VBI-2601 (BRII-179) is a therapeutic vaccine candidate that targets 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-2601 is designed to impact the key extracellular steps in the HBV lifecycle in order to restore immunologic control over the infection.
VBI-2601 is indicated for the functional cure for the treatment of chronic hepatitis B infection.
November 14, 2019: VBI Vaccines Inc. and Brii Biosciences (“Brii Bio”), 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.
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.