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'

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

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

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

HIV/AIDS research portfolio in H2020 * includes € 10m InnovFin ID loan EUR 126.5 million* (2014-2017) 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

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

Approaches for HIV vaccine development Non-replicating vectors

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

European and Developing Countries Clinical Trial partnership

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

ONE HEALTH #EUAMRaction

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

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

THANK YOU for the attention @Moedas @EUScienceInnov @EU_H2020 @HorizonMagEU .. and THANK YOU to all volunteers for their committment and involvement in clinical studies