RGB
chagas diagnostics_OL_RGB
Drugs
(6 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Anfoleish Drugs for Neglected Diseases initiative (DNDi)
PECET (Program for the Study and Control of Tropical Diseases), Universidad de Antioquia Medellin Colombia
Humax Pharmaceutical, Colombia
Corifungin Acea Biotech
Sandler Centre for Drug Discovery (UCSF)
CpG-D35 Drugs for Neglected Diseases initiative (DNDi)
University of Osaka
VL-2098 Drugs for Neglected Diseases initiative (DNDi)
TB Alliance
Advinus Therapeutics
Endolytics
Nitroimidazole backup (VL) Drugs for Neglected Diseases initiative (DNDi)
TB Alliance
Auckland University
Laboratory of Microbiology Parasitology and Hygiene (LMPH) University of Antwerp
WuXi AppTech
Oxaleish programme   (primary lead: DNDi/Oxa-2035804) Drugs for Neglected Diseases initiative (DNDi)
Anacor Pharmaceuticals
SCYNEXIS Inc
Vaccines
(5 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
LEISH-F1 Infectious Disease Research Institute (IDRI)
LEISH-F2 Infectious Disease Research Institute (IDRI)
LEISH-F3 Infectious Disease Research Institute (IDRI)
Gennova Biopharmaceuticals
LdNH36 with Lutzomyia sandfly antigens Sabin Vaccine Institute
LeishDNAvax Charité – Universitätsmedizin Berlin
Drugs for Neglected Diseases initiative (DNDi)
Indian Institute of Chemical Biology
Institut Pasteur de Tunis
London School of Hygiene and Tropical Medicine (LSHTM)
MOLOGEN AG
Rajendra Memorial Research Institute of Medical Sciences, India
The Hebrew University of Jerusalem
Diagnostics
(5 candidates)
Product/Candidate name Key developers/partners Early development Late development
ELISA test for Leishmania antigens Foundation for Innovative New Diagnostics (FIND)
Drugs for Neglected Diseases initiative (DNDi)
International Centre for Diarrhoeal Disease Research Bangladesh (ICDDR,b)
Kenya Medical Research Institute (KEMRI)
LAMP Test Foundation for Innovative New Diagnostics (FIND)
Royal Tropical Institute, Netherlands
Wellcome Trust
Sanger Institute
TiPharma
Eiken Chemical Co Ltd
IDRI diagnostic next generation Infectious Disease Research Institute (IDRI)
WHO Special Programme for Research and Training in Tropical Diseases
DPP Leishmaniasis RDT Infectious Disease Research Institute (IDRI)
Chembio Diagnostics Systems Inc.
QuantiFERON-Leishmania Banaras Hindu University

Sleeping Sickness

7
products in
the pipeline
chagas drugs_OL_RGB
Lepdiagnostics_OL_RGB
kinetoplastids vectorcontrol_OL_RGB
Drugs
(3 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Fexinidazole Drugs for Neglected Diseases initiative (DNDi)
HAT Platform Partners
Sanofi-Aventis
Swiss Tropical and Public Health Institute
Oxaborole SCYX-7158 Drugs for Neglected Diseases initiative (DNDi)
Anacor Pharmaceuticals Inc
Pace University
SCYNEXIS Inc
Swiss Tropical and Public Health Institute
Advinus Therapeutics
DB829 (CPD-0802) Consortium for Parasitic Drug Development
Georgia State University
The University of North Carolina at Chapel Hill
Diagnostics
(2 candidates)
Product/Candidate name Key developers/partners Early development Late development
LAMP Test Foundation for Innovative New Diagnostics (FIND)
Murdoch University
Obihiro University
Eiken Chemical Co Ltd
Lateral-flow RDT (2nd generation)

Foundation for Innovative New Diagnostics (FIND)

Standard Diagnostics

Vector Control Products
(2 candidates)
Product/Candidate name Key developers/partners Early development Late development
Genetic modification of a tsetse fly gut bacterium blocking parasite proteins Swansea University
Identification of different chemical blends to repel tsetse flies Université des Montagnes

Diarrhoeal diseases

Shigella

13
products in
the pipeline
chagas vaccine
Vaccines
(13 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Chemically prepared glycoconjugate National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health & Human Development
VirG-based live attenuated (WRSS1 WRSs3 WRSf3) Walter Reed Army Institute of Research (WRAIR)
GVXN SD133 GlycoVaxyn
Inactivated trivalent Shigella whole cell PATH
GMMA GSK (ex-Novartis Vaccines Institute for Global Health)
GuaBA-based live attenuated (CVD1208S) University of Maryland (UMB) Baltimore
34kDa OMP National Institute of Cholera and Enteric Diseases, India
DB Fusion PATH
InvaplexAR Walter Reed Army Institute of Research (WRAIR)
OMV University of Navarra, Spain
PSSP1 International Vaccine Institute (IVI)
Synthetic glycoconjugate Institut Pasteur
Ty21a typhoid vaccine expressing Shigella LPS Protein Potential

Enteroaggregative E.coli (EAggEC)

8
products in
the pipeline
DDvaccine_OL_RGB
Vaccines
(8 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
ACE527 (aroC omp F and Omp C-based live attenuated; may include dmLT adjuvant) Johns Hopkins Bloomberg School of Public Health
PATH
Pierrel Research USA
TD Vaccines A/S
China National Biotec Group
ETVAX PATH
Scandinavian BioPharma
Anti-adhesin based subunit vaccine US Naval Medical Research Center (NMRC)
PATH
dmLT National Institute of Allergy and Infectious Diseases (NIAID)
PATH
Tulane University
Anti-adhesin-toxoid fusion (MEFA) Kansas State University (KSU)
Johns Hopkins Bloomberg School of Public health (JHBSPH)
LT-ST fusion/LTB-ST conjugate The International Enteric Vaccine Consortium (EntVac)
Global Health and Vaccination Research (GLOBVAC)
STOPENTERICS
PATH
Second-generation 1208S attenuated
Shigella vaccine expressing CF/CS
antigens and LT toxoid
Center for Vaccine Development, University of Maryland
Typhetec Prokarium

Rotavirus

5
products in
the pipeline
leish vaccine_OL_RGB
Vaccines
(5 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
BRV-PV Serum Institute of India
BRV-TV ChengDu Institute of Biological Products Co Ltd (CDIBP)
Instituto Butantan São Paulo
Shantha Biotech
RV3_BB PATH
Murdoch University
Australian Government
Bio-Farma
Gadjah Mada University
Otago University
Royal Children’s Hospital
University of Melbourne
WHO
P2-VP8 recombinant subunit rotavirus
vaccine
PATH
Heat stable Rotavirus Vaccine Hilleman Laboratories (Merck MSD and Wellcome Trust joint venture)

Cholera

3
products in
the pipeline
RFvaccine_OL_RGB
Cryptodrugs_OL_RGB
Vaccines
(2 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
PXVX-0200 PaxVax Inc
Live attenuated Vibrio cholerae strain 638 (CV638) Finlay Institute
Drugs
(1 candidate)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
AKT10082 Akthelia Pharmaceuticals

Giardia

1
product in
the pipeline
BPMdiagnostics_OL_RGB
Diagnostics
(1 candidate)
Product/Candidate name Key developers/partners Early development Late development
Multiplex fluorescence optofluidic microscopy for diagnosis of enteric parasites California Institute of Technology

Multiple diarrhoeal diseases

1
product in
the pipeline
Cryptodrugs_OL_RGB
Drugs
(1 candidate)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
AKT10081 Akthelia Pharmaceuticals

Helminth infections

Schistosomiasis

15
products in
the pipeline
BPMvaccine_OL_RGB
chagas drugs_OL_RGB
BPMdiagnostics_OL_RGB
Vaccines
(11 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Bilhvax (Sh-GST28) Eurogentec
French National Institute of Health and Medical Research (Inserm)
Institut Pasteur
Sm28-GSTe Institute Pasteur
Sm28-TPIe Harvard School of Public Health
Sm97 paramyosin Cornell University
Case Western Reserve University
National Institute of Allergy and Infectious Diseases (NIAID)
SmTSP-2c (tetraspanin D) Sabin Vaccine Institute PDP
Sm14 (Schisto) Brazillian Innovation Agency
Oswaldo Cruz Foundation
CT-SOD State University of New York
Oswaldo Cruz Foundation
Brown University
rSm-p80 Texas Tech University
Sm23 Johns Hopkins
Harvard University
Sm29 Oswaldo Cruz Foundation
The George Washington University
Sm-p80-VR1020 Texas Tech University
Drugs
(3 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III

Co-Arinate FDC (Artesunate-Sulfamethoxypyrazine/

Pyrimethamine)

Dafra Pharma Research & Development BVBA
Praziquantel paediatric Astellas Pharma
Merck Serano
Swiss TPH
TI Pharma
Deuterated praziquantel analogues CoNCERT Pharmaceuticals Inc
US National Institutes of Health (NIH)
Diagnostics
(1 candidate)
Product/Candidate name Key developers/partners Early development Late development
Up-converting phosphore technology lateral flow assay (UCP-LF strop) Leiden University Medical Center
Ampath Laboratories

Onchocerciasis

4
products in
the pipeline
RFvaccine_OL_RGB
Dengue drugs_OL_RGB
Vaccines
(2 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Ov-103 The Onchocerciasis Vaccine for Africa (TOVA) Initiative
Sabin Vaccine Institute PDP
Ov-RAL-2 The Onchocerciasis Vaccine for Africa (TOVA) Initiative
Sabin Vaccine Institute PDP
Drugs
(2 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Moxidectin Pfizer Inc
WHO/TDR
Medicines Development for Global Health
Emodepside Bayer AG
Drugs for Neglected Diseases initiative (DNDi)
Astellas Pharma

Hookworm

2
products in
the pipeline
RFvaccine_OL_RGB
Vaccines
(2 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
NaAPR-1 Sabin Vaccine Institute PDP
NaGST-1 Sabin Vaccine Institute PDP

Lymphatic filariasis (elephantitiasis)

2
products in
the pipeline
Lepdiagnostics_OL_RGB
Diagnostics
(2 candidates)
Product/Candidate name Key developers/partners Early development Late development
Filaria Detect IgG4 ELISA InBios
Ov16/Wb123 biplex rapid test PATH
US National Institutes of Health (NIH)
Standard Diagnostic (SD-Alere)

Whipworm (Trichuriasis)

1
product in
the pipeline
Lepdrugs_OL_RGB
Drugs
(1 candidate)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Oxantel pamoate Swiss TPH
University of Basel

Salmonella infections

Non-typhoidal S. enterica (NTS)

7
products in
the pipeline
NTSvaccine_OL_RGB
Vaccines
(7 candidates)

Sleeping sickness

Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
WTO5 Microscience Ltd
Bivalent conjugate (O:45-CRM197
and O:9-CRM197)
Novartis Vaccines Institute for Global Health
COPS: FliC conjugates using CVD 1925 and CVD 1943 reagent strains University of Massachusetts Boston (UMB)
Bharat Biotech
Wellcome Trust
CVD 1931 and CVD 1944 (Bivalent live oral NTS vaccine) University of Maryland Center for Vaccine Development
NTS-GMMA GSK (ex-Novartis Vaccines Institute for Global Health)
O:4-TT US National Institutes of Health (NIH)
Lanzhou Institute of Biological Products Co Ltd
OmpD University of Birmingham

Typhoid

6
products in
the pipeline
typhoidvaccine_OL_RGB
Vaccines
(6 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
O:2-TT + Vi-TT (Bivalent conjugate enteric fever vaccine) US National Institutes of Health (NIH)
Lanzhou Institute of Biological Products
Vi-CRM197 (conjugate typhoid vaccine) Novartis Vaccines Institute for Global Health
Biological E
CVD 1902 + CVD 909 (Live oral bivalent enteric fever vaccine) University of Maryland Center for Vaccine Development
Bharat biotech
Vi-DT (conjugate typhoid vaccine) International Vaccine Institute (IVI)
US National Institutes of Health (NIH)
PT BioFarma
O:2-CRM197 + Vi-CRM197 (Bivalent conjugate enteric fever vaccine) Novartis Vaccines Institute for Global Health
Biological E
O:2-DT + Vi-DT (Bivalent conjugate enteric fever vaccine) International Vaccine Institute (IVI)

Bacterial pneumonia & meningitis

Pneumococcal pneumonia

10
products in
the pipeline
pneumonia vaccine_OL_RGB
Vaccines
(10 candidates)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
PhtD/pneumolysoid/PcpA common protein vaccine Sanofi Pasteur
Pneumococcal whole cell vaccine PATH
Boston Children’s Hospital
V114 Merck MSD
Serum Institute of India
GSK2189242A PATH
GSK
MRC labs
London School of Hygiene and Tropical Medicine (LSHTM)
Live Recombinant Attenuated Salmonella Vaccine Arizona State University
Trivalent protein Genocea Biosciences
Liverpool School of Tropical Medicine (LSTM)
PneuGEM Mucosis BV
Radboud University Nijmegen Medical Centre
Pneumococcal 13-valent conjugate vaccine SinoVac Biotech Ltd
Low-cost pneumococcal conjugate vaccine PATH
Serum Institute of India
Novel conjugation technology using common protein carriers Multiple Antigen Presenting System (MAPS) PATH
Affinivax Inc

Meningitis

2
products in
the pipeline
Buruli ulcervaccine_OL_RGB
BPMdiagnostics_OL_RGB
Vaccines
(1 candidate)
Product/Candidate name Key developers/partners Discovery

Pre-

clinical

Phase I Phase II Phase III
Low-cost thermostable ACWXY meningococcal conjugate vaccine PATH
Serum Institute of India
Diagnostics
(1 candidate)
Product/Candidate name Key developers/partners Early development Late development
Paper-based microfluidic POC device University of Texas at El Paso

This is the first comprehensive global picture of the neglected disease R&D pipeline since 2012. It looks at 34 of the 35 neglected diseases within the scope of G-FINDER survey (Ebola is not included), covering all product categories including vector control products, and all stages of research from early stage R&D through to product registration. The data is the result of a comprehensive review of the neglected disease R&D landscape conducted by Policy Cures in late 2015, and is presented as a snapshot of the pipeline as at October 2015. For details on the methodology behind this review please see the bottom of the home page; for a quick overview of the diseases and associated products covered in this pipeline you can view the R&D matrix here.

Policy Cures Research Logo, Brisbane Street, email info[at]policycuresresearch.org