DNA Vaccine for Shingles
(GLS-5100)

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Development background

One of the recently fast-growing "silver" medicines

- Incidence of 15~20% in global population; 67% in 50 years of age or older; continuously increasing with aging
- Nerve, eyes, skin, internal organ damage, and severe nerve pain after shingles (PHN, Post-herpetic Neuralgia).
- UK Health Authority recommends shingles vaccine injection in seniors between 70 and 79 years of age (2013).

Problems of existing shingles vaccine

- The only shingles vaccine available in the market, Zostavax, increases the potency by concentrating the
  chickenpox vaccine (Varivax). This is not optimized for enhancing the CD8+ T-cell immune response
  that is very critical to preventing shingles. The actual prevention rate is limited to 51%1).
- Zostavax, a live attenuated vaccine, cannot be administered to immunocompromised patients.

※ There is a need for a new shingles vaccine with high safety and efficacy in immunocompromised patients.

Features and advantages of GLS-5100

Global leading shingles vaccine

- First-In-Class(first use of CD8+ CMI), Best-In-Class, latent varicella-zoster virus(VZV) elimination by
  potent T-immune cell in adult patients of 55 years of age or older who are expected to take
  immunosuppressant

Competitiveness compared to existing shingles vaccines (MSD, ZOSTAVAX®)

- Three antigens involved in virus latency selected and candidates determined (patent filing completed)
- Studies in experimental animals demonstrated potent T-cell immune response: high prevention rate expected
  in the product development (currently in the level about 50%)
- With easy production at a large scale and stable vaccine supply, it can be a blockbuster product
  (overcoming limitations of existing vaccines).

1) N Engl J med 2005, 352:2271-2284
Difference of Shingles vaccines by platform
  DNA vaccine platform Live attenuated vaccine platform
Case GLS-5100 Zostavax
Developer GeneOne Life Science, Inc. MSD
Development state Under development
(in process of pre-clinical study)
Available in the market
Use in
immunocompromised
patients
Allowed Not allowed
Antibody response
Immunogenicity
+++ +++
CD4 T-cell
Immunogenicity
+++ +++
CD8 T-cell
Immunogenicity
+++ ++
Flexibility of
antigen selection
Critical antigens in VZV reactivation can be
flexibly selected.
There is no flexibility in antigen selection.
Production capacity Produced with plasmid purification process
via large-scale E.coli fermentation
Limited production scale by using
concentrated chickenpox vaccine (Varivax)
++ : good +++ : very good