Brii Biosciences Announces Two Breakthrough Therapy Designations for BRII-877 and BRII-835 Building on Extensive Clinical Evidence from Multiple Phase 2 Studies
DURHAM, N.C. and BEIJING,
The Breakthrough Therapy Designation for BRII-877 (tobevibart) was supported by Phase 1 and 2 studies conducted by
"Receiving Breakthrough Therapy Designations for BRII-877 and BRII-835 as well as the earlier Breakthrough Therapy Designation for BRII-179 further supports our long-held scientific rationales in the development of functional cure combination regimens for patients with chronic HBV infection," said Dr.
Having three breakthrough therapeutic modalities puts the Company in a unique position to address the broader populations of HBV infections including co-infection with HDV. As part of Brii Bio's approach to developing a functional cure for HBV, the Company and its partner Vir are progressing plans to initiate multiple combination studies in 2024 to further optimize the curative regimens that will inform the Company's registration strategy to bring the best regimens to HBV patients.
About Hepatitis B
Hepatitis B viral infection (HBV) is one of the world's most significant infectious disease threats with more than 254 million people infected globally.1 Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV each year.1 HBV is of exceptional concern in
About Hepatitis D
Hepatitis D is a liver inflammation caused by the hepatitis D virus (HDV), which relies on hepatitis B virus (HBV) for replication. This infection can only occur in the presence of HBV. The combination of HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis, leading to a quicker progression towards hepatocellular carcinoma and liver-related death. Globally, nearly 5% of individuals with chronic HBV infection are affected by HDV. HDV infection can occur through either simultaneous infection with both hepatitis B and D (co-infection) or acquiring hepatitis D after already having hepatitis B (super-infection).3
About BRII-877 (Tobevibart)
BRII-877 (tobevibart) is an investigational subcutaneously administered neutralizing monoclonal antibody designed to block entry of HBV and HDV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. BRII-877 (tobevibart), which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to potentially function as a T-cell vaccine against HBV and HDV, as well as to have an extended half-life. Brii Bio licensed exclusive rights to develop and commercialize BRII-877 (tobevibart) for the greater
About BRII-835 (Elebsiran)
BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. 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. Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater
About BRII-179
BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in
About Brii Bio
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