DNA Vaccine for H7N9 Influenza (GLS-3700)

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Development background

High fatality of novel influenza A(H7N9) (highly pathogenic)

- Since the first human infection was reported in China on Feb 2013, 453 patients have been diagnosed
  as of Oct 2014 and 175 of them have died, demonstrating a high mortality rate of 38%1)
  (mortality rate of usual seasonal flu below 0.1%2).

Preparation for H7N9 pandemic

- There is no vaccine available in the world for prevention of the novel avian influenza A(H7N9) infection.
- The development of national reserve products is required in case of a pandemic before the
  development of H7N9 vaccine.

Preparation for mutation of novel influenza A(H7N9) virus

- The influenza virus causes antigenic drift, a point-mutation accumulation in virus proteins (HA and NA),
   due to RNA polymerase without proof reading function. The antigenic drift results in rapid genetic
   variation that requires annual replacement of influenza virus vaccine3).

※ There is a need for the development of vaccine against the novel influenza A(H7N9) viruses and variants.

1) 2014. 10. 02, WHO RISK ASSESSMENT
2) The Threat of Pandemic Influenza: Are We Ready? Workshop Summary 2005
3) Nature Education 2008, 1(1):83
Features and advantages of GLS-3700

Global leading H7N9 Influenza vaccine

- First-In Class, preventive vaccine for healthy population, vaccine to cope with frequent virus variation
- Low side effects and high prevention rate expected, compared to existing vaccines

Preparation for domestic inflow of novel influenza A(H7N9)-China and virus genetic
variations

- 271 patients were infected during 2013 and 2014; 77 died (33% death rate).

H7N9 pandemic 1st vaccine is under development for national reserve product after Phase 1/2 studies.

- Preparation for the period after pandemic until vaccine development
- Short-term large-scale manufacturing and long-term storage available

Product candidate selected and preliminary efficacy evaluation completed

- The results are published in the journal Vaccine (Vaccine 2014, 19;32(24): 2833-2842).