www.euvaccine.eu

European Vaccine Initiative

Supporting the development of urgently
needed vaccines for global healthSophie Houard, Director of Vaccine Development

GHIT-PDP Webinar Session 5 EVI/MVI Developing Effective and Affordable Vaccines throughPartnerships March 24 2022

Today’s catalyst for tomorrow’s vaccinesIntroduction PDP
Situation
Important Infectious Diseases are Neglected by funders

Only USD $4.05 billion (<2%) of the estimated $240 billion annual spend on health R&D is for poverty-relateddiseases
Every year diseases of poverty affect 1.7 billion people, and kill >10 million

Problem•Absence, or limited market potential of products for low-income populations, even with major public healthvalue but low commercial return, results in low private sector engagement and restricted innovation in
global health R&D technologies

This triggered in the 1990’s the creation of Product Development Partnerships (PDPs) focusing ontechnologies that:1.

target diseases that are disproportionately affecting low- and middle-income countries

2.

are affordabe, accessible and available to low-income populations
2Introduction: PDPs-Non-profit organisations that work to address the absence of commercial
incentive to develop innovative tools for populations affected by povertyrelated, neglected diseases-Public health-driven and focused on patients’ needs in low- and middle-income
populations (LMIC) with a high disease burden-Cover specific research gaps or the full innovation cycle, from early discovery
stages to the implementation of a product-R&D portfolio approach: an R&D process that simultaneously develops
multiple candidates to minimize risks associated with product failures during
the lengthy development process and helps facilitate a greater number ofappropriate products and combinations of products passing through thepipeline-Partnership-based: work with academic, public research institutions, private
sector, governments, and civil society - including partners from LMIC

-Bring together financial, technical & in-kind contributions from public & private
sectorIntroduction PDPs
PDP
Technologies: vaccines, treatments, diagnostics, devices and vector
controls

Diseases: poverty-related diseases and TB, HIV/AIDS, and malaria, as wellas improved tools for women’s and children’s health2010-2020 achievements
66 products reached the market
LOGO>375 products in development
Research capacity strengthened at >550 sites
in > 80 countries
Keeping the Promise: PDP COALITION MEMBERS
Building Partnerships
Creating Solutions
Saving Lives4

About EVI•European Vaccine Initiative (EVI) is a

Our strengths
In-house expertise

non-profit, science-driven organisation

Strategic
competencies,and extensive vaccine
development
experience•Supports the development of safe,
effective and affordable vaccines for
global health•Lean, cost-efficient virtual biotech

Capacity building

business model•1998: European Malaria Vaccine
initiative (EMVI), hosted by SSI in
Copenhagen (first European PDP)
•2010: Independent legal structure;
new name (EVI), broader scope, HQ in
Heidelberg.

Strategic alliances,tools and training for
tomorrow’s vaccines

Emerging
infectious
diseases
Diarrheal
diseases

Projectmanagement

Leishmaniasis
Malaria

Vaccines

Operational
R&D Support

Cross-cutting
vaccinology

Cross-cutting
activities

Creating consortia andcoordinating
multinational projects

Wide portfolio of R&D
projects covering
Research
vaccine candidates ininfrastructure,different stages ofcapacity
development
strengthening, control
testing, policy andnetworkingSupporting researchand development
across all stages

Communicationto academia,
pharmaceutical andbiotech networks,
policy makers &donors
5Valley of Death for diseases of poverty

EVI

Funding/Investment
highRESOURCE
SPublic Funding
and Universities

Private Sector

NETWORKKNOWHOW

Funding andKnowledge Gap

Manufacturing-Innovation Process

Low
Basic
research

Preclinical

PreBasic
EVI main expertiseclinic
researc
al

GMP

GMP

late preclinical and early clinical development

Toxandsafety

Tox
andsafet
yPhaseIPhaseII+IIIPhasPhaseeI
II+III
Vaccine manufacturing

Target product profile, roadmaps, Regulatory affairs, science communication

LaunchLaunch6

EVI Projects Portfolio
Pre-clinical proof
of concept

Clinical proof
of concept
Phase I

Phase IIa

Cross-cutting
activities

Development
Phase IIb

Phase III

Phase IVMalaria

Zika Virus Infection
Nipah virus disease
COVID-19: current stage: funding secured

FLUCOPØ € 200 million
mobilised for clinicaldevelopment ofvaccines
Ø Collaborating
partners: 444

VAC2VAC

2 different vaccine
candidates

INNO4VAC

Diarrheal diseases

PrIMAVeRa

Leishmaniasis

ISIDORe> 40 vaccine
formulations clinicallytestedTRANSVAC 2 & TRANSVAC-DS

several different vaccine
candidates

7

Malaria Vaccine candidates
Pre-clinicalproof of concept

Clinical proof of concept
Phase I

Phase IIa

Development
Phase IIb

Phase III

Phase IV
RTS,S

Pre-erythrocytic
stage

R21
ME-TRAP (prime – target)
PfSPZ-CVacMalaria

BK-SE36 CpG

Blood stage

NPC-SE36/CpG

PfRH5G2019-208
G2016-106
G2014-109
T2018-151

PfRipr5
Placental Malaria

Comparative testing

PAMVAC

G2020-214

PRIMVACTransmission Blocking

Pfs25/Pfs230

Multi stage
8

Partnerships with GHIT Fund and Japanese partners
PAMVAC and PRIMVAC Placental malaria vaccine candidates developed byUniversity of Copenhagen and Inserm to reduce the incidence and severity ofmalaria in pregnancy, protecting the mother and unborn child already early inpregnancy
G2020-214

Clinical development

SE36 Malaria blood stage vaccine candidate developed at RIMD, Osaka University
aiming at protecting against clinical diseaseG2014-109
Phase Ib SE36+ AlOH

G2016-106
Phase Ib Improving theimmunogenicity SE36+ AlOH
with CpG adjuvant (Ken Ishi)

G2019-208
Preparing Phase IINPC-SE36/CpG

PfRipr5 Protein malaria blood stage vaccine candidate developed by Ehime University incollaboration with Sumitomo Dainippon Pharma Co., Ltd., Japan.
T2018-151
Preclinical development
9Partnerships with GHIT Fund and Japanese partners
1. Why the business model of PDPs is important to vaccine R&D of infectious diseases (Malaria, TB, NTDs)?
Industry has limited economic incentive, such as intellectual property rights, to develop drugs or technologies forconditions like poverty-related and neglected diseases.
PDP are non-profit (focused on their mission not profitability), this allows development of health products/ technologies forpeople who are neglected by traditional markets.
PDPs facilitate global collaborations between public, private, academic and philanthropic sectors. They generally use private
sector approaches in their R&D activities, while leveraging mainly public and philanthropic funds and working with external
partners. This allows for sharing of risks and benefits in pursuit of a common goal that would not otherwise be attainable.
2. How GHIT’s establishment in 2013 impacted the R&D work of EVI?
-providing access to Japanese innovations, capacity and investment-allowing to establish new scientific collaborations with Japanese R&D entities-catalyzing synergies between organizations- supporting R&D research from early stage to full clinical development, insuring for the most promising products a startand continued development.
GHIT Fund has been crucial in supporting R&D work to develop a more robust pipeline to fight against infectious diseases.
10Experience working with Japanese partners

Partnership with GHIT fund and Japanese partners• Achievements
From basis science to clinical development: successful preclinical developments and phase I clinical trials and future
clinical development underway for neglected population, and for even more neglected population: mother and babies• Lessons learned
Complementary multidisciplinary expertise is important, however trustful relationship between partners is critical.
The support, openness and flexibility of GHIT Fund team has been instrumental to overcome project hurdles• Challenge
Distance between Japan and Europe and Africa: lowering the frequency of face-to face meetings that are importantfor nurturing relationship and affecting the shipment of clinical trial samples between partners. This is even moreexacerbated by travel restriction, supply chain disruption related to COVID-19 pandemics or geopolitical situation• Expectations from Japanese partners
Continuation of the current partnerships, more innovation from Japanese researchers to continue filling the pipeline
for poverty-related, neglected diseases, looking for new collaborations
11COVID and Vaccine R&D
1.

In 2020, the first year of the COVID-19 pandemic, global
funding for basic research and product development forneglected diseases was $3,937m, a drop of $172m (-4.2%)
from 2019 (single year story won’t tell the whole story)

2.

The immediate impact of COVID-19 seems to have fallen
mostly on clinical trials3.

COVID-19 interrupted clinical trials in low- and middleincome countries

4.

It is assumed that this drop was due to the difficulties ofconducting trials in the face of lockdowns and travelrestrictions
G-Finder 2021

12COVID and Vaccine R&D
The COVID-19 pandemic-severe economic reduction around the world- fight against the virus has cost governments billions of dollars-the policy focus is shifting towards pandemic preparedness.
As a consequence, PDPs are already facing the risk of a funding shortfall.
Other infectious diseases continue to devastate vulnerable populations, year afteryear, in much the same way as COVID-19 has over the last 2 years.
Ongoing epidemics of disease with similar symptoms (febrile illnesses) makes thedetection of new pathogens with pandemic potential more difficult, hence
increasing the risk of a next pandemic.
GHIT Fund investment and partnership with Japanese R&D entities are vital todeveloping innovative tools to tackle these diseases and enhancing global healthsecurity.
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Thanks to GHIT Fund
Annual meetings SE36 vaccine partners 2015----201914

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