Ομιλία – Παρουσίαση: Γρηγόρης Ντάκουλας, Medical Director AstraZeneca Ελλάδος Τίτλος: «H AstraZeneca στη μάχη ενάντια στον SARS CoV-2»

1. AstraZeneca
against
SARS-CoV-2
June 16
2020
Gregory Ntakoulas, MD
Medical Director
AstraZeneca, Greece

2. COVID-19 Employee Toolkit 20206/29/20202
https://racap.com/covid-19 Clinicaltrials.gov
1915 studies
ongoing on
COVID-19

3. 3 29 June 2020Name
AZ’s research response to
COVID19
• AZD1222* Vaccine Development
(Oxford University partnership)
• Monoclonal antibody research
• Investigating potential treatments
*formally known as ChAdOx1 nCoV-19

4. AstraZeneca’s COVID-19 treatment and prevention response
4
COVID-19 monoclonal
antibody research
Three approaches to
identifying candidates
Research partnerships with
academia, governments,
biotech companies
Aiming for Phase 1 in 3-5
months
Oxford COVID-19
vaccine development
Landmark agreement with
University of Oxford
to globally develop and
distribute potential vaccine
Phase 1 data ~end May /
Late-stage trials mid-2020
Investigating potential
treatments
Exploring how our
compounds might help in
the treatment of COVID-19
- CALAVI Trial with Acalabrutinib
- Effect on exaggerated imune response
(Cytokine Storm)
- DARE-19 Trial with anti-diabetic drug
- Reduce risk of serious complications and
organ failure
SOC: Standard of Care; WHO: Wold Health Organization; BARDA: Biomedical Advanced Research and Development Authority, ClinicalTrials.gov Identifier: NCT04346199; NCT04350593

5. COVID-19 Employee Toolkit 20206/29/20205
https://clinicaltrials.gov/ct2/show/NCT04324606
AZD1222: About the AZ COVID-19 candidate Vaccine

6. COVID-19 Vaccine Landscape
Platform Pros Cons Examples
Subunit
Safe, non-infectious, easy to manufacture and
store
Poor immunogenicity, breadth and immune
memory, require adjuvants, limited global
production capacity
Innovax
WRAIR
Sanofi Pasteur
Peptide
Non-infectious, easy to manufacture and store
Poor immunogenicity, breadth and immune
memory, require adjuvants, reactogenic
Innovax
Axon Neuroscience
mRNA
Non-infectious, design flexibility, highly
scalable, rapid manufacture, non-integrating
Reactogenic, unstable, off-target responses,
atypical antigen processing, requires
specialised administration
Moderna
CureVac
Imperial College London
DNA
Non-infectious, long-lasting immune response,
design flexibility, highly scalable, rapid
manufacture, heat-stable
Risk of genomic integration, oncogenesis, off-
target responses, atypical antigen processing,
requires administration to nucleus
Inovio
Karonlinska Institute
Applied DNA Sciences
Attenuated
Potent and broad immune response, self-
replicating, may only require single dose
Risk of disease, requiring extensive safety
testing, cannot be administered to the
immunosuppressed, challenging to
manufacture and store
Codagenix
Inactivated
Potent and broad immune response, may only
require single dose
Less immunogenic than attenuated, large
amounts of infectious virus need to be
handled, challenging to manufacture and store
Sinovac
Wuhan Institute of Virology
BIKEN
Virus-Like Particles
Non-infectious, easy to manufacture and store More complex manufacturing and QC than
subunit vaccines
Medicago
Expression Biotechnologies
Imophoron
Viral Vectors (eg Lentivirus; Adenovirus)
Non-infectious, good transduction
efficiency
Risk of genomic integration, oncogenesis,
pre-existing vector immunity
University of Oxford
CanSino Biological
GeoVax

7. 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Vaccine Development has taken a decade or longer, but the
ambition is to develop a COVID-19 vaccine in 18 Months
Academic Research
Phase I
Pre-Clin
Phase II
Phase III
Building Factories
Manufacturing
Approval
Distribution
Vaccine by
May 2036
Plotkin´s Vaccines (7th ed)

8. SARS-CoV
14 April 2003
Influenza H5N1
11 Feb2006
Influenza H1N1
27 April 2009
20 months
11 months
4 Months
6 12 18
Months
Time to Response in Vaccine Development for emerging
diseases
(Genetic Sequencing to FIH injection)
Plotkin´s Vaccines (7th ed)
Virus genetic sequencing

9. Oxford vaccine ChAdOx1 nCoV-19: the path to development
104 days from sequence to human
10

10. 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
COVID-19 Vaccine Accelerated Development Scenario
Academic Research
Phase I
Pre-Clin
Phase II
Phase III
Building Factories
Manufacturing
Approval
Distribution
Vaccine by
May 2036
Vaccine by
August 2021
15 years less!
Plotkin´s Vaccines (7th ed)

11. 29 June 2020Name12
Clinical
development
plan for
AZD1222
Phase 1/2
n=~1000
(UK/University of
Oxford)
Phase 2/3
up to
~10000
(UK/University of
Oxford)
Q2
2020
RoW
Q3
2020

12. Summary
• AZ has an holistic response to the unprecedented challenges of COVID-19
• AZD 1222 is candidate vaccine that uses an adenoviral vector that contains the
genetic material of SARS-CoV-2
• Recombinant adenovirus (ChAdOx1) was chosen to generate a strong immune
response from a single dose
• AZD1222 is in Phase III trials in the UK following successful review of initial
safety and immune response data
• AZ has concluded the first agreements for at least 1.2bn doses and have
secured total manufacturing capacity for 2bn doses so far and will begin first
deliveries in September 2020.
• Agreements are continuing to be secured to deliver AstraZeneca’s
commitment to ensure global access

13. Thank youThank you
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