Brii Biosciences, Vir Biotechnology and VBI Vaccines Announce Initiation of Phase 2 Clinical Trial of BRII-835 (VIR-2218) in Combination with BRII-179 (VBI-2601) for the Treatment of Hepatitis B - Seite 2

Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s chief medical officer, said: “We believe that a functional cure for HBV is possible, and will require restoration of HBV-specific immunologic control in addition to viral suppression mechanisms. Data from our previous study suggest BRII-179 (VBI-2601) was able to restimulate both antibody and T cell responses specific to HBV. This combination study represents the first combination of a therapeutic HBV vaccine to restore HBV-immunity with antivirals designed to reduce the levels of HBV surface antigens. We look forward to seeing the outcome of the trial, a milestone that will be meaningful in our collective efforts to provide an effective solution for patients with such a complex and highly infectious virus.”

About BRII-835 (VIR-2218)
BRII-835 (VIR-2218) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the Vir Biotechnology’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. Brii Bio licensed exclusive rights to develop and commercialize VIR-2218 for the greater China territory from Vir in 2020.

In addition to the Phase 2 combination trial with BRII-179 (VBI-2601), VIR-2218 is being evaluated in two ongoing trials: as a monotherapy for HBV, and in combination with pegylated interferon-alpha (PEG-IFN-α). Two additional Phase 2 trials of VIR-2218 are expected to start in 2021.

About BRII-179 (VBI-2601)
VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate, and is designed to target enhanced B-cell and T-cell immunity. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences in the licensed territory of China, Hong Kong, Macau, and Taiwan as part of a potential functional cure for chronic hepatitis B infection.