VIR Vir Biotechnology Inc.

35.65
-0.74  -2%
Previous Close 36.39
Open 36.17
52 Week Low 25.31
52 Week High 141.01
Market Cap $4,635,920,225
Shares 130,039,838
Float 69,022,035
Enterprise Value $4,069,300,704
Volume 531,297
Av. Daily Volume 748,043
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-PEAK)
COVID-19
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Sotrovimab (VIR-7831 / GSK4182136) - (ACTIV-3)
Mild to moderate COVID-19
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
VIR-1111
HIV T cell vaccine
Phase 1
Phase 1
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
VIR-7832 (AGILE)
COVID-19 vaccine/therapeutic
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
VIR-2218 with pegylated interferon-alpha (PEG-IFN-α)
Hepatitis B
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
VIR-2218 and VIR-3434 (MARCH)
Hepatitis B
Phase 2
Phase 2
Phase 2 initiation announced July 15, 2021.
VIR-3434
Hepatitis B
Phase 1
Phase 1
Phase 2 trial planned for 2H 2021.
VIR-2482
Influenza
Phase 1/2
Phase 1/2
Phase 2 trial planned.
VIR-2218 with pegylated interferon-alpha
Chronic hepatitis B virus (HBV)
Phase 2
Phase 2
Phase 2 initial data presented at EASL meeting June 2021.
Bamlanivimab (LY-CoV555) and Sotrovimab (VIR-7831 / GSK4182136) - BLAZE-4
COVID-19 antibody
Phase 2
Phase 2
Phase 2 data released March 29, 2021 - 70 percent (p<0.001) relative reduction in persistently high viral load.
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-ICE)
COVID-19 antibody
Approved
Approved
FDA Emergency Use Authorization filing approval announced May 26, 2021.
BRII-835 (VIR-2218) and BRII-179 (VBI-2601)
Hepatitis B
Phase 2
Phase 2
Phase 2 trial initiation announced April 21, 2021.

Latest News

  1. LONDON and SAN FRANCISCO, July 28, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk…

    LONDON and SAN FRANCISCO, July 28, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.

    This action follows the positive scientific opinion issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), under Article 5(3) of Regulation 726/2004, which can be considered by the national authorities in EU Member States when taking evidence-based decisions on the early use of the medicine prior to marketing authorization. Sotrovimab is included in the European Commission's portfolio of promising candidate therapies as part of its COVID-19 Therapeutics Strategy. In addition, the documentation to support the forthcoming marketing authorization application for sotrovimab is under rolling regulatory review with the EMA. In June, the companies announced confirmatory full results for the Phase 3 COMET-ICE trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalizations for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial.

    George Katzourakis, senior vice president, Europe, GSK said: "This agreement with the European Commission represents a crucial step forward for treating cases of COVID-19 in participating EU Member States, as it enables access to sotrovimab for high-risk patients who have contracted the virus. As the COVID-19 landscape continues to evolve and we meet new challenges – such as the Delta variant spreading across the globe – there remains an urgent need for treatment options to help those who do get sick to potentially avoid hospitalization or death."

    George Scangos, Ph.D., chief executive officer of Vir, said: "It remains abundantly clear that additional treatment options are needed to fully address the toll of this pandemic. This agreement recognizes that monoclonal antibody treatments for those who become infected are essential, and we are pleased that European healthcare providers and their patients now have access to sotrovimab. Notably, the fact that sotrovimab was designed from the beginning to maintain activity against the evolution of this virus and has demonstrated, in vitro, its ability to maintain activity against the tested circulating variants of concern and interest, including Delta and Lambda, underscore its critical role in the fight against COVID-19."

    Recognizing the acute urgency of patient need across the world, the companies are engaging with governments and procurement bodies to make sotrovimab available to support the pandemic response. GSK and Vir have secured supply agreements with multiple governments around the world and will continue those efforts as the pandemic continues to evolve. In May 2021, sotrovimab was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in high-risk patients. GSK and Vir have announced plans to submit a Biologics License Application (BLA) to the U.S. FDA in the second half of 2021. Sotrovimab has also been authorized for emergency use in Bahrain, Kuwait, Qatar, Singapore and United Arab Emirates.

    GSK and Vir are committed to ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge. Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against currently circulating variants of concern and interest of the SARS-CoV-2 virus including Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2), Epsilon (B.1.427/B.1.429), Gamma (P.1), Iota (B.1.526), Kappa (B.1.617.1) and Lambda (C.37), as well as new variants from Bristol (B.1.1.7+E484K) and Cameroon (B.1.619), which encodes both N440K and E484K mutations that may lead to reduced activity for other neutralizing monoclonal antibodies against the SARS-CoV-2 virus. GSK and Vir are continuing to evaluate the ability of sotrovimab to maintain activity against new and emerging variants through in vitro studies. The clinical impact of these in vitro variant data is not yet known.

    About the COMET-ICE Study

    The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated intravenous (IV) infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease. In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy and is continuing to follow trial participants for 24 weeks. Interim data results have been shared with regulatory authorities and formed the basis of the positive scientific opinion reached by the EMA's CHMP, under Article 5(3) of Regulation 726/2004.

    This ongoing trial evaluated the safety and efficacy of a single IV infusion of sotrovimab (500 mg) or placebo in non-hospitalized participants globally. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for greater than 24 hours for acute management of any illness or death from any cause.

    The final COMET-ICE trial results in the full study population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalization for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. The number of patients who were hospitalized for >24 hours for acute management of any illness or death from any cause at Day 29 was six patients in the sotrovimab arm (1%), versus 30 patients in the placebo arm (6%). In the sotrovimab arm, it is possible that half of those patients who were hospitalized were for reasons other than progression of COVID-19 (e.g., small bowel obstruction, lung cancer and diabetic foot ulcer); this was not the case for patients in the placebo arm.

    In the safety analysis, 1,037 participants were followed through at least 29 days. The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.

    About the Sotrovimab Clinical Development Program

    In addition to the COMET-ICE trial, the full COMET clinical development program for sotrovimab includes:

    • COMET-PEAK, a pharmacokinetic trial in outpatients with mild-to-moderate COVID-19 investigating intramuscular (IM) administration of sotrovimab, is near completion and initial data are expected in the second half of 2021.
    • COMET-TAIL has been initiated. This is a Phase 3 trial evaluating the role of IM-administered sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalized adult and pediatric patients (12 years of age and older). Data are anticipated in the first half of 2022.

    The companies also plan to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection.

    About Sotrovimab

    Sotrovimab is an investigational SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

    Important Information about Sotrovimab in Europe

    For more information on the EMA positive scientific opinion, please review the EU Conditions of Use.

    All side effects have been mild or moderate. Healthcare professionals should look out for side effects and take appropriate action.

    Reporting of suspected adverse reactions

    Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

    Sotrovimab in the United States

    Healthcare providers in the U.S. should review the Fact Sheets for information on the authorized use of sotrovimab and mandatory requirements of the EUA.

    Sotrovimab has been authorized by the U.S. FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use. 

    Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

    Authorized Use 

    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

    Limitations of Authorized Use 

    Sotrovimab is not authorized for use in patients: 

    • who are hospitalized due to COVID-19, OR 
    • who require oxygen therapy due to COVID-19, OR 
    • who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity).

    Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

    Please see the FDA Letter of Authorization, full Fact Sheet for Healthcare Providers and full Fact Sheet for Patients, Parents, and Caregivers.

    About the Vir and GSK Collaboration

    In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

    GSK Commitment to Tackling COVID-19

    GSK's response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to our vaccine candidates in development with partner organizations.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, we recently announced positive Phase 2 data from our collaboration with Sanofi to develop an adjuvanted, protein-based vaccine candidate and started a Phase 3 trial in Q2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

    GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19 vaccine. GSK is also providing manufacturing support for up to 60m doses of Novavax' COVID-19 vaccine in the UK.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

    Vir's Commitment to COVID-19

    Vir was founded with the mission of addressing the world's most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.

    About GSK

    GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Vir Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of sotrovimab to treat and/or prevent COVID-19, our collaboration with GSK, an agreement with the European Commission to supply sotrovimab and other potential supply agreements, the clinical development program for sotrovimab and the ability of sotrovimab to maintain activity against circulating variants of concern. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir's competitors, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contacts:
    
    Heather Rowe Armstrong
    VP, Investor Relations
    
    +1 415 915 4228
    
    Cara Miller
    VP, Corporate Communications
    
    +1 415 941 6746
    
    GSK Contacts:
     
    Media:
    
    Tim Foley
    +44 (0) 20 8047 5502
    (London)
    
    Kristen Neese
    +1 804 217 8147
    (Philadelphia)
    
    Kathleen Quinn
    +1 202 603 5003
    (Washington DC)
    
    Lyndsay Meyer
    +1 202 302 4595
    (Washington DC)
    
    Analysts/Investors:
    
    James Dodwell
    +44 (0) 20 8047 2406
    (London)
    
    Sonya Ghobrial
    +44 (0) 7392 784784
    (Consumer)
    
    Mick Readey
    +44 (0) 7990 339653
    (London)
    
    Jeff McLaughlin
    +1 215 751 7002
    (Philadelphia)
    
    Frannie DeFranco
    +1 215 751 4855
    (Philadelphia)

    Primary Logo

    View Full Article Hide Full Article
  2. SAN FRANCISCO, July 22, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the second quarter ended June 30, 2021 on Thursday, August 5, 2021.

    The update will be provided via a press release after market close and will be accessible under Press Releases in the Investors section of the Vir website at www.vir.bio.

    About Vir Biotechnology
    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical…

    SAN FRANCISCO, July 22, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the second quarter ended June 30, 2021 on Thursday, August 5, 2021.

    The update will be provided via a press release after market close and will be accessible under Press Releases in the Investors section of the Vir website at www.vir.bio.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.



    Contacts:
    
    Investors
    Heather Rowe Armstrong
    VP, Investor Relations
    
    +1-415-915-4228
    
    Media
    Cara Miller
    VP, Corporate Communications
    
    +1-415-941-6746

    Primary Logo

    View Full Article Hide Full Article
  3. SAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the first patient has been dosed in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection – a combination designed to achieve a functional cure.

    VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as…

    SAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the first patient has been dosed in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection – a combination designed to achieve a functional cure.

    VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 "vaccinal mutation," allowing it to potentially function as a therapeutic T cell vaccine against HBV. 

    "HBV infection remains an urgent global public health challenge associated with significant morbidity and mortality, and we believe that a combination approach focused on immune restoration will be critical to achieving a functional cure," said Phil Pang, M.D., Ph.D., Vir's chief medical officer. "We are excited about the potential of VIR-2218 to serve as the cornerstone of that approach. We believe that combining it with VIR-3434, which has already demonstrated the ability to markedly lower hepatitis B surface antigen at low doses in an ongoing Phase 1 trial, and, most importantly, has the potential to function as a therapeutic T cell vaccine, could be a game changer."

    The multi-center, open-label Phase 2 trial is designed to evaluate the safety, tolerability and efficacy of the combination of VIR-2218 and VIR-3434 in approximately 90 adult patients (ages 18 to 65) with chronic HBV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Both VIR-2218 and VIR-3434 will be administered via subcutaneous injection at varying dose levels over the course of the trial for a treatment period ranging from four to 20 weeks, and a follow-up period of up to 116 weeks, depending on the dosing cohort. The primary endpoints of the trial are the proportion of patients with treatment-emergent adverse events and serious adverse events; grading of post-treatment clinical laboratory parameters; and the proportion of patients achieving a functional cure (defined as undetectable HBsAg and sustained suppression of HBV DNA).

    About VIR-2218

    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 company's collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

    About VIR-3434

    VIR-3434 is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood. VIR-3434, which has been Fc engineered to potentially function as a T cell vaccine against HBV in infected patients, also incorporates Xencor's Xtend™ in order to have an extended half-life.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of VIR-2218 and VIR-3434 (as monotherapies or combination therapies) to treat and/or prevent chronic HBV infection, and the timing, design and enrollment plans for the Phase 2 MARCH trial. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir's competitors, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.



    Contact:
    Heather Rowe Armstrong
    VP, Investor Relations
    
    +1 415.915.4228
    
    Cara Miller
    VP, Corporate Communications
     
    +1 415.941.6746

    Primary Logo

    View Full Article Hide Full Article
  4. – Results demonstrate positive safety profiles and a reduction in HBsAg for two novel HBV therapies administrated as monotherapy or in combination with other agents –

    – Management to host conference call today, Friday, June 25, 2021, at 11:00 a.m. ET –

    SAN FRANCISCO, June 25, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results, which demonstrate positive safety findings plus a reduction in hepatitis B surface antigen (HBsAg) for both compounds, were presented in two oral and two poster presentations at the European Association for the Study…

    – Results demonstrate positive safety profiles and a reduction in HBsAg for two novel HBV therapies administrated as monotherapy or in combination with other agents –

    – Management to host conference call today, Friday, June 25, 2021, at 11:00 a.m. ET –

    SAN FRANCISCO, June 25, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results, which demonstrate positive safety findings plus a reduction in hepatitis B surface antigen (HBsAg) for both compounds, were presented in two oral and two poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress 2021, which is taking place virtually. Vir will hold a conference call and webcast today, Friday, June 25, 2021, at 11:00 a.m. ET, to discuss the new data presented at the meeting.

    In summary, data presented this week demonstrate the promising safety profile and potential durable response of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), through 48 weeks. In a separate analysis evaluating VIR-2218 in combination with pegylated interferon alfa (PEG-IFN-α) for 12 weeks, a more rapid and substantial HBsAg decline was observed in the co-administration cohort compared to VIR-2218 alone. The treatment regimen resulted in no new safety signals.

    Additionally, two new analyses from an ongoing Phase 1 trial of VIR-3434 showed no safety signals in healthy volunteers dosed with up to 3,000 mg, and a rapid reduction in HBsAg levels one week after subcutaneous administration of this investigational HBV-neutralizing monoclonal antibody, which has been Fc engineered to include the XX2 "vaccinal mutation," allowing it to potentially function as a T cell vaccine.

    "For years, the field has been hoping that viral antigen knockdown will help unlock the ability of immunomodulatory agents to control chronic hepatitis B – a devastating viral disease resulting from a loss of immune control," said Phil Pang, M.D., Ph.D., Vir's chief medical officer. "These new data are exciting because they suggest this may indeed be the case. Knockdown of all HBV proteins by VIR-2218, coupled with the immunomodulatory agent pegylated interferon alfa, resulted in potentially more than additive declines in hepatitis B surface antigen. Findings also strongly support our overall strategic approach of combining VIR-2218 with various immune modulators. Meanwhile, the monotherapy results for VIR-3434, which speak for themselves, support my belief that the combination of VIR-3434 and VIR-2218 has significant potential. That combination trial is expected to start in the second half of this year."

    VIR-2218: Key Data

    Results from a Phase 2 multiple-ascending dose trial of VIR-2218 in 32 patients with chronic HBV infection evaluating the safety and antiviral activity of two doses of VIR-2218 (20 to 200 mg) administered subcutaneously four weeks apart demonstrate:

    • Dose-dependent reductions in HBsAg through 48 weeks in both trial participants with hepatitis B e antigen (HBeAg), a marker of actively replicating HBV, and those without.

    • Of the 12 participants who received the 100 mg or 200 mg dose, four participants experienced sustained HBsAg reductions of >1 log10 IU/mL and absolute HBsAg levels below 100 IU/mL through Week 48.

    • Treatment with VIR-2218 achieved dose-related reductions in other viral biomarkers; one patient receiving 200 mg experienced HBeAg loss at Week 24 and anti-HBe seroconversion at Week 16 that was sustained through Week 48.

    • Adverse events were mild, and no dose-dependent changes in post-treatment ALT levels (a signal of liver damage) occurred. No trial participants discontinued treatment.



      Oral Presentation:
      Prof. Edward Gane, M.D., professor of medicine at the University of Auckland and chief hepatologist, transplant physician and deputy director of the New Zealand Liver Transplant Unit (Abstract #44).

    In a separate ongoing Phase 2 trial, 47 adult patients with chronic HBV infection were assigned to receive subcutaneously injected VIR-2218 alone or in combination with PEG-IFN-α. Preliminary results through Week 12 of the treatment period demonstrate:

    • VIR-2218 alone and in combination with PEG-IFN-α were associated with HBsAg reductions of >1 log10 IU/mL by Week 12.

    • Co-administration of VIR-2218 with PEG-IFN-α (Cohort 3) resulted in a more rapid and substantial HBsAg decline compared to VIR-2218 alone.

    • In Cohort 3, the mean HBsAg decline from baseline was 2.0 log10 IU/mL at Week 12 and 0.6 log10 IU/mL greater than in the two cohorts evaluating VIR-2218 alone.

    • In published studies, PEG-IFN-α alone in virally suppressed patients was associated with ≤ 0.25 log10 IU/mL HBsAg decline, on average, over the first 12 weeks.

    • No treatment-related grade ≥3 treatment-emergent adverse events or serious adverse events were reported with VIR-2218 alone or in combination with PEG-IFN-α, and the combination did not appear to increase the known side effects of PEG-IFN-α.



      Poster Presentation: Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., chair professor and chief of the division of gastroenterology and hepatology, deputy head of the department of medicine and Li Shu Fan Medical Foundation professor in medicine at The University of Hong Kong (Abstract #824).

    VIR-3434: Key Data

    Results from a Phase 1 trial evaluating VIR-3434 in 40 virally suppressed patients with chronic HBV infection who were randomized to receive a single low dose of either 6 mg or 18 mg for four weeks demonstrate:

    • Treatment with VIR-3434 resulted in rapid >1 log10 IU/mL reductions in HBsAg, with the largest reductions (>1.5 log10 IU/mL) observed in the 18 mg cohort; maximum reductions were generally observed within one week.

    • No new safety signals were identified with single doses of VIR-3434; all adverse events were grade 1 or 2.

    • No significant changes in liver-related laboratory parameters or clinically significant changes in ALT or other liver-related laboratory parameters were reported.



      Oral Presentation: Kosh Agarwal, M.D., consultant hepatologist and transplant physician at the Institute of Liver Studies, King's College Hospital NHS Foundation Trust in London (Abstract #211).

    In a separate Phase 1 trial in 40 healthy adult volunteers evaluating single doses of up to 3,000 mg of VIR-3434 administered subcutaneously or intravenously, results demonstrate:

    • Subcutaneous administration of VIR-3434 showed favorable pharmacokinetic properties, with VIR-3434 remaining in the serum for 24 weeks.

    • No new safety signals were identified; specifically, no grade 3/4 adverse events, serious adverse events or adverse events leading to trial discontinuation were reported.



      Poster Presentation: Sneha Gupta, Ph.D., associate director of clinical pharmacology at Vir Biotechnology (Abstract #43).

    Conference Call and Webcast Details

    Management will host a conference call and webcast featuring Professor Yuen at 11:00 a.m. ET today, June 25, 2021, to discuss the new data presented at the International Liver Congress 2021.

    To access the call via telephone, please dial (833) 727-9519 (North America) or (830) 213-7696 (International), conference ID: 5476112.

    A live webcast of the presentation can be accessed under Events & Presentations in the Investors section of the Vir website at www.vir.bio and will be archived there following the presentation for 30 days.

    The Company has used, and intends to continue to use, the Investors page of its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investors website, in addition to following the Company's press releases, Securities and Exchange Commission filings, public conference calls, presentations and webcasts.



    About Vir's Clinical Program for Chronic HBV

    In addition to the ongoing Phase 2 trials of VIR-2218 alone and in combination with pegylated interferon-alfa (PEG-IFN-α), Vir entered into a clinical collaboration with Gilead Sciences, Inc. to evaluate VIR-2218 in a Phase 2 combination therapy trial with selgantolimod (GS-9688), Gilead's investigational TLR-8 agonist, and nivolumab, an approved PD-1 inhibitor, in both treatment-experienced and treatment-naïve patients with HBV. The trial, aimed at developing a functional cure for chronic HBV, is expected to start in the second half of 2021. Additionally, Vir's collaborator Brii Biosciences initiated a Phase 2 trial evaluating VIR-2218 in combination with BRII-179 (VBI-2601), an investigational T cell vaccine, for the treatment of chronic HBV infection.

    In addition to the ongoing Phase 1 trial evaluating VIR-3434 for the treatment of patients with chronic HBV, Vir plans to initiate a Phase 2 trial of VIR-3434 in combination with VIR-2218 in the second half of 2021.

    About VIR-2218

    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 company's collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

    About VIR-3434

    VIR-3434 is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV in infected patients, as well as to have an extended half-life.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding clinical data from Vir's ongoing trials of VIR-2218 and VIR-3434, timing of the Phase 2 trial of VIR-3434 in combination with VIR-2218, the ability of VIR-2218, VIR-3434, and a combination of both in treating patients with chronic hepatitis B virus infection and Vir's collaboration with Gilead Sciences, Inc. to evaluate VIR-2218 in a combination therapy trial with GS-9688. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir's competitors, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.



    Contact:
    Heather Rowe Armstrong
    VP, Investor Relations
    
    +1 303 641 2052
    
    Cara Miller
    VP, Corporate Communications
    
    +1 415 941 6746

    Primary Logo

    View Full Article Hide Full Article
  5. – Analysis of final Day 29 data from COMET-ICE confirms sotrovimab significantly reduces 
    hospitalization and risk of death in adults with mild-to-moderate COVID-19 who are at high risk 
    of progression to severe disease –

    – U.S. National Institutes of Health (NIH) COVID-19 Treatment Guidelines
    updated to recommend use of sotrovimab –

    – Further research initiated to evaluate intramuscular administration of sotrovimab for the
    early treatment of mild-to-moderate COVID-19 in high-risk patients in a Phase 3 study –

    LONDON and SAN FRANCISCO, June 21, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced final, confirmatory results from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody…

    – Analysis of final Day 29 data from COMET-ICE confirms sotrovimab significantly reduces 

    hospitalization and risk of death in adults with mild-to-moderate COVID-19 who are at high risk 

    of progression to severe disease –

    – U.S. National Institutes of Health (NIH) COVID-19 Treatment Guidelines

    updated to recommend use of sotrovimab –

    – Further research initiated to evaluate intramuscular administration of sotrovimab for the

    early treatment of mild-to-moderate COVID-19 in high-risk patients in a Phase 3 study –

    LONDON and SAN FRANCISCO, June 21, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced final, confirmatory results from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial demonstrating that sotrovimab, an investigational SARS-CoV-2 monoclonal antibody, significantly reduced the risk of hospitalization or death among high-risk adult outpatients with mild-to-moderate COVID-19. Additionally, the U.S. National Institutes of Health (NIH) updated its COVID-19 treatment guidelines to recommend sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression and noted that sotrovimab appears to retain activity against current variants of concern and interest.

    The primary efficacy analysis of all 1,057 patients in the COMET-ICE trial demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalization for more than 24 hours or death due to any cause, by Day 29 compared to placebo, meeting the primary endpoint of the trial.

    The number of patients in the trial who were hospitalized for >24 hours for acute management of any illness or death from any cause at Day 29 was six patients in the sotrovimab arm (1%), versus 30 patients in the placebo arm (6%). In the sotrovimab arm, it is possible that half of those patients who were hospitalized were for reasons other than progression of COVID-19 (e.g., small bowel obstruction, lung cancer and diabetic foot ulcer); this was not the case for patients in the placebo arm. In the safety analysis, 1,037 participants were followed through at least 29 days. The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo. The companies plan to submit the full COMET-ICE data set to a peer-reviewed journal for publication.

    Christopher Corsico, senior vice president of development, GSK, said: "Effective medicines to treat those who become infected with SARS-CoV-2 remain a critical part of the solution to this pandemic. We are working diligently to increase access to sotrovimab in the U.S. and across the globe, including evaluating the potential to simplify administration with an intramuscular formulation."

    George Scangos, Ph.D., chief executive officer of Vir, said: "We are pleased that the profound interim efficacy from the COMET-ICE trial has now been validated by the full study population. These results, combined with the growing number of pending global authorizations, as well as the recent recommendation by the NIH COVID-19 Treatment Guidelines Panel, support our confidence in the potential role of sotrovimab in the fight against this pandemic."

    Updated NIH Guidelines Recommend Sotrovimab

    The NIH recently updated its guidelines regarding the emergency use authorizations of anti-SARS-CoV-2 monoclonal antibodies for the treatment of COVID-19 in the U.S. to recommend the use of sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression. The guidelines note that the target binding site of sotrovimab is in a region of the virus that does not overlap with the binding site location of key mutations in current variants of concern and interest. These guidelines were based upon an interim analysis of 583 patients in the COMET-ICE trial, which was stopped early in March 2020 by an independent data monitoring committee because interim results demonstrated evidence of sotrovimab's clinical efficacy. The interim study results demonstrated an 85% (p=0.002) reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial.

    These data have informed global regulatory reviews to date, including the positive scientific opinion issued by the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004, as well as the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA).

    The companies are actively working with government agencies around the world to make sotrovimab available to patients in need of treatment.

    • GSK and Vir plan to submit a Biologics License Application (BLA) to the U.S. FDA in the second half of 2021.
    • The EMA has started a rolling review of data on sotrovimab that will continue until enough evidence is available to support the filing of a formal marketing authorization application.
    • The companies' strategic manufacturing network is enabling the manufacture of approximately two million doses to support emergency supply in the first year following U.S. Emergency Use Authorization, with approximately 450,000 doses on hand.

    Continued Progress with the COMET Clinical Development Program

    The companies are also pleased to announce continued progress with the robust COMET clinical development program, which aims to provide clinical evidence from several studies over the course of the next year.

    • COMET-PEAK, a pharmacokinetic study in outpatients with mild-to-moderate COVID-19 investigating intramuscular (IM) administration of sotrovimab, is near completion and initial data is expected in second half of 2021.
    • COMET-TAIL has been initiated. This is a Phase 3 study evaluating the role of IM-administered sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalized adult and pediatric patients (12 years of age and older). Data are anticipated in the first half of 2022.
    • A prophylaxis study is planned in uninfected immunocompromised adults to determine whether IM-administered sotrovimab can prevent symptomatic COVID-19 infection.

    GSK and Vir are committed to ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge. Data from in vitro studies, published in bioRxiv, have demonstrated that sotrovimab maintains activity against circulating variants of concern and interest, including the Gamma (P.1), Epsilon (B.1.427/B.1.429), Delta (B.1.617.1), Iota (B.1.526), Beta (B.1.351) and Alpha (B.1.1.7) variants. GSK and Vir are continuing to evaluate the ability of sotrovimab to maintain activity against new and emerging variants through in vitro studies. The clinical impact of this in vitro variants data is not yet known.

    About Sotrovimab (previously VIR-7831)

    Sotrovimab is an investigational SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

    The following is a summary of information for sotrovimab. Healthcare providers in the U.S. should review the Fact Sheets for information on the authorized use of sotrovimab and mandatory requirements of the EUA. Please see the FDA Letter of AuthorizationFact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers. For more information on the EMA positive scientific opinion, please review the EU Conditions of Use.

    Important Information about Sotrovimab

    Sotrovimab has been authorized by the FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use. 

    Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

    Authorized Use 

    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

    Limitations of Authorized Use 

    Sotrovimab is not authorized for use in patients: 

    • who are hospitalized due to COVID-19, OR 
    • who require oxygen therapy due to COVID-19, OR 
    • who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity). 

    Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

    Important Safety Information for Sotrovimab

    Warnings

    There are limited clinical data available for sotrovimab. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use.

    Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

    Serious hypersensitivity reactions, including anaphylaxis have been observed with administration of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

    Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. These reactions may be severe or life threatening.

    Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness and diaphoresis.

    Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

    Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.

    Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration

    Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.

    Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19

    Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Therefore, sotrovimab is not authorized for use in patients: who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

    ADVERSE EVENTS

    The most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (2%) and diarrhea (1%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.

    Lactation

    There are no available data on the presence of sotrovimab in human milk, the effects on the breastfed infant, or the effects on milk production. Individuals with COVID-19 who are breastfeeding should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

    About the Vir and GSK Collaboration

    In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

    GSK Commitment to Tackling COVID-19

    GSK's response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to our vaccine candidates in development with partner organizations.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, we recently announced positive Phase 2 data from our collaboration with Sanofi to develop an adjuvanted, protein-based vaccine candidate and expect to begin a Phase 3 trial in Q2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

    GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19 vaccine. GSK is also providing manufacturing support for up to 60m doses of Novavax' COVID-19 vaccine in the UK.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy, based on an interim analysis of data from the trial. An analysis of data through Day 29 of the COMET-ICE trial was consistent with interim results. We have received Emergency Use Authorization in the U.S. and are seeking authorizations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

    Vir's Commitment to COVID-19

    Vir was founded with the mission of addressing the world's most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Vir Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the final data from the COMET-ICE trial, NIH guidelines recommending the use of sotrovimab in the treatment of COVID-19, the initiation of Vir's COMET-TAIL clinical trial, the clinical development program for sotrovimab, Vir's capacity to manufacture and supply sotrovimab, the ability of sotrovimab to treat and/or prevent COVID-19, the ability of sotrovimab to maintain activity against circulating variants of concern, and statements related to regulatory authorizations and approvals, including plans and discussions with the FDA, EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir's competitors, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contact:
    
    Cara Miller
    VP, Corporate Communications
     
    +1 415 941 6746
    
    GSK Contacts:
       
    Media:
    
    Simon Steel
    +44 (0) 20 8047 5502
    (London)
    
    Tim Foley
    +44 (0) 20 8047 5502
    (London)
    
    Kristen Neese
    +1 804 217 8147
    (Philadelphia)
    
    Kathleen Quinn
    +1 202 603 5003
    (Washington DC)
    
    Lyndsay Meyer
    +1 202 302 4595
    (Washington DC)
        
    Analysts/Investors:
    
    James Dodwell
    +44 (0) 20 8047 2406
    (London)
    
    Sonya Ghobrial
    +44 (0) 7392 784784
    (Consumer)
    
    Mick Readey
    +44 (0) 7990 339653
    (London)
    
    Jeff McLaughlin
    +1 215 751 7002
    (Philadelphia)
    
    Frannie DeFranco
    +1 215 751 4855
    (Philadelphia)

    Primary Logo

    View Full Article Hide Full Article
View All Vir Biotechnology Inc. News