TB Vaccine Development Pathway Danielle Roordink & Georges Thiry Accelerating the TB vaccine pipeline – towards Horizon Europe 28 JAN 2020
Table of content • Introduction and objectives of the Stage Gate criteria project • What has been achieved in 2019, and what is new in the Pathway • Examples of use • What is planned in 2020 • Conclusion
TB Vaccine Development Pathway A ‘Stage Gate’ methodology for TB vaccine was initiated in 2010 by TBVI and AERAS (now IAVI), with a publication in 2012 * The project Stage Gate Criteria II (2017-2021), funded by the BMGF, allows for biannual revision and development of target- specific criteria. Revised in 2017, launched on internet in 2018 as ‘TB Vaccine Development Pathway - a tool to accelerate progression of TB vaccine candidates’ . V alidated through external stakeholder consultations, and endorsed by the GTBVP * Ref: Barker, Hessel, Walker, Tuberculosis, 2012
Cycle of Stage Gates project activities
www.tbvacpathway.com In 2019: • SG from discovery to implementation • Added 2 Stages / Gates • Guidance for three indications: ₋ Neonatal, ₋ Adolescents/adults ₋ Therapeutic • Revised version online September 2019 • Brochure
TB Vaccine Development Pathway Stages, criteria and guidance; the expertise
TB Vaccine Development Pathway Stages, criteria and guidance; exemple of a Stage
TB Vaccine Development Pathway Stages, criteria and guidance; example of a ‘Guidance’
Example of use: Selection pre-clinical evaluation in TBVAC2020 Applications for testing reviewed by PMC and selected using stage-gating approach and prioritisation criteria – up to Stage C 42 Selected 44 Different vaccine 64 Applications concepts /formulations = Potential candidates 22 Not selected Stage C: Pre-clinical Stage A: Discovery Stage B: Proof of Concept • Advanced, human – relevant Preliminary in vivo • Independent verification of safety model e.g. NHP safety, immunogenicity immuno or efficacy • Efficacy and Immune and efficacy • Data from second model /species correlates • Head to head comparisons for • Go/No-Go decisions and to prioritisation refine /feedback Data to support entry to PoC development Iterative improvement Down-selection Kindly from Ann Rawkins 9
Example of use: Portfolio assessment – TBVAC2020 Progression in TBVI/TBVAC2020 Vaccine Pipeline 2015-2019 Stage D Stage E Stage B Stage A Stage F Stage G Stage H Stage C Prepare first-in- First-in- Proof of B C A D E F G H Discovery Preclinical Ph2a Ph2b Ph3 human human Concept BCG Δ ZMP1 BG::ESX-1- Mtb Beijing- 6 Marinum VPM1002 MTBVAC Δ Rv1503c- Mtb Δ phoPR BG::ESX-1- Infants Δ espFG1 Δ pp Marinum e25-pe19 Mtb Δ espFG1 Δ ppe 25-pe19 24 ChAdOx1 CysVac2/ 85A – Aero* advax MVA85- Aero* Adols / H1-Rv2034c Adults Spore FP1 CAF01/CAF09 H64/H74/H76 MTBVAC (H107/CAF01 ) Live Attenuated 12 ChAdOx1PP LV-H56-H64 Killed Inactivated E15/85 + MVAPPE15 Protein/adjuvant + MVA-85A Vector 24 Experimental * RUTI H64/H74/H76 1 medicine Thera- (H107/CAF01) approach peutic 4 MVATG18598 10 Kindly from Brij Patel
What is planned in 2020: • Revision – Survey, 1q2020 – Initiate revision, 3q20 • Dissemination – Publication in Vaccine, 2-3q20 – Presentations
Conclusion • The “Pathway” is a body of knowledge and a data-driven methodology that guide the development of a TB vaccine, for developers, funders and decision-makers • From discovery to commercialization, with guidance for TB vaccine indications; aligned with the WHO preferred product characteristics • Offers criteria for selection and a structure for portfolio • Available on internet, further dissemination ongoing, next revision planned • Please use it, share it, criticize it, and continue to contribute…
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Working Group Georges Thiry, Leo van der Pool, Gerald Voss, Bernard Fritzell, Jelle Thole, Dereck Tait Anne Marie Gerdill, Marit Holleman, Danielle Roordink, Ann Rawkins, Emmanuelle Gerdil, Maria LempickiA Missing on photo: Ann Ginsberg, Ilona van den Brink Thank you to : Barry Walker, Luc Hessel, Danilo Casimero, Dominick Laddy and the whole TB community
Acknowledgements • BMGF • All the researchers and developers • The Stage Gate Working Group • GTBVP: BMGH, EDCTP, European Commission, IAVI, TBVI; WHO and NIH
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