VBI Vaccines and Brii Biosciences Initiate Phase 1b/2a Study of BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B Infection

- Novel recombinant, protein-based immuno-therapeutic for the treatment of chronic hepatitis B virus (HBV) infection

- Two-part, dose-escalation study expected to enroll up to 65 patients

- Initial data expected in H2 2020

CAMBRIDGE, MA, USA & BEIJING, China & DURHAM, NC, USA I November 14, 2019 I VBI Vaccines (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, and Brii Biosciences (“Brii Bio”), a clinical-stage company committed to serving patients’ needs and improving public health in China and around the world, today announced the first patient dosed in a Phase 1b/2a proof-of-concept study of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic candidate in development for the treatment of chronic hepatitis B virus (HBV) infection.

“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.”

“Alleviating the disease burden of HBV through a functional cure would be transformational for individuals and societies around the world,” said Zhi Hong, Ph.D., co-founder, and CEO of Brii Bio. “We, together with our colleagues at VBI, are pleased to announce the start of this clinical study of BRII-179 (VBI-2601) as we work hard to address this unmet need, and we look forward to sharing the initial human proof-of-concept results from this study in the second half of 2020.”

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.

The Phase 1b/2a clinical study of BRII-179 (VBI-2601) is a randomized, controlled study designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601) in patients with chronic HBV infection. The study is designed as a two-part dose-escalation study assessing different dose levels of BRII-179 (VBI-2601), and is expected to enroll up to 65 patients.

Initial human proof-of-concept data from the Phase 1b/2a clinical study are expected in the second half of 2020.

The study is sponsored by Brii Bio and will be conducted at multiple study sites in New Zealand, Australia, Thailand, South Korea, Hong Kong SAR, and China.

About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

About VBI Vaccines
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with the only commercially-approved trivalent hepatitis B vaccine, Sci-B-Vac®, which is approved for use in Israel and 10 other countries and is currently in a Phase 3 program in the U.S., Europe, and Canada, and with an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. Integrating its cytomegalovirus (CMV) expertise with the eVLP platform technology, VBI’s lead eVLP program candidates include a prophylactic CMV vaccine candidate and a glioblastoma (GBM) vaccine immunotherapeutic candidate. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. For more information, visit www.vbivaccines.com.

About Brii Biosciences
Brii Biosciences (Brii Bio) is committed to serving patients’ needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight. With operations in the People’s Republic of China and the United States, the company is poised to serve as a bridge to deliver transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the health and wellbeing of patients around the world. The company is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and other illnesses. For more information, visit www.briibio.com.

SOURCE: VBI Vaccines

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