DNA Vaccine for Ebola (INO-4212)

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Development background

Preventive Ebola vaccine market and need for development

- Since the first Ebolavirus discovered in 1976, it has affected 2,387 people and caused 1,509 deaths by 20121)
  However in the year 2014, over 20,000 people have been infected with the virus and over 8,000 people have
  died.
- There is no Ebola vaccine or treatment currently available in the market. Recently, Phase 1 studies with the
  vaccines and treatments have started.
- Although an multiple Ebolavirus vaccines with excellent efficacy in rodent and primate studies
  have been developed and published as long as 10 years ago, there has been minimal investment
  in human trials until the current outbreak because prior outbreaks were small, and involved
  remote regions in resource regions of Africa limiting commercialization potential.

※ With recent global trade exchange and the expansion of new infectious diseases, the growth of
  vaccine and treatment development market is surely feasible.

1) 2014 Ebolavirus Survival and Mortality, WHO, 2014. 11.
Features and advantages of INO-4212

Ebola DNA vaccine program combines three separate plasmids

- Plasmid expressing GP antigen of the recent Guinea strain 2014
- Plasmid expressing common GP antigen of highly infectious Zaire strains (8 outbreaks between 1976 and
  2008)
- Plasmid expressing common GP antigen of Zaire strains weighted towards 2008 and 2014 outbreak strains

Pre-clinical studies demonstrated 100% virus suppression in experimental animals.

- The results are published in Nature publishing group journals (Molecular Therapy 2013, 21(7): 1432-1444).
- Excellent antibody formation and T-cell activation confirmed in experiments with primates

One of 10 drugs that can defeat Ebola, as cited by Fierce Biotech (14 Oct 2014)

Entered into agreement for joint clinical development with Inovio (25 Sep 2014)

Grant from DARPA, US Department of Defense (9 Apr 2015)

- 49 billion KRW for 2 years; up to 61.1 billion KRW when including additional options

Comparison with competitive vaccine
  INO-4212 cAd3-EBOV rVSV G-EBOV-GP Ad26.ZEBOV
MVA-BN-Filo
Developer Joint development
with the support of
DARPA
GSK Merck J&J
Target
antigen
GP
(Zaire strains ,
Current outbreak
strain )
GP
(Unspecified Zaire
strain)
GP
(Mayinga [1976] Zaire
strain)
GP
(Unspecified Zaire
strain)
Antigen
gene
delivery
Naked DNA
(plasmid)
Replication-deficient
chimpanzee adenovirus,
modified vaccinia virus
Replication competent
vesicular
stomatitis virus
Replication-deficient
human adenovirus,
modified vaccinia virus
Feature Very safe,
repeat injection
allowed
Grade III & IV AEs
reported,
Booster injection may
lower response
Significant AEs
reported,
Booster injection with
additional toxicity
Unknown AEs from
live virus,
unknown utility with
booster doses
Production
method
(large scale)
E. coli Large-scale
fermentation/ rapid
large production
Animal cell culture/
production delayed,
due to installation of
dedicated facility
Animal cell culture/
production delayed,
due to installation of
dedicated facility
Animal cell culture/
production delayed,
due to installation of
dedicated facility
Storage/
Shipment
Transfer in ice pack /
store in
refrigerator
Store and transfer
below -80℃
Store and transfer
below -80℃
Store and transfer
below -80℃
Joint development organization with support  
  from DARPA, US Department of Defense
- Permanent eradication of Ebola virus disease through
  preventive and therapeutic treatments
- DNA vaccine : outbreak prevention, post-treatment and long
  term prevention of Ebola