Hepatitis B Vaccine Candidate Doses 1st Patient

Two vaccine companies announced the 1st patient was dosed in a Phase 1b/2a proof-of-concept clinical study of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic candidate, for the treatment of chronic hepatitis B virus (HBV) infection.

This is important news as HBV infections are a leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers.

In 2017, there were 1,727 death certificates among USA residents that listed hepatitis B as the underlying or a contributing cause of death.

Information from this new study is expected in the second half of 2020, said VBI Vaccines Inc. and Brii Biosciences, in a November 14, 2019, press release. 

“Chronic HBV has long been considered one of the most challenging viral infections to treat, due to its complex life cycle once it takes hold in the liver,” said Jeff Baxter, President, and CEO of VBI.

“There is growing consensus in the scientific community that a functional cure for HBV is possible and that it will require restoration of HBV immunity to ensure the body’s own ability to control the viral infection.”

“We believe BRII-179 (VBI-2601) has the potential to be a critical and differentiated component of a functional cure for HBV,” concluded Baxter.

The company says ‘BRII-179 (VBI-2601) is uniquely formulated to target both B-cell and T-cell immunity through multiple mechanisms of action, including neutralizing the circulating hepatitis B virus, blocking hepatitis B infection of hepatocytes mediated through Pre-S1, and enabling immune-mediated clearance of HBV-infected hepatocytes.’

Where many investigational agents work inside the infected liver cells downstream of transcription, BRII-179 (VBI-2601) is designed to impact the key extracellular steps in the HBV lifecycle in order to restore immunologic control over the infection.

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma, says the US Centers for Disease Control and Prevention (CDC), last updated on November 8, 2019.

Chronic hepatitis B infections primarily occur (75%) among persons born outside the US in countries with intermediate or high rates of hepatitis B prevalence.

Excluding case reports with unknown or missing data, about 58 percent of chronic HBV infections were among Asian/Pacific Islanders.

Recent Hepatitis B vaccine news

• September 19th, 2019 – A new analysis of Hepatitis B virus (HBV) status among women of childbearing age found increasing infection rates in Mississippi, Kentucky, and West Virginia.
• June 19, 2019 – A new study reported that an HBV infection was associated with the risk of non-liver cancer, especially digestive system cancers. This study was published in JAMA on June 14, 2019, concluded that hepatitis B surface antigen (HBsAg) seropositivity was associated with the risk of hepatocellular carcinoma, stomach cancer, colorectal cancer, oral cancer, pancreatic cancer, and lymphoma.

The CDC continues to say the ‘best way to prevent hepatitis B is by getting vaccinated. The hepatitis B vaccine is safe and effective. Completing the series of shots is needed for full protection.’

In the USA, there are 3 single-antigen vaccines and 2 combination HBV vaccines available:

• Single-antigen hepatitis B vaccines: ENGERIX-B, RECOMBIVAX HB, and HEPLISAV-B
• HBV combination vaccines include PEDIARIX and TWINRIX

Additionally, the CDC is sharing this 5-minute online assessment which offers a personalized report on hepatitis testing and vaccination recommendations.

This Phase 1b/2a clinical study of BRII-179 (VBI-2601) is designed as a 2-part dose-escalation study assessing different dose levels of BRII-179 (VBI-2601) and is expected to enroll up to 65 patients. Brii Bio will conduct the study at multiple study sites in New Zealand, Australia, Thailand, South Korea, Hong Kong SAR, and China.

VBI is a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines. And, Brii Bio is a clinical-stage company committed to serving patients’ needs and improving public health in China and around the world.

Hepatitis vaccine information published by Precision Vaccinations