March 24, 2022

Malaria Vaccine Development
throughInnovation and Partnerships

Yimin Wu, Ph.D

Outline• Mission of PATH’s Malaria Vaccine Initiative as a PDP• The first malaria vaccine, RTS,S/AS01 (RTS,S), is a product of innovationand partnerships• Developing 2nd generation malaria interventions through innovation andpartnership• Key elements in a productive partnership

PATH Mission:
advance health equity through innovation and partnerships

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Center for Vaccine
Innovation and Access(CVIA)
spans every stage of vaccine
research, development, andintroduction to make lifesavingvaccines widely available tocommunities around the globe.

Malaria Vaccine Initiative
Enteric & Diarrheal
Respiratory infection and Maternal
Immunization
Pollio4

RTS,S/AS01 is a Product of Innovation + Partnership

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RTS,S pilot introduction (MVIP) involves many partners

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2nd Gen Malaria Vaccine Development

Clinically validated Ph 3
(Pilot introduction, RTS,S)
Early stage (Ph 1/Ph 2)

Transmissionblocking
Pfs48/45,
Pfs230Blood-stage
Rh5 Complex
Var2CSA

Sporozoite
infection

Killing infected
hepatocytes

CSP

Whole SPZ

Adapted from: Maier et al., Trends in Parasitology Vol 35, Issue 6, p. 481-2

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2nd gen malaria vaccine development via Innovations + partnership
YearProject

2013

Express pre-erythrocytic stage antigen, screen for antiinfection malaria vaccine candidate

2014

Express mosquito stage antigen, screen for transmission
blocking vaccine candidate

2016

Design and display Pfs230 as TBV candidate

2019

Co-delivery of Pfs230 and CSP with a novel CoPoP
liposomes-based adjuvant

2019

Preclinical development of Pfs230 as TBV candidate
formulated with SA-1, a novel TLR7 adjuvant

2020

Evaluate full-length CSP formulated with SA-1, incomparison with RTS,S/AS01 as a benchmark

2022

Preclinical development of an anti-CSP mAb derived fromRTS,S human trialPartners

9Innovation + Partnership Advanced Pfs230D1/SA-1 as a TBV Candidate

SA-1
Pre-IND
meeting with FDA
IND-Enabling
Repeated-dose
Toxicology in Rats
Tangential Flow
Filtration

Chromatography

Large ScaleFermentation

Pre-culture
Scale up

10Seed StockInnovation + Partnershipenabled evaluation of flPfCSP in new adjuvants+ Full-Length CSP

SA-1
Head-to-Headcomparison withRTS,S as benchmark+ Full-Length CSP
11Key elements in a productive partnership• Excellence in science, innovation• Ehime University, a premier academic malaria research partner• Sumitomo Dainippon Pharma, a big pharma with novel adjuvant technology• PATH MVI, a leading PDP in malaria vaccine development• Complementary skill sets for a common goal
• Target product profile to guide project design• Clear go/no go criteria to guide investment

Special Challenges for Global Health Initiatives• Partnership critical for product development• Assemble complementary skill sets: specialized knowledge required•••••

PathogenCutting edge technology
Production, quality, safety testing
Regulatory
Clinical trials• Target Product Profile guides process toward impact• Developing world and developed world have different requirements• IP must meet global access requirement• Clear go/no go criteria to assure efficient use of precious resources• Connect partnerships to accelerate toward success• Research to Development to Implementation

Thank you14