Direct evidence that BRII-179-induced functional antibody responses lead to increased and sustained HBsAg loss
New insights into using BRII-179 to enhance patients’ intrinsic humoral immune response to improve HBsAg disappearance or HBV functional cure rate
New data supports entry into late-stage clinical development, data expected to inform treatments for chronic hepatitis B
“We are pleased to share these data at the Liver Conference, which demonstrate the versatility of our HBV portfolio and the important insights we have in the search for a cure for HBV,” said
In its latest poster presentation, Brii Bio announced additional interim data from BRII-179 with pegylated interferon-alpha (PEG-IFNα) in patients with CHB infection. Findings from this presentation include:
- Add-on therapy with BRII-179 to existing PEG-IFNα therapy was generally safe and tolerated, with adverse events similar to those previously reported for PEG-IFNα therapy and BRII-179.
- At week 36 (12 weeks after end of treatment (EOT)), the BRII-179 + PEG-IFNα combination group achieved greater HBsAg disappearance compared with the placebo + PEG-IFNα group (Full Analysis Set (FAS) :24.6% vs. .14.0%, per protocol set (PPS): 31.8% vs. 14.9%). Differences in HBsAg disappearance rates were observed at week 24 (EOT) and maintained through week 36. Clinical studies also found that the HBsAg seroconversion rate in the combination group was significantly higher than that in the placebo + PEG-IFNα group (FAS: 15.8% vs. 1.8) %, p=0.016; PPS: 19.6% 2.0%, p=0.0058) at week 24 (EOT).
- The addition of BRII-179 induced a robust and functional HBsAg antibody response, with participants in the BRII-179 + PEG-IFNα combination group achieving significantly higher HBsAg antibody responses than those in the placebo + PEG-IFNα group at week 24. Hepatitis B surface antibody (HBsAb) response rate (FAS: 38.6% vs. 14.0%, p=0.0052; PPS: 39.1% 13.7%, p=0.0054) and Week 36 (FAS: 33.3% vs. 12.3%, p=0.0131; PPS: 34.1% 10.6%, p=0.0105). HBsAb titer was significantly associated with HBsAg loss at 24 and 36 weeks. 4 out of 5 patients Quinn No antibody response was detected in the rebound.
- Data from this proof-of-concept study demonstrate that the addition of BRII-179 induces a functional immune response that improves the rate and duration of HBsAg loss in patients with chronic hepatitis B Quinn Receive PEG-IFNα treatment to improve the functional cure rate of CHB.
In a second updated poster presentation, Brii Bio presents translational research data from the BRII-179-001 and BRII-179-835-001 studies demonstrating that unique BRII-179-induced HBsAg is only observed in a subset of CHB subjects Antibody responses, suggesting that the intrinsic immune response to HBV may be more severely impaired in some patients. Additionally, the researchers found:
- BRII-179 in combination with BRII-835 (VIR-2218) was generally well tolerated at doses up to 9 months, with no >Grade 2 treatment-related adverse events.
- In participants with chronic hepatitis B receiving nucleos
- The PK profile of BRII-835 in patients with chronic HBV infection is generally similar to that in healthy volunteers. A dose-dependent increase in systemic exposure was observed at the 50 and 100 mg doses. There was no significant accumulation in plasma after the second dose was given four weeks later.
- Similar PK profiles among enrolled patients
Asia-Pacific and mainlandChina Proof of Chinese origin from Mainland ChinaChina It has no obvious impact and can be used as a bridge to support the mainland.China’s Participate in future global trials to further evaluate BRII-835.
As part of Brii Bio’s efforts to develop functional cures for hepatitis B, the company and its partners are conducting multiple ongoing Phase 2 studies, including the combination of BRII-835 and BRII-179, the combination of BRII-179 and PEG-IFN⍺, BRII – 835, BRII-877 (VIR-3434), with or without PEG-IFN⍺. Additionally, Vir Biotechnology, Inc. (“Vir”) is investigating VIR-2218 and/or VIR-3434 for the treatment of HBV/HDV coinfections.
About hepatitis B
Hepatitis B virus infection is one of the world’s most serious infectious disease threats, with more than 290 million people infected globally.1 Chronic HBV infection is a major cause of liver disease, and an estimated 820,000 people die from complications of chronic HBV each year.1 Hepatitis B virus (HBV) receives special attentionChina 87 million people were infected.2About BRII-179
BRII-179 (VBI-2601) is a novel HBV immunotherapy candidate based on recombinant proteins expressing Pre-S1, Pre-S2 and S HBV surface antigens designed to induce enhanced and broad B-cell and T-cell immunity. BRII-179 is currently being studied in two Phase 2 clinical trials in combination with BRII-835 or PEG-IFNα as part of a potential functional cure regimen for the treatment of chronic HBV infection.Brii Bio licenses BRII-179 from VBI Vaccines, Inc. (“VBI”)
December 2018 provides Brii Bio with commercial rights to BRII-179 in the following license territories:China ,Hongkong ,Macao andTaiwan . Exclusive license for BRII-179 expanded to global marketsJuly 2023 .About BRII-835
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 employ enhanced stability chemical enhancement (ESC+) technology to enhance stability and minimize off-target activity, which may result in an increased therapeutic index. Brii Bio acquires exclusive rights to develop and commercialize BRII-835 to facilitate broader developmentChina Acquired territory from Vir Biotechnology, Inc. (“Vir”) in 2020.About BRII-877
BRII-877 (VIR-3434) is an investigational, subcutaneously administered HBV-neutralizing monoclonal antibody designed to block the entry of all 10 genotypes of HBV into hepatocytes and reduce blood levels of virions and subviral particles. BRII-877 (VIR-3434) combines Xencor’s Xtend™ and other Fc technologies and is engineered as a T-cell vaccine against HBV in infected patients with an extended half-life. Brii Bio acquires exclusive rights to develop and commercialize BRII-877 to facilitate broader developmentChina 2022 Seize territory from Vir Biotechnology, Inc. (“Vir”).About Borui Biotechnology
Borui Biotechnology Co., Ltd. (“Brii Bio”, stock code: 2137.HK) is a commercial-stage biotechnology company developing therapies to address major public health challenges that leave patients with high unmet medical needs, limited options and serious social consequences shame. Focused on infectious diseases and central nervous system diseases, the company is advancing a unique pipeline of therapeutic candidates, including lead programs targeting hepatitis B virus infection (HBV), postpartum depression (PPD) and major depressive disorder (MDD) .The company is led by a visionary and experienced leadership team and operates in major biotechnology centers includingRaleigh-Durham thissan francisco bay area ,Beijing andShanghai . For more information, please visit www.briibio.com.1 World Health Organization. (
June 2022 ). Hepatitis B. World Health Organization. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
2 World Health Organization. hepatitis. World Health Organization. Retrieved from https://www.who.int/china/health-topics/hepatitis#:~:text=There%20are%2087%20million%20people,living%20with%20chronic%20hepatitis%20C.
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