Vir Biotechnology, Inc 8-K, filed May 27, 2021
Vir Biotechnology, Inc. (VIR)
About this 8-K
Vir Biotechnology, Inc filed this 8-K on May 27, 2021, reporting on events of May 26, 2021.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01 | Other Events. |
Sotrovimab (VIR-7831) Emergency Use Authorization
On May 26, 2021, Vir Biotechnology, Inc. (the “Company”) and GlaxoSmithKline plc (“GSK”) issued a press release announcing that 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.
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 United States while the pandemic remains a public health emergency. 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 the Company plan to submit a Biologics License Application to the FDA in the second half of 2021.
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.
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 the Company 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 the Company 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. GSK and the Company are actively working with government agencies around the world to make sotrovimab available to patients in need of treatment.
A copy of the press release is attached hereto as Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Updated Corporate Presentation
On May 26, 2021, the Company posted an updated corporate presentation to its website. A copy of the presentation is attached as Exhibit 99.2.
Forward-Looking Statements
This Current Report on Form 8-K 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 the Company’s expectations and assumptions as of the date of this Current Report on Form 8-K. Forward-looking statements contained in this Current Report on Form 8-K 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 the
Company’s competitors, changes in expected or existing competition, delays in or disruptions to the Company’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 the Company’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release of the Company and GSK, dated May 26, 2021. | |
| 99.2 | Presentation, dated May 26, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| VIR BIOTECHNOLOGY, INC. | ||||||
| Date: May 27, 2021 | By: | /s/ Howard Horn | ||||
| Howard Horn | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
GSK and Vir Biotechnology Announce Sotrovimab (VIR-7831) Receives
Emergency Use Authorization from the US FDA for Treatment of Mild-to-Moderate COVID-19 in High-Risk Adults and Pediatric Patients
– 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 – GlaxoSmithKline plc (LSE/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.
1
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.
| 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). |
2
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.
3
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.
4
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.
5
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.
6
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
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 Lyndsay Meyer |
+1 202 603 5003 +1 202 302 4595 |
(Washington DC) (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) | ||||
7
Vir Biotechnology, Inc. A WORLD WITHOUT INFECTIOUS DISEASE May 26, 2021 Exhibit 99.2
Legal disclaimers © 2021 Vir Biotechnology, Inc. Forward-Looking Statements Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the expected success, cost, and timing of our research and clinical development plans and clinical trials, our goals with respect to the prophylaxis or treatment of COVID-19, HBV, influenza A and HIV, our objectives, strategy, technology platform and clinical trial designs, the potential benefits of our collaborations, and our ability to complete certain milestones. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of Vir Biotechnology, Inc. (the “Company”) as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing the Company’s products and technologies, future results from the Company’s ongoing and planned clinical trials such as unexpected data or clinical site activation rates or clinical trial enrollment rates that are lower than expected, difficulties arising from our collaborations, challenges in accessing adequate manufacturing capacity, the Company’s ability to obtain adequate financing to fund its planned clinical trials and other expenses, statements related to regulatory authorizations and approvals, trends in the industry, changes in the competitive landscape, delays or disruptions due to the COVID-19 pandemic, the legal and regulatory framework for the industry, unexpected litigation or disputes and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. The Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 for all forward-looking statements. This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.
© 2021 Vir Biotechnology, Inc. Taking on the most serious infectious diseases Products and product candidates with demonstrated clinical impact Applying learnings to broad ID pipeline Potential significant near-term value drivers
mAB114*: approved for therapy; as effective as three-antibody cocktail from Regeneron1 Antibodies with clinical impact © 2021 Vir Biotechnology, Inc. Ebola Sotrovimab (VIR-7831): U.S. Emergency Use Authorization (EUA) and European Medicines Agency (EMA) positive opinion under Article 5(3); 85% reduction in hospitalization or death in high-risk outpatients; retains neutralizing activity against all circulating variants tested in preclinical studies COVID-19 VIR-3434: mean 1.3 log10 drop in HBsAg after single 6 mg dose** HBV VIR-2482: pan-influenza A with 58-day half-life**; pan-influenza (A+B) in development Flu *Marketed as Ebanga by Ridgeback Biotherapeutics LP **Based on preliminary clinical data COVID-19: coronavirus disease 2019 HBV: hepatitis B virus HBsAg: hepatitis B virus surface antigen 1. Mulangu, S., et al. N Engl J Med 2019; 381:2293-2303.
Antibody engineering technologies © 2021 Vir Biotechnology, Inc. XX2 vaccinal mutation LS mutation Sotrovimab VIR-3434 VIR-7832 VIR-2482 VIR-7832 VIR-3434 Licensed from Rockefeller University Increase potency Induce T cell protection Licensed from Xencor Extend half-life Increase tissue concentration
Antibodies in R&D Based on preclinical data © 2021 Vir Biotechnology, Inc. RSV/MPV Malaria Other diseases Pan-coronavirus HIV MRSA Broad strain coverage Single antibody covers two related respiratory pathogens Blocks infection Potential for long-lasting prophylaxis C. Diff Dengue Let’s be ready for the next one Broad strain coverage “XX2” vaccinal mutation Resistance-proof cocktail Zika Herpes RSV: respiratory syncytial virus MPV: human metapneumovirus HIV: human immunodeficiency virus MRSA: Methicillin-resistant Staphylococcus aureus C.Diff: Clostridium difficile
Additional technology platforms © 2021 Vir Biotechnology, Inc. siRNA Rights to Alnylam siRNA technology for a certain number of infectious diseases Includes ESC+ modification to reduce off-target activity and potentially increase safety CMV Vaccines (T cell) Systematic CRISPR screening Cellular targets that block infection in preclinical studies Potential multi-pathogen compounds Anti-viral compounds in hand Functional Genomics (Innate immunity) Uniquely protects non-human primates from SIV Programmable T cell responses Gates Foundation funding for HIV and TB Broad potential SIV: simian immunodeficiency virus
Disease Area Product Candidate Treatment/ Prophylaxis Pre-clinical Phase 1 Phase 2 Phase 3 Authorized Collaborator COVID-19 Sotrovimab* Treatment Sotrovimab + bamlanivimab Treatment Sotrovimab* Prophylaxis VIR-7832 Treatment HBV VIR-2218 Treatment VIR-2218 + PEG-IFN-⍺ Treatment VIR-3434 Treatment VIR-2218 + VIR-3434 Treatment VIR-2218 + TLR81 + PD-12 Treatment VIR-2218 + BRII-179 Treatment Influenza A VIR-2482 Prophylaxis HIV VIR-1111** Prophylaxis siRNA T cell Antibody Vir clinical development pipeline Planned 2H:2021 start Planned 2H:2021 start *Sotrovimab (VIR-7831) IV formulation used in Phase 3 COMET-ICE trial; IM formulation currently in Phase 2 COMET-PEAK trial, and pending in Phase 3 COMET-TAIL and COMET-STAR trials **Vaccine designed to establish proof of concept in Phase (Ph) 1 clinical trial to determine whether unique immune response observed in non-human primates can be replicated in humans; ultimately, any candidates we advance as a potential HIV vaccine will require modifications to VIR-1111 before further clinical development. 1: GS-9688 2: nivolumab †In the U.S., EUA received on 5/26/2021. In the EU, EMA positive opinion under Article 5(3) received on 5/21/2021. © 2021 Vir Biotechnology, Inc. U.S., EU†
Vir Biotechnology, Inc. COVID-19
* Sarbecoviruses. 1. Pinto D, et al. Nature. 2020;583:290–5; 2. Vir Biotechnology, Press release, 18 May 2020 (accessed November 13, 2020); 3. Hope, IAS 2019- HIV & HBV Cure Forum, Mexico City 4. Sotrovimab incorporates Xencor’s Xtend technology © 2021 Vir Biotechnology, Inc. Sotrovimab: Design principles and clinical data COMET-ICE Data (Sotrovimab) 85% (p=0.002) reduction in hospitalization or death in high-risk outpatients versus placebo No reported safety signals ____________________________ BLAZE-4 Data (Sotrovimab + bamlanivimab) 70% relative reduction in Persistent High Viral Load (PHVL) at day 7 in low-risk outpatients versus placebo No reported safety signals Engineered to have potent and lasting effects against SARS-CoV-2 and other CoVs*4 High barrier to resistance; potential to address future pandemics2 Improved lung bioavailability3 Blocks viral entry into healthy cells (neutralization)1,2 Clears infected cells by recruiting the immune system1,2 Extended half-life1,2 Low dose to allow for IM formulations
Sotrovimab: Active against variants in circulation SA, BR mutant and other E484K + UK and other N501Y mutant + Scottish mutant + Mink mutant + Columbus, NY CA mutant and other L452R Month & Year * GISAID (human spike protein seqs; <10% Xs; >1018 aa (80% full length) © 2021 Vir Biotechnology, Inc. As of April 22, 2021, GISAID* None of these mutations are in the sotrovimab epitope Sotrovimab maintains activity against these variants, as well as the India variant (B.1.617), in preclinical pseudotyped virus assay tests
Potential next-generation antibodies © 2021 Vir Biotechnology, Inc. RBM Antibodies VIR-7832 Two leading candidates Highly potent in preclinical studies Cover all tested variants in circulation Same epitope as sotrovimab Enhancements intended for additional potency and induction of T cell protection with XX2 alteration Clinical trial start pending in the UK RBM: receptor-binding motif
Vir Biotechnology, Inc. Hepatitis B (HBV)
Broad HBV functional cure portfolio © 2021 Vir Biotechnology, Inc. VIR-2218 Potential Best-In-Class siRNA as “backbone” of therapy Substantial, Durable, and Dose Dependent Reduction of HBsAg through 36 weeks1 Ongoing / Planned Combination Trials Placebo, n=8 20 mg, n=3 50 mg, n=9 100 mg, n=6 200 mg, n=6 Week 0 4 8 12 16 20 24 28 32 36 -1.5 -1.0 -0.5 0.0 Mean Change in Log10 HBsAg (IU/mL) Currently in Phase 2 PEG-IFN-⍺ Start Phase 2 trial in 2H:2021 VIR-3434 mAb Start Phase 2 trial in 2H:2021 GS-9688 TLR-8 agonist nivolumab PD-1 antagonist Currently in Phase 2 BRII-179 T cell vaccine Note: current and planned trials are/will be conducted in patients with chronic HBV on nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs), which are standard of care treatment. PEG-IFN: pegylated interferon alpha. 1. Gane et al., Digital International Liver Conference 2020.
5,000-fold more potent than HBIG in in vitro neutralization assays Attractive properties of Vir-3434 © 2021 Vir Biotechnology, Inc. Potent Alteration in Fc shown to increase potency and induce protective T cell responses in animal models XX2 No significant adverse events identified in healthy volunteers up to 3,000 mg Safety Meaningful drop at very low dose in a Phase 1 clinical study HBsAg HBIG: hepatitis B immunoglobulin
© 2021 Vir Biotechnology, Inc. VIR-3434 Phase 1 clinical data First blinded cohort of eight patients with HBsAg levels less than 1,000 IU/ml Two received placebo Six received a single 6 mg dose of VIR-3434 Six of eight patients achieved a mean reduction of 1.3 log10 IU/mL HBsAg by day eight, the day when nadir was achieved in most patients Additional clinical data expected in 2Q:2021
A Phase 1 study evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434 in participants with chronic hepatitis B virus infection Safety and antiviral activity of VIR-2218, an X-targeting RNAi therapeutic, in participants with chronic hepatitis B infection: week 48 follow-up results 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 Preliminary pharmacokinetics and safety in healthy volunteers of VIR-3434, a monoclonal antibody for the treatment of chronic hepatitis B infection Four abstracts accepted for EASL 2021 (2 orals, 2 posters) © 2021 Vir Biotechnology, Inc. PRESENTER Dr. Kosh Agarwal PRESENTER Prof. Edward Gane PRESENTER Prof. Dr. Man-Fung Yuen PRESENTER Dr. Sneha V. Gupta Oral Oral Poster Poster © 2021 Vir Biotechnology, Inc.
GSK collaboration 2.0 Expansion of original coronavirus collaboration to include: mAbs for influenza treatment and prevention (including an option on VIR-2482) Up to 3 mAbs for non-influenza infectious disease targets Functional genomics for respiratory targets $345m in upfront and equity investment Accelerates development of additional promising compounds in Vir pipeline © 2021 Vir Biotechnology, Inc.
© 2021 Vir Biotechnology, Inc. 2021 anticipated catalysts Sotrovimab (mAb) Phase 3 (Early Treatment, COMET-TAIL, IM) Start 2Q VIR-3434 (mAb) Phase 1 Data 2Q VIR-2218 (siRNA) + PEG-IFN-⍺ Phase 2 initial clinical data Data 2Q VIR-2218 (siRNA) Phase 2 one-year response durability Data 2Q 1H 2021 2H 2021 COVID-19 HBV HIV Sotrovimab (mAb) BLA (Early Treatment, COMET-ICE, IV) File 2H Sotrovimab (mAb) Phase 2 (Early Treatment, COMET-PEAK, IM) Data 2H Sotrovimab (mAb) EMA rolling review (Early Treatment, COMET-ICE, IV) Com- plete 2H Sotrovimab (mAb) Phase 3 (Prophylaxis, COMET-STAR, IM) Start 2H VIR-7832 (mAb) Phase 1b (Early Treatment, AGILE, IV) Data 2H VIR-2218 (siRNA) + VIR-3434 (mAb) Phase 2 Start 2H VIR-2218 (siRNA) + GS-9688 + nivolumab Phase 2 Start 2H VIR-1111 (T cell) Phase 1 Data 2H