1. SAN FRANCISCO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that Howard Horn, chief financial officer, is scheduled to present at the H.C. Wainwright 23rd Annual Global Investment Conference on Monday, Sept. 13, at 4:00 a.m. PT / 7:00 a.m. ET.

    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…

    SAN FRANCISCO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that Howard Horn, chief financial officer, is scheduled to present at the H.C. Wainwright 23rd Annual Global Investment Conference on Monday, Sept. 13, at 4:00 a.m. PT / 7:00 a.m. ET.

    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 Biotechnology

    Vir Biotechnology is a commercial-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.



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    harmstrong@vir.bio
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    cmiller@vir.bio
    +1-415-941-6746

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  2. SAN FRANCISCO, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the first marketing authorization, granted in Australia, for its first commercial product, sotrovimab, developed in partnership with GlaxoSmithKline (GSK). This announcement follows news shared by GSK Australia that the Australian Therapeutic Goods Administration (TGA) has granted provisional marketing authorization for sotrovimab (under the brand name, Xevudy®), a 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 initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalization or death. Sotrovimab is the…

    SAN FRANCISCO, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the first marketing authorization, granted in Australia, for its first commercial product, sotrovimab, developed in partnership with GlaxoSmithKline (GSK). This announcement follows news shared by GSK Australia that the Australian Therapeutic Goods Administration (TGA) has granted provisional marketing authorization for sotrovimab (under the brand name, Xevudy®), a 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 initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalization or death. Sotrovimab is the first monoclonal antibody approved in Australia. As part of its overarching effort to address COVID-19, the Australian Government also recently announced an agreement to purchase sotrovimab, the first supply of which arrived in the country last week.

    The TGA had previously granted sotrovimab a provisional determination in April, which provides a mechanism for accelerating the provisional marketing authorization of promising new medicines. This approval pathway allows companies to apply for registration of medicines for conditions with high unmet clinical need based on promising early clinical data.

    Globally, sotrovimab is authorized for emergency use in the U.S., received a positive scientific opinion from the Committee for Human Medicinal Products (CHMP) in the European Union (EU), and has been granted temporary authorization in Bahrain, Canada, Egypt, Italy, Kuwait, Qatar, Singapore and the United Arab Emirates.

    George Scangos, Ph.D., chief executive officer of Vir, said: "The provisional approval of sotrovimab in Australia marks an important milestone for Vir, as it is the first marketing authorization of our first commercial product. It also represents an important step forward in the Australian Government's efforts to combat the pandemic and prevent the most severe effects of COVID-19, particularly in the face of new and emerging variants. We eagerly anticipate additional regulatory decisions around the world in the coming months and look forward to working with our partner, GSK, to expand patient access to a much-needed treatment option that continues to demonstrate, in vitro, its ability to retain activity against the tested, currently circulating variants of concern and interest, including Delta and Delta Plus."

    The regulatory applications currently under assessment around the world, include results of the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in all-cause 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.

    In vitro data, published in bioRxiv also 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), Delta Plus (AY.1 or AY.2), Epsilon (B.1.427/B.1.429), Eta (B.1.525), 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 predominantly includes both N440K and E484K mutations that may lead to reduced activity for other neutralizing monoclonal antibodies against the SARS-CoV-2 virus.

    This announcement is part of a collaboration between Vir and GSK, signed in April 2020, to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. GSK is responsible for the commercial marketing of sotrovimab around the world.

    About Sotrovimab (Outside of Australia)

    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 Australia

    Minimum Product Information

    XEVUDY ▼ (sotrovimab) Concentrated injection solution for infusion

    Indications: XEVUDY has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalization or death. The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

    Contraindications: Hypersensitivity to the active substance or any of the excipients

    Precautions: Hypersensitivity reactions. In a study in patients hospitalized with COVID-19, hypersensitivity reactions, including serious reactions such as anaphylaxis, have been reported following infusion of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration and initiate appropriate supportive care.

    In COMET-ICE, mild to moderate hypersensitivity reactions have been observed. If mild to moderate hypersensitivity reactions occur, consider slowing or stopping the infusion along with appropriate supportive care. Pregnancy: Category B2. Lactation: No data in human milk. Fertility: No data in humans. Pediatric use: Safety and efficacy in children under 12 years of age or weighing less than 40kg has not yet been established. For further details, please refer to the full Product Information (PI).

    Interactions: No formal interaction studies have been performed. The efficacy and safety of sotrovimab in subjects who have received a COVID-19 vaccine at any time prior to its administration has not been established. The receipt of a COVID-19 vaccine within 48 hours prior to, or 4 weeks following treatment with XEVUDY has not been studied.

    Adverse reactions: Diarrhea, hypersensitivity reactions (includes rash, dermatitis contact, skin reaction, hypersensitivity, multiple allergies, infusion-related reaction and bronchospasm). One case of anaphylaxis was reported following infusion of sotrovimab in a study in hospitalized patients; the patient received epinephrine and the event resolved. This is not a complete list, see full PI.

    Dosage and Administration: Adults and adolescents (12 years or older and weighing at least 40 kg): recommended dose is a single 500 mg dose administered as an intravenous infusion over 30 minutes. It is recommended that XEVUDY is administered within 5 days of onset of symptoms of COVID-19. XEVUDY must be diluted prior to administration and must not be administered as an intravenous push or bolus injection. XEVUDY should be administered in healthcare facilities in which patients can be monitored during and for one hour after administration of XEVUDY. As part of risk stratification of patients, the pivotal consideration is the comorbidities, alongside age, particularly multiple comorbidities. XEVUDY should not be used in patients hospitalized due to COVID-19. For further details, please refer to the full PI.

    XEVUDY Min PI v1. For further details, please refer to the full PI.

    ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

    Full Product Information is available by contacting GSK Australian Medical Information at +61 1800 033 109; or, if dialing from the US, contact the GSK US Response Center (Rx) at +1 888 825 5249.

    PBS INFORMATION: This product is not listed on the PBS. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Australian Medical Information at +61 1800 033 109; or, if dialing from the US, contact the GSK US Response Center (Rx) at +1 888 825 5249. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC. © 2021 GSK group of companies or its licensor. XEVUDY is a registered trademark of the GSK group of companies. PI-8601 Date of approval: August 2021

    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 US 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 of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the is terminated or revoked sooner.

    Authorized Use in the United States

    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.

    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 Vir Biotechnology

    Vir Biotechnology is a commercial-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.

    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 provisional approval of sotrovimab in Australia, the ability of sotrovimab to treat and/or prevent COVID-19, the supply of sotrovimab to the Australian government and the timing of that delivery, statements related to additional regulatory authorizations and approvals around the world and their anticipated timing and the ability of sotrovimab to maintain activity against circulating variants of concern and interest. 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.



    Contacts:
    Heather Rowe Armstrong
    VP, Investor Relations
    harmstrong@vir.bio
    +1-415-915-4228
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  3. SAN FRANCISCO, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2021.

    "Vir made strong progress this quarter across our extensive infectious disease portfolio, the most notable of which is that our monoclonal antibody sotrovimab is now available for patients who become ill with COVID-19 and are at high risk for hospitalization," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "In lab experiments, sotrovimab retains efficacy against circulating variants of concern and interest, including the Delta, Delta Plus and Lambda variants. Additionally, its low dose may allow for more convenient…

    SAN FRANCISCO, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2021.

    "Vir made strong progress this quarter across our extensive infectious disease portfolio, the most notable of which is that our monoclonal antibody sotrovimab is now available for patients who become ill with COVID-19 and are at high risk for hospitalization," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "In lab experiments, sotrovimab retains efficacy against circulating variants of concern and interest, including the Delta, Delta Plus and Lambda variants. Additionally, its low dose may allow for more convenient intramuscular administration, which is now being tested in two clinical trials. Sotrovimab has been authorized for emergency use and, with our partner GSK, we have established supply agreements with multiple countries around the world. Together, we plan to submit a Biologics License Application to the FDA later this year and, in May of this year, the EMA began a rolling review of data to support a marketing authorization application in Europe."

    Dr. Scangos continued, "Beyond our lead program, we have built a deep and broad hepatitis B portfolio in our quest to develop a functional cure. We recently initiated a Phase 2 combination trial of VIR-2218 with VIR-3434, and another Phase 2 trial evaluating VIR-2218 with Gilead's investigational TLR-8 agonist and nivolumab is planned to start soon. We also plan to share additional data later this year from our combination trial of VIR-2218 with pegylated interferon alfa and our VIR-3434 monotherapy trial."

    Corporate Update

    COVID-19 Updates

    • During and after the quarter, sotrovimab was authorized for emergency use in the U.S., received a positive Committee for Human Medicinal Products (CHMP) scientific opinion in the European Union (EU), and was granted interim, emergency or conditional authorization in Bahrain, Canada, Italy, Kuwait, Qatar, Singapore and the United Arab Emirates.
    • Together with GlaxoSmithKline (GSK), we have established supply agreements with multiple governments around the world and continue to work actively to make sotrovimab available to patients in need. In July, the companies also signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab. 
    • 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), Delta Plus (AY.1 or AY.2), Epsilon (B.1.427/B.1.429), Eta (B.1.525), 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 predominantly includes both N440K and E484K mutations that may lead to reduced activity for other neutralizing monoclonal antibodies against the SARS-CoV-2 virus. The Company and GSK are continuing to evaluate the ability of sotrovimab to maintain activity against new and emerging variants through in vitro studies.
    • In April, the first patient was dosed in the United Kingdom National Health Service-supported AGILE initiative. The trial initiative is the first to evaluate VIR-7832 in a Phase 1b/2a trial of adults with mild-to-moderate COVID-19. VIR-7832 shares the same characteristics as sotrovimab and has been engineered to potentially be a therapeutic T cell vaccine to further help treat and/or prevent COVID-19. Initial safety data are expected in the second half of 2021. Additionally, in July, the U.S. Food and Drug Administration (FDA) cleared the Company's investigational new drug (IND) application for VIR-7832.
    • In May, the European Medicines Agency's (EMA) CHMP initiated a rolling review of data on sotrovimab that will continue until enough evidence is available to support a formal marketing authorization application (MAA). The rolling review process is expected to be complete in the second half of 2021.
    • In May, the EMA's CHMP issued a positive scientific opinion on sotrovimab 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 CHMP opinion under Article 5(3) can now be considered by the national authorities in EU member states when making evidence-based decisions on the early use of the medicine prior to marketing authorization.
    • In May, the FDA granted an Emergency Use Authorization (EUA) to sotrovimab for the treatment of mild-to-moderate 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. Together with GSK, the Company plans to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.
    • In June, the Company and GSK announced confirmatory full results for the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in all-cause 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.
    • In June, 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. The NIH guidelines note that sotrovimab appears to retain activity against current variants of concern and interest. The Infectious Disease Society of America (IDSA) also updated its treatment guidelines in June to recommend use of sotrovimab in the same patient population.
    • The Company and GSK are continuing to advance additional trials of sotrovimab:
      • The Phase 2 COMET-PEAK (Patient SafEty, TolerAbility, PharmacoKinetics) pharmacokinetic trial in outpatients with mild-to-moderate COVID-19 is investigating intramuscular (IM) administration of sotrovimab (500 mg intravenous (IV) vs. 500 mg IM and 250 mg IM). Enrollment is complete and initial data are expected in the fall of 2021.
      • The Phase 3 COMET-TAIL (Treatment of Acute COVID-19 with Intramuscular monocLonal antibody) trial for early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adult and pediatric patients is evaluating the role of IM-administered sotrovimab (500 mg IV vs. 500 mg IM vs 250 mg IM). The trial was initiated in June and data are now expected in the second half of 2021.
      • A prophylaxis trial is planned in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection.
    • The Company and GSK have established a strategic manufacturing network that will enable the manufacture of approximately two million doses to support emergency supply in the first year following U.S. EUA, with approximately 450,000 doses currently on hand.

    Chronic Hepatitis B Virus (HBV) Updates

    • In April, the Company announced that its collaborator Brii Biosciences initiated a Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the treatment of chronic HBV infection.
    • In June, the Company presented clinical data from its ongoing Phase 2 trials of VIR-2218 and an ongoing Phase 1 trial of VIR-3434 in patients with chronic HBV infection at the European Association for the Study of the Liver (EASL) International Liver Congress 2021.
      • Data demonstrated a promising safety profile and the potential durable response of VIR-2218 through 48 weeks.
      • In a separate analysis evaluating VIR-2218 in combination with pegylated interferon alfa (PEG-IFN-α) for 12 weeks from Day 1, a more rapid and substantial decline in hepatitis B surface antigen (HBsAg) was observed compared to VIR-2218 alone. The treatment regimen resulted in no new safety signals.
      • 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 VIR-3434 to virally suppressed patients with chronic HBV infection.

    Additional data are expected in the second half of 2021.

    • In July, the Company initiated a Phase 2 trial to evaluate the combination of VIR-2218 and VIR-3434 as a functional cure regimen for chronic HBV infection. Initial data are expected in the first half of 2022.
    • In the second half of 2021, as part of a clinical collaboration, the Company and Gilead Sciences, Inc. plan to initiate a Phase 2 trial to evaluate the combination of VIR-2218, selgantolimod (GS-9688), Gilead's investigational TLR-8 agonist, and nivolumab, an approved PD-1 inhibitor, as a functional cure regimen for chronic HBV infection.

    Additional Pipeline Updates

    • The Company is continuing to enroll patients in a Phase 1 trial of VIR-1111, an investigational HIV T cell vaccine based on human cytomegalovirus (HCMV). This proof-of-concept trial is testing the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines. Initial clinical data are expected in the second half of 2021.
    • Given the relatively low incidence of influenza during the COVID-19 pandemic, and the current rise in COVID-19 cases due to variants, the Company and its collaboration partner, GSK, are currently evaluating potential timelines for advancing VIR-2482 and other influenza therapies covered under their expanded agreement.

    Publications

    • During and following the second quarter, 11 manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other infectious diseases. The publications can be found on the Literature Archive page of the Vir website.

     Second Quarter 2021 Financial Results

    • Revenues: Total revenues for the quarter ended June 30, 2021, were $177.1 million, compared to $67.0 million for the same period in 2020.
      • Collaboration revenue for the quarter ended June 30, 2021 was $5.3 million, compared to zero for the same period in 2020. The increase for the quarter was related to revenue from the Company's profit-sharing arrangement with GSK for the sale of sotrovimab under the Company's 2020 GSK agreement. The Company's contractual share of 72.5% from the sales of sotrovimab is based upon the revenue reported to the Company by GSK, net of cost of sales and allowable expenses (including distribution, selling and marketing expenses) in the period.
      • Contract revenue for the quarter ended June 30, 2021 was $168.7 million, compared to $43.5 million for the same period in 2020. The increase for the quarter was primarily due to $168.3 million from deferred revenue related to the license granted to GSK under the Company's 2021 GSK agreement. The revenue was recognized in this quarter when the Company transferred the license to GSK upon execution of the definitive agreement. As of June 30, 2021, the remaining deferred revenue from the Company's 2021 GSK agreement was $91.5 million. The prior year quarter included $43.3 million of revenue related to the license granted under the Company's 2020 GSK agreement.
      • Grant revenue for the quarter ended June 30, 2021 was $3.1 million, compared to $0.7 million for the same period in 2020. The increase for the quarter was primarily due to the timing of research activities under the HIV and TB grants with the Bill & Melinda Gates Foundation.
      • License revenue from a related party for the quarter ended June 30, 2021 was zero, compared to $22.7 million for the same period in 2020. The decrease for the quarter was related to Brii Biosciences Offshore Limited's exercise of its option to obtain exclusive rights to develop and commercialize compounds arising from VIR-2218 in greater China.
    • Cost of Revenue: Cost of revenue for the quarter ended June 30, 2021, was $1.1 million, with no comparable amount for the same period in 2020. The increase for the quarter was due to third-party royalties owed based on the sales of sotrovimab, which received an EUA in May 2021.
    • Research and Development Expenses: Research and development expenses were $86.1 million for the quarter ended June 30, 2021, which includes $10.9 million of non-cash stock-based compensation expense, compared to $79.7 million for the same period in 2020, which included $2.7 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to personnel-related expenses resulting from higher headcount, clinical costs related to sotrovimab and VIR-2218 clinical trials, costs incurred under collaboration arrangements with GSK, which were partially offset by a decrease in contract manufacturing expenses for the Company's COVID-19 product candidates completed in the third quarter of 2020, and lower fair value of the Company's contingent consideration.
    • General and Administrative Expenses: General and administrative expenses were $28.8 million for the quarter ended June 30, 2021, which includes $10.1 million of non-cash stock-based compensation expense, compared to $16.4 million for the same period in 2020, which included $3.1 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to personnel-related expenses resulting from additional headcount, external consulting services and recruiting expenses.
    • Net Income (Loss): Net income for the quarter ended June 30, 2021, was $61.8 million, or $0.48 per share, basic and $0.46 per share, diluted, compared to a net loss of $31.2 million, or $0.27 per share, basic and diluted, for the same period in 2020. Net income in the quarter was largely due to recognition of revenue related to the license granted to GSK under the Company's 2021 GSK agreement.
    • Cash and Cash Equivalents: As of June 30, 2021, excluding restricted cash, the Company had approximately $876.7 million in cash, cash equivalents and investments.

    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 VIR-7832

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend™ and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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-1111

    VIR-1111 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines.

    About VIR-2482

    VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482, which incorporates Xencor's Xtend technology, also has been half-life engineered so that a single dose has the potential to last the entire flu season.

    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 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 timing of availability of clinical data, program updates and data disclosures related to Vir's clinical trials, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the ability of sotrovimab to maintain activity against circulating variants of concern and interest, the ability of sotrovimab to be administered via an IM route, statements related to regulatory authorizations and approvals, including plans and discussions with the FDA and EMA, the timing and expected number of therapeutic doses that Vir will be able to supply to patients, the potential of Vir's ongoing trials of VIR-2218 and VIR-3434 (as monotherapies or combination therapies), the ability of VIR-2218, VIR-3434, and a combination of both in treating patients with chronic hepatitis B virus infection, Vir's collaboration with Gilead Sciences, Inc. to evaluate VIR-2218 in a combination therapy trial with GS-9688, the ability of VIR-1111 to elicit a T cell immune response to HIV, and potential timelines for advancing influenza therapies, including VIR-2482 and other therapies covered under the expanded agreement with GSK. 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.

    Contacts:

    Heather Rowe Armstrong

    VP, Investor Relations

    harmstrong@vir.bio

    +1-415-915-4228

    Cara Miller

    VP, Corporate Communications

    cmiller@vir.bio

    +1-415-941-6746

    Vir Biotechnology, Inc.

    Condensed Consolidated Statements of Operations

    (unaudited; in thousands, except share and per share data)

      Three Months Ended June 30,  Six Months Ended June 30, 
      2021  2020  2021  2020 
    Revenue:            
    Collaboration revenue $5,333  $  $5,333  $ 
    Contract revenue  168,653   43,522   169,266   44,009 
    Grant revenue  3,082   719   4,453   5,950 
    License revenue from a related party     22,747      22,747 
    Total revenue  177,068   66,988   179,052   72,706 
    Operating expenses:            
    Cost of revenue  1,144      1,152    
    Research and development  86,126   79,653   220,996   144,632 
    Selling, general and administrative  28,781   16,386   54,520   29,035 
    Total operating expenses  116,051   96,039   276,668   173,667 
    Income (loss) from operations  61,017   (29,051)  (97,616)  (100,961)
    Other income (expense):            
    Interest income  97   825   261   2,580 
    Other income (expense), net  752   (2,895)  (9,494)  (9,964)
    Total other income (expense)  849   (2,070)  (9,233)  (7,384)
    Income (loss) before provision for income taxes  61,866   (31,121)  (106,849)  (108,345)
    Provision for income taxes  (53)  (46)  (249)  (62)
    Net income (loss) $61,813  $(31,167) $(107,098) $(108,407)
    Net income (loss) per share, basic $0.48  $(0.27) $(0.83) $(0.97)
    Net income (loss) per share, diluted $0.46  $(0.27) $(0.83) $(0.97)
    Weighted-average shares outstanding, basic  130,121,943   114,980,652   128,938,851   111,684,283 
    Weighted-average shares outstanding, diluted  133,789,977   114,980,652   128,938,851   111,684,283 
                     

    Vir Biotechnology, Inc.

    Condensed Consolidated Balance Sheets

    (unaudited; in thousands, except share and per share data)

      June 30,

    2021
      December 31,

    2020
     
    ASSETS      
    CURRENT ASSETS:      
    Cash and cash equivalents $741,951  $436,575 
    Short-term investments  84,107   300,286 
    Restricted cash and cash equivalents, current  7,004   7,993 
    Prepaid expenses and other current assets  29,233   27,511 
    Total current assets  862,295   772,365 
    Intangible assets, net  33,554   33,820 
    Goodwill  16,937   16,937 
    Property and equipment, net  20,251   17,946 
    Operating right-of-use assets  58,972   61,947 
    Restricted cash and cash equivalents, noncurrent  7,002   6,919 
    Long-term investments  50,680    
    Other assets  7,890   8,827 
    TOTAL ASSETS $1,057,581  $918,761 
    LIABILITIES AND STOCKHOLDERS' EQUITY       
    CURRENT LIABILITIES:      
    Accounts payable $11,032  $5,077 
    Accrued and other liabilities  64,074   76,936 
    Deferred revenue, current portion  44,718   6,451 
    Contingent consideration, current portion  26,200   10,600 
    Total current liabilities  146,024   99,064 
    Deferred revenue, noncurrent  55,496   3,815 
    Operating lease liabilities, noncurrent  68,938   66,556 
    Contingent consideration, noncurrent  42,692   25,374 
    Deferred tax liability  3,253   3,253 
    Other long-term liabilities  3,853   3,847 
    TOTAL LIABILITIES  320,256   201,909 
    STOCKHOLDERS' EQUITY:      
    Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2021 and December 31, 2020; no shares issued and outstanding as of June 30, 2021 and December 31, 2020      
    Common stock, $0.0001 par value; 300,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 130,479,975 and 127,416,740 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively  13   13 
    Additional paid-in capital  1,512,928   1,385,301 
    Accumulated other comprehensive loss  (1,334)  (1,278)
    Accumulated deficit  (774,282)  (667,184)
    TOTAL STOCKHOLDERS' EQUITY  737,325   716,852 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $1,057,581  $918,761 
             



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  4. 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
    harmstrong@vir.bio
    +1 415 915 4228
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +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
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    (Philadelphia)

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  5. 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
    harmstrong@vir.bio
    +1-415-915-4228
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  6. 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
    harmstrong@vir.bio
    +1 415.915.4228
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio 
    +1 415.941.6746

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  7. – 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
    harmstrong@vir.bio
    +1 303 641 2052
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1 415 941 6746

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  8. – 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
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    +1 415 941 6746
    
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    Simon Steel
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  9. SAN FRANCISCO, June 14, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that four abstracts highlighting data from its hepatitis B clinical program have been accepted for two oral and two poster presentations at the European Association for the Study of the Liver (EASL) Digital International Liver Congress taking place virtually from June 23-26, 2021.

    Vir will hold a conference call and webcast on Friday, June 25, 2021, at 11:00 AM ET, to discuss the new data presented at EASL. Vir management will be joined by Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., Chair Professor and Chief of Division of Gastroenterology and Hepatology, Deputy Head of Department of Medicine, Li Shu Fan Medical Foundation Professor in Medicine…

    SAN FRANCISCO, June 14, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that four abstracts highlighting data from its hepatitis B clinical program have been accepted for two oral and two poster presentations at the European Association for the Study of the Liver (EASL) Digital International Liver Congress taking place virtually from June 23-26, 2021.

    Vir will hold a conference call and webcast on Friday, June 25, 2021, at 11:00 AM ET, to discuss the new data presented at EASL. Vir management will be joined by Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., Chair Professor and Chief of Division of Gastroenterology and Hepatology, Deputy Head of Department of Medicine, Li Shu Fan Medical Foundation Professor in Medicine, The University of Hong Kong.

    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.

    Presentation details are as follows:

    Oral Presentations:

    • Title: A phase 1 study evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434 in participants with chronic hepatitis B virus infection (Abstract #211)

      Session: Hepatitis B: Novel Therapeutic Approaches (Viral Hepatitis)

      Date: Friday, June 25, 2021

      Time: 14:00-14:15 CET (8:00-8:15 am ET)

      Presenter: Kosh Agarwal, M.D., Consultant Hepatologist and Transplant Physician at the Institute of Liver Studies, Kings College Hospital, London, United Kingdom
    • Title: Safety and antiviral activity of VIR-2218, an X-targeting RNAi therapeutic, in participants with chronic hepatitis B infection: week 48 follow-up results (Abstract #44)

      Session: Hepatitis B: Novel Therapeutic Approaches (Viral Hepatitis)

      Date: Friday, June 25, 2021

      Time: 14:30-14:45 CET (8:30-8:45 am ET)

      Presenter: Prof. Edward Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit

    Poster Presentations:

    • Title: Preliminary on-treatment data from a phase 2 study evaluating VIR-2218 in combination with pegylated interferon alfa-2a in participants with chronic hepatitis B infection (Abstract #824)

      Date: Wednesday, June 23, 2021

      Time: 8:00 am CET (2:00 am ET)

      Presenter: Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., Chair Professor and Chief of Division of Gastroenterology and Hepatology, Deputy Head of Department of Medicine, Li Shu Fan Medical Foundation Professor in Medicine, The University of Hong Kong
    • Title: Preliminary pharmacokinetics and safety in healthy volunteers of VIR-3434, a monoclonal antibody for the treatment of chronic hepatitis B infection (Abstract #43)

      Date: Wednesday, June 23, 2021

      Time: 8:00 am CET (2:00 am ET)

      Presenter: Sneha Gupta, Associate Director, Clinical Pharmacology, Vir Biotechnology, Inc.

    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 XtendTM 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," "potential," "aim," "could" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the presentation of data from its VIR-2218 and VIR-3434 clinical trials and the potential benefits of VIR-2218 and VIR-3434. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, difficulties in obtaining regulatory approval, difficulties in collaborating with other companies, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, 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
    harmstrong@vir.bio
    +1 303 641 2052
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1 415 941 6746

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  10. SAN FRANCISCO, June 02, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that George Scangos, Ph.D., chief executive officer, will participate in a virtual fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on Wednesday, June 9th at 12:00 pm PT / 3:00 pm ET.

    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…

    SAN FRANCISCO, June 02, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that George Scangos, Ph.D., chief executive officer, will participate in a virtual fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on Wednesday, June 9th at 12:00 pm PT / 3:00 pm ET.

    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 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.



    Contact:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
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  11. – Treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalization or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial –

    – In vitro data indicate sotrovimab maintains activity against all known variants of concern, including the variant from India –

    – Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the U.S. in the coming weeks –

    – Discussions with global regulators regarding authorizations in additional countries continue to advance –

    LONDON and SAN FRANCISCO, May 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the U.S. Food and Drug Administration (FDA…

    – Treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalization or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial –

    – In vitro data indicate sotrovimab maintains activity against all known variants of concern, including the variant from India –

    – Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the U.S. in the coming weeks –

    – Discussions with global regulators regarding authorizations in additional countries continue to advance –

    LONDON and SAN FRANCISCO, May 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for sotrovimab (previously VIR-7831), an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate 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.

    Adrienne E. Shapiro, M.D., Ph.D., an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial, said: "Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting COVID-19. While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk – allowing them to avoid hospitalization or worse."

    George Scangos, Ph.D., chief executive officer of Vir, said: "Our distinctive scientific approach has led to a single monoclonal antibody that, based on an interim analysis, resulted in an 85% reduction in all-cause hospitalizations or death, and has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India. I believe that sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks, as well. At Vir, our aim is not only to deliver a clinically effective therapy for COVID-19, but also to provide effective therapy against SARS-CoV-2 variants and potential pandemics of tomorrow."

    Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "The fast pace of COVID-19 vaccinations in the U.S. is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications. In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need."

    Sotrovimab has been granted an EUA by the FDA to facilitate the availability and use of this investigational monoclonal antibody for the treatment of COVID-19 in the U.S. while the pandemic remains a public health emergency. The FDA Fact Sheet for Healthcare Providers regarding the emergency use of sotrovimab reflects the recently updated definition of high risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease. The EUA for sotrovimab also includes post-authorization commitments as specified in the Letter of Authorization.

    Sotrovimab is continuing to be studied in ongoing clinical trials. An analysis of safety and efficacy data at day 29 for the full population from the COMET-ICE trial is expected as early as the first half of 2021. GSK and Vir plan to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.

    Evidence of Sotrovimab's Profound Clinical Efficacy

    The EUA was granted to sotrovimab based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial in high-risk adult outpatients, which was stopped early by an independent data monitoring committee in March 2021 due to evidence of profound clinical efficacy. As previously announced, 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. The most common 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. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

    In Vitro Data Indicate Sotrovimab Maintains Activity Against All Known Variants of Concern

    Sotrovimab targets a conserved epitope of the spike protein that is less likely to mutate over time. The EUA submission also included data from published in vitro studies, which demonstrated that sotrovimab maintains activity against all known circulating variants of concern, including the variants from Brazil (P.1), California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526), South Africa (B.1.351) and the UK (B.1.1.7). GSK and Vir will continue to evaluate the ability of sotrovimab to maintain activity against new and emerging variants. The clinical impact of these in vitro variant data is not yet known. Data collection and analysis is still ongoing.

    GSK and Vir's Commitment to Patient Access to Sotrovimab

    GSK and Vir are working to make sotrovimab available to U.S. patients in the coming weeks with the intent that all appropriate patients will have access to it, with little to no out-of-pocket costs. Patients and healthcare professionals can access more information about eligibility, availability and financial support at gskcovidcontactcenter.com or by calling 866-GSK-COVID (866-475-2684).

    GSK and Vir are actively working with government agencies around the world to make sotrovimab available to patients in need of treatment.

    • On May 21, 2021, the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. The opinion relates to the use of sotrovimab 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 EMA has also 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.
    • In April, Health Canada initiated a review of sotrovimab under the expedited Interim Order application pathway for COVID-19 drugs.
    • GSK and Vir are continuing discussions with other global regulators on the regulatory pathways available so that sotrovimab can be made available to patients with COVID-19 as soon as possible.

    About the COMET-ICE Study Design

    The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated intravenous (IV) infusion of sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease.

    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 safety of sotrovimab is primarily based on an interim analysis from 868 patients (430 patients in the treatment arm and 438 in the placebo arm) through day 15. Among those studied, 63% were Hispanic or Latino and 7% were Black or African American. According to the Centers for Disease Control and Prevention, these populations are approximately three times more likely to be hospitalized and approximately two times more likely to die of COVID-191. 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 illness or death.

    In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy.

    About the Sotrovimab Clinical Development Program

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

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered sotrovimab to 500 mg intravenously administered sotrovimab among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between sotrovimab manufactured by different processes
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 as an early treatment for COVID-19 in high-risk adults, to assess whether IM-administered sotrovimab can reduce hospitalization or death due to COVID-19
    • COMET-STAR: A Phase 3 trial expected to begin in the second half of 2021 in uninfected adults at high risk to determine whether IM-administered sotrovimab can prevent symptomatic infection.

    Sotrovimab was also evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including sotrovimab, versus placebo in low-risk adults with mild to moderate COVID-19. An interim analysis found that bamlanivimab (700 mg) co-administered with sotrovimab (500 mg) demonstrated a 70% relative reduction in patients with persistently high viral load at day 7 compared to placebo, meeting the primary endpoint.

    Additionally, sotrovimab, along with VIR-7832 is being evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    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.

    About VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    The following is a summary of information for sotrovimab. Healthcare providers 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 Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers.

    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 use of sotrovimab. 

    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 (e.g., 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 (e.g., 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, arrythmia (e.g., 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. Based on experience with other adjuvanted vaccines, there is potential for increased cross protection against COVID-19 variants which will be further studied.

    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 recently 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. 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 timing and availability of sotrovimab to providers and patients, the timing and availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalized population, the ability of sotrovimab to neutralize the SARS-CoV-2 live virus, the ability of sotrovimab to maintain activity against all known variants of concern, including the variant from India, and other potential pandemics, statements related to the planned full analysis of the COMET-ICE trial, 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


    1 Data source: U.S. Centers for Disease Control and Prevention: Risk for COVID-19 Infection, Hospitalization, and Death By Race/Ethnicity (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html).



    Vir Biotechnology Contacts:
    Neera Ravindran, MD
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1 415 506 5256
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +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

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  12. – Opinion based on the EMA's Committee for Human Medicinal Products (CHMP) review of available data on sotrovimab (previously VIR-7831) for the early treatment of COVID-19 –

    – EU member states can use the CHMP positive scientific opinion when making national decisions about the early use of sotrovimab prior to EMA marketing authorization –

    – Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the U.S. in the coming weeks –

    LONDON and SAN FRANCISCO, May 21, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab…

    – Opinion based on the EMA's Committee for Human Medicinal Products (CHMP) review of available data on sotrovimab (previously VIR-7831) for the early treatment of COVID-19 –

    – EU member states can use the CHMP positive scientific opinion when making national decisions about the early use of sotrovimab prior to EMA marketing authorization –

    – Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the U.S. in the coming weeks –

    LONDON and SAN FRANCISCO, May 21, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. The opinion relates to the use of sotrovimab 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 CHMP opinion under Article 5(3) can now 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.

    Christopher Corsico, senior vice president, development, GSK, said: "As the COVID-19 pandemic continues and the virus generates new variants of concern, including those that recently emerged in India, the need for therapies that can slow the progression of disease in patients who are at high risk for developing severe complications remains a top priority. Monoclonal antibody treatments are a critical part of a comprehensive solution to COVID-19, especially as less than 40% of adults across EU member states have received at least one dose of a vaccine to date1. We are encouraged by this positive scientific opinion from the EMA, as it hopefully brings us closer to making sotrovimab available for patients across Europe."

    George Scangos, Ph.D., chief executive officer of Vir, said: "Today's opinion is great news for patients across Europe, as EU member states are now more easily able to move forward with their own temporary authorizations for sotrovimab. Based on our most recent in vitro data, sotrovimab continues to combat COVID-19 as it evolves and has retained activity against all circulating variants of concern. We look forward to continuing to work with regulators around the world to make sotrovimab available to more patients in need and help bring an end to the pandemic."

    The CHMP reached its opinion following a review of data including an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Efficacy results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. The CHMP also considered data on the medicine's quality and safety.

    The CHMP also reviewed data from several in vitro studies which demonstrated that sotrovimab maintains activity against multiple circulating variants of concern, including the variants from Brazil (P.1), California (B.1.427/B.1.429), South Africa (B.1.351) and the UK (B.1.1.7), based on in vitro data from live virus and pseudotyped virus assays. Additional in vitro data demonstrating activity against variants from New York (B.1.526) and India (B.1.617) were also recently published by bioRxiv. The clinical impact of these variants is not yet known. Sotrovimab targets a conserved epitope of the spike protein which is less likely to mutate over time. Data collection and analysis is still ongoing.

    The CHMP's review took place in parallel to the EMA's ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. The rolling review will continue until enough evidence is available to support a formal Marketing Authorization Application.

    An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the U.S. Food and Drug Administration (FDA) and it is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs.

    Sotrovimab is an investigational compound and has not been granted a marketing authorization anywhere in the world.

    About the COMET-ICE Study Design

    The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated intravenous (IV) infusion of sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease.

    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 safety of sotrovimab is primarily based on an interim analysis from 868 patients (430 patients in the treatment arm and 438 in the placebo arm) through Day 29. Among those studied, 63% were Hispanic or Latino and 7% were Black or African American. According to the U.S. Centers for Disease Control and Prevention, these populations are approximately three times more likely to be hospitalized and approximately two times more likely to die2 of COVID-19. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

    The only event to occur with a frequency of greater than 1% in the sotrovimab arm was diarrhea (less than 1% in placebo group). All other adverse events with a frequency of greater than 1% occurred in the placebo arm. No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo. Sotrovimab's safety and efficacy is continuing to be studied in ongoing clinical trials with analysis of safety and efficacy data at Day 29 for the full population from COMET-ICE expected as early as the first half of 2021.

    About the Sotrovimab Clinical Development Program

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

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered sotrovimab to 500 mg intravenously administered sotrovimab among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between sotrovimab manufactured by different processes
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 as an early treatment for COVID-19 in high-risk adults to assess whether IM-administered sotrovimab can reduce hospitalization or death due to COVID-19
    • COMET-STAR: A Phase 3 trial expected to begin in the third quarter of 2021 in uninfected adults at high risk to determine whether IM-administered sotrovimab can prevent symptomatic infection.

    Sotrovimab was also evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including sotrovimab, versus placebo in low-risk adults with mild to moderate COVID-19. An interim analysis found that bamlanivimab (700 mg) co-administered with sotrovimab (500 mg) demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo, meeting the primary endpoint.

    Additionally, sotrovimab, along with VIR-7832 is being evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 (GSK4182137) is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    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 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.

    About VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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. Based on experience with other adjuvanted vaccines, there is potential for increased cross protection against COVID-19 variants which will be further studied.

    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 recently 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. 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 timing and availability of sotrovimab to providers and patients, including arrangements with commercial payers, the timing of availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalized population, the ability of sotrovimab to neutralize the SARS-CoV-2 live virus, the ability of sotrovimab to maintain activity against variants of concern, including the Indian variant, and other potential pandemics, and statements related to regulatory authorizations and approvals, including plans and discussions with global regulators in additional countries. 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


    1 European Centre for Disease Prevention and Control. COVID-19 Vaccine Tracker: European Centre for Disease Prevention and Control. www.vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab. 18 May 2021.

    2 Data source: U.S. Centers for Disease Control and Prevention: Risk for COVID-19 Infection, Hospitalization, and Death By Race/Ethnicity (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html)



    Vir Biotechnology Contacts:
    Neera Ravindran, MD
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1 415 506 5256
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +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)

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  13. SAN FRANCISCO, May 10, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) reminds stockholders that it will hold its 2021 Annual General Meeting of Stockholders on Thursday, May 20, 2021, at 11:30 a.m. PT. The Annual Meeting will be held in virtual format only via live audio webcast.

    Vir Biotechnology's stockholders of record as of March 22, 2021 (the "Record Date"), can attend and vote at the Annual Meeting by accessing the meeting center at http://www.virtualshareholdermeeting.com/VIR2021 and entering the control number on the proxy card or Notice of Internet Availability of Proxy Materials previously received. Instructions on how to connect to the Annual Meeting and participate via the Internet are also posted at http://www.virtualshareholdermeeting.com/VIR2021

    SAN FRANCISCO, May 10, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) reminds stockholders that it will hold its 2021 Annual General Meeting of Stockholders on Thursday, May 20, 2021, at 11:30 a.m. PT. The Annual Meeting will be held in virtual format only via live audio webcast.

    Vir Biotechnology's stockholders of record as of March 22, 2021 (the "Record Date"), can attend and vote at the Annual Meeting by accessing the meeting center at http://www.virtualshareholdermeeting.com/VIR2021 and entering the control number on the proxy card or Notice of Internet Availability of Proxy Materials previously received. Instructions on how to connect to the Annual Meeting and participate via the Internet are also posted at http://www.virtualshareholdermeeting.com/VIR2021. Online access to the Annual Meeting will begin at 11:15 a.m. PT. Stockholders should allow ample time for the check-in procedures.

    Whether or not stockholders plan to virtually attend the Annual Meeting, Vir Biotechnology urges them to vote and submit their proxy in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting.  

    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
    Neera Ravindran, MD
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  14. – Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 –

    – Review will support a formal Marketing Authorization Application –

    – GSK and Vir continue discussions with global regulators to make sotrovimab
    available to patients with COVID-19 –

    LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years…

    – Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 –

    – Review will support a formal Marketing Authorization Application –

    – GSK and Vir continue discussions with global regulators to make sotrovimab

    available to patients with COVID-19 –

    LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

    The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. The EMA will assess the medicine's compliance with the usual standards for efficacy, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.

    The review of the data is being carried out by the EMA's Committee for Medicinal Products for Human Use (CHMP). The decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% (p=0.002) reduction in hospitalizations over 24 hours or deaths in those receiving sotrovimab compared to placebo, the primary endpoint of the trial.

    Separately, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 and is expected to provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization.

    Sotrovimab is an investigational compound and has not been granted a marketing authorization anywhere in the world.

    An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs.

    About the COMET-ICE Study Design

    The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease.

    This Phase 3 trial evaluated the safety and efficacy of a single IV infusion of sotrovimab (500 mg) or placebo in non-hospitalized participants globally. The efficacy interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

    In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of efficacy and is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed and will be published in a peer reviewed medical journal. In COMET-ICE, infusion-related reactions were reported at a low frequency (1%) in sotrovimab-treated patients and was comparable to the incidence in the placebo arm (1%). These infusion-related reactions occurring within 24 hours of study treatment included pyrexia, chills, dizziness, dyspnea, pruritus and rash, which were Grade 1 (mild) or Grade 2 (moderate) and no events consistent with antibody dependent enhancement (ADE) were observed.

    About the Sotrovimab Clinical Development Program

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

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered sotrovimab to 500 mg intravenously administered sotrovimab among low-risk adults with mild to moderate COVID-19, and to evaluate the similarity in pharmacokinetics between sotrovimab manufactured by different processes
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 as an early treatment in high-risk adults to assess whether IM-administered sotrovimab can reduce hospitalization or death due to COVID-19
    • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered sotrovimab can prevent symptomatic infection.

    Sotrovimab was also evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including sotrovimab, versus placebo in low-risk adults with mild to moderate COVID-19. An interim analysis found that bamlanivimab (700 mg) co-administered with sotrovimab (500 mg) demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo, meeting the primary endpoint. The three companies are engaging with the FDA regarding the possible co-administration of bamlanivimab and sotrovimab for the treatment of COVID-19.

    Additionally, sotrovimab, along with VIR-7832, is being evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    About Sotrovimab

    Sotrovimab is an investigational dual-action 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, and less likely to mutate over time. 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.

    About VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. 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 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 recently 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 efficacy, based on an interim analysis of data from the trial. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). 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 we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. Sotrovimab has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. 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 our 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 timing and availability of sotrovimab to providers and patients, including arrangements with commercial payers, the timing of availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalized population, the ability of sotrovimab to neutralize the SARS-CoV-2 live virus, statements related to the planned full analysis of the COMET-ICE trial, and statements related to marketing authorizations and regulatory authorizations and approvals, including plans and discussions with the EMA, FDA, Health Canada 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 US 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.

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  15. SAN FRANCISCO, May 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2021.

    "We've had an active start to the year, achieving significant clinical and collaboration milestones across our portfolio of investigational compounds for serious infectious diseases," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Based on the profound efficacy results from our Phase 3 trial of VIR-7831 and our belief in its ongoing ability to address known variants of concern, we remain confident in the potential of this dual-action monoclonal antibody to play an important role in bringing the COVID-19 pandemic to an end…

    SAN FRANCISCO, May 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2021.

    "We've had an active start to the year, achieving significant clinical and collaboration milestones across our portfolio of investigational compounds for serious infectious diseases," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Based on the profound efficacy results from our Phase 3 trial of VIR-7831 and our belief in its ongoing ability to address known variants of concern, we remain confident in the potential of this dual-action monoclonal antibody to play an important role in bringing the COVID-19 pandemic to an end. We look forward to the pending Emergency Use Authorization decisions in the U.S. and Europe. In the interim, we are rapidly progressing the initiation of new studies aimed at both the prevention and treatment of COVID-19, as well as new delivery methods that we hope will help ease administration and access in the future. Importantly, we are also excited to share several new data sets from our robust hepatitis B pipeline in the second quarter, and expect to maintain our executional momentum throughout the year."

    Corporate Update

    COVID-19 Updates

    • In February, the Company initiated COMET-PEAK (COVID-19 Monoclonal antibody Efficacy Trial - Patient SafEty, TolerAbility, PharmacoKinetics), a Phase 2 trial with two parts. The first part, initiated in February, is evaluating the similarity in pharmacokinetics between VIR-7831 manufactured by different processes. The second part, which began in April, is comparing the safety and viral kinetics of intramuscularly (IM) administered VIR-7831 to intravenously (IV) administered VIR-7831 among low-risk adults with mild to moderate COVID-19. The low 500 mg dose of VIR-7831 lends itself to administration via an IM route, and could facilitate broader access to monoclonal antibody therapy in settings where IV administration is not feasible. Data are expected in the second half of 2021.
    • In March, the Company announced that the VIR-7831 arm of the National Institutes of Health's (NIH) ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Program Phase 3 clinical trial met initial pre-specified criteria, and no safety signals were reported. Based on sensitivity analyses of the available data, the independent Data and Safety Monitoring Board recommended the VIR-7831 arm be closed to enrollment. The Company anticipates an NIH-led manuscript to be published later this year.
    • In March, the Company announced an Independent Data Monitoring Committee (IDMC) recommended the Phase 3 COMET-ICE trial evaluating VIR-7831 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. The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. VIR-7831 was well tolerated. As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.
    • In March, the Company announced the submission of an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for VIR-7831 for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death. The submission is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE trial. These data will also form the basis for a Biologics License Application (BLA) submission to the FDA, planned in the second half of 2021.
    • In March, the Company announced topline data from Eli Lilly and Company's (Eli Lilly) expanded Phase 2 BLAZE-4 trial evaluating the potential benefits of VIR-7831 together with Eli Lilly's investigational bamlanivimab (LY-CoV555) in low-risk adult patients with mild to moderate COVID-19. Results from the trial, which began dosing in January, showed that bamlanivimab 700 mg co-administered with VIR-7831 500 mg demonstrated a 70% (p<0.001) relative reduction in persistently high viral load (>5.27; cycle threshold value <27.5) at day 7 compared to placebo, meeting the primary endpoint. In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5, and 7 in SARS-CoV-2 viral load. No serious adverse events were reported in either trial arm. Together with Eli Lilly and GlaxoSmithKline plc (GSK), the Company is engaging with the FDA and anticipates working with other global regulators regarding the possible co-administration of bamlanivimab and VIR-7831 for the treatment of COVID-19.
    • In April, the Company announced that the European Medicines Agency (EMA) initiated a review of VIR-7831 for the treatment of adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The review is being carried out by the EMA's Committee for Human Medicinal Products (CHMP) and will provide European Union-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization Application.
    • In April, the first patient was dosed in the UK National Health Service-supported AGILE initiative. The trial initiative, which the Company announced in January, is the first to evaluate VIR-7832 in a Phase 1b/2a trial of adults with mild to moderate COVID-19. VIR-7832 shares the same characteristics as VIR-7831 and has been engineered to potentially be a therapeutic T cell vaccine to further help treat and/or prevent COVID-19. Initial safety data are expected in the second half of 2021.
    • In the second quarter of 2021, the Company plans to initiate two additional trials evaluating IM administration of VIR-7831:
      • COMET-TAIL (Treatment of Acute COVID-19 with Intramuscular monocLonal antibody) – a Phase 3 trial in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19
      • COMET-STAR (Stop Transmission of Acute SARS-CoV-2) – a Phase 3 trial in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic COVID-19 infection
    • In connection with the advancement of Vir's SARS-CoV-2 monoclonal antibody programs, the Company has established a strategic manufacturing network that will enable the manufacture of approximately two million doses to patients in the first year following potential EUA, and several fold that in the second year, depending on titer and yield.

    Chronic Hepatitis B Virus (HBV) Updates

    • In January, the Company entered into a clinical collaboration with Gilead Sciences, Inc. (Gilead) 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, which is aimed at developing a functional cure for chronic HBV, is expected to start in the second half of 2021.
    • In late January, the Company announced initial topline data from an ongoing Phase 1 trial evaluating VIR-3434, an HBV-neutralizing monoclonal antibody with the potential to be a therapeutic T cell vaccine, for the treatment of patients with chronic HBV. The first blinded cohort consisted of eight patients with chronic HBV who were taking nucleoside reverse transcriptase inhibitors (NRTIs), two of whom received placebo, and six of whom received a single dose of 6 mg VIR-3434. Six of eight patients achieved a mean 1.3 log10 IU/mL reduction in serum HBV surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients. Additional safety and efficacy data will be presented at The European Association for the Study of the Liver's (EASL) International Liver Conference in June. The Company also expects to initiate a Phase 2 trial of VIR-3434 in combination with VIR-2218 in the second half of 2021.
    • In February, the Company presented encore data on VIR-2218 at the Asian Pacific Association for the Study of the Liver. Presentations included preliminary results from the Company's ongoing Phase 2 trial of VIR-2218 (oral) and data characterizing the urine and plasma pharmacokinetics of VIR-2218 (poster). One-year response durability data for VIR-2218 as a monotherapy for HBV will be presented at the EASL International Liver Conference in June.
    • In April, the Company announced that its collaborator Brii Biosciences initiated a Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the treatment of chronic HBV infection.
    • During the quarter, the Company continued to progress a Phase 2 combination trial of VIR-2218 with pegylated interferon-alpha (PEG-IFN-α) to evaluate the potential for this combination to result in a functional cure for HBV. Initial clinical data will be presented at the EASL International Liver Conference in June.
    • The Company received notification of acceptance of four abstracts for presentation at the EASL International Liver Conference, to be hosted virtually June 23-26.
      • Oral Presentation: A Phase 1 study evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434 in participants with chronic hepatitis B virus infection. (Presenter: Dr. Kosh Agarwal)
      • Oral Presentation: Safety and antiviral activity of VIR-2218, an X-targeting RNAi therapeutic, in participants with chronic hepatitis B infection: week 48 follow-up results. (Presenter: Prof. Edward Gane)
      • Poster Presentation: Preliminary on-treatment data from a Phase 2 study evaluating VIR-2218 in combination with pegylated interferon alfa-2a in participants with chronic hepatitis B infection. (Presenter: Prof. Man-Fung Yuen)
      • Poster Presentation: Preliminary pharmacokinetics and safety in healthy volunteers of VIR-3434, a monoclonal antibody for the treatment of chronic hepatitis B infection (Presenter: Dr. Sneha Gupta)

    Additional Pipeline Updates

    • In January, the Company initiated a Phase 1 clinical trial of VIR-1111, an investigational HIV T cell vaccine based on human cytomegalovirus (HCMV). This proof-of concept trial is designed to test the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines. If observed, this T cell vaccine could potentially have utility in additional types of infections and other challenging areas, including cancer. Initial clinical data are anticipated in the second half of 2021.
    • In February, the Company signed a binding collaboration agreement with GSK to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The expanded collaboration, which builds on the agreement signed in 2020 to research and develop therapies for coronaviruses, provides GSK exclusive rights to collaborate with Vir on the development of potential best-in-class monoclonal antibodies for the prevention or treatment of influenza. As part of the agreement, the companies will also engage in two additional research programs: 1) an expansion of the current functional genomics collaboration to include other respiratory virus targets; and 2) the development of up to three neutralizing monoclonal antibodies identified using Vir's antibody technology platform to target non-influenza pathogens during a three-year research period. Given the relatively low incidence of influenza during the COVID-19 pandemic, the companies are currently evaluating the potential timelines for advancing VIR-2482 and other influenza therapies covered under the expanded agreement. Under the terms of the agreement, GSK will pay $345 million in a combination of an upfront payment and a further equity investment in Vir.

    Publications

    During and following the first quarter, nine manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other viruses.

    In January:

    • Cell published "Circulating SARS-CoV-2 spike N439K variants maintain fitness while evading antibody-mediated immunity" (Thompson, et al.), which was previously posted on bioRxiv. The paper characterized the virulence, fitness, clinical and epidemiologic impact, molecular features and immune response to N439K, a prevalent receptor binding motif (RBM) variant of the SARS-CoV-2 spike protein first identified in Scotland in March 2020, and how this mutation might evade immunity.



    In February:

    • medRxiv posted a pre-print manuscript, "SARS-CoV-2 B.1.1.7 escape from mRNA vaccine-elicited neutralizing antibodies" (Collier, et al.), which highlighted the importance of designing next-generation vaccines with mutated S sequences and using alternative viral antigens.
    • Research Square posted a pre-print manuscript, "SARS-CoV-2 variants show resistance to neutralization by many monoclonal and serum-derived polyclonal antibodies" (Diamond, et al.), which indicated that the cell line in which the virus is grown and the cell line in which the assays are performed significantly affected the in vitro potency of certain antibodies against SARS-CoV-2.

    In March:

    • bioRxiv posted a pre-print manuscript, "The dual function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate potent in vitro and in vivo activity against SARS-CoV-2" (Cathcart, et al.), which demonstrated that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants.
    • Cell published "N-terminal domain antigenic mapping reveals a site of vulnerability for SARS-CoV-2" (McCallum, et al.), which was pre-published in January on bioRxiv. The paper characterized the N-terminal domain (NTD) on the SARS-CoV-2 spike protein.

    In April:

    • bioRxiv posted a pre-print manuscript, "SARS-CoV-2 immune evasion by variant B.1.427/B.1.429" (McCallum, et al.), which further established the ability of VIR-7831 to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California variant (B.1.427/B.1.429).
    • bioRxiv posted a pre-print manuscript, "Membrane lectins enhance SARS-CoV-2 infection and influence the neutralizing activity of different classes of antibodies" (Lempp, et al.), which adds to the growing body of evidence suggesting monoclonal antibodies that target a conserved epitope, such as VIR-7831, have the potential to be highly effective against SARS-CoV-2 and associated known mutations.
    • bioRxiv posted a pre-print manuscript, "Structural basis for broad sarbecovirus neutralization by a human monoclonal antibody" (Tortorici, et al.), which further recognized the importance of monoclonal antibodies with a highly conserved epitope, broad neutralization capabilities and the potential for a high barrier to resistance to address pan sarbecoviruses.
    • bioRxiv posted a pre-print manuscript, "Antibodies to the SARS-CoV-2 receptor-binding domain that maximize breadth and resistance to viral escape" (Starr, et al.), which highlighted the importance of mAbs that target the RBD, given their high neutralization activity and potency, and suggested the potential for RBD-based vaccines as a means of addressing future variants.

    First Quarter 2021 Financial Results

    • Revenues: Total revenues for the quarter ended March 31, 2021, were $2.0 million, compared to $5.7 million for the same period in 2020. The decrease for the quarter was primarily due to timing of research activities under our grant agreements with the Bill & Melinda Gates Foundation.
    • Research and Development Expenses: Research and development expenses were $134.9 million for the quarter ended March 31, 2021, which includes $8.4 million of non-cash stock-based compensation expense, compared to $65.0 million for the same period in 2020, which included $1.5 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to clinical activities related to VIR-7831 and VIR-2218, higher fair value of our contingent consideration, costs incurred under our collaboration with GSK and contract manufacturing expenses for our COVID-19 programs, and personnel-related expenses due to additional headcount.
    • General and Administrative Expenses: General and administrative expenses were $25.7 million for the quarter ended March 31, 2021, which includes $7.0 million of non-cash stock-based compensation expense, compared to $12.6 million for the same period in 2020, which included $1.5 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to personnel-related expenses attributable to additional headcount, legal fees and external consulting expenses.
    • Net Loss: Net loss for the quarter ended March 31, 2021, was $168.9 million, or $1.32 per share, basic and diluted, compared to a net loss of $77.2 million, or $0.71 per share, basic and diluted, for the same period in 2020.
    • Cash and Cash Equivalents: As of March 31, 2021, excluding restricted cash, the Company had approximately $733.0 million in cash, cash equivalents and investments. This includes $120.0 million from equity sold to GSK under the expanded collaboration agreement signed in February 2021.

    About VIR-7831

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About VIR-7832

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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-1111

    VIR-1111 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines.

    About VIR-2482

    VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482, which incorporates Xencor's Xtend technology, also has been half-life engineered so that a single dose has the potential to last the entire flu season.

    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. VIR-7831 is the first SARS-CoV-2-targeting antibody we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. VIR-7831 has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. 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 our partners.

    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 timing of availability of clinical data, program updates and data disclosures related to Vir's clinical trials, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the ability of VIR-7831 to be administered via an IM route, the timing and expected number of therapeutic doses that Vir will be able to supply to patients, the potential of Vir's combination therapy trials with VIR-2218 to result in a functional cure for HBV, initial topline data from the ongoing Phase 1 trial of VIR-3434 in the treatment of patients with HBV and VIR-3434's potential to be a therapeutic T cell vaccine, the ability of VIR-1111 to elicit a T cell immune response to HIV, potential timelines for advancing influenza therapies, including VIR-2482 and other therapies covered under the expanded agreement with GSK. Many factors may cause differences between current expectations and actual results, including challenges in enrollment, 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:

    Cara Miller

    VP, Corporate Communications

    cmiller@vir.bio

    +1-415-941-6746

    Vir Biotechnology, Inc.

    Condensed Consolidated Statements of Operations

    (unaudited; in thousands, except share and per share data)

     Three Months Ended March 31, 
     2021  2020 
    Revenues:       
    Grant revenue$1,371  $5,231 
    Contract revenue 605   487 
    Total revenue 1,976   5,718 
    Operating expenses:       
    Research and development 134,870   64,979 
    General and administrative 25,739   12,649 
    Total operating expenses 160,609   77,628 
    Loss from operations (158,633)  (71,910)
    Other income (expense):       
    Interest income 164   1,755 
    Other expense, net (10,246)  (7,069)
    Total other income (expense) (10,082)  (5,314)
    Loss before provision for income taxes (168,715)  (77,224)
    Provision for income taxes (196)  (16)
    Net loss$(168,911) $(77,240)
    Net loss per share, basic and diluted$(1.32) $(0.71)
    Weighted-average shares outstanding, basic and diluted 127,742,614   108,387,913 
            

    Vir Biotechnology, Inc.

    Condensed Consolidated Balance Sheets

    (unaudited; in thousands, except share and per share data)

     March 31,

    2021
      December 31,

    2020
     
    ASSETS       
    CURRENT ASSETS:       
    Cash and cash equivalents$521,396  $436,575 
    Short-term investments 211,636   300,286 
    Restricted cash and cash equivalents, current 8,601   7,993 
    Receivable from collaboration 112,500    
    Contract asset 112,500    
    Prepaid expenses and other current assets 26,481   27,511 
    Total current assets 993,114   772,365 
    Intangible assets, net 33,687   33,820 
    Goodwill 16,937   16,937 
    Property and equipment, net 17,291   17,946 
    Operating right-of-use assets 60,461   61,947 
    Restricted cash and cash equivalents, noncurrent 6,998   6,919 
    Other assets 7,096   8,827 
    TOTAL ASSETS$1,135,584  $918,761 
    LIABILITIES AND STOCKHOLDERS' EQUITY       
    CURRENT LIABILITIES:       
    Accounts payable$3,701  $5,077 
    Accrued and other liabilities 70,069   76,936 
    Deferred revenue, current portion 262,929   6,451 
    Contingent consideration, current portion 24,400   10,600 
    Total current liabilities 361,099   99,064 
    Deferred revenue, noncurrent 3,815   3,815 
    Operating lease liabilities, noncurrent 66,615   66,556 
    Contingent consideration, noncurrent 46,036   25,374 
    Deferred tax liability 3,253   3,253 
    Other long-term liabilities 3,815   3,847 
    TOTAL LIABILITIES 484,633   201,909 
    STOCKHOLDERS' EQUITY:       
    Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020     
    Common stock, $0.0001 par value; 300,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 129,891,856 and 127,416,740 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 13   13 
    Additional paid-in capital 1,488,337   1,385,301 
    Accumulated other comprehensive loss (1,304)  (1,278)
    Accumulated deficit (836,095)  (667,184)
    TOTAL STOCKHOLDERS' EQUITY 650,951   716,852 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$1,135,584  $918,761 



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  16. SAN FRANCISCO, April 22, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the first quarter ended March 31, 2021 on Thursday, May 6, 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, April 22, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the first quarter ended March 31, 2021 on Thursday, May 6, 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.

    Contact:

    Cara Miller

    VP, Corporate Communications

    cmiller@vir.bio

    +1 415 941 6746 



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  17. – New combination trial of an RNA-targeted therapeutic candidate and an HBV immunotherapeutic candidate aimed at delivering a functional cure for chronic hepatitis B infection –

    Brii Biosciences (Brii Bio), Vir Biotechnology, Inc. (NASDAQ:VIR), and VBI Vaccines Inc. (NASDAQ:VBIV) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

    This press release…

    – New combination trial of an RNA-targeted therapeutic candidate and an HBV immunotherapeutic candidate aimed at delivering a functional cure for chronic hepatitis B infection –

    Brii Biosciences (Brii Bio), Vir Biotechnology, Inc. (NASDAQ:VIR), and VBI Vaccines Inc. (NASDAQ:VBIV) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210421005339/en/

    The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy of BRII-835 (VIR-2218) compared to the combination of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with and without interferon-alpha as a co-adjuvant. Both agents have demonstrated proof of mechanism in HBV patients (NCT04507269 BRII-835 China study and ACTRN12619001210167 BRII-179 APEC study). Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VIR and VBI, and is the sponsor of the Phase 2 study (NCT04749368). It will be conducted at sites in Australia, China, Taiwan, Hong Kong Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand.

    Li Yan, M.D., Ph.D., chief medical officer of Brii Bio, said: "Sustained seroclearance of HBV surface antigen, also known as a functional cure, occurs rarely in the natural history of HBV infection or during the current standard of care treatment. We believe that both viral antigen knockdown with BRII-835 (VIR-2218) and sustained induction of HBV-specific host immune responses by BRII-179 (VBI-2601) are required to remove viral immunosuppression and subsequently break immune tolerance. The combination of these two agents is a step toward developing a functional cure for HBV."

    Phil Pang, M.D., Ph.D., chief medical officer of Vir, said: "This new combination trial represents an important addition to our HBV portfolio approach of combining VIR-2218 with various immunomodulators, including pegylated interferon alpha, VIR-3434 and with a TLR8 agonist, via our previously announced collaboration with Gilead. We look forward to determining if such combinations can stimulate an effective immune response that may result in a finite duration of treatment."

    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 Company'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.

    About Brii Biosciences

    Brii Biosciences (Brii Bio) is a multi-national company committed to serving patients' needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight. With operations in the People's Republic of China and the United States, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the public health and wellbeing of patients around the world. Brii Bio is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and CNS diseases. For more information, visit www.briibio.com.

    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.

    About VBI Vaccines Inc.

    VBI Vaccines Inc. ("VBI") is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles ("VLPs"), including a proprietary enveloped VLP ("eVLP") platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, please visit www.vbivaccines.com.

    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," "potential," "aim," "could" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-2218, BRII-179, pegylated interferon-alpha, and VIR-3434 (individually or in combination), the expected timing of commencement of clinical trials and availability of clinical data, our goals with respect to the prophylaxis and/or treatment of HBV, the potential ability of our product candidates (individually or in combination with other agents) to functionally cure HBV and change the standard of care, the potential of ESC+ technology to enhance the therapeutic index of VIR-2218, and the potential benefits of Vir's collaboration with Brii Biosciences and other partners. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, difficulties in obtaining regulatory approval, difficulties in collaborating with other companies, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, successful development and/or commercialization of alternative product candidates by our 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.

    VBI Cautionary Statement on Forward-Looking Information

    Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

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  18. DURHAM, N.C. and BEIJING and SAN FRANCISCO and CAMBRIDGE, Mass., April 21, 2021 (GLOBE NEWSWIRE) -- Brii Biosciences ("Brii Bio"), Vir Biotechnology, Inc. (NASDAQ:VIR), and VBI Vaccines Inc. (NASDAQ:VBIV) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

    The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy…

    DURHAM, N.C. and BEIJING and SAN FRANCISCO and CAMBRIDGE, Mass., April 21, 2021 (GLOBE NEWSWIRE) -- Brii Biosciences ("Brii Bio"), Vir Biotechnology, Inc. (NASDAQ:VIR), and VBI Vaccines Inc. (NASDAQ:VBIV) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

    The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy of BRII-835 (VIR-2218) compared to the combination of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with and without interferon-alpha as a co-adjuvant. Both agents have demonstrated proof of mechanism in HBV patients (NCT04507269 BRII-835 China study and ACTRN12619001210167 BRII-179 APEC study). Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VIR and VBI, and is the sponsor of the Phase 2 study (NCT04749368). The study will be conducted at sites in Australia, China, Taiwan, Hong Kong Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand.

    Li Yan, M.D., Ph.D., chief medical officer of Brii Bio, said: "Sustained seroclearance of HBV surface antigen, also known as a functional cure, occurs rarely in the natural history of HBV infection or during the current standard of care treatment. We believe that both viral antigen knockdown with BRII-835 (VIR-2218) and sustained induction of HBV-specific host immune responses by BRII-179 (VBI-2601) are required to remove viral immunosuppression and subsequently break immune tolerance. The combination of these two agents is a step toward developing a functional cure for HBV."

    Phil Pang, M.D., Ph.D., chief medical officer of Vir, said: "This new combination trial represents an important addition to our HBV portfolio approach of combining VIR-2218 with various immunomodulators, including pegylated interferon alpha, VIR-3434 and with a TLR8 agonist, via our previously announced collaboration with Gilead. We look forward to determining if such combinations can stimulate an effective immune response that may result in a finite duration of treatment."

    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.

    About Brii Biosciences

    Brii Biosciences (Brii Bio) is a multi-national company committed to serving patients' needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight. With operations in the People's Republic of China and the United States, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the public health and wellbeing of patients around the world. Brii Bio is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and CNS diseases. For more information, visit www.briibio.com.

    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.

    About VBI Vaccines Inc. 

    VBI Vaccines Inc. ("VBI") is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles ("VLPs"), including a proprietary enveloped VLP ("eVLP") platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, please visit www.vbivaccines.com.

    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," "potential," "aim," "could" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-2218, BRII-179, pegylated interferon-alpha, and VIR-3434 (individually or in combination), the expected timing of commencement of clinical trials and availability of clinical data, our goals with respect to the prophylaxis and/or treatment of HBV, the potential ability of our product candidates (individually or in combination with other agents) to functionally cure HBV and change the standard of care, the potential of ESC+ technology to enhance the therapeutic index of VIR-2218, and the potential benefits of Vir's collaboration with Brii Biosciences and other partners. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, difficulties in obtaining regulatory approval, difficulties in collaborating with other companies, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, successful development and/or commercialization of alternative product candidates by our 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.

    VBI Cautionary Statement on Forward-Looking Information

    Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

     



    Contact:
    Lisa Beck
    Brii Biosciences
    media@briibio.com
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746
    
    Nicole Anderson
    Director, Corporate Communication & IR
    IR@vbivaccines.com
    (617) 830-3031 x124

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  19. LONDON and SAN FRANCISCO, April 15, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action 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 high risk of progressing to severe COVID-19.

    The review is being carried out by the EMA's Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004 and will provide EU-wide recommendations for national authorities who may take evidence-based…

    LONDON and SAN FRANCISCO, April 15, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action 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 high risk of progressing to severe COVID-19.

    The review is being carried out by the EMA's Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004 and will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization Application.

    The review will include data from an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. The CHMP review will also consider data on the medicine's quality and safety.

    This week, the Australian Therapeutic Goods Administration (TGA), part of the Department of Health, granted VIR-7831 a provisional determination. VIR-7831 is the first anti-SARS-CoV-2 monoclonal antibody to have been granted this designation, which provides a formal and transparent mechanism for accelerating the registration of promising new medicines with preliminary clinical data.

    VIR-7831 is an investigational compound and has not been granted a marketing authorization anywhere in the world. An Emergency Use Authorization (EUA) application for VIR-7831 has been submitted to the U.S. Food and Drug Administration (FDA).

    Preclinical data suggest VIR-7831 targets a highly conserved epitope of the SARS-CoV-2 spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional preclinical data published in bioRxiv, VIR-7831 also appears to maintain activity against the California variant.

    GSK is planning to submit a full Marketing Authorization Application (MAA) to the EMA which will include the data from the COMET-ICE trial.

    About COMET-ICE

    The multi-center, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 2 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States. In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial.

    In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy but is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

    The Phase 3 portion of the trial assessed the safety and efficacy of a single IV infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

    About the VIR-7831 Clinical Development Program

    In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
    • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

    VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Topline data announced in March 2021 showed that in combination, the two monoclonal antibodies demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo.

    Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    VIR-7831 and VIR-7832 are investigational compounds and have not been granted marketing authorizations anywhere in the world.

    About VIR-7831 / GSK4182136

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. 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 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 recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and 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.

    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.

    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 EMA's review of VIR-7831, the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 to treat and/or prevent COVID-19 (as monotherapy and in combination with bamlanivimab), the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including plans to continue discussions with the FDA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, 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 our competitors, changes in expected or existing competition, delays in or disruptions to our 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.

    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.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    Vir Biotechnology Contacts:

    Cara Miller

    VP, Corporate Communications

    cmiller@vir.bio 

    +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)
        
    Analysts/Investors:James Dodwell+44 (0) 20 8047 2406(London)
     Sonya Ghobrial+44 (0) 7392 784784(Consumer)
     Jeff McLaughlin+1 215 751 7002(Philadelphia)
     Frannie DeFranco+1 215 751 4855(Philadelphia)



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  20. – Growing body of evidence suggests monoclonal antibodies that target a conserved epitope have the potential to be highly effective against SARS-CoV-2 and associated known mutations –

    – Newly identified cell surface proteins play a role in SARS-CoV-2 infection and determine how certain classes of antibodies work –

    SAN FRANCISCO, April 08, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new preclinical research highlighting novel mechanisms by which SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) enters host cells and identifying how auxiliary receptors may impact the clinical efficacy of monoclonal antibodies (mAbs). The research highlights the distinct mechanism…

    – Growing body of evidence suggests monoclonal antibodies that target a conserved epitope have the potential to be highly effective against SARS-CoV-2 and associated known mutations –

    – Newly identified cell surface proteins play a role in SARS-CoV-2 infection and determine how certain classes of antibodies work –

    SAN FRANCISCO, April 08, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new preclinical research highlighting novel mechanisms by which SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) enters host cells and identifying how auxiliary receptors may impact the clinical efficacy of monoclonal antibodies (mAbs). The research highlights the distinct mechanism of action of non-receptor-binding motif (RBM)-targeting antibodies, such as VIR-7831 and VIR-7832, the Company's investigational SARS-CoV-2 mAbs that target a conserved non-RBM site within the receptor binding domain (RBD).

    While prior literature has shown that SARS-CoV-2 infection is mediated by the virus binding to the ACE-2 entry receptor, findings from this research, posted on BioRxiv, highlight the importance of three additional auxiliary receptors that enhance infection mediated by the ACE-2 receptor. This new study addresses the role of DC-SIGN and L-SIGN lectins in infection and further identifies the SIGLEC1 lectin as a new participant in infection. SIGLEC1 is of particular importance because it is highly expressed and associated with SARS-CoV-2 in macrophages – an inflammatory cell type that is prominent in the lungs of patients with severe COVID-19. These cells can bind to infectious SARS-CoV-2 and present the virus to another cell to establish infection in that second cell. These auxiliary receptors also play an important role in modulating the neutralizing activity of different classes of spike-specific antibodies and may contribute to viral dissemination in the most severe COVID-19 cases.

    This study addresses another important aspect related to the influence of the experimental methods used in measuring the neutralizing activity of different classes of spike-specific antibodies. Cells that overexpress ACE-2 at levels in excess of normal cells are widely used in neutralization assays because they can be infected with high efficiency. While these cell lines effectively measure the neutralizing activity of antibodies that target the RBM of the SARS-CoV-2 spike protein, they inadequately measure the neutralizing activity of non-RBM antibodies, as well as antibodies that target the N-terminal domain (NTD) of the spike. The NTD is a major target of human immunity to SARS-CoV-2. This observation indicates the significant limitations of the use of cells overexpressing ACE-2 for studies of mAbs and measuring serum neutralizing antibodies elicited by vaccination or infection.

    When tested in more physiologic conditions, with cells expressing low levels of ACE-2 together with lectin receptors, non-RBM antibodies showed an enhanced ability to block viral infection. S309 (the precursor to VIR-7831 and VIR-7832), which targets a conserved non-RBM site within the RBD, showed enhanced neutralizing activity, reaching 100% neutralization. In contrast, antibodies that target the RBM were less effective in preventing infection. Additionally, a subset of the RBM-targeting antibodies analyzed in the study, including three clinical-stage antibodies, were shown to promote cell-cell fusion driven by the SARS-CoV-2 spike protein, potentially promoting cell-to-cell spread of the infection.

    "As we continue to advance research that elucidates the mechanisms of SARS-CoV-2 infection, including the development of the disease and immunity to infection, one consistent finding of this study appears to be that certain classes of mAbs have potential advantages at blocking auxiliary receptor-enhanced infection," said Herbert "Skip" Virgin, M.D., Ph.D., chief scientific officer of Vir. "These data, together with recent studies showing an 85% reduction in hospitalization and death in high-risk outpatients receiving VIR-7831 compared to placebo and promising performance against SARS-CoV-2 variants in the lab, add to the growing body of evidence suggesting that antibodies that bind to a conserved non-RBM site of the virus are well suited to help treat and/or prevent COVID-19 infection and have the potential to address both current and future mutations."

    VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority.

    About VIR-7831

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About VIR-7832

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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 timing of availability of program updates and data disclosures related to VIR-7831 and VIR-7832, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, and the ability of VIR-7831 and VIR-7832 to maintain activity against variant strains of the virus. 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 in 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:
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1 415 941 6746

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  21. SAN FRANCISCO, April 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that George Scangos, Ph.D., chief executive officer, will participate in a virtual fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13th at 8:45 am PT / 11:45 am ET.

    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.

    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…

    SAN FRANCISCO, April 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that George Scangos, Ph.D., chief executive officer, will participate in a virtual fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13th at 8:45 am PT / 11:45 am ET.

    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.

    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.



    Contact:
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  22. – Data add to growing body of pre-clinical evidence demonstrating that VIR-7831 maintains activity against all known circulating variants of concern –

    – Plasma from vaccinated individuals and several therapeutic monoclonal antibodies showed a reduction in neutralization potency against the California variant –

    SAN FRANCISCO, April 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced new preclinical research demonstrating the ability of VIR-7831, the company's investigational SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California…

    – Data add to growing body of pre-clinical evidence demonstrating that VIR-7831 maintains activity against all known circulating variants of concern –

    – Plasma from vaccinated individuals and several therapeutic monoclonal antibodies showed a reduction in neutralization potency against the California variant –

    SAN FRANCISCO, April 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced new preclinical research demonstrating the ability of VIR-7831, the company's investigational SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California variant (B.1.427/B.1.429). Study results also demonstrate that the L452R mutation reduced both the neutralization potency of plasma from vaccinated and convalescent donors and the neutralization activity of 14 RBD-specific and 10 N-terminal domain (NTD)-specific monoclonal antibodies, including three clinical-stage mAbs. Data were published on April 1, 2021 on bioRxiv, and have been submitted to a peer-reviewed journal for future print publication.

    In this new study, researchers at Vir and the University of Washington, report the rapid and exponentially increasing spread of the California variant throughout all 50 states and in 29 additional countries worldwide, and characterize the impact of its three mutations: S13I and W152C in the NTD and L452R in the RBD.

    Data from 43 vaccinated donors and nine convalescent donors demonstrated that, in a pseudotyped virus system, the S13I, W152C and L452R mutations reduced the neutralization potency of plasma by three-to-six-fold. In addition, the L452R mutation reduced the neutralization activity of 14 out of 35 RBD-specific mAbs, including three clinical-stage antibodies. Researchers also observed a complete loss of neutralization by all NTD-specific mAbs that is mediated by an unconventional escape mechanism. VIR-7831, which targets a non-receptor binding motif (RBM) epitope, was unaffected by the L452R mutation.

    "The rapid increase in frequency of this variant in California and neighboring states and its ability to confer some degree of resistance to vaccines and antibody therapies is concerning," said David Veesler, Ph.D., associate professor of biochemistry, University of Washington in Seattle. "The reduced sensitivity of this variant to plasma antibodies results from three individual spike mutations that mediate evasion from both RBD (partial) and NTD (total) specific antibodies. Together, these data demonstrate that if we are to combat current and anticipated future variants, there is a critical need for monoclonal antibodies that target invariant regions of the spike protein with the potential for a high barrier to resistance."

    "These data add to the growing body of evidence supporting our rationale for targeting a non-RBM epitope and the potential of VIR-7831 to combat the current variants of concern, including the evasive California variant, either as monotherapy or as a foundational therapy for future combinations," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "We believe VIR-7831 could significantly impact both the trajectory of the pandemic and the outcomes of patients facing the more dire consequences of COVID-19. We look forward to continuing to work with global regulatory authorities to bring VIR-7831 to patients as quickly as possible."

    VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration or any other regulatory authority.

    About VIR-7831

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    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 timing of availability of program updates and data disclosures related to VIR-7831, the ability of VIR-7831 to treat and/or prevent COVID-19, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus and the ability of VIR-7831 to maintain activity against variant strains of the virus. 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.



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  23. In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared…

    INDIANAPOLIS and SAN FRANCISCO and LONDON, March 29, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE:LLY), Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint.

    In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5 and 7 in SARS-CoV-2 viral load. There were no events for the secondary endpoint of COVID-19 related hospitalization or death by day 29 in either study arm. One patient (in the treatment arm) visited the emergency room for COVID-19 related symptoms. No serious adverse events were seen with co-administration of bamlanivimab and VIR-7831.

    Bamlanivimab and VIR-7831 bind to different regions of the spike protein of SARS-CoV-2. Preclinical data suggest the administration of these two investigational antibodies together may provide protection against current variants of SARS-CoV-2 that are resistant to bamlanivimab.

    Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said: "The reduction in persistently high viral load is an important virology endpoint that was demonstrated in Lilly's Phase 2 BLAZE-1 trial, and subsequently validated in the Phase 3 trial, to be strongly correlated with the clinical outcome of COVID-19 related hospitalizations and deaths in high-risk patients. These virology data support our belief that bamlanivimab and VIR-7831 together could be a promising option for COVID-19 treatment."

    George Scangos, Ph.D., chief executive officer of Vir, said: "This virologic evaluation of two antibodies with distinct resistance profiles is an encouraging advance in our fight against the pandemic. VIR-7831 demonstrated positive results in the COMET-ICE trial and recent pre-clinical data suggest that VIR-7831 maintains activity against current circulating variants of concern. Now, with these exciting new data from the BLAZE-4 trial, we believe that VIR-7831 has an important role to play as both monotherapy and in combination with other mAbs. We look forward to continuing conversations with the FDA about VIR-7831 as monotherapy and co-administered with bamlanivimab."

    Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "These early data from the BLAZE-4 trial, coupled with the results of the COMET-ICE trial demonstrating an 85 percent reduction in progression to hospitalization or death using VIR-7831, support our hypothesis that by targeting a highly conserved epitope, VIR-7831 may help deliver benefits to patients. We're continuing to work with regulators to bring VIR-7831 as a monotherapy and potentially co-administered with other monoclonal antibodies to patients in need."

    VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. An Emergency Use Authorization (EUA) application for VIR-7831 has been submitted to the FDA, based on the results of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which stopped enrollment early based on data from an interim analysis demonstrating an 85 percent reduction in hospitalisation or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. The three companies anticipate engaging with global regulators, including the FDA, regarding the possible co-administration of bamlanivimab and VIR-7831 for the treatment of COVID-19.

    Important Information about bamlanivimab

    Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

    Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).

    Authorized Use and Important Safety Information

    Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate 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 progressing to severe COVID-19 and/or hospitalization.

    Limitations of Authorized Use

    • Bamlanivimab 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 bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.

    Important Safety Information

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

    Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

    Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab. 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 have been observed with administration of bamlanivimab. 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 (e.g., 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, dizziness, and diaphoresis.

    If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

    Clinical Worsening After Bamlanivimab Administration

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

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

    Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. See Limitations of Authorized Use.

    Adverse Events

    Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).

    Use in Specific Populations

    Pregnancy

    There are insufficient data on the use of bamlanivimab during pregnancy. Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

    Breastfeeding

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

    About BLAZE-4

    BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

    The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include viral load change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

    About COMET-ICE

    COMET-ICE is a multi-center, double-blind, placebo-controlled Phase 3 trial evaluating VIR-7831 in adults with mild or moderate COVID-19 at high risk of progression to severe disease. The trial was stopped for enrollment on March 10, 2021, based on an interim analysis, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo.

    About bamlanivimab 

    Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

    Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

    Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

    About VIR-7831 / GSK4182136

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About the Vir and GSK Coronavirus 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.

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly's COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.

    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.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. 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 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 recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and 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.

    About Eli Lilly and Company  

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news.

    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.

    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.

    Lilly Cautionary Statement Regarding Forward-Looking Statements

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, alone and in combination with other antibodies, including VIR-7831, and Lilly's development plans and collaboration efforts, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization and in drug collaborations. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab alone or administered with VIR-7831 or any other therapy will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab alone or administered with VIR-7831 or any other therapy will receive regulatory approvals or additional authorizations, that patients will volunteer to participate in a study of bamlanivimab alone or administered with VIR-7831 or any other therapy or achieve positive outcomes or that Lilly and its partners can provide an adequate supply of bamlanivimab alone or administered with VIR-7831 or any other therapy in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. 

    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 timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 to treat and/or prevent COVID-19 (as monotherapy and in combination with bamlanivimab), the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including plans to continue discussions with the FDA, the EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

    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.

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  24. LONDON and SAN FRANCISCO, March 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

    The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated…

    LONDON and SAN FRANCISCO, March 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

    The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.

    Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional soon to be published preclinical data, VIR-7831 also appears to maintain activity against the California variant.

    GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. 

    About COMET-ICE 

    The multi-center, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 2 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States. In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial.

    In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy but is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

    The Phase 3 portion of the trial assessed the safety and efficacy of a single IV infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

    About the VIR-7831 Clinical Development Program

    In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
    • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

    VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. 

    About VIR-7831 / GSK4182136

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. 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 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 recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and 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.

    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.

    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 timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including Vir's plans to submit a BLA to the FDA and continue discussions with the EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

    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.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contacts:
    Cara Miller
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    cmiller@vir.bio
    +1 415 941 6746
    
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    +44 (0) 20 8047 5502
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  25. – Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalization or death –

    – Vir and GSK plan to immediately seek Emergency Use Authorization in the U.S. and authorizations in other countries –

    – Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants –

    SAN FRANCISCO and LONDON, March 10, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for…

    – Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalization or death –

    – Vir and GSK plan to immediately seek Emergency Use Authorization in the U.S. and authorizations in other countries –

    – Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants –

    SAN FRANCISCO and LONDON, March 10, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) 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.

    The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. VIR-7831 was well tolerated. As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

    Based on these results, Vir and GSK plan to submit an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) and for authorizations in other countries. Data from this registrational trial will also form the basis for a Biologics License Application (BLA) submission to the FDA.

    The companies also announced today the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African and Brazilian variants, based on in vitro data from pseudotyped virus assays. In contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop.

    In addition to COMET-ICE, the full COMET clinical development program for VIR-7831 includes:

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
    • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

    George Scangos, Ph.D., chief executive officer of Vir, said: "These exciting data with a single antibody against a conserved epitope bring us one step closer to delivering an effective new solution to patients around the globe. The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics. These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus."

    Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients. We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further exploring its potential in other settings."

    The Phase 3 portion of the COMET-ICE trial assessed the safety and efficacy of a single intravenous infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally, and this interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. According to the Centers for Disease Control and Prevention, these populations are approximately three times more likely to be hospitalized¹ and approximately two times more likely to die² of COVID-19.

    VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19.

    Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. 

    COMET-ICE Clinical Trial Design

    The multi-center, double-blind, placebo-controlled COMET-ICE trial is investigating VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 1 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States.

    In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial. This part of the trial is assessing the safety and efficacy of a single IV infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally.

    About VIR-7831 / GSK4182136

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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 two potential treatments in addition to our vaccine candidates in development.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to work with Sanofi, our collaboration with Medicago on an adjuvanted, protein-based vaccine candidate is now in late-stage clinical trials. An earlier stage collaboration with SK Bioscience is also ongoing, with funding from CEPI and 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, 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, if approved.

    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.

    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.

    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.

    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 timing of availability of clinical data, program updates and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus and statements related to the planned full analysis of the COMET-ICE 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

    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 published on 9 March 2021 or contained in the Company's Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

    Inside Information

    This announcement contains inside information. The person responsible for arranging the release of this announcement on behalf of GSK is Victoria Whyte, Company Secretary.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    _______________________________

    ¹ Data source: COVID-NET (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html, accessed March 1, 2020, through January 30, 2021). Numbers are ratios of age-adjusted rates standardized to the 2019 US standard COVID-NET catchment population.

    ² Data source: NCHS provisional death counts (https://data.cdc.gov/NCHS/Deaths-involving-coronavirus-disease-2019-COVID-19/ks3g-spdg, data through January 30, 2021). Numbers are ratios of age-adjusted rates standardized to the 2019 US intercensal population estimate.



    Vir Biotechnology Contacts: 
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1 415 941 6746
    
    GSK Contacts:
        
    Media:
    
    Simon Steel
    +44 (0) 20 8047 5502 
    (London)
    
    Tim Foley
    +44 (0) 20 8047 5502 
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    +1 804 217 8147 
    (Philadelphia)
    
    Kathleen Quinn    
    +1 202 603 5003 
    (Washington DC)
        
    Analysts/Investors:
    
    Sarah Elton-Farr
    +44 (0) 20 8047 5194 
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    Sonya Ghobrial       
    +44 (0) 7392 784784 
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    Danielle Smith
    +44 (0) 20 8047 0932 
    (London)
    
    James Dodwell       
    +44 (0) 20 8047 2406 
    (London)
    
    Jeff McLaughlin       
    +1 215 751 7002 
    (Philadelphia)
    
    Frannie DeFranco
    +1 215 751 4855 
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  26. SAN FRANCISCO and LONDON, March 03, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while…

    SAN FRANCISCO and LONDON, March 03, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The companies will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data. 

    The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3.

    George Scangos, Ph.D., chief executive officer of Vir, said: "While we are disappointed with the recommendation of the DSMB, we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients. We want to thank NIH for their work to assess the benefits of VIR-7831 and other agents, and look forward to working with them to further understand the potential of VIR-7831 to provide a benefit in this population. In addition, we are eagerly anticipating the upcoming data from the Phase 3 COMET-ICE trial in newly-diagnosed COVID-19 patients at high risk of hospitalization."

    Christopher Corsico, Senior Vice President Development, GSK, said: "We want to thank the patients who participated in this study and the NIH for investing in the ACTIV trial to evaluate the four monoclonal antibodies, as it recognizes the need for differentiated treatments, especially as new variants emerge globally. These and other anticipated data will provide valuable insights about how VIR-7831 can contribute to the fight against this pandemic."

    VIR-7831 is an investigational, dual-action monoclonal antibody that has been shown in preclinical trials to both block viral entry into healthy cells and clear infected cells, which may protect patients from disease progression.

    The antibody has also shown the ability to neutralize the SARS-CoV-2 live virus by binding to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. So far, the variants of concern, including the UK, South African and Brazilian variants, do not overlap with the VIR-7831 targeted epitope of the virus, and, therefore, VIR and GSK believe that it should maintain full activity against these strains.

    In addition to the ACTIV-3 trial, VIR-7831 is also being evaluated in the outpatient setting in the following clinical trials:

    • COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early): A Phase 3 trial to evaluate VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization or death.
    • BLAZE-4 (sponsored by Eli Lilly and Company): A Phase 2 trial designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. 

    Additionally, VIR-7831, along with VIR-7832, will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. 

    About VIR-7831 / GSK4182136

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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 two potential treatments in addition to our vaccine candidates in development.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to work with Sanofi, our collaboration with Medicago on an adjuvanted, protein-based vaccine candidate is now in late-stage clinical trials. An earlier stage collaboration with SK Bioscience is also ongoing, with funding from CEPI and 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, 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, if approved.

    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.

    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.

    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.

    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 timing of availability of clinical data, program updates and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus and the ability of VIR-7831 to maintain full activity against variant strains of the virus. 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

    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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contacts: 
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1 415 941 6746
    
    GSK Contacts:
        
    Media:
    
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  27. SAN FRANCISCO, Feb. 25, 2021 (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, 2020.

    "Vir closed 2020 delivering strong progress across our entire development pipeline with six distinct molecules addressing four serious infectious diseases. Our momentum continues in 2021 with the signing of new collaborations designed to help speed the development of multiple promising candidates, as well as pending data from two Phase 3 studies evaluating our novel monoclonal antibody, VIR-7831, against COVID-19," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Additionally, we are now evaluating an…

    SAN FRANCISCO, Feb. 25, 2021 (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, 2020.

    "Vir closed 2020 delivering strong progress across our entire development pipeline with six distinct molecules addressing four serious infectious diseases. Our momentum continues in 2021 with the signing of new collaborations designed to help speed the development of multiple promising candidates, as well as pending data from two Phase 3 studies evaluating our novel monoclonal antibody, VIR-7831, against COVID-19," said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. "Additionally, we are now evaluating an intramuscular formulation of VIR-7831, and expect the first trial evaluating VIR-7832, our second antibody aimed at COVID-19, to begin shortly. Vir's strong execution is evident across our full portfolio, with the recent compelling initial data from our Phase 1 trial of VIR-3434 demonstrating a significant and rapid reduction in hepatitis B surface antigen, and the continued forward momentum of our influenza and HIV programs. We anticipate a transformational year ahead."

    Corporate Update

    Expanded GSK Collaboration

    • In February, the Company signed a binding agreement with Glaxo Wellcome UK Limited, a subsidiary of GlaxoSmithKline plc, to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The expanded collaboration, which builds on the agreement signed in 2020 to research and develop therapies for coronaviruses, provides GSK exclusive rights to collaborate with Vir on the development of potential best-in-class monoclonal antibodies for the prevention or treatment of influenza. As part of the agreement, the companies will also engage in two additional research programs: 1) an expansion of the current functional genomics collaboration to include other respiratory virus targets; 2) the development of up to three neutralizing monoclonal antibodies identified using Vir's antibody technology platform to target non-influenza pathogens during a three-year research period. Under the terms of the agreement, GSK, through its subsidiaries, will make an upfront payment of $225 million and a further equity investment in Vir of $120 million. Vir will fund the development of VIR-2482 through completion of Phase 2 trials, after which time GSK may pay a fee of $300 million to exercise its option to co-develop VIR-2482. The companies will share the development costs and related profits associated with the development of all other programs in this expanded collaboration. GSK may also pay Vir up to $200 million based on the successful delivery of pre-defined regulatory milestones for the first product arising from the influenza program. 

    SARS-CoV-2 Updates

    • In October, based on a positive evaluation of safety and tolerability data of VIR-7831 from the Phase 2 lead-in, the Company began enrolling patients in the global Phase 3 portion of COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early). VIR-7831 is a dual-action SARS-CoV-2 monoclonal antibody that, among other attributes, 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 (the virus that causes COVID-19) 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. COMET-ICE is evaluating VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization or death. Primary endpoint results are expected in the first quarter of 2021. If positive, these data will be used to seek Emergency Use Authorization and, ultimately, approval through the submission of a Biologics License Application.
    • In December, the Company announced the initiation of the National Institutes of Health (NIH)-sponsored ACTIV-3 Phase 3 trial evaluating VIR-7831 for the treatment of hospitalized adults with COVID-19. An evaluation of the benefit/risk profile of VIR-7831 in this challenging patient population is expected in the first quarter of 2021 and will determine whether VIR-7831 continues in the next part of the ACTIV-3 trial.
    • In January, the Company announced an agreement with the National Health Service-supported AGILE initiative to evaluate VIR-7832 in a Phase 1b/2a trial of adults with mild to moderate COVID-19. VIR-7832 shares the same characteristics as VIR-7831 but has also been engineered to potentially be a therapeutic T cell vaccine to further help treat and/or prevent COVID-19. The AGILE trial, which is the first to test VIR-7832 in humans, is expected to begin in the first quarter of 2021.
    • In January, the Company announced a collaboration with Eli Lilly and Company to evaluate whether the administration of VIR-7831 together with Eli Lilly's bamlanivimab (LY-CoV555) can provide potential benefits beyond monotherapy in low-risk adults with mild to moderate COVID-19. Initial results for this arm of Eli Lilly's Phase 2 BLAZE-4 trial are expected in the first half of 2021.
    • In February, the Company initiated COMET-Patient SafEty, TolerAbility, PharmacoKinetics, or COMET-PEAK , a Phase 2 study with two parts. The first part will evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes. The second part will compare the safety and viral kinetics of intramuscularly (IM) administered VIR-7831 to intravenously (IV) administered VIR-7831 among low-risk adults with mild to moderate COVID-19. The low, 500 mg dose of VIR-7831 lends itself to administration via an IM route and could facilitate broader access to monoclonal antibody therapy in settings where IV administration is not feasible.
    • In the second quarter of 2021, the Company plans to initiate two additional trials evaluating IM administration of VIR-7831:

      • COMET-TAIL (Treatment of Acute COVID-19 with Intramuscular monocLonal antibody) – a Phase 3 trial in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19

      • COMET-STAR (Stop Transmission of Acute SARS-CoV-2) – a Phase 3 trial in uninfected adults at high risk to determine wither IM-administered VIR-7831 can prevent symptomatic infection
    • In connection with the advancement of Vir's SARS-CoV-2 monoclonal antibody programs, the Company has established a strategic manufacturing network that will enable the manufacture of approximately two million doses to patients the first year following potential Emergency Use Authorization, and several fold that in the second year, depending on titer and yield.

    Chronic Hepatitis B Virus (HBV) Updates

    • In January, Vir entered into a clinical collaboration with Gilead Sciences, Inc. to evaluate the Company's HBV-targeting small interfering ribonucleic acid (siRNA), 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, which is aimed at developing a functional cure for chronic HBV, is expected to start in 2021.
    • In late January, the Company announced initial topline data from an ongoing Phase 1 trial evaluating VIR-3434, an HBV-neutralizing monoclonal antibody with the potential to be a therapeutic T cell vaccine, for the treatment of patients with chronic HBV. The first blinded cohort consisted of eight patients with chronic HBV who were taking nucleoside reverse transcriptase inhibitors, two of whom received placebo, and six of whom received a single dose of 6 mg VIR-3434. Six of eight patients responded and achieved a mean 1.3 log10 IU/mL reduction in serum HBV surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients. Additional clinical data are anticipated in the second quarter of 2021. The Company also expects to initiate a Phase 2 trial of VIR-3434 in combination with VIR-2218 in the second half of 2021.
    • In February, the Company presented encore data on VIR-2218 at the Asian Pacific Association for the Study of the Liver. Presentations included preliminary results from the Company's ongoing Phase 2 trial of VIR-2218 (oral) and data characterizing the urine and plasma pharmacokinetics of VIR-2218 (poster). One-year response durability data for VIR-2218 as a monotherapy for HBV are anticipated in the first half of 2021.
    • During the quarter, the Company continued to progress a Phase 2 combination trial of VIR-2218 with pegylated interferon-alpha (PEG-IFN-α) to evaluate the potential for this combination to result in a functional cure for HBV. Initial clinical data are anticipated in the second quarter of 2021.
    • The Company expects Brii Biosciences Offshore Limited (Brii Bio) to initiate a Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, in the first half of 2021.

    Additional Pipeline Updates

    • In October, the Company presented new clinical data on VIR-2482 and health economics research on the burden of influenza A on the elderly at the Infectious Disease Society of America IDWeek 2020. Initiation of the Phase 2 trial for VIR-2482, which was delayed due to the impact of COVID-19, is now expected in the fourth quarter of 2021 with proof-of-concept results anticipated in the first half of 2022.
    • In January, the Company initiated a Phase 1 clinical trial of VIR-1111, an investigational HIV T cell vaccine based on human cytomegalovirus (HCMV). This proof-of-concept vaccine is designed to test the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines, which, if observed, could potentially have utility in additional types of infections and other challenging areas, including cancer. Initial clinical data are anticipated in the second half of 2021.

    Publications

    During and following the fourth quarter, seven manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other viruses.

    In October:

    • Nature published "Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection" (Bournazos, et al.), detailing results from research in an influenza clinical model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response.

    In November:

    • bioRxiv published "The circulating SARS-CoV-2 spike variant N439K maintains fitness while evading antibody-mediated immunity" (Thomson, et al.), characterizing variation in the SARS-CoV-2 spike protein and virulence of a prevalent immune evasion variant, N439K.

    In December:

    • The Lancet Regional Health – Europe published "Risk assessment and seroprevalence of SARS-CoV-2 infection in healthcare workers of COVID-19 and non-COVID-19 hospitals in Southern Switzerland" (Piccoli, et al.), demonstrating that the use of protective measures was effective in reducing nosocomial viral transmission among hospital healthcare workers.

    In January:

    • bioRxiv published "N-terminal domain antigenic mapping reveals a site of vulnerability for SARS-CoV-2" (McCallum, et al.), characterizing the N-terminal domain (NTD) on the SARS-CoV-2 spike protein.
    • Cell published "Circulating SARS-CoV-2 spike N439K variants maintain fitness while evading antibody-mediated immunity" (Thompson, et al), which was previously posted on bioRxiv. The paper characterized the virulence, fitness, clinical and epidemiologic impact, molecular features and immune response to N439K, a prevalent receptor binding motif (RBM) variant of the SARS-CoV-2 spike protein first identified in Scotland in March 2020, and how this mutation might evade immunity.

    In February:

    • medRxiv published "SARS-CoV-2 B.1.1.7 escape from mRNA vaccine-elicited neutralizing antibodies" (Collier, et al.), which highlights the importance of designing next- generation vaccines with mutated S sequences and using alternative viral antigens.
    • Research Square published "SARS-CoV-2 variants show resistance to neutralization by many monoclonal and serum-derived polyclonal antibodies" (Diamond, et al.), which indicates that the cell line in which the virus is grown and the cell line in which the assays are performed significantly affected the in vitro potency of certain antibodies against SARS-CoV-2.

    New Board Appointment

    • In December, the Company appointed Jeffrey Hatfield to the Board of Directors. Mr. Hatfield is an accomplished industry executive with more than three decades of commercial and business experience. He currently serves as chief executive officer of Vividion Therapeutics, Inc.

    Fourth Quarter and Full Year 2020 Financial Results

    • Revenues: Total revenues for the quarter ended December 31, 2020, were, $1.7 million, compared to $1.0 million for the same period in 2019. Total revenue for the year ended December 31, 2020, were $76.4 million, compared to $8.1 million for the same period in 2019. The increase for the quarter was primarily due to the timing of research activities under the HIV and TB grants with the Bill & Melinda Gates Foundation. The increase for the year was primarily due to $43.3 million of revenue related to the license granted to GSK under our collaboration agreement, and $22.7 million of revenue related to Brii Biosciences' exercise of its option to obtain exclusive rights to develop and commercialize compounds arising from VIR-2218 in the China territory.
    • Research and Development Expenses: Research and development expenses were $87.1 million for the quarter ended December 31, 2020, which includes $5.3 million of non-cash stock-based compensation expense, compared to $52.9 million for the same period in 2019, which included $1.1 million of non-cash stock-based compensation expense. For the year ended December 31, 2020, research and development expenses were $302.4 million, which includes $13.7 million of non-cash stock-based compensation expense, compared to $148.5 million for the same period in 2019, which includes $3.0 million of non-cash stock-based compensation expense. The increase for the quarter and the full year was primarily due to contract manufacturing expenses for our SARS-CoV-2 program, higher fair value of our contingent consideration due to achievement of clinical development milestones, costs incurred under our collaboration with GSK, personnel-related expenses due to additional headcount, and clinical costs due to activities related to VIR-7831, VIR-3434 and VIR-2218. 
    • General and Administrative Expenses: General and administrative expenses were $23.0 million for the quarter ended December 31, 2020, which includes $5.0 million of non-cash stock-based compensation expense, compared to $11.8 million for the same period in 2019, which includes $1.6 million of non-cash stock-based compensation expense. For the year ended December 31, 2020, general and administrative expenses were $70.9 million, which includes $13.9 million of non-cash stock-based compensation expense, compared to $37.6 million for the same period in 2019, which includes $5.7 million of non-cash stock-based compensation expense. The increase for the quarter and the full year was primarily due to personnel-related expenses attributable to additional headcount, legal fees, external consulting and other expenses due to costs associated with operating as a public company, including additional compliance-related expenses as a result of no longer being an emerging growth company. 
    • Net Loss: Net loss for the quarter ended December 31, 2020, was $105.6 million, or $0.83 per share, basic and diluted, compared to a net loss of $63.8 million, or $0.69 per share, basic, and $0.71 per share, diluted, for the same period in 2019. For the year ended December 31, 2020, net loss was $298.7 million, or $2.51 per share, basic and diluted, compared to a net loss of $174.7 million, or $5.76 per share, basic and diluted, for the same period in 2019.
    • Cash and Cash Equivalents: As of December 31, 2020, excluding restricted cash, the Company had approximately $736.9 million in cash, cash equivalents and investments. For the year ended December 31, 2020, net cash used in operating activities and property and equipment purchases was $197.5 million.

    About VIR-7831

    VIR-7831 is an investigational dual-action 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. VIR-7831, 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.

    About VIR-7832

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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-2482

    VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482, which incorporates Xencor's Xtend technology, also has been half-life engineered so that a single dose has the potential to last the entire flu season.

    About VIR-1111

    VIR-1111 is an investigational subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines.

    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 timing of availability of clinical data, program updates and data disclosures related to Vir's clinical trials, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19 and the timing and expected number of therapeutic doses that Vir will be able to supply to patients, the potential of Vir's combination therapy trials with VIR-2218 to result in a functional cure for HBV, initial topline data from the ongoing Phase 1 trial of VIR-3434 in the treatment of patients with HBV and VIR-3434's potential to be a therapeutic T cell vaccine, the ability of VIR-2482 to provide broad strain coverage for the flu, and the ability of VIR-1111 to elicit a T cell immune response to HIV. 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.

    Vir Biotechnology, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

     Three Months Ended

    December 31,
      Year Ended

    December 31,
     
     2020  2019  2020  2019 
    Revenue:               
    Grant revenue$1,433  $609  $9,123  $7,380 
    License revenue from a related party       22,747  $ 
    Contract revenue 301   371   44,498   711 
    Total revenue 1,734   980   76,368   8,091 
    Operating expenses:               
    Research and development 87,095   52,932   302,411   148,472 
    General and administrative 23,043   11,807   70,937   37,598 
    Total operating expenses 110,138   64,739   373,348   186,070 
    Loss from operations (108,404)  (63,759)  (296,980)  (177,979)
    Other income (expense):               
    Interest income 288   1,947   2,836   8,511 
    Other income (expense), net 2,437   (1,810)  (4,467)  (5,061)
    Total other income (expense) 2,725   137   (1,631)  3,450 
    Loss before benefit from (provision for) income taxes (105,679)  (63,622)  (298,611)  (174,529)
    Benefit from (provision for) income taxes 30   (149)  (54)  (154)
    Net loss$(105,649) $(63,771) $(298,665) $(174,683)
    Net loss per share, basic$(0.83) $(0.69) $(2.51) $(5.76)
    Net loss per share, diluted$(0.83) $(0.71) $(2.51) $(5.76)
    Weighted-average shares outstanding, basic 127,295,719   91,871,498   119,159,424   30,349,920 
    Weighted-average shares outstanding, diluted 127,295,719   91,901,590   119,159,424   30,349,920 
                    

    Vir Biotechnology, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands, except share and per share data)

      December 31, 
      2020  2019 
    ASSETS        
    CURRENT ASSETS:        
    Cash and cash equivalents $436,575  $109,335 
    Short-term investments  300,286   274,101 
    Restricted cash and cash equivalents, current  7,993   6,181 
    Prepaid expenses and other current assets  27,511   13,378 
    Total current assets  772,365   402,995 
    Intangible assets, net  33,820   35,694 
    Goodwill  16,937   16,937 
    Property and equipment, net  17,946   16,308 
    Operating right-of-use assets  61,947    
    Restricted cash and cash equivalents, noncurrent  6,919   7,300 
    Long-term investments     24,290 
    Other assets  8,827   8,547 
    TOTAL ASSETS $918,761  $512,071 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    CURRENT LIABILITIES:        
    Accounts payable $5,077  $5,881 
    Accrued and other liabilities  76,936   26,495 
    Deferred revenue, current portion  6,451   6,181 
    Contingent consideration, current portion  10,600   8,200 
    Derivative liability     12,449 
    Total current liabilities  99,064   59,206 
    Deferred revenue, noncurrent  3,815   12,670 
    Operating lease liabilities, noncurrent  66,556    
    Contingent consideration, noncurrent  25,374   9,380 
    Deferred tax liability  3,253   3,305 
    Other long-term liabilities  3,847   3,568 
    TOTAL LIABILITIES  201,909   88,129 
    Commitments and contingencies        
    STOCKHOLDERS' EQUITY:        
    Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2020 and 2019; no shares issued or outstanding as of December 31, 2020 and 2019      
    Common stock, $0.0001 par value; 300,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 127,416,740 and 107,648,925 shares issued and outstanding as of December 31, 2020 and 2019, respectively  13   11 
    Additional paid-in capital  1,385,301   793,051 
    Accumulated other comprehensive loss  (1,278)  (601)
    Accumulated deficit  (667,184)  (368,519)
    TOTAL STOCKHOLDERS' EQUITY  716,852   423,942 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $918,761  $512,071 
             


    Contact:
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  28. – Companies applying their combined expertise in immunology and infectious diseases to accelerate the development of promising monoclonal antibody candidates for influenza –

    – Functional genomics collaboration expanded to include respiratory viruses, Vir's unique technology, and access to GSK's small molecule compounds –

    – Additional exploration of up to three other antibodies for pathogens
    beyond influenza and coronaviruses –

    – GSK is increasing its equity investment by $120 million and making an upfront
    payment of $225 million –

    LONDON and SAN FRANCISCO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a binding agreement to expand their existing…

    – Companies applying their combined expertise in immunology and infectious diseases to accelerate the development of promising monoclonal antibody candidates for influenza –

    – Functional genomics collaboration expanded to include respiratory viruses, Vir's unique technology, and access to GSK's small molecule compounds –

    – Additional exploration of up to three other antibodies for pathogens

    beyond influenza and coronaviruses –

    – GSK is increasing its equity investment by $120 million and making an upfront

    payment of $225 million –

    LONDON and SAN FRANCISCO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses.

    The expanded collaboration, which builds on the agreement signed in 2020 to research and develop therapies for coronaviruses, provides GSK exclusive rights to collaborate with Vir on the development of potential best-in-class monoclonal antibodies (mAbs) for the prevention or treatment of influenza. These include VIR-2482, an intramuscularly administered investigational mAb designed as a universal prophylactic for influenza A that has completed a Phase 1 trial, as well as next-generation antibodies for the prevention or treatment of influenza during a three-year research period. GSK will have the exclusive option to co-develop VIR-2482 after Vir completes and reports Phase 2 trial outcomes, and will share development costs on the development of all other influenza mAbs.

    Influenza causes up to 500,000 hospitalizations and 34,000 deaths each year in the United States alone,1 approximately 75% of which are caused by influenza A.2 The protection provided by current vaccines varies from season to season, based on the virus strains circulating. People over 65 years of age with at least one comorbidity, such as cardiovascular disease, diabetes or who are immunocompromised, are at significantly increased risk of flu and flu-related hospitalization and mortality. This is also a population where the currently available vaccines have historically had lower efficacy.

    As part of the new collaboration agreement, the companies will also engage in two additional research programs. The first is an expansion of their current functional genomics collaboration to develop potential pan-coronavirus therapeutics to now include other respiratory virus targets. Under the second program, the companies will collaborate to develop up to three neutralizing monoclonal antibodies identified using Vir's antibody technology platform to target non-influenza pathogens during a three-year research period.

    Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "We believe, now more than ever, that it is very important to develop new therapies to treat and ideally prevent infectious diseases. I am delighted that we are expanding our collaboration with Vir whose focus on novel antibodies, expertise in functional genomics, unique technology and talented scientists will further strengthen GSK's position as a world leader in infectious diseases."

    George Scangos, Ph.D., CEO, Vir Biotechnology, said: "GSK has been a valuable strategic partner and scientific collaborator in the fight against COVID-19. As part of our functional genomics collaboration directed at COVID-19, we have turned up multiple targets that have the potential to treat influenza and other respiratory viruses, and it makes sense to extend the scope of our collaboration to include these new targets. This expanded collaboration supports the rapid advancement of multiple promising investigational compounds in our pipeline, increasing the likelihood that these potential life-saving treatments will reach patients sooner, and will advance our shared goal of developing single drugs that can address multiple ‘bugs.'"

    Under the terms of the agreement, GSK will make an upfront payment of $225 million and a further equity investment in Vir of $120 million. Initially, Vir will continue to fund the development of VIR-2482 through completion of Phase 2 trials, after which time, if GSK exercises its option to co-develop VIR-2482, it will pay an option fee of $300 million. Following option exercise for VIR-2482, and for each other program in the expanded collaboration, the companies will share the development costs and related profits associated with this agreement. GSK will also pay Vir up to $200 million based on the successful delivery of pre-defined regulatory milestones. The equity investment and collaboration agreement are conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

    GSK and Vir entered into an initial strategic collaboration in April 2020 to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The focus of the collaboration to date has been the development of specific antibody candidates identified by Vir's monoclonal antibody platform, VIR-7831 and VIR-7832, that have demonstrated the potential to both block viral entry into healthy cells and clear infected cells, and to provide a high barrier to resistance. VIR-7831 is currently in two global Phase 3 studies as monotherapy and one Phase 2 study as combination therapy, with initial results from the first of the Phase 3 studies expected in the first quarter of 2021. VIR-7832 has been accepted into the NHS-supported AGILE Phase 1b/2a study with a planned start in February 2021.

    About Vir's Antibody Platform

    Vir has a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. The platform is used to identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential. This platform has been used to identify and develop antibodies for pathogens including SARS-CoV-2, hepatitis B virus, influenza A, Ebola (mAb114, approved for use in the U.S. as EbangaTM and marketed by Ridgeback Therapeutics LP), malaria and others.

    About VIR-2482

    VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season.

    About VIR-7831 / GSK4182137

    VIR-7831 is an investigational dual-action 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. VIR-7831 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.

    About VIR-7832 / GSK4182136

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832 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. Importantly, VIR-7832 has also been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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 are leveraging 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 are also applying their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

    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.

    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.

    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 statements regarding the potential benefits of the collaboration with GSK, the completion of a definitive collaboration agreement, the total potential deal value of the collaboration, the ability to obtain clearance under the HSR Act and to satisfy the other closing conditions, the potential benefits of VIR-2482, and Vir's ability to address influenza, respiratory diseases, coronaviruses, including the current COVID-19 pandemic, and future outbreaks of any such diseases. 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

    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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q4 Results and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    1 2018-2019 flu season data from the Centers for Disease Control and Prevention.

    2 Zhou et al. Clinical Infectious Diseases. 2012:54:1427-1436.



    Vir Biotechnology Contact:
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  29. SAN FRANCISCO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the fourth quarter and full year ended December 31, 2020 on Thursday, February 25, 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…

    SAN FRANCISCO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the Company will provide a corporate update and report financial results for the fourth quarter and full year ended December 31, 2020 on Thursday, February 25, 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.



    Contact:
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    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  30. – Scientists continuing to advance critical research on mechanisms of immune evasion exemplified by emerging SARS-CoV-2 variants –

    – Study identifies the N-terminal domain of the SARS-CoV-2 spike protein as a target of potent neutralizing antibodies, but a target that can vary –

    – Separate research results published in Cell characterize the virulence and antibody response to N439K, a prevalent variant of the SARS-CoV-2 receptor binding motif –

    SAN FRANCISCO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) spike protein – specifically the N-terminal domain…

    – Scientists continuing to advance critical research on mechanisms of immune evasion exemplified by emerging SARS-CoV-2 variants –

    – Study identifies the N-terminal domain of the SARS-CoV-2 spike protein as a target of potent neutralizing antibodies, but a target that can vary –

    – Separate research results published in Cell characterize the virulence and antibody response to N439K, a prevalent variant of the SARS-CoV-2 receptor binding motif –

    SAN FRANCISCO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) spike protein – specifically the N-terminal domain (NTD). The study findings were made available online on bioRxiv on January 14, 2021 and have been submitted to a peer-reviewed journal for future print publication. This manuscript, together with data on immune evasion by mutations elsewhere in the spike protein published by scientists in Cell, begin to paint a comprehensive picture of the mechanisms that SARS-CoV-2 may utilize to evade immunity. Collectively, these data indicate the importance of carefully targeting conserved regions of the spike for vaccines and clinical monoclonal antibodies.

    The receptor binding motif (RBM) of SARS-CoV-2, the region of the receptor binding domain (RBD) that interacts with the SARS-CoV-2 receptor, is a common target of COVID-19 natural and vaccine-induced immune responses, as well as monoclonal antibodies. However, recently published research has characterized the frequent occurrence of mutations within the RBM, highlighting the need for targeting alternate sites within the spike protein.

    "This new research indicates the NTD is another site on the SARS-CoV-2 spike protein that, like the RBM, contains mutations as well as deletions in emerging variants," said Davide Corti, Ph.D., senior vice president of antibody research for Vir. "Mutations in these immunodominant domains can evade natural immune responses and are of concern for vaccines and for therapeutic monoclonal antibodies targeting these regions. This underscores the need to advance therapies that have a high barrier to resistance."

    Little is known about neutralizing antibodies that bind to the NTD and their contribution to protection from infection and disease. In this new study, researchers at Vir, the University of Washington and other universities in the United States and Europe isolated and extensively characterized 41 human monoclonal antibodies that recognize the SARS-CoV-2 NTD. A subset of these NTD-specific monoclonal antibodies neutralize SARS-CoV-2 with potency similar to potential best-in-class monoclonal antibodies that target the RBD. Notably, several new SARS-CoV-2 genetic variants, including the widely prevalent variants identified in South Africa and the UK, were found to possess frequent mutations in the NTD.

    These new findings build upon recent research published in Cell by Vir scientists in collaboration with colleagues at MRC-University of Glasgow Centre for Virus Research, which demonstrate the RBM of the SARS-CoV-2 spike protein – a major target of neutralizing monoclonal antibodies – is particularly variable.

    "Our ongoing effort to characterize the SARS-CoV-2 spike protein is proving ever more critical as new variants continue to emerge. These new findings reinforce the approach we have taken with our monoclonal antibody, VIR-7831, which is currently in Phase 3 trials," said George Scangos, Ph.D., chief executive officer of Vir. "By targeting a very conserved region of the RBD, VIR-7831 was designed to be effective against SARS-CoV-2 and variants that might emerge in this outbreak or future outbreaks of related viruses."

    The findings published in Cell characterize the virulence, fitness, clinical and epidemiologic impact, molecular features and immune response to N439K, a prevalent RBM variant of the SARS-CoV-2 spike protein first identified in Scotland in March 2020. Since then, a second lineage has independently emerged in other European countries, which, by January 2021, was detected in more than 30 countries across the globe. Although N439K variants are not believed to be more virulent or transmissible than the original SARS-CoV-2 strain, this research is the first to demonstrate mutations that maintain viral fitness can evade immunity.

    To understand whether and how the N439K mutation might evade immunity, researchers in the findings published in Cell noted the binding of polyclonal sera to the SARS-CoV-2 spike was reduced by the mutation in a sizeable fraction of the 445 samples obtained from recovered individuals. Additionally, out of 144 human neutralizing mAbs isolated from individuals who recovered from SARS-CoV-2 infection early in the pandemic, a significant number failed to efficiently recognize N439K. When tested across four clinical-stage antibodies – S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 – S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant.

    About VIR-7831

    VIR-7831 is an investigational dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 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.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    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 statements regarding print publication of Vir's research in a peer-reviewed journal, the emergence of new SARS-CoV-2 variants, the identification of N-terminal domain as a target of potent neutralizing antibodies, the importance of advancing therapies that have a high barrier to resistance and the potential ability of VIR-7831 to evade such variants in the protection and treatment of COVID-19 and in the prevention of future pandemics of related coronaviruses. 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.



    Contact:
    
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    nravindran@vir.bio
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    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
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  31. INDIANAPOLIS, SAN FRANCISCO and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE:LLY), Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

    Bamlanivimab is a neutralizing…

    INDIANAPOLIS, SAN FRANCISCO and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE:LLY), Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

    Bamlanivimab is a neutralizing antibody directed against the spike protein of SARS-CoV-2 designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Bamlanivimab is authorized for emergency use for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.

    VIR-7831 is a dual-action monoclonal antibody that was selected for clinical development based on its potential to both block viral entry into healthy cells and clear infected cells, as well as its potential to provide a high barrier to resistance. In pre-clinical trials, the antibody has shown the ability to neutralize the SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. Vir and GSK are advancing VIR-7831 as part of their collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.

    "Bamlanivimab is a potent antibody – with data from multiple Phase 2 and 3 clinical trials, which have demonstrated robust evidence for both treating and preventing COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized."

    "We believe that VIR-7831 has significant potential as a single agent, and we are optimistic about the pending interim data from two Phase 3 trials evaluating its potential for early treatment and in hospitalized patients," said George Scangos, Ph.D., chief executive officer of Vir. "As the virus continues to evolve, we, along with Lilly and GSK, share the view that we should pursue all possibilities to help end the pandemic and maximize the number of lives that can be saved. This trial is a first step to assess whether the administration of VIR-7831, with its high barrier to resistance and potent effector function, alongside bamlanivimab, which has strong outcomes data in early treatment, can provide potential benefits beyond monotherapy."

    "Despite the significant progress on vaccines, there remains an urgent patient need for multiple therapeutic approaches to prevent the more severe consequences of COVID-19," said Dr. Hal Barron, chief scientific officer and president R&D of GSK. "Partnering with Lilly to study VIR-7831 with bamlanivimab will provide the scientific community with further data on the important role these therapies could play in reducing the impact of this devastating pandemic."

    Bamlanivimab alone has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) based on interim data from the Phase 2 BLAZE-1 trial, which was published in the New England Journal of Medicine. These data show the therapy may help patients clear the virus and reduce COVID-19-related hospitalizations when given early in the disease course. The safety and efficacy of bamlanivimab is being evaluated with other neutralizing antibodies to provide a possible safeguard against potential viral resistance.

    VIR-7831 is an investigational compound, not approved by the U.S. FDA or any other regulatory authority. VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization.

    Important Information about bamlanivimab

    Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

    Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).

    Authorized Use and Important Safety Information

    Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate 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 progressing to severe COVID-19 and/or hospitalization.

    Limitations of Authorized Use

    • Bamlanivimab 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 bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.

    Important Safety Information

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

    Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

    There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. 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 have been observed with administration of bamlanivimab. Signs and symptoms of infusion-related reactions may include:

    • fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness.

    If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

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

    Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. See Limitations of Authorized Use.

    Adverse Events

    Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).

    Use in Specific Populations

    Pregnancy

    There are insufficient data on the use of bamlanivimab during pregnancy. Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

    Breastfeeding

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

    About BLAZE-4

    BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

    The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

    About bamlanivimab

    Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

    Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

    Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

    About etesevimab

    Etesevimab (LY-CoV016, also known as JS016) is a recombinant, fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

    Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.

    About VIR-7831 / GSK4182136

    VIR-7831 (GSK4182136) is an investigational dual-action 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 which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 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 COMET clinical development program for VIR-7831 includes a planned Phase 3 trial for the prevention of symptomatic infection. VIR-7831 is also being evaluated in a sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. 

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly's COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.

    GSK commitment to tackling COVID-19

    GSK's response to COVID-19 has been one of the broadest in the industry with potential treatments and vaccine candidates in development.

    GSK is collaborating with several organisations working on promising COVID-19 vaccines by providing access to our adjuvant technology. In a collaboration with Sanofi that brings together two of the world's largest vaccine companies, GSK is developing an adjuvanted recombinant protein-based COVID-19 vaccine candidate with a phase 2b study expected to start in February 2021. GSK also is collaborating with Medicago and Clover Biopharmaceuticals on adjuvanted, protein-based vaccine candidates, which are progressing into late-stage clinical trials. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. Currently, collaborating on the phase 3 clinical development of VIR-7831 (GSK4182136), a dual-action monoclonal antibody that has shown the ability in preclinical trials to both neutralize SARS-CoV-2 live virus in vitro and in vivo and kill already infected cells.

    About Eli Lilly and Company 

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news

    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 hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio

    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

    Lilly Cautionary Statement Regarding Forward-Looking Statements

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, alone and in combination with other neutralizing antibodies, including VIR-7831 and etesevimab (LY-CoV016), Lilly's development plans and collaboration efforts, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization and in drug collaborations. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab alone or administered with VIR-7831or etesevimab will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab alone or administered with VIR-7831 or etesevimab will receive regulatory approvals or additional authorizations, that patients will volunteer to participate in a study of bamlanivimab alone or administered with VIR-7831 or etesevimab or achieve positive outcomes or that Lilly and its partners can provide an adequate supply of bamlanivimab alone or administered with VIR-7831 or etesevimab in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. 

    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 statements regarding the potential benefits of VIR-7831 as a single agent and in combination with bamlanivimab in the treatment of COVID-19, the potential benefits of participating in the BLAZE-4 trial, and the potential benefits of Vir, Lilly, and GSK's collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. 

    GSK's 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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q3 Results and any impacts of the COVID-19 pandemic. 



    Contact:
    
    Investors, Vir
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1-415-506-5256
    
    Media, Vir
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746
    
    Investors, Lilly
    Kevin Hern
    hern_kevin_r@lilly.com
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    Molly McCully
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    Dani Barnhizer
    dbarnhizer@lilly.com
    +1-317-607-6119
    
    Investors, GSK
    Jeff McLaughlin
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    Lyndsay Meyer
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  32. – Novel HBV-neutralizing monoclonal antibody with therapeutic vaccine potential demonstrated a mean HBsAg reduction from baseline of 1.3 log10 IU/mL by day eight –

    SAN FRANCISCO, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced initial topline data from its ongoing trial of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients.

    VIR-3434 is an HBV-neutralizing…

    – Novel HBV-neutralizing monoclonal antibody with therapeutic vaccine potential demonstrated a mean HBsAg reduction from baseline of 1.3 log10 IU/mL by day eight –

    SAN FRANCISCO, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced initial topline data from its ongoing trial of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients.

    VIR-3434 is an 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. It has also been Fc engineered to include the XX2 "vaccinal mutation," allowing it to potentially function as a T cell vaccine, in this case, against HBV. The XX2 vaccinal mutation, which has the potential to transform standard antibodies into T cell vaccines, has also been incorporated into one of Vir's investigational COVID-19 monoclonal antibodies, VIR-7832, which is currently planned to enter a Phase 1b/2a trial this quarter. Vir has licensed exclusive rights to the XX2 mutation for use in infectious diseases.

    "The need for a functional cure for the nearly 300 million people living with chronic HBV is paramount. Lowering HBsAg may help unlock a patient's immune system, allowing it to provide the immune control necessary to achieve a functional cure," said Kosh Agarwal, M.D., lead study investigator and consultant hepatologist and transplant physician at the Institute of Liver Studies, King's College Hospital NHS Foundation Trust in London. "These early, first-in-patient results are exciting because they demonstrate that even at a very low dose, VIR-3434 is able to markedly lower HBsAg."

    "Extrapolating from our preclinical data, we expected it might require much higher doses of VIR-3434 to achieve this level of HBsAg knockdown. To have achieved it with a dose of 6 mg is unexpected," said Phillip Pang, M.D., Ph.D., Chief Medical Officer of Vir. "Coupled with initial data that shows VIR-3434 was well tolerated at up to 3,000 mg in healthy volunteers, I am hopeful that we are seeing just the beginning of VIR-3434's capabilities."

    The Phase 1 clinical trial of VIR-3434 is a randomized, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, antiviral and immunomodulatory activity of VIR-3434 in healthy volunteers and patients with chronic HBV infection with HBsAg levels less than 1,000 IU/ml. The trial is designed to progress from healthy volunteers to chronic HBV patients in a staggered, parallel fashion with the goal of rapidly generating early proof-of-concept data in patients. Additional data will be submitted for presentation at an upcoming medical conference. A Phase 2 trial combining VIR-3434 with Vir's HBV-targeting siRNA, VIR-2218, is expected to commence in the second half of this year.

    About VIR-2218

    VIR-2218 is a 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 a 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 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-7832

    VIR-7832 is a dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832 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. Importantly, VIR-7832 has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    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 initial data from ongoing trial of VIR-3434 in the treatment of patients with HBV, the therapeutical vaccine potential of both VIR-3434 and VIR-7832, which have both been engineered to include the XX2 vaccinal mutation, expected timing of clinical study results and clinical trial design around VIR-3434, VIR-7832, and the combination of VIR-3434 with VIR-2218.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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.



    Contact:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  33. – First Phase 2 clinical trial to combine immunomodulation and antigen suppression approaches in HBV cure research –

    FOSTER CITY, Calif. and SAN FRANCISCO, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (NASDAQ:GILD) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic combination strategies aimed at developing a functional cure for chronic hepatitis B virus (HBV).

    The companies plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead's investigational TLR-8 agonist; VIR-2218…

    – First Phase 2 clinical trial to combine immunomodulation and antigen suppression approaches in HBV cure research –

    FOSTER CITY, Calif. and SAN FRANCISCO, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (NASDAQ:GILD) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic combination strategies aimed at developing a functional cure for chronic hepatitis B virus (HBV).

    The companies plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead's investigational TLR-8 agonist; VIR-2218, Vir's investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist. People in the trial with HBV treatment experience may also receive Gilead's Vemlidy® (tenofovir alafenamide fumarate, TAF). The primary outcome of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.

    Both companies retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial.

    "Gilead has a two-decade commitment to people with hepatitis B and we have worked tirelessly to bring new treatments forward with the goal of helping to improve their lives," said Anuj Gaggar, vice president, Clinical Research, Virology at Gilead Sciences. "We believe that selgantolimod and VIR-2218 have the potential to be best-in-class therapeutics and could provide a compelling new combination approach to a functional cure for HBV."

    "We are enthusiastic about this collaboration," said Phil Pang, M.D., Ph.D., chief medical officer of Vir Biotechnology. "We believe a functional cure for the majority of patients will require a reduction of the levels of circulating viral proteins together with an immune boost to stimulate the production of new T-cells that can bring the infection under control. We believe that this collaboration with Gilead adds a novel and significant new combination to our efforts to find a cure for HBV."

    HBV affects more than 290 million people worldwide. Globally, HBV is a leading cause of liver cancer and each year it is estimated that more than 800,000 people die of HBV-related liver disease. While current antiviral therapies result in sustained HBV viral suppression, they rarely completely clear the virus and therefore people with HBV require lifelong therapy.

    The safety and efficacy of selgantolimod and VIR-2218 have not been established. They are investigational compounds, not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

    U.S. Important Safety Information and Indication for VEMLIDY

    IMPORTANT SAFETY INFORMATION

    BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

    • Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

    Warnings and Precautions

    • Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
    • New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.
    • Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir DF. Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

    Adverse Reactions

    Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia.

    Drug Interactions

    • Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
    • Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.

    Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

    Dosage and Administration

    • Testing Prior to Initiation: HIV infection.
    • Prior to or when initiating, and during treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
    • Dosage in Adults: 1 tablet taken once daily with food.
    • Renal Impairment: Not recommended in patients with end stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.
    • Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

    INDICATION

    VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

    Please click here to see full Prescribing Information for VEMLIDY, including BOXED WARNING.

    About Gilead Sciences

    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    Gilead Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Gilead may not realize the potential benefits of the collaboration with Vir Biotechnology, the possibility of unfavorable results from clinical trials involving Vemlidy and selgantolimod and the possibility that Gilead may be unable to initiate or complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of selgantolimod and any combination therapies, or that the parties may make a strategic decision to discontinue their collaboration at any time, and as a result, selgantolimod and any combination therapies may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

    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 "aim," "will," "may," "potential," "plan," "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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the clinical collaboration between Vir and Gilead Sciences, the ability to develop a functional cure for chronic HBV, the initiation of a Phase 2 trial of VIR-2218 to evaluate it as a combination therapy, VIR-2218's ability to stimulate an effective immune response and the effects of including ESC+. Many factors may cause differences between current expectations and actual results, including unexpected safety, tolerability, or immunogenicity data or results observed during the Phase 2 trial, challenges in clinical site activation rates or clinical trial enrollment rates that are lower than expected, the failure to achieve the primary outcome of the study, 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.

    U.S. Prescribing Information for Vemlidy including BOXED WARNING, is available at www.gilead.com.

    Vemlidy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

     



    Contact:
    
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    VP, Head of Investor Relations & Strategic Communications
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    cmiller@vir.bio
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    +1-650-522-5132
    
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    Darcy Bowman
    +353 (87) 382-6777

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    • Second monoclonal antibody from Vir-GSK collaboration to be investigated as a potential COVID-19 treatment
    • Preclinical data suggest VIR-7832 has two distinguishing properties: enhanced ability to clear infected cells and potential to enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection
    • Trial targeted to begin in 1Q:2021 at multiple sites across the UK

    SAN FRANCISCO and LONDON, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in a Phase 1b/2a clinical trial. VIR-7832 is a neutralizing COVID-19 antibody that preclinical…

    • Second monoclonal antibody from Vir-GSK collaboration to be investigated as a potential COVID-19 treatment
    • Preclinical data suggest VIR-7832 has two distinguishing properties: enhanced ability to clear infected cells and potential to enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection
    • Trial targeted to begin in 1Q:2021 at multiple sites across the UK

    SAN FRANCISCO and LONDON, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in a Phase 1b/2a clinical trial. VIR-7832 is a neutralizing COVID-19 antibody that preclinical data suggests has two distinguishing properties: an enhanced ability to clear infected cells and the potential to enhance virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection.

    The AGILE trial platform, which will be the first to test VIR-7832 in humans, uses adaptable protocols and statistical models to enable the evaluation of candidate medicines for COVID-19 treatment. The initiative is a collaboration between the University of Liverpool, Liverpool School of Tropical Medicine, Liverpool University Hospitals NHS Foundation Trust, University of Southampton and Lancaster University and coordinated by the National Institute for Health Research Southampton Clinical Trials Unit across the UK Clinical Research Facility Network. The trial is due to begin in the first quarter of 2021.

    George Scangos, Ph.D., chief executive officer of Vir, said: "We are pleased to have the support of the NHS behind our efforts to evaluate and advance VIR-7832 for the treatment and potential prevention of COVID-19. This study will be critical to our efforts as we work to understand whether the modifications we have made to this monoclonal antibody increase its potency and stimulate a T cell response to not only provide therapeutic benefits but also potentially confer a vaccine-like effect that could be applicable to prophylaxis."

    Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "While vaccine development has been very successful, current infection and hospitalization rates show that multiple vaccines and therapeutic options will be needed to combat and ultimately end this pandemic. We are grateful to everyone involved in the AGILE study for supporting this important research and expect initial results from the study to provide important insights into the use of VIR-7832 early in the course of infection with SARS-CoV-2."

    VIR-7832 is set to become the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. The first antibody, VIR-7831, is currently being investigated in two global phase 3 studies; for the early treatment of COVID-19 in patients who are at high risk of hospitalization, and for the treatment of hospitalized patients with COVID-19.

    Phase 1b/2a AGILE Study Design

    AGILE is a randomized, controlled, multi-center, seamless, adaptive Phase 1b/2a platform for the rapid evaluation of candidates of COVID-19 treatment in hospitalized patients and also in the community with early disease. The AGILE platform will assess VIR-7832 and VIR-7831 in adult outpatients with mild to moderate COVID-19 infection. The dose-escalation Phase 1b part of the study will evaluate the safety and tolerability of a single dose of VIR-7832 given by intravenous (IV) infusion and determine the dose for evaluation in the Phase 2a part of the study. A total of 24 study participants will be randomized 3:1 to VIR-7832 or placebo. The Phase 2 part of the study will include three treatment arms: 50 patients randomized to VIR-7832, 50 patients to VIR-7831, and 25 patients to placebo. The co-primary endpoints are safety and virologic activity of VIR-7832 as assessed by a change in SARS-CoV-2 viral load from baseline to Day 8. The Phase 2 part of the study also will assess the T cell responses to SARS-CoV-2 of VIR-7832 and VIR-7831. The trial is being conducted at up to five sites in the UK.

    About VIR-7832 / GSK4182137

    VIR-7832 is a dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832 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. Importantly, VIR-7832 has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    About VIR-7831 / GSK4182136

    VIR-7831 is a dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 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.

    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.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    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.

    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 potential benefits of VIR-7832 and VIR-7831 in the treatment of COVID-19, the potential benefits of participating in the AGILE study, and statements around the expected timing of the Phase 1b/2a clinical trial. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

    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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contacts:
      
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1 415 506 5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +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)
        
    Analysts/Investors:
    Sarah Elton-Farr   +44 (0) 20 8047 5194   (London)
    Sonya Ghobrial   +44 (0) 7392 784784   (Consumer)
    Danielle Smith   +44 (0) 20 8047 0932   (London)
    James Dodwell   +44 (0) 20 8047 2406   (London)
    Jeff McLaughlin   +1 215 751 7002   (Philadelphia)
    Frannie DeFranco   +1 215 751 4855   (Philadelphia)

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  34. SAN FRANCISCO, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, announced that the first patient was dosed in late December 2020 in a Phase 1 clinical trial of VIR-1111, an investigational human immunodeficiency virus (HIV) T cell vaccine. VIR-1111 is a proof-of-concept vaccine designed to test the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines. VIR-1111 is uniquely designed to elicit abundant and durable CD4 and CD8 T cells that are programmed to attack virus-infected cells. This trial is being conducted in collaboration with Oregon Health & Science…

    SAN FRANCISCO, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, announced that the first patient was dosed in late December 2020 in a Phase 1 clinical trial of VIR-1111, an investigational human immunodeficiency virus (HIV) T cell vaccine. VIR-1111 is a proof-of-concept vaccine designed to test the hypothesis that this new approach can elicit potentially protective immune responses that differ from other HIV vaccines. VIR-1111 is uniquely designed to elicit abundant and durable CD4 and CD8 T cells that are programmed to attack virus-infected cells. This trial is being conducted in collaboration with Oregon Health & Science University's (OHSU) Vaccine and Gene Therapy Institute with support from the Bill & Melinda Gates Foundation.

    "We are pleased to have initiated the first Phase 1 trial to evaluate our T cell platform, which explores the potential for immune-programmed vaccines to treat and prevent serious infectious diseases like HIV," said Herbert "Skip" Virgin, M.D., Ph.D., chief scientific officer of Vir. "If observed, a programmed immune response could be a significant step forward in the fight against HIV and in the field of vaccines, with ramifications that could extend to other challenging areas like cancer immunotherapy."

    The randomized, placebo-controlled, Phase 1 clinical trial is evaluating the safety and immunogenicity (ability to induce an immune response) of VIR-1111. The trial is enrolling healthy adults (ages 18 to 50) who are considered to be at low risk of HIV infection and who were previously infected with human cytomegalovirus (HCMV). They will receive two doses of VIR-1111 or placebo given by subcutaneous injection and be assessed for safety, reactogenicity (common, expected adverse reactions following vaccination, such as pain and redness), tolerability and immunogenicity.

    The viral vector technology that will be used in this trial was developed in a collaboration between Vir scientists and a team of OHSU scientists led by Louis Picker, M.D., and Klaus Frueh, Ph.D.

    "Along with the many OHSU investigators who worked on this project over the years, we are very excited that this new vaccine platform is being evaluated in a clinical trial," Drs. Picker and Frueh said. "This marks the first time that this new type of vaccine is being tested in humans. If successful, this approach could provide an entirely new set of tools for vaccine development."

    Key publications highlighting the potential impact of this approach include:

    About VIR-1111        

    VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding Vir's collaboration with Oregon Health & Science University and the Bill & Melinda Gates Foundation, the timing of the first patient dosed in the Phase 1 clinical trial for VIR-111, the design and potential ability of VIR-1111 to program specific T cell responses, the potential benefits that immune-programmed vaccines could have in the treatment and prevention of serious infectious diseases like HIV, the design for the Phase 1 clinical trial for VIR-111, including information on the immune response already observed in preclinical studies, details regarding patient enrollment and dosing, as well as statements around the use and potential impact of viral vector technology in prophylactic and therapeutic T cell vaccination and CD8+ T cell responses. Many factors may cause differences between current expectations and actual results, including unexpected safety, tolerability, or immunogenicity data or results observed during the Phase 1 clinical trial, the failure to replicate in humans the specific immune response observed in non-human primates in the preclinical trial, challenges in clinical site activation rates or clinical trial enrollment rates that are lower than expected, 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:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  35. SAN FRANCISCO, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today announced that George Scangos, Ph.D., chief executive officer will virtually present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12th at 11:00 am PT/ 2:00 pm ET.

    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.

    About Vir Biotechnology
    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies…

    SAN FRANCISCO, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today announced that George Scangos, Ph.D., chief executive officer will virtually present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12th at 11:00 am PT/ 2:00 pm ET.

    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.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.



    Contact:
    Vir Biotechnology, Inc.
    
    Investors
    Neera Ravindran, MD
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio
    +1-415-506-5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1-415-941-6746

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  36. – Randomized, placebo-controlled, multicenter, global Phase 3 trial will investigate the safety and efficacy of VIR-7831 in hospitalized adults with COVID-19 –

    SAN FRANCISCO and LONDON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2…

    – Randomized, placebo-controlled, multicenter, global Phase 3 trial will investigate the safety and efficacy of VIR-7831 in hospitalized adults with COVID-19 –

    SAN FRANCISCO and LONDON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) investigational monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs (one of the major sites of infection).

    ACTIV-3 is one of several ongoing trials in the NIH's ACTIV program, an NIH led public-private partnership designed to accelerate development of the most promising treatments and vaccine candidates for COVID-19. ACTIV-3 has been designed as a "master protocol" that allows for the simultaneous evaluation of multiple investigational therapeutics as they become available, but within the same clinical trial structure, across multiple trial sites.

    George Scangos, Ph.D., chief executive officer of Vir, said: "Recent data suggest that the neutralizing activity of antibodies may be insufficient to protect hospitalized adults from the most severe consequences of COVID-19. We are hopeful that the differentiating factors and broad anti-coronavirus activity of VIR-7831 may allow it to help those patients and add to our preparedness for related coronaviruses that could emerge in the future."

    Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "With new infection and hospitalization rates reaching record highs, the world needs multiple options to help combat this pandemic. We are developing solutions to fight this virus, from prevention through treatment, to provide relief from COVID-related illness. Our treatment option, VIR-7831, which has a high barrier to resistance and has the potential to neutralize the virus and kill infected cells, could allow this treatment to be effective for patients in hospital settings, where other antibodies have so far not shown an impact."

    In addition to the Phase 3 ACTIV-3 trial, VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization. The Phase 3 part of the COMET-ICE trial is assessing the safety and efficacy of a single intravenous (IV) infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of adults who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. The COMET clinical development program for VIR-7831 also includes a planned Phase 3 trial for the prevention of symptomatic infection.

    ACTIV-3 Clinical Trial Design

    The ACTIV-3 trial arm evaluating VIR-7831 will initially compare 300 participants who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms, who will receive either VIR-7831 or placebo. Participants also will receive standard care for COVID-19, including the FDA-approved antiviral remdesivir. Five days after dosing, participants' clinical status will be assessed, based on need for supplemental oxygen, mechanical ventilation, or other supportive care. If the VIR-7831 treatment arm appears to have a positive benefit:risk profile, the trial will enroll an additional 700 participants, including those who are more severely ill (i.e., adults with organ failure requiring mechanical support, or COVID-19-associated dysfunction of organs other than the lungs). Trial participants will be followed for 90 days following enrollment to analyze their response to treatment. The primary efficacy endpoint is the participants' sustained recovery for 14 days after release from the hospital.

    About VIR-7831 / GSK4182136

    VIR-7831 (GSK4182136) is a monoclonal antibody for which preclinical data suggest its ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831/GSK4182136 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

    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.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    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.

    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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-7831 in treating hospitalized patients with COVID-19, the potential benefits of participating in the ACTIV-3 trial, the ability of using a combination of a potent effector function and neutralization capabilities in enhancing the efficacy of monoclonal antibodies to treat hospitalized patients, the efficacy and safety of a single intravenous (IV) infusion of VIR-7831, Vir's plans around the evaluation of interim analyses and the expected timing of clinical study results for VIR-7831, the ability of VIR-7831 to prevent symptomatic infection, the clinical trial design around ACTIV-3 as well as statements around the potential benefits of Vir and GSK's collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, 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 our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. 

    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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contacts:
    
    Investors
    Neera Ravindran, M.D.
    VP, Head of Investor Relations & Strategic Communications
    nravindran@vir.bio 
    +1 415 506 5256
    
    Media
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +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)
    
    Analysts/Investors:
    Sarah Elton-Farr  +44 (0) 20 8047 5194  (London)
    Sonya Ghobrial  +44 (0) 7392 784784  (Consumer)
    Danielle Smith  +44 (0) 20 8047 0932  (London)
    James Dodwell  +44 (0) 20 8047 2406  (London)
    Jeff McLaughlin  +1 215 751 7002  (Philadelphia)
    Frannie DeFranco  +1 215 751 4855  (Philadelphia)

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  37. SAN FRANCISCO, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the appointment of Jeffrey Hatfield, an accomplished industry executive with more than three decades of commercial experience, to its Board of Directors.

    "We are pleased to welcome Jeff to the Vir team during this important period of rapid growth and transition. His passion for and experience building platform-based companies and advancing commercial programs based on cutting-edge technology will be invaluable as we continue to advance a full portfolio of novel compounds across a range of therapeutic areas," said Vicki Sato, Ph.D., chairman of Vir's Board of Directors.

    "Jeff is a talented executive whose leadership experience and commercial…

    SAN FRANCISCO, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the appointment of Jeffrey Hatfield, an accomplished industry executive with more than three decades of commercial experience, to its Board of Directors.

    "We are pleased to welcome Jeff to the Vir team during this important period of rapid growth and transition. His passion for and experience building platform-based companies and advancing commercial programs based on cutting-edge technology will be invaluable as we continue to advance a full portfolio of novel compounds across a range of therapeutic areas," said Vicki Sato, Ph.D., chairman of Vir's Board of Directors.

    "Jeff is a talented executive whose leadership experience and commercial expertise make him an ideal and timely addition to our Board," said George Scangos, Ph.D., chief executive officer of Vir. "We look forward to applying his insights and experience to the near-term milestones and catalysts that have the potential to transform Vir, and to our longer-term potential to impact the trajectory of serious infectious diseases."

    Hatfield currently serves as chief executive officer of Vividion Therapeutics, Inc. Previously, he was chief executive officer of Vitae Pharmaceuticals, Inc., where he led the company from start-up to clinical-stage advancement of multiple first-in-class programs, and ultimately to its $640 million acquisition by Allergan Plc. Prior to that, Hatfield worked at Bristol Myers Squibb in a variety of executive positions, including: Senior Vice President, Immunology and Virology Divisions; President and General Manager, BMS-Canada; and Vice President, U.S. Managed Health Care. 

    "As a company at the forefront of the COVID-19 pandemic, Vir is making incredible contributions to the science of infectious disease when the world needs it most," said Hatfield. "I am honored to join the Vir Board of Directors and look forward to contributing to the advancement of a broad portfolio of medicines designed to address some of the world's most complex public health challenges."

    Hatfield earned an M.B.A. from the Wharton School of the University of Pennsylvania, and a B.S. from the Purdue University College of Pharmacy. He is chairman of the Board of miRagen Therapeutics, Inc. and a member of the Board of aTyr Pharma. He also serves as a Key Advisory Board member for the Harvard Business School's Blavatnik Fellowship in Life Science Entrepreneurship and is a faculty member at Purdue University.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

    Contact:

    Investors

    Neera Ravindran, M.D.

    VP, Head of Investor Relations & Strategic Communications

    nravindran@vir.bio

    +1-415-506-5256

    Media

    Cara Miller

    VP, Corporate Communications

    cmiller@vir.bio

    +1-415-941-6746 



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  38. SAN FRANCISCO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2020.

    "I am proud of the Vir team's effort and success in accelerating our lead SARS-CoV-2 product candidate, VIR-7831, into a global Phase 3 trial, particularly in light of the more than 141,000 new COVID-19 infections recently reported in a single day in the U.S.," said George Scangos, Ph.D., chief executive officer of Vir. "We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient…

    SAN FRANCISCO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2020.

    "I am proud of the Vir team's effort and success in accelerating our lead SARS-CoV-2 product candidate, VIR-7831, into a global Phase 3 trial, particularly in light of the more than 141,000 new COVID-19 infections recently reported in a single day in the U.S.," said George Scangos, Ph.D., chief executive officer of Vir. "We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient populations alongside the initiation of a Phase 1b/2a trial for our second investigational SARS-CoV-2 neutralizing antibody, VIR-7832. Simultaneously, we continue to advance our broader portfolio of product candidates for chronic hepatitis B, influenza A and HIV, as we seek to address some of the world's most challenging infectious diseases."

    Corporate Update

    SARS-CoV-2 Updates

    • In August, the Company initiated COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early), a Phase 2/3 clinical trial evaluating VIR-7831, a potent SARS-CoV-2 neutralizing monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
    • In September, an Independent Data Monitoring Committee recommended the global expansion into Phase 3 of the COMET-ICE trial based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in. Global Phase 3 enrollment is ongoing and interim data may be available as early as January 2021. Results for the primary endpoint are expected in the first quarter of 2021.
    • In connection with the advancement of its SARS-CoV-2 programs, the Company has established a strategic manufacturing network, which will enable the supply of millions of doses to patients the first year following approval, depending on titer and yield.
    • The Company plans to initiate two additional Phase 3 trials in the COMET clinical development program for VIR-7831:

      • A trial for the treatment of hospitalized adults with COVID-19 is planned as a sub-study of the National Institutes of Health-sponsored ACTIV-3 trial and is expected to begin as soon as regulatory and ethical approvals are in place.

      • A trial for prophylaxis or prevention of symptomatic infection is expected to begin in the first quarter of 2021.
    • The Company is also preparing to advance its second investigational SARS-CoV-2 neutralizing antibody into a Phase 1b/2a trial in the first quarter of 2021. VIR-7832 shares the same characteristics as VIR-7831, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T cell response.
    • Pre-clinical studies for VIR-2703, an inhaled SARS-CoV-2-targeting small interfering ribonucleic acid (siRNA), are being led by Alnylam Pharmaceuticals, Inc. Alnylam is working to obtain additional efficacy data prior to further program advancement.

    Additional Pipeline Updates

    • In July, the Company initiated a Phase 2 combination trial of VIR-2218, an HBV-targeting siRNA, with pegylated interferon-alpha (PEG-IFN-α), evaluating the potential for this cocktail to result in functional cure of HBV-infected patients. Initial clinical data are anticipated in 2021.
    • The Company also plans to evaluate VIR-2218 in combination with VIR-3434, an HBV-neutralizing monoclonal antibody with the potential to be a therapeutic T cell vaccine. VIR-3434 is currently being evaluated in a Phase 1 trial, the results of which are expected to enable the Company to initiate a Phase 2 combination trial of VIR-3434 in combination with VIR-2218 in 2021.
    • In October, the Company presented data from its influenza A research program virtually at the Infectious Disease Society of America IDWeek 2020. Company presentations included two poster presentations on VIR-2482, an influenza A-neutralizing monoclonal antibody, and one oral presentation highlighting the severe economic and clinical burden of influenza A on elderly patients with underlying conditions in the United States. Initiation of the Phase 2 trial for VIR-2482, which was delayed due to the impact of COVID-19, is now expected in the fourth quarter of 2021 with proof-of-concept results anticipated in the first half of 2022.
    • The Company expects to initiate a Phase 1 clinical trial for VIR-1111, an HIV T cell vaccine based on human cytomegalovirus, in the fourth quarter of this year. This trial is designed to determine whether VIR-1111 elicits a specific type of T cell immune response to HIV, known as an HLA-E restricted immune response.

    Publications

    During and following the third quarter, five manuscripts were published related to the Company's efforts to address SARS-CoV-2 and other conditions that may benefit from treatment with monoclonal antibodies.

    In September:

    • Science published "Ultrapotent human antibodies protect against SARS-CoV-2 challenge via multiple mechanisms" (Tortorici, et al.), discussing the neutralizing abilities of two ultrapotent SARS-CoV-2 antibodies (S2E12 and S2M11) in clinical models.

    • Cell published "Mapping Neutralizing and immunodominant sites on the SARS-CoV-2 spike receptor-binding domain by structure-guided high-resolution serology" (Piccoli, et al.), characterizing differences in both the binding properties and kinetics of neutralizing antibody responses to SARS-CoV-2.

    • EMBO Molecular Medicine published "A combination of two human monoclonal antibodies cures symptomatic rabies" (de Melo, et al.), outlining proof-of-concept data for an antibody-based therapeutic approach for the treatment of symptomatic rabies.

    In October:

    • Nature published "Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection" (Bournazos, et al.), detailing results from research in an influenza clinical model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response.

    In November:

    • bioRxiv published "The circulating SARS-CoV-2 spike variant N439K maintains fitness while evading antibody-mediated immunity" (Thomson, et al.), characterizing variation in the SARS-CoV-2 spoke protein and virulence of a prevalent immune evasion variant, N439K.

    New Board Appointment

    • In September, the Company announced the appointment of Janet Napolitano to the Board of Directors. Ms. Napolitano formerly served as the Governor of Arizona, the U.S. Secretary of Homeland Security under President Barack Obama, and most recently as the President of the University of California for the past seven years. Her appointment follows the July addition of Elliott Sigal, M.D., Ph.D., to the Board.

    Third Quarter 2020 Financial Results

    • Revenues: Total revenues for the quarter ended September 30, 2020 were $1.9 million, compared to $1.4 million for the same period in 2019. The increase for the quarter was primarily due to the timing of research activities under the HIV and TB grants with the Bill & Melinda Gates Foundation.
    • Research and Development Expenses: Research and development expenses were $70.7 million for the quarter ended September 30, 2020, which includes $4.2 million of non-cash stock-based compensation expense, compared to $39.9 million for the same period in 2019, which included $0.9 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to contract manufacturing expenses for our SARS-CoV-2 programs, higher fair value of our contingent consideration due to achievement of clinical development milestones, personnel-related expenses due to additional headcount, and clinical costs due to activities related to VIR-7831, VIR-3434 and VIR-1111.
    • General and Administrative Expenses: General and administrative expenses were $18.9 million for the quarter ended September 30, 2020, which includes $4.4 million of non-cash stock-based compensation expense, compared to $9.2 million for the same period in 2019, which includes $1.3 million of non-cash stock-based compensation expense. The increase for the quarter was primarily due to personnel-related expenses attributable to additional headcount, legal fees, external consulting and other expenses due to costs associated with operating as a public company.
    • Net Loss: Net loss for the quarter ended September 30, 2020 was $84.6 million, or $0.67 per share, basic and diluted, compared to a net loss of $48.3 million, or $4.60 per share, basic and diluted, for the same period in 2019.
    • Cash and Cash Equivalents: As of September 30, 2020, excluding restricted cash, the Company had approximately $826.6 million in cash, cash equivalents and investments.

    About VIR-7831

    VIR-7831 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

    About VIR-7832

    VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine.

    About VIR-2703

    VIR-2703 is an inhaled SARS-CoV-2-targeting siRNA that has demonstrated the ability to significantly reduce SARS-CoV-2 live virus replication in vitro. VIR-2703 is designed to degrade the viral genome, leading to inhibition of viral protein synthesis and blocking the production of infectious virus. It targets a nucleic acid sequence in the SARS-CoV-2 genome that is highly conserved amongst currently available viral sequences and is also conserved in SARS-CoV-1 (also known as SARS). VIR-2703 leverages Alnylam Pharmaceuticals, Inc.'s latest advances in lung delivery of siRNAs.

    About VIR-2218

    VIR-2218 is a 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 a 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 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.

    About VIR-2482

    VIR-2482 is an intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season, which is typically five to six months long.

    About VIR-1111

    VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response.

    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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. 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," "expect," "plan," "aim," "anticipate," "estimate," "intend," "potential," "prepare" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials and completion of preclinical studies, the timing of availability of clinical data, the evaluation criteria, designs, program updates and data disclosures related to Vir's clinical trials, the ability of VIR-7831, VIR-7832, and VIR-2703 to treat and/or prevent COVID-19 and other diseases caused by the SARS-CoV-2 virus, the clinical efficacy of VIR-7831 and VIR-7832, the capacity to manufacture, develop and commercialize a product candidate to treat COVID-19, the timing of availability and expected number of therapeutic doses, the ability to address the current global COVID-19 pandemic and future outbreaks of diseases caused by coronaviruses, the potential for the combination of VIR-2218 and PEG-IFN-α to result in the functional cure of HBV, the ability of VIR-3434 to neutralize and treat HBV, the ability of VIR-2482 to provide broad strain coverage for the flu, and the ability of VIR-1111 to elicit a T cell immune response to HIV. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in neutralizing SARS-CoV-2, other coronaviruses and HBV, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our 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.

    Vir Biotechnology, Inc.

    Condensed Consolidated Statements of Operations

    (unaudited; in thousands, except share and per share data)

      Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
      2020  2019  2020  2019 
    Revenues:                
    Grant revenue $1,740  $1,166  $7,690  $6,771 
    License revenue from a related party        22,747    
    Contract revenue  188   237   44,197   340 
    Total revenue  1,928   1,403   74,634   7,111 
    Operating expenses:                
    Research and development  70,684   39,863   215,316   95,541 
    General and administrative  18,859   9,220   47,894   25,790 
    Total operating expenses  89,543   49,083   263,210   121,331 
    Loss from operations  (87,615)  (47,680)  (188,576)  (114,220)
    Other income (expense):                
    Interest income  412   2,012   2,548   6,564 
    Other income (expense), net  2,616   (2,659)  (6,904)  (3,251)
    Total other income (expense)  3,028   (647)  (4,356)  3,313 
    Loss before benefit from (provision for) income taxes  (84,587)  (48,327)  (192,932)  (110,907)
    Benefit from (provision for) income taxes  (22)  13   (84)  (5)
    Net loss $(84,609) $(48,314) $(193,016) $(110,912)
    Net loss per share, basic and diluted $(0.67) $(4.60) $(1.66) $(11.53)
    Weighted-average shares outstanding, basic and diluted  125,810,907   10,500,848   116,427,529   9,615,379 
                     

    Vir Biotechnology, Inc.

    Condensed Consolidated Balance Sheets

    (unaudited; in thousands, except share and per share data)

      September 30,

    2020
      December 31,

    2019
     
    ASSETS        
    CURRENT ASSETS:        
    Cash and cash equivalents $462,521  $109,335 
    Short-term investments  364,074   274,101 
    Restricted cash and cash equivalents, current  9,363   6,181 
    Prepaid expenses and other current assets  13,614   13,378 
    Total current assets  849,572   402,995 
    Intangible assets, net  33,944   35,694 
    Goodwill  16,937   16,937 
    Property and equipment, net  16,948   16,308 
    Operating right-of-use assets  14,762    
    Restricted cash and cash equivalents, noncurrent  1,201   7,300 
    Long-term investments     24,290 
    Other assets  9,895   8,547 
    TOTAL ASSETS $943,259  $512,071 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    CURRENT LIABILITIES:        
    Accounts payable $6,796  $5,881 
    Accrued and other liabilities  44,339   26,495 
    Deferred revenue, current portion  5,563   6,181 
    Contingent consideration, current portion  20,300