1. The EU’s research strategy and its impact on the HIV vaccine landscape
EHVA symposium at IAS2017
23 July 2017
The EU’s research strategy and its impact on the HIV vaccine landscape
Alessandra Martini, PhD
European Commission
Directorate-General "Research and Innovation"
Unit: 'Fighting infectious diseases and advancing public health'

2. The involvement of the EC in research and innovation
To develop and implement the European Research and Innovation policy agreed by its Member States (EU Council) and the European Parliament
G-FINDER 2016 report
The EU is the world's 2nd largest public funder of research on poverty-related and neglected infectious diseases

3. The fight against HIV/AIDS: one challenge, many instruments
Collaborative projects
Public-private partnership with big pharma
Public-public partnerships with EU Member States & beyond
Grants for small businesses
Blue sky research
Loans for small and big R&I companies

4. Collaborative research
SC1: EC funding instruments for feeding the pipeline
Resources
required
PUSH
PULL
Risk level
Discovery,
PoC
Preclinic
Clinical Phases
1-3
Upscaling
Manufacturing
Uptake Delivery
EDCTP
ERC
Horizon Prize
Collaborative research
InnovFin ID
IMI

5. HIV/AIDS research portfolio in H2020 * includes € 10m InnovFin ID loan
EUR million* ( )
Main areas:
Basic research (ERC), fellowships (MSCA)
& SME-instruments
Collaborative research (SC1)
host-pathogen interactions, genomics, mode of transmission, immune modulators, …
Development/optimisation novel diagnostics tools, vaccines, treatment and curative options, Development of tools for mHealth for patient empowerment
EDCTP2
* includes € 10m InnovFin ID loan
and € 38.5m EDCTP2 grants

6. SC1: Collaborations for HIV vaccine research
EHVA
5 years - €22.2m
Coord: Y. Levy, Inserm, FR
EAVI2020
5 years - € 23 m
Coord: R. Shattock, Imperial College London, UK
HIVACAR
5 years - € 6.7 m
Coord: F Garcia, IDIBAPS, Barcelona, SP
39 partners - 11 EU countries, 4 Sub-Sahara Africa, US
23 partners - 9 EU countries, Australia, Canada
14 partners – 5 EU countries, US, Canada
Develop Multidisciplinary Vaccine Platform (MVP) for prophylactic and therapeutic vaccines; test at least 2 candidates in phase I CT, identify immune correlates associated with control of HIV replication following immunological intervention
Design novel HIV-1 native envelope glycoproteins and novel highly conserved HIV immunogens to elicit broad humoral or cellular responses, test ~ 10 candidates in first-in man CT
Design and conduct proof-of-concept phase I/IIa CT for HIV functional cure: combines immune-based therapies (incl. therapeutic vaccines, broadly neutralizing antibodies and latency reversing agents
Feeding the pipeline for EDCTP2

7. Approaches for HIV vaccine development
Non-replicating vectors

8. Approaches for HIV vaccine development with EU-funded actions
DNA, MVA and ChAdOx1
tHIVconsvX (mosaic T cell antigens)
HTI (conserved beneficial T cell antigens)
Biobrick Library
Non-replicating vectors
IDLV, BCG, VSV
Stabilized membrane expressed trimers (bnAbs)
HIVConsvX, HTI (T cell antigens)
DREP, RREP & mRNA
HTI-TriMIX, personalized vaccine targeting non-mutated epitopes
Stabilized membrane expressed trimers (bnAbs), HIVConsvX, HTI, dGag (T cell antigens)
Proteins
Recombinant proteins, stabilized native like trimers (SOSIP, Linker) are undergoing GMP manufacture for phase I clinical trials
Delivery and Formulation
EC (EHVA,
EAVI2020)
NIH
Gates
Trimers
Stabilized native like gp140 trimers (x8) SOSIP etc; liposome tethered trimers; Gp41 liposomes (bnAbs), Glycan priming, 3s peptide
Glycan shield gp120
Others:
Env selected by B-cell lineage bNabs, mimotopes/glycopeptide mimetics
VLP/DC targeting delivery, novel adjuvant formulation

9. European and Developing Countries Clinical Trial partnership

10. H2020 - main policy and multilateral activities on infectious diseases
Neglected infectious diseases
Poverty related diseases (HIV, TB, malaria)
Emerging epidemics
Anti microbial resistance (AMR)
European and Developing Countries Clinical Trials partnership (EDCTP2)
Global HIV Vaccine Enterprise (GVE)
Global TB Vaccine Partnership (GTBVP)
Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)
Support to Coalition for Epidemic Preparedness Innovations (CEPI)
Joint Programming Initiative on AMR (JPI-AMR)
2nd European One Health Action Plan against AMR

11. ONE HEALTH
#EUAMRaction

12. Research Development and Innovation at the centre of the new Action plan – Pillar 2
Special attention to WHO's priority list, TB, HIV, malaria
and neglected infectious diseases
The Commission will:
Improve knowledge on detection, effective infection control and surveillance
Develop new therapeutics and alternatives
Develop new preventive vaccines
Develop novel diagnostics
Develop new economic models and incentives
Close knowledge gaps on AMR in the environment and on how to prevent transmission

13. TOWARDS FP9:
LEARNING FROM THE PAST,CONSIDERING THE FUTURE & BENEFITING FROM CO-DESIGN
STAKEHOLDER CONSULTATION
EU budget under intense scrutiny: return on investment, impact on the ground, output-based funding, flexibility …
Challenging political climate: EU added value; UK; EP elections
Strong steer from Juncker priorities and objectives of Commissioner Moedas (3 Os, EIC); simplification…
POLITICAL DRIVERS:
H2020 INTERIM EVALUATION
STAKEHOLDER CONSULTATION
PROPOSAL FOR THE SUCCESSOR FRAMEWORK PROGRAMME
FORESIGHT
HIGH LEVEL GROUP CHAIRED BY PASCAL LAMY
IMPACT ASSESMENT
PROGRAMME DRIVERS:
ECONOMIC CASE OF R&I
Research and innovation

14. THANK YOU for the attention
.. and THANK YOU to all volunteers for their committment and involvement in clinical studies