Malaria Vaccine Pipeline

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1 Malaria Vaccine Pipeline Perspectives and Challenges Carla Botting World Vaccine Congress Asia June 2008

2 Discussion Points Scope of the problem: the burden and challenge of malaria Malaria vaccine goals State of malaria vaccine development Vaccine challenges MVI focus and perspective

3 Malaria s Reach and Retreat

4 Ultimate Goal (again): Malaria Eradication

5 What is the Goal of the Malaria Vaccine Community? To develop an 80% efficacious malaria vaccine by 2025 that would provide protection for longer than four years.

6 The Deadliest Parasite: Plasmodium Falciparum > 90% of disease burden in sub-saharan Africa Africa's leading cause of mortality (20%) in children age 0 to 5 years Main cause of clinical and severe malaria and death Image: Plasmodium falciparum from Medical Structural Genomics of Pathogenic Protozoa

7 State of Malaria Vaccine Development 30 Number of vaccine candidates Preclinical Safety trials-non- Safety trials - Efficacy trials- endemic endemic endemic MVI sponsored Others *Source: The Malaria Product Pipeline, The George Institute for International Health, September 2007, modified to reflect recent changes in MVI s portfolio

8 What are the Challenges? R&D Challenges Business Development Challenges Financing Challenges

9 R&D Challenges No vaccine has ever been developed for human use against parasites There are no known correlates of immunity for malaria vaccines to establish proof of concept

10 Business Development Challenges Historically, work on malaria vaccines has been conducted by the military, government and academia, due to Limited financial return anticipated Major technical and scientific hurdles Complicated regulatory pathways

11 Financing Challenges Current funding for malaria research is starkly inadequate Vaccine costs at least $500 million from lab to jab Government and NGO push funding is essential (i.e. MVI with Gates Foundation support) Pull mechanisms also needed Advance market commitments from governments and promises of future purchases by the public sector

12 PATH Malaria Vaccine Initiative Created in 1999 with a grant from the Bill & Melinda Gates Foundation A program of PATH Mission: To accelerate the development of malaria vaccines and ensure their availability and accessibility in the developing world Vision: A world free from malaria

13 Malaria Vaccine Targets and the If the vaccine targets. Plasmodium Lifecycle Its goal is to. Preerythrocytic Stage Blood-stage Sexual transmission blocking Prevent infection Reduce clinical disease Prevent the spread of parasites by mosquitoes

14 MVI R&D Strategy Antigens SBRI WEHI Adjuvants / Formulations IDRI Intercell etc. 80% efficacious vaccine Viral and bacterial vectors etc. Platforms (& Delivery) ELISA, GIA, T Cell, ADCI Human Challenge Evaluation Technologies

15 MVI s Portfolio, June 2008 Construct Selection Process Dev Final Formulation Toxicology Phase 1a Phase 1/2a Phase 1b Phase 2b Phase 3 Monash MSP4 ICGEB/BBI PvRII WRAIR/GSK AMA1 AS01/AS02 GSK RTS,S AS01/AS02 Sanaria PfSPZ GenVec Ad5/CSP- LSA1-Ag2 + Ad5/MSP1- AMA1 LaTrobe MSP2 ISA 720 MVDB AMA1-C1 ISA 720 Future Portfolio Goals: 8 Preclinical Candidates (4) 4 Early Clinical Programs (3) 1 Late Clinical Program (1) Adjuvanted Recombinant Proteins Viral Vectored Live Attenuated

16 Objective of the RTS,S Program Successfully test the most advanced malaria vaccine that may protect infants and children, living in malaria endemic regions, from Plasmodium falciparum malaria disease

17 RTS,S Clinical Research Center Network IRSS - Centre Muraz KHRC, Kintampo KCCR, Kumasi HAS, Lambarene KEMRI - Kisumu KEMRI - Kilifi JMP, Korogwe IHDRC, Bagamoyo UNC, Lilongwe RTS,S - MVI-GSK Program in Africa CISM, Manhiça

18 Sanaria A Different Approach Targets the whole parasite Uses a live, attenuated parasite

19 Preparing for Malaria Vaccines Availability: Assessing demand Regulatory processes Accessibility: Preparing countries for the vaccine introduction Decision-making framework A world free from malaria

20 Final Thoughts Goal is to eradicate malaria: this will not happen without vaccines Malaria vaccine R&D needs more funding Partnerships are the key to success