DNA Vaccine for MERS (GLS-5300)

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MERS (GLS-5300)
Development background

Preventive MERS vaccine market and needs for development

- Since MERS first emerged in Saudi Arabia in 2012, to Jun 2015, more than 20 countries have
  been affected by MERS.
  : Since 2015, MERS cases in Korea, China, Thailand, and Indonesia have been increased.
- Since 2012, MERS incidence and secondary infection compared to first infection has been
- The development of a killed or live attenuated vaccine is difficult because of a high mortality
  rate about 40% similar to Ebola. → There are needs for the development of a gene-based
  vaccine such as DNA vaccine.
- The development of national reserve products is required in case of a pandemic.

1) Microbe and Infection 2014, 16:529–531
Features and advantages of GLS-5300

Target for MERS DNA vaccine for perfect prevention

- MERS-CoV gene sequences was obtained from outbreak strains since 2012.
- Spike protein that mediate virus entry was targeted (Figure).
- Consensus Spike sequence affords cross-protection among coronaviruses.

Figure. Target for MERS DNA vaccine

- Spike (S) protein : surface glycoprotein of the virus, binds to host cell surface receptor

The only MERS vaccine to advance to Clinical Trials

- Most rapid development into clinical trials of any vaccine to date

Pre-clinical studies demonstrated excellent preventive effect in experimental animals.

- Mouse Study : Neutralizing antibodies elicited in 100% of vaccine immunized mice.
- Primate Study : Macaques immunized with the MERS vaccine were protected from symptoms of
                       pneumonia and reduced MERS viral loads after viral challenge with MERS-CoV.
                       The study also showed protection against MERS with only 1 or 2 injections.
- Camel Study : Robust Neutralizing antibody titers were detected in immunized camels post vaccine.

Entered into agreement for joint clinical development with Inovio (27 May 2015)

Entered into Joint Agreement with WRAIR, US Department of Defense (11 Nov 2015)

- WRAIR provides support for all clinical activities.