HBV Therapeutic Program

Potential to contribute to a functional cure by inducing and sustaining broad and effective immunity against chronic Hepatitis B infection

HBV Immuno-Therapeutic (VBI-2601)

VBI is leveraging its significant hepatitis B virus (“HBV”) expertise to develop VBI-2601 to contribute to the pursuit of a functional cure for the treatment of chronic hepatitis B infection.

VBI’s approach focuses on inducing and sustaining broad and effective immunity against hepatitis B. VBI believes VBI-2601 has the unique potential to do this by targeting B- and T-cell immunity through several key mechanisms of action, including neutralizing circulation of the hepatitis B virus, blocking infection of hepatocytes via Pre-S1 immunity, and enabling immune-mediated clearance of HBV-infected hepatocytes.

VBI has entered into a license and collaboration agreement with Brii Bio (“Brii”). Under the agreement, VBI and Brii will collaborate in the development of the product through to completion of a proof-of-concept clinical trial in China, following which, Brii Bio will be responsible for funding all development in the licensed territory. Brii Bio will retain commercial rights in the licensed territory, while VBI will retain all rights outside of the licensed territory.

Chronic Hepatitis B Infection

Hepatitis B infection is the most prevalent global infection with 250 million infected worldwide. According to the World Health Organization (“WHO”), more than 780,000 people die each year due to HBV-related complications, including cirrhosis and liver cancer. The Centers for Disease Control and Prevention (“CDC”) has estimated that there are between 847,000 and 2.2 million people chronically infected in the United States alone. The highest rates of chronic infections are found in sub-Saharan Africa, central and eastern Europe, the Middle East, east Asia, and the Indian subcontinent, with more than one-third of the globally infected population residing in China.

Not only is global HBV infection rampant, but there is also a high unmet need for effective therapies, as current treatments generate a functional cure in less than 10 percent of those treated. Achieving a functional cure, therefore, is a global health priority.

Worldwide Rates of Chronic Hepatitis B

Source: U.S. CDC, 2010

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