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J.Van Hoof, M.D. Global Therapeutic Area Head IDV Janssen Pharmaceuticals

Decision IMI2 Ebola+

Call

21-28 Oct 2014

Call launch

6 Nov 2014

Submission deadline

1 Dec 2014

First 4 projects start

!

Invitation to Granting

Phase

19 Dec 2014

Signature Grant

Agreements

Jan –Feb 2015

A fast-track single-stage process resulting in 8 projects selected for funding Total budget: EUR 215 million

The family of Ebola+ projects

• Joint

Information

Repository

• Joint Scientific

Advisory Board

• Joint Ethics

Board In-depth immunogenicity

VSV-ZEBOV

Manufacturing

challenges Deployment &

compliance

Phase 1 & 3 trials

Janssen prime-boost

vaccine

VSV-EBOVAC Sclavo Vacc. Assoc

In-depth immunogenicity

VSV-ZEBOV

EBOVAC 1 LSHTM, Janssen

Phase 1 & 3 trials Janssen

prime-boost vaccine

EBOVAC 2 Inserm, Janssen

Phase 2 trials Janssen

prime-boost vaccine

EBOMAN Vibalogics, Janssen

Manufacturing challenges

EBODAC LSHTM, Janssen

Deployment & compliance

EbolaMoDRAD Public Health Institute Sweden

Portfolio of rapid diagnostic tools

FILODIAG GNA Biosolutions

Ultra-fast diagnostics based on

laser-heated nanoparticles

Mofina Public Health England, Altona

Mobile pan-filovirus nucleic

acid test

Overview of the IMI2 Ebola+ programme Multi-stakeholder collaboration: public and private partners joining forces

Project Partners Project description

EBOMAN Coordinator: Vibalogics Project Lead: Janssen Bavarian Nordic

Vaccine manufacturing

EBOVAC 1 Coordinator: LSHTM Project Lead: Janssen UOXF INSERM

Phase 1 trials in Europe (UK, France) in Africa (Kenya, Tanzania, Uganda) Phase 3 trial in Sierra Leone

EBOVAC 2 Coordinator: INSERM Project Lead: Janssen LSHTM UOXF Centre Muraz Inserm Transfert

Phase 2 trials in Europe (UK, France) in Africa (Burkina Faso, Uganda, Kenya, Ivory Coast, Rwanda, ...)

EBODAC Coordinator: LSHTM Project Lead: Janssen World Vision Grameen Foundation

Vaccine deployment, acceptance and compliance

Janssen Commitment to a Filovirus Vaccine

• 2002-2008 Cooperative Research and Development Agreement1 with NIH/VRC to develop jointly, test and manufacture an adenovirus-based Ebola vaccine

• Since 2008 contract with NIAID/DMID2

• A Heterologous Prime Boost regimen for optimal and durable immunity

• Aim is to protect against Marburg, Sudan and Ebola

• Combination of replication incompetent Ad26 and Ad35 or MVA-BN vectors

• Proof of concept obtained in highly stringent NHP model using multivalent vaccines

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1 CRADA NIH AI-0114 2 Funded in whole or in part with direct Federal funds and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health (NIH), under Contract Numbers HHSN272200800056C, HHSN272201000006I, and HHSN272201200003I, respectively

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Favorable Manufacturability and Stability

• Ad26.ZEBOV & MVA-BN-Filo Production ongoing

o High-yield platforms

o >1.5 million dose regimens drug substance produced (investment at risk)

o >800k regimens filled & labeled; >450k regimens released

• Stability profile

o -60ºC for long-term storage of bulk and vaccine vials (at manufacturer’s sites)

o -20ºC for storage of vaccine vials in the country central warehouse (target ≥ 2 year)

o Ongoing studies: Ad26.ZEBOV: ≥ 6 months; MVA-BN-Filo: ≥ 6 months

o +2 to +8ºC for storage at vaccination sites

o Ongoing studies: Ad26.ZEBOV: ≥ 9 months; MVA-BN-Filo: ≥ 6 months

Confidential - Do not distribute

Ongoing and Planned Clinical Trials

US

UK

AF

AF

EU

AF

Phase I studies – US & UK

• Status: fully enrolled,

interim data available

Phase I studies –

Kenya, Tanzania

and Uganda

• Status: fully enrolled

Phase II studies –

Europe & Africa

• Status: UK, France

started

Phase III

studies –

Africa

• Status: started

sept 30

AF

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Confidential - Do not distribute

Solid immune responses, humoral and CMI, with

remarkable durability : up to 6 months data

8 0 5 0 1 0 0 1 5 0 2 0 0

1 0

1 0 0

1 0 0 0

1 0 0 0 0

1 0 0 0 0 0

E L IS A

D a y s

EL

ISA

Un

its

/ml

M V A /A d 2 6 0 , 2 8

M V A /A d 2 6 0 , 5 6

A d 2 6 /M V A 0 , 2 8

A d 2 6 /M V A 0 , 5 6

0 5 0 1 0 0 1 5 0 2 0 0

1 0

1 0 0

1 0 0 0

1 0 0 0 0

1 0 0 0 0 0

A n tib o d ie s (E L IS A )

D a y s

EL

ISA

Un

its

/ml

M V A /A d 2 6 0 , 2 8

M V A /A d 2 6 0 , 5 6

A d 2 6 /M V A 0 , 2 8

A d 2 6 /M V A 0 , 5 6

0 5 0 1 0 0 1 5 0 2 0 0

0 .0 1

0 .1

1

1 0

C D 8 + T c e lls ( IC S )

D a y s

To

tal

cy

tok

ine

re

sp

on

se

(% o

f s

ub

se

t)

M V A /A d 2 6 0 , 2 8

M V A /A d 2 6 0 , 5 6

A d 2 6 /M V A 0 , 2 8

A d 2 6 /M V A 0 , 5 6

• Robust antibody and T cell responses at 6 months

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Modular platform scalable for future deployment of vaccines

EBODAC - EBOla vaccine Deployment, Acceptance and Compliance

Ensuring the prime-boost vaccine regimen is well accepted & successfully deployed amongst communities in West-Africa

• PART ONE: in support of study

• PART TWO: full scale deployment

Develop community engagement strategy

Develop and install identification tools

Implement mobile technology

Capacity building

• EPI (Expanded Programme on Immunization) support

• Technical & social mobilization training

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Central Information Repository – Current View – DRAFT -

Ebovac 1 Vaccine

Devt RCT Data

Ebovac 2 Vaccine

Devt RCT Data

VSV-Ebovac

Safety and Immunogeni

city

Eboman Manufactu

ring

Ebodac Deployment Compliance

of Vaccination

Regimes

Mofina Epi /

genomic data

Filodiag Epi /

genomic data

EbolaMoDRAD Epi /

genomic data

Central Information Repository

Data Governance Committee

Private Research Envt

Private Research Envt

Private Research Envt

Dataset catalog

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Janssen Ebola Vaccine - Conclusions

Potential contributor to address future Ebola virus outbreaks

• Well tolerated and immunogenic

o phase I data EU, US (Africa = immuno pending)

o Robust humoral and cellular immune response after Ad26 prime further enhanced by MVA (Modified Vaccinia Ankara) boost

o 6 months data available suggest durable immune responses

• Significant manufacturing capacity

o > 800,000 drug product regimens available

o > 1.5 million regimen produced

• Stability profile compatible with existing vaccine distribution channels in Africa

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Great Public – Private Partnership : From decision to pivotal study in < 1 year !

These projects have received funding from the Innovatives Medicines Initiative 2 Joint Undertaking under grant agreement No 115850, 115854, 115861, 115847. These Joint Undertaking receive support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. www.imi.europe.eu