vir公司年报

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乙型肝炎病毒（HBV）和丁型肝炎病毒（HDV）

VIR-2218是一种研究性HBV靶向siRNA。VIR-3434是一种研究性HBV中和单克隆抗体，它结合了Xencor的Xtend等Fc技术。

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2022年10月，我们在美国肝病研究协会（AASLD，The Liver Meeting ® 2022）上公布了多份摘要（两份口头报告、一份海报和一份最新海报，展示了一项评估慢性HBV治疗模式的20年试验的真实数据），将于2022年11月4日至8日举行。这两份口头报告都被AASLD选为“最佳肝脏会议”摘要。
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正在进行的乙型肝炎2期单克隆抗体siRNA组合试验（MARCH）B部分的初步数据，该试验评估了VIR-2218与VIR-3434联合治疗24和48周，以及与VIR-3434和干扰素联合治疗24和48周，预计在2023年下半年。先前报道的MARCH A部分试验结果表明，VIR-3434和VIR-2218的组合导致乙型肝炎表面抗原或HBsAg下降约3个对数，而迄今为止没有报告安全信号。
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VIR-2218与VIR-3434联合用于病毒血症患者的2期PREVAIL平台试验及其THRIVE/STRIVE子方案预计将于2022年第四季度启动，初步数据预计将于2023年下半年发布。
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由Brii Biosciences Offshore Limited或Brii Bio牵头的第二阶段试验的初步数据预计将于2022年底发布，该试验评估VIR-2218与BRII-179（一种研究性T细胞疫苗）联合用于慢性HBV感染的潜在治疗。
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2022年9月，我们启动了SOLSTICE 2期试验，评估VIR-2218和VIR-3434作为单一疗法和联合疗法治疗慢性HDV（一种侵袭性最强的病毒性肝炎）的患者。该试验正在评估两种联合用药组合降低HDV病毒血症和阻断病毒进入的能力，最近的研究表明，这两种联合用药组合可有效抑制慢性HDV感染。初步数据预计在2023年下半年发布。

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vir今年看点

vir2218+vbi2601停药6个月转阴率


vir2218+vir3434+干挠素三联结果

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Press Release Details
Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
02/23/23 at 4:06 PM EST
PDF Version
– Transformational year ahead with critical Phase 2 readouts expected for programs in hepatitis B, hepatitis D and influenza with the potential for significant patient impact –

– $1.5 billion of sotrovimab collaboration revenue recognized in 2022 –

– Strong balance sheet expected to fund Vir’s robust portfolio through major inflection points with the flexibility to evaluate external opportunities –

SAN FRANCISCO, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2022.

“2022 was a seminal year for Vir. We remained on the front lines of the COVID-19 pandemic with the delivery of sotrovimab to millions of patients around the world, initiated two critical Phase 2 trials in influenza and hepatitis D, reported important new data on hepatitis B, secured a multi-year government contract with the potential for up to $1 billion, and recognized $1.5 billion in revenue – all of which served to establish an exceptionally strong foundation on which we will continue to build in 2023,” said George Scangos, Ph.D., Chief Executive Officer of Vir Biotechnology.

Dr. Scangos added, “I am incredibly proud of all that the Vir team has accomplished in just a few short years and the key elements that are now in place to ensure the Company’s ongoing success – an exciting pipeline, near-term catalysts that have the potential to support important new therapies, a long-term strategic plan, significant cash and an exceptional incoming CEO. I look forward to continuing to support the Company through this important transition period and advancing our ambitious mission of delivering a world without infectious disease.”

Corporate Update

General – senior leadership changes

In the first quarter of 2023, the Company announced:
George Scangos, Ph.D., will retire from his position as Chief Executive Officer, effective April 3, 2023. The Company’s Board of Directors appointed industry veteran Marianne De Backer, MSc, Ph.D., MBA, currently Executive Vice President, Head of Pharmaceuticals Strategy, Business Development and Licensing/Open Innovation, and member of the Executive Committee for Bayer Pharmaceuticals, as his successor, effective April 3, 2023. She will also join Vir’s Board of Directors.
The appointment of 20-year biotech veteran Sung Lee as Chief Financial Officer, following the resignation of Howard Horn who is departing to pursue the next chapter in his career.
Hepatitis B Virus (HBV) – data expected from multiple trials in 2023, building on 2022 progress

In November, at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, the Company presented new data from multiple ongoing trials evaluating the potential for VIR-2218 and VIR-3434 to achieve a functional cure for chronic HBV, as well as health outcomes research. Highlights included:
Initial Phase 2 end-of-treatment data demonstrated that 30.8% of participants receiving 48 weeks of VIR-2218 plus PEG-IFN-α achieved hepatitis B surface antigen (HBsAg) seroclearance and each of those participants also achieved seroconversion, suggesting an improvement in those participants’ immune function (anti-HBs levels >10mIU/mL). No safety signals have been reported to date. Additional data are expected in the first half of 2023.
Initial end-of-treatment results from Part A of the Phase 2 Monoclonal Antibody siRNA Combination against Hepatitis B (MARCH) trial demonstrated mean HBsAg reductions of ≥2.7 log10 IU/mL across all three cohorts. These data show that VIR-2218 and VIR-3434 are additive in reducing HBsAg. No safety signals have been reported to date. Additional data from Part A are expected in the first half of 2023. Initial data from Part B, evaluating VIR-2218 in combination with VIR-3434 for 24 and 48 weeks, and in triple combination with VIR-3434 and PEG-IFN-α for 24 and 48 weeks, are expected in the second half of 2023.
Initiation of the Phase 2 PREVAIL platform trial and its THRIVE/STRIVE sub-protocols of VIR-3434 and/or VIR-2218 and/or PEG-IFN-α in viremic patients is expected in the first half of 2023. The THRIVE sub-protocol will evaluate inactive carriers defined as adults with chronic HBV that are hepatitis B e-antigen (HBeAg) negative with HBV DNA ≤2000 IU/mL and ALT ≤ ULN. The STRIVE sub-protocol will evaluate immune active, treatment-naïve patients defined as adults with chronic HBV who have not received prior nucleotide/nucleoside reverse transcriptase inhibitors or PEG-IFN-α therapy and are HBeAg positive or negative with HBV DNA >2000 IU/mL, ALT > ULN and ≤ 5× ULN. Initial data are expected in the first half of 2024.
In February, initial data from the Phase 2 trial led by Brii Biosciences evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection were presented at the Asian Pacific Association for the Study of the Liver (APASL). Although the combination of VIR-2218 and BRII-179 had greater anti-HBs responses and improved HBsAg-specific T cell responses, comparable HBsAg reduction were observed in all cohorts at the end of treatment (-1.7-1.8 log10 IU/mL). The combination of VIR-2218 and BRII-179 was generally well tolerated.
Hepatitis D Virus (HDV) – initial data from novel combination strategy expected in 2023

Initial data from the Phase 2 SOLSTICE trial evaluating VIR-2218 and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic HDV, the most aggressive form of viral hepatitis, are expected in the second half of 2023