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PATH Malaria Vaccine Initiative
Christian Loucq, MDDirector, PATH Malaria Vaccine Initiative2 December 2009
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MVI mission, vision, and goal
• Mission: To accelerate the development of malaria vaccines and ensure their availability and accessibility in the developing world
• Vision: A world free from malaria
• Goal: To develop by 2025 a malaria vaccine with 80% or greater efficacy that lasts for at least four years
MVI was established in 1999 as a program of PATH,an international nonprofit organization that creates sustainable,culturally relevant solutions, enabling communities worldwide to
break longstanding cycles of poor health.
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Malaria 101• A parasitic infection transmitted
through the bite of infected female Anopheles mosquitoes
• Plasmodium falciparum and P. vivax cause the vast majority of clinical cases
• An estimated 250 million cases of malaria occur every year; roughly3.3 billion people are at risk of contracting the disease.
• Of 900,000 deaths worldwide each year, 91% occur in Africa—most of them among infants and children under 5 years of age.
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How MVI works• MVI partners to achieve its mission; success depends on the
strength of its collaborations.
• MVI is a non-profit vaccine investor; it supports others to do the development.
• Partners include academia, government agencies, biotechs, and pharmaceutical companies.
• MVI identifies potentially promising malaria vaccine approaches for development.
• MVI systematically moves projects through the development process.
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Challenges to developing malaria vaccines
Commercial• Limited market in
developed countries• Malaria-endemic countries
are mostly poor• Vaccine development is
high-risk, high-cost
Scientific • No vaccine is in human use
against a parasite• Malaria parasite has
~6,000 genes, many more than a virus
• How to predict a vaccine candidate’s success?
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Malaria vaccines: The missing tool• Tools such as drugs, bed nets and insecticides have
reduced the burden of malaria in some areas, however – The parasite develops resistance to drugs– The mosquito develops resistance to insecticides
• From smallpox to polio to whooping cough, vaccines have offered a cost-effective and efficacious means of preventing disease and death.
• Malaria vaccines would represent powerful, complementary tools to existing interventions.
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MVI’s R&D strategy• Pre-erythrocytic vaccine approaches that
target P. falciparum
• Approaches that target P. vivax
• Transmission-blocking vaccine approaches that target P. falciparum and P. vivax
• Feasibility studies to ensure availability of vaccine approaches aligned with strategy
• Evaluation technologies across all program areas
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Strengths of MVI’s PDP model
• Strong and diverse collaborations to implement coherent R&D strategy
• Product development and testing• Develops products to fit within the existing
system• Combines public health imperative with private
sector rigor
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Our partners and collaborators…
SANARIAMALARIA ERADICATION THROUGH VACCINATION
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NIH(conjugates)
USMMVP/NIH/GenVec
(Ad5/Protein+Adj)
Juvaris/NIH(JVRS-100)
Lipoxen/NIH(Imu/Xen)
WEHI/NIH(EBA/Rh
NIH/QIMR
(AMA1)VGX/U Penn(pDNA/EP)
LaTrobe/WRAIR(AMA1)
LaTrobe/QIMR(MSP2)
ICGEB(PvRII)
GenVec
(Ad28)WEHI
(AMA1)
GSK Biologicals
(RTS,S/AS01)
Sanaria
(whole irradiated sporozoite)
Crucell
(Ad26/35-CSP)
Aeras(rBCG)
SBRI(antigen
selection)
Phase 3Phase 2bPhase 2aPhase 1PreclinicalDeliveryAntigens
CandidateVaccines
Translational ProjectsPreclinical
Feasibility Studies*
NIH(conjugates)
USMMVP/NIH/GenVec
(Ad5/Protein+Adj)
Juvaris/NIH(JVRS-100)
Lipoxen/NIH(Imu/Xen)
WEHI/NIH(EBA/Rh
NIH/QIMR
(AMA1)VGX/U Penn(pDNA/EP)
LaTrobe/WRAIR(AMA1)
LaTrobe/QIMR(MSP2)
ICGEB(PvRII)
GenVec
(Ad28)WEHI
(AMA1)
GSK Biologicals
(RTS,S/AS01)
Sanaria
(whole irradiated sporozoite)
Crucell
(Ad26/35-CSP)
Aeras(rBCG)
SBRI(antigen
selection)
Phase 3Phase 2bPhase 2aPhase 1PreclinicalDeliveryAntigens
CandidateVaccines
Translational ProjectsPreclinical
Feasibility Studies*
Transmission-blocking
Blood-stage
Pre-erythrocytic
Transmission-blocking
Blood-stage
Pre-erythrocytic
*Selected projects
Our portfolio
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Key accomplishments• The first large-scale Phase 3 trial of a malaria vaccine candidate,
called RTS,S, is underway in 7 African countries.• More than 30 African countries have endorsed a framework
that will pave the way for informed decision-making to use, or not, a malaria vaccine.
• Progress in developing and refining evaluation technologies that allow malaria vaccine researchers to assess vaccine approaches in vitro.
• The first-in-human trial of a vaccine approach modeled after the experiments of 40 years ago is currently underway.
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MVI revenue and expenditures
2008 (Actual) 2009 (Projected)Revenue
Foundations $33,775,636 $54,946,328US Government 3,010,947 5,402,614 Corporations 250 250 Individuals 2,076 2,000 Other (consultancies, honoraria, etc.) 95,366 100,000 Total Revenue $36,884,275 $60,451,192
ExpendituresProgram Services $34,345,404 $57,500,765Management and General 2,538,871 2,950,427 Total Expenditures $36,884,275 $60,451,192
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R&D partner funding (2009–2013)(in USD millions)
$ $20 $40 $60 $80 $100 $120
Next-generation Pf PE vaccines
Pf attenuated sporozoiteprogram
Transmission-blocking vaccine program
Pv vaccine program
Pf blood-stage feasibilitystudies
Evaluation technologies
RTS,S program
Funds available Funding gap (2010) Funding gap (2011–2013)
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Funding gaps• RTS,S
– Malaria transmission intensity (data for policymakers) – Phase 3 immunology (data for implementation, future R&D)– Phase 4 studies (post-licensure studies)
• Attenuated sporozoites • Prime-boost• Transmission-blocking• Human challenge trial facilities
– Critical to maintain facilities in “slow” periods
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MVI management and advisors MVI Leadership Team:• Ashley Birkett• Carla Botting• Alan Brooks• Sally Ethelston• Santiago Ferro• Christian Loucq• Katya Spielberg
Scientific Advisors include:• John H. Adams• John Boslego• Brendan Crabb• David Kaslow• Tom Monath• Moriya Tsuji• Marie Paul Kieny• David Salisbury• George Siber
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Portfolio management at MVI
DirectorChristian Loucq
Leadership Team(Unit Heads)
Technical Advisory Groups
Vaccine Science PortfolioAdvisory Council
Unit Staff Members(Functional Competencies)
R&D PortfolioManagement Committee
BusinessDevelopment Teams
Vaccine StrategicProgram TeamsBusiness
Development TeamsBusiness
Development Teams
Vaccine StrategicProgram TeamsVaccine StrategicProgram Teams
VaccineProgram Areas
Technical Advisory GroupsTechnical Advisory Groups
Portfolio Management System
Advisory bodies
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Summary• MVI’s goal of an ≥80%
effective malaria vaccine is achievable.
• Vaccine development is costly, but the benefits are huge.
• Individual and smaller institutional funders can make a difference.
“…With a vaccine candidate now in a late stage Phase III trial across Africa, we are closer than ever before to having a new tool that could strengthen the arsenal at our disposal….”
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Thank you to …
• The dozens of non-profit organizations, government agencies, companies, and scientists who collaborate with us
• The Bill & Melinda Gates Foundation, US Agency for International Development (USAID), ExxonMobil Foundation, and individual donors
