HCV Vaccine Program

HCV Program Overview

VBI’s Hepatitis C (“HCV”) vaccine candidate leverages the company’s eVLP Platform, which enables the development of enveloped (“e”) virus-like particle (“VLP”) vaccines. eVLPs are an innovative new class of synthetic vaccines that are designed to closely resemble the structure of viruses.

VBI envisions therapeutic use in patients infected with any genotype of HCV to eliminate the need for interferon, the use of which is associated with significant toxicities and side effects that include fatigue, flu-like symptoms, anemia, and depression.1 VBI believes a therapeutic vaccine has health-economic benefits in certain markets. VBI is seeking to partner or co-develop its broadly neutralizing Hepatitis C (“HCV”) therapeutic vaccine candidate.

Target Product Profile
  • Indication: Therapeutic use in patients infected with HCV (any genotype) to eliminate use of interferon
  • Regions: Southeast Asia / Vietnam where a therapeutic vaccine has clear health economic benefit
  • Ages/classes: Seropositive adults
  • Regimen: Six monthly immunizations + ribavirin
  • Efficacy: Non-inferior to current standard of care (interferon + ribavirin); improved efficacy against non-genotype 1 or drug-resistant HCV
  • Safety: Reduced toxicity due to lack of interferon

Preclinical Data

VBI demonstrated strong cross-reactive neutralizing antibody responses against divergent genotypes of HCV in rhesus macaques.2 This is a critical issue for HCV, as the virus is characterized by multiple, geographically distinct genotypes.

Addressing the genetic diversity of the Hepatitis C virus may provide an advantage in developing successful antiviral regimens or therapeutic vaccines. In addition, VBI believes its HCV vaccine candidate may be capable of replacing interferon when used in combination with standard antivirals.

Neutralizing Antibody Response in Rhesus Macaques (n=4)

Sources: P. Garrone, et al Sci. Transl Med 3, 94ra71 (2011); Internal Reference: VAC0805 CrossNeutral; Neutralizing Ab titers were measured at Week 12 following first eVLP immunization

HCV Medical Need

Hepatitis C is a blood-borne virus. Approximately 70%–85% of people who become infected with HCV will experience a long-term, chronic infection.3 If not properly treated, chronic HCV can result in long-term health problems and death.

Market Snapshot4
  • 130 – 150M people globally have chronic HCV infection
  • A significant number of chronically infected individuals will develop liver cirrhosis or liver cancer
  • 350,000 – 500 000 people die each year from HCV-related liver diseases
  • Antivirals can cure Hepatitis C, but access to diagnosis and treatment in certain markets remains low
Hepatitis C Prevalence in Established and Growing Economies
Region Countries Total Infected Infection Rate GDP/Capita
China / Southeast Asia China 20,000,000 1.50% $8,862
Vietnam 2,600,000 2.90% $3,503
Thailand 1,900,000 2.80% $9,371
Taiwan 1,000,000 4.40% $30,874
Korea 635,000 1.30% $19,890
Middle East / India Egypt 10,700,000 14.90% $4,753
India 9,500,000 1.50% $1,330
Pakistan 8,800,000 4.70% $2,976
Russia / Eastern Europe Russia 4,252,500 3.00% $9,900
Romania 770,000 3.50% $9,446
North America / Europe Italy 3,400,000 5.50% $30,791
U.S. 2,500,000 1.00% $45,218
Spain 1,200,000 2.60% $28,810

Sources: Liver International, v31 suppl 2, July 2011; IMF WEO Online Database

 

REFERENCES

  1. http://www.ncbi.nlm.nih.gov/pubmed/9305675
  2. Garrone, P (2011) Sci Transl Med 3, 94ra71
  3. http://www.cdc.gov/hepatitis/hcv/index.htm
  4. http://www.who.int/mediacentre/factsheets/fs164/en/