Pathway Danielle Roordink & Georges Thiry Accelerating the TB - - PowerPoint PPT Presentation

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Pathway Danielle Roordink & Georges Thiry Accelerating the TB - - PowerPoint PPT Presentation

Feb 10, 2023 106 likes •270 views

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

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TB Vaccine Development Pathway

Danielle Roordink & Georges Thiry

Accelerating the TB vaccine pipeline – towards Horizon Europe

28 JAN 2020

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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
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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’. Validated through external stakeholder consultations, and endorsed by the GTBVP

* Ref: Barker, Hessel, Walker, Tuberculosis, 2012

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Cycle of Stage Gates project activities

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  • SG from discovery to

implementation

  • Added 2 Stages / Gates
  • Guidance for three

indications: ₋ Neonatal, ₋ Adolescents/adults ₋ Therapeutic

  • Revised version online

September 2019

  • Brochure

In 2019:

www.tbvacpathway.com

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TB Vaccine Development Pathway

Stages, criteria and guidance; the expertise

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TB Vaccine Development Pathway

Stages, criteria and guidance; exemple of a Stage

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TB Vaccine Development Pathway

Stages, criteria and guidance; example of a ‘Guidance’

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Example of use: Selection pre-clinical evaluation in TBVAC2020

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Applications for testing reviewed by PMC and selected using stage-gating approach and prioritisation criteria – up to Stage C

64 Applications 42 Selected 22 Not selected 44 Different vaccine concepts /formulations = Potential candidates Stage A: Discovery Preliminary in vivo safety, immunogenicity and efficacy Stage B: Proof of Concept

  • Independent verification of safety

immuno or efficacy

  • Data from second model /species
  • Head to head comparisons for

prioritisation Data to support entry to PoC development Down-selection Iterative improvement Stage C: Pre-clinical

  • Advanced, human –relevant

model e.g. NHP

  • Efficacy and Immune

correlates

  • Go/No-Go decisions and to

refine /feedback

Kindly from Ann Rawkins

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Mtb ΔespFG1Δpp e25-pe19 BG::ESX-1- Marinum Stage A Discovery Stage B Proof of Concept Stage C Preclinical Stage D Prepare first-in- human Stage E First-in- human Stage F Ph2a Stage G Ph2b Stage H Ph3

A B C D E F G H

24

1 4

H64/H74/H76 (H107/CAF01)

MVATG18598 RUTI

Thera- peutic

6

Mtb Beijing- ΔRv1503c- ΔphoPR BCGΔZMP1

VPM1002

Infants

MTBVAC

Progression in TBVI/TBVAC2020 Vaccine Pipeline 2015-2019

24 12 H1-Rv2034c CAF01/CAF09 CysVac2/ advax H64/H74/H76 (H107/CAF01) Spore FP1 LV-H56-H64 ChAdOx1PP E15/85 + MVAPPE15 + MVA-85A

MVA85- Aero*

ChAdOx1 85A – Aero*

MTBVAC

Adols / Adults 10 Live Attenuated Killed Inactivated Protein/adjuvant Vector Experimental medicine approach

*

Example of use: Portfolio assessment – TBVAC2020

BG::ESX-1- Marinum Mtb ΔespFG1Δppe 25-pe19

Kindly from Brij Patel

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What is planned in 2020:

  • Revision

– Survey, 1q2020 – Initiate revision, 3q20

  • Dissemination

– Publication in Vaccine, 2-3q20 – Presentations

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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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Feedback…

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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

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Acknowledgements

  • BMGF
  • All the researchers and developers
  • The Stage Gate Working Group
  • GTBVP: BMGH, EDCTP, European Commission, IAVI, TBVI;

WHO and NIH