Therapeutic DNA Vaccine for
Chronic Hepatitis C (VGX-6150)

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Chronic Hepatitis C (VGX-6150)
Development background

Hepatitis C virus (HCV), one of the major causes of chronic hepatitis, liver cirrhosis, and liver carcinoma

- 50~80% of patients infected with HCV develop chronic hepatitis1).
- 15~30% of patients with chronic hepatitis C develop liver cirrhosis over 30 years2).
- 1~5% of patients with liver cirrhosis develop liver carcinoma3).

Problems of existing treatment of hepatitis C (standard of care)

- Peg-Interferon alfa and ribavirin has low SVR 54-56% and is associated with many side
  effects4)5)6)7)8)9)10)11) and high cost (~US$30,000).
- Newly approved Direct Acting Antiviral Agents (DAA) have greater efficacy with SVR ~95% and are
  well tolerated, the cost is higher (~US$100,000).
- Treatment does not prevent re-infection with Hepatitis C.

※ There is a continued critical need of cost-effective hepatitis C treatment and preventive modalities with low
    side effects.

1) KASL, 2013 Guidelines for management of hepatitis C
2) Hepatology 2008, 48:418-431
3) Gastroenterology 2009, 136:138-148
4) N Engl J Med 2002, 347:975-982
5) Lancet 2001, 358:958-965
6) Hepatology 2004, 39:1147-1171
7) Ann Intern Med 2004, 140:346-355
8) J Clin Psychiatry 2012, 73:1128-1138
9) Gut 2006, 55:1350-1359
10) Endocrinol Metab Clin North Am 2007, 36:1051-1066
11) Hepatology 2000, 31:997-1004
Features and advantages of VGX-6150

Immune treatment of chronic hepatitis C

- First-In-Class, treatment via potent T-cell immune response specific to chronic hepatitis C
  (three main HCV antigens)
- Reduced side effects and increased dose convenience (3~4 doses) compared to existing SOC

Medical competitiveness in the recently fast-growing chronic hepatitis C market

- A new market valued over US$8 billion yearly has been formed (since the launch of virus replication inhibitors
  of global pharmaceutical companies in 2013).
- With a different mechanism of action from that of virus replication inhibitors, combined treatment is permitted
  and distinct market can be formed.

Advantages of DNA vaccine platform

- Designed consensus genes of HCV genotype 1 antigens (NS3/NS4A, NS4B, NS5A) are highly immunogenic
  and are directed at the most common genotypes: 1a and 1b.
- Effectively induces HCV non-structural protein-specific T-cell immune response that plays an important role in
   HCV elimination1)2)3)4)5).
- With easy production at a large scale and stable vaccine supply, it has the potential for worldwide applicability
  both as a therapeutic and preventative vaccine.

It can be expanded for the prevention of chronic hepatitis C-derived liver cancer (15 % of
total cancer cases)

- Long-term effects due to in vivo immune memory : Differentiated feature from existing anti-virus treatments
- Follow-up clinical studies are in preparation : Phase 1b/2a study to evaluate preventive effects of liver cancers
in patients with liver cirrhosis
Phase 1 study to evaluate prevention of hepatitis C
in high risk subjects

Introduction of immune adjuvants

- The IL-28B-expressing gene efficiently increases T-cell immune response that eliminates HCV6).

1) J Clin Invest 1996, 98:706-714
2) Lancet 1995, 346:1006-1007
3) Hum Vaccine 2011, 7:1326-1335
4) Mol Ther 2012, 20:669-678
5) PLoS ONE 7:e52165. 2012
6) Mol Ther 2010, 18:1714–1723