j.van hoof, m.d. global therapeutic area head idv janssen
TRANSCRIPT
1
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
5
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
6
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
7
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
9
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
10
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
11
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
12
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