PATH Malaria Vaccine Initiative

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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