Pipeline 01 - InThera

Norovirus vaccines preventing food poisoning

Globally ~700 million cases per year (2016) & A vaccine candidate with a great commercial value due to market
demand in both developing and developed countries
The absence of a norovirus cell culture system & Unfeasible to develop vaccines with conventional methods
→ A novel VLP vaccine can create a large market.

Medical Unmet Needs

Acute gastroenteritis with
diarrhea & vomiting
Highly contagious & infectious
High prevalence
Major target population:
Soldiers, Schools, Hospitals/
Nursing home, Travelers, etc.

Norovirus

- The Major pathogen of winter food poisoning - Infection through direct/indirect contact with a patient

Long lasting
at low temperature
Pathogenesis
with small amount
Poor personal hygiene
due to cold weather
Indoor activities facilitate
human-to-human transmission

Market Trends

Global Market
- cases per year(2016)
  700million
- deaths worldwide(2016)
  219,000
- Developing countries
  ~70,000deaths< 5 years old
Domestic Market
- Annual food poisoning patients
  Norovirus 1,471/Total 6,268
  23%
- Food poisoning patients in winter
  Noroviru 451/Total 861
  52%

Features of InThera’s multivalent norovirus VLP vaccine

Mass & rapid production of high-quality homogeneous VLPs by in vitro self-assembly

Limitations of producing VLP in insect cells

1 Drawbacks of VLP formation in culture cells
- - Containing insect cell-derived impurities in particles
- - Particle heterogeneity
2Difficulty in removing Baculovirus, the vector to deliver
antigen genes into culture cells

Low yield & high manufacturing cost
3Expensive cell culture facilities & a long-term
manufacturing period

Expected benefits of developing E. coli-produced VLP

1 in vitro assembly with purified protein antigens
- - Antigen purity , Impurities
- - VLP homogeneity
Higher efficacy &
lower side-effects
2High-efficient and rapid production in E. coli (within a week)
3Significant reduction in investment & manufacturing costs