PATH Malaria Vaccine Initiative

Christian Loucq, MD
Director, PATH Malaria Vaccine Initiative
2 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,
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culturally relevant solutions, enabling communities worldwide to
break longstanding cycles of poor health.
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; roughly
3.3 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. 3
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
Scientific Commercial
• No vaccine is in human use • Limited market in
against a parasite developed countries
• Malaria parasite has • Malaria-endemic countries
~6,000 genes, many more are mostly poor
than a virus
• How to predict a vaccine • Vaccine development is
candidate’s success? high-risk, high-cost

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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…

SANARIA
MALARIA ERADICATION THROUGH VACCINATION

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Our portfolio
Preclinical Candidate
Translational Projects
Feasibility Studies* Vaccines
Antigens Delivery Preclinical Phase 1 Phase 2a Phase 2b Phase 3

SBRI Crucell Sanaria GSK Biologicals

Aeras
(antigen (Ad26/35- (whole irradiated sporozoite) (RTS,S/AS01)
(rBCG)
selection) CSP)

GenVec LaTrobe/QIMR
WEHI ICGEB
(MSP2)
(AMA1) (Ad28) (PvRII)

LaTrobe/WRAIR VGX/U Penn NIH/QIMR

(AMA1) (pDNA/EP) (AMA1)

WEHI/NIH Lipoxen/NIH
(EBA/Rh (Imu/Xen)

Juvaris/NIH
(JVRS-100)

USMMVP/NIH/
GenVec
(Ad5/Protein+Adj)
Pre-erythrocytic

NIH Blood-stage
(conjugates)
Transmission-
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*Selected projects blocking
 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 $54,946,328
US 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

Expenditures
Program Services $34,345,404 $57,500,765
Management 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)

RTS,S program

Evaluation technologies

Pf blood-stage feasibility
studies

Pv vaccine program

Transmission-blocking vaccine
program

Pf attenuated sporozoite
program

Next-generation Pf PE vaccines

$ $20 $40 $60 $80 $100 $120

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: Scientific Advisors include:
• Ashley Birkett • John H. Adams
• Carla Botting • John Boslego
• Alan Brooks • Brendan Crabb
• Sally Ethelston • David Kaslow
• Santiago Ferro • Tom Monath
• Christian Loucq • Moriya Tsuji
• Katya Spielberg • Marie Paul Kieny
• David Salisbury
• George Siber

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Portfolio management at MVI

Director
Christian Loucq

Vaccine Science Portfolio

Advisory Council

Leadership Team
(Unit Heads)

R&D Portfolio
Unit Staff Members Management Committee
(Functional Competencies) Technical Advisory Groups
Technical
TechnicalAdvisory
AdvisoryGroups
Groups

Vaccine Strategic
Business Vaccine Strategic
Business Vaccine
Program Strategic
Teams
Business
Development Teams Vaccine
Program Teams
Development
DevelopmentTeams Program
Teams ProgramTeams
Areas

Portfolio Management
System 16
Advisory bodies
Summary
• MVI’s goal of an ≥80%
effective malaria vaccine
is achievable.
• Vaccine development is
“…With a vaccine candidate now
costly, but the benefits
in a late stage Phase III trial
are huge. across Africa, we are closer than
• Individual and smaller ever before to having a new tool
institutional funders can that could strengthen the arsenal
at our disposal….”
make a difference.

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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

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