GSK GlaxoSmithKline PLC

34.38
-0.3  -1%
Previous Close 34.68
Open 34.68
52 Week Low 31.43
52 Week High 43.385
Market Cap $86,483,234,866
Shares 2,515,510,031
Float 2,515,510,031
Enterprise Value $115,227,229,729
Volume 6,114,892
Av. Daily Volume 5,734,127
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Upcoming Catalysts

Drug Stage Catalyst Date
VIR-7831 / GSK418213 (COMET-ICE)
COVID-19 antibody
Phase 3
Phase 3
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Adjuvanted COVID-19 vaccine
COVID-19 vaccine
Phase 2
Phase 2
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Bamlanivimab (LY-CoV555) and VIR-7831 (GSK4182136) - BLAZE-4
COVID-19 antibody
Phase 2
Phase 2
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Benlysta (belimumab) and rituximab
Systemic lupus erythematosus (SLE)
sNDA Filing
sNDA Filing
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Bintrafusp alfa
Biliary tract cancer
Phase 2/3
Phase 2/3
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Belantamab mafodotin (GSK2857916) - DREAMM-4
Multiple Myeloma
Phase 3
Phase 3
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S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum
COVID-19 vaccine
Phase 2/3
Phase 2/3
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Cobolimab (TSR-022) AMBER
Solid tumors
Phase 1
Phase 1
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Daprodustat
Anemia
Phase 3
Phase 3
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Zejula and dostarlimab - MOONSTONE
Ovarian cancer
Phase 2
Phase 2
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Dostarlimab Plus Carboplatin-paclitaxel (RUBY)
Endometrial Cancer
Phase 3
Phase 3
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Belantamab Mafodotin (DREAMM 5)
Multiple Myeloma
Phase 3
Phase 3
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Gepotidacin
Uncomplicated urinary tract infection (uUTI)
Phase 3
Phase 3
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Belantamab mafodotin (DREAMM-3)
Multiple Myeloma
Phase 3
Phase 3
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Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (DREAMM-8)
Multiple Myeloma
Phase 3
Phase 3
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Otilimab (MOR103/GSK3196165)
Rheumatoid Arthritis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
VIR-7832 (AGILE)
COVID-19 vaccine/therapeutic
Phase 2
Phase 2
Phase 2 trial to commence 1Q 2021.
Otilimab
COVID-19
Phase 2a
Phase 2a
Phase 2a data noted treatment difference but did not reach statistical significance.
Cabotegravir + rilpivirine - ATLAS2M
HIV
sNDA Filing
sNDA Filing
sNDA filing announced February 24, 2021.
Dolutegravir + rilpivirine
HIV
Approved
Approved
FDA approval announced January 21, 2021.
Bintrafusp alfa
Non-small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial unlikely to meet primary endpoint - to be discontinued.
VIR-7831/GSK4182136 (ACTIV-3)
Mild to moderate COVID-19
Phase 3
Phase 3
Phase 3 trial commencement announced December 17, 2020.
Benlysta (belimumab)
Lupus Nephritis
Approved
Approved
FDA approval announced December 17, 2020.
Dostarlimab
dMMR pan-tumor
Phase 3
Phase 3
Phase 3 positive in-house data.
Mepolizumab (NUCALA)
Nasal polyps
Phase 3
Phase 3
Regulatory filing submitted 2H 2020.
Nucala (Mepolizumab)
Severe hypereosinophilic syndrome (HES)
Approved
Approved
FDA approval announced September 25, 2020.
Closed Triple - CAPTAIN
Asthma
Approved
Approved
FDA approval announced September 9, 2020.
Dolutegravir + lamivudine
HIV
Approved
Approved
FDA approval announced August 6, 2020.
GSK’916 - belantamab mafodotin (BCMA)
Multiple myeloma
Approved
Approved
FDA approval granted August 5, 2020.
Fostemsavir
HIV
Approved
Approved
FDA Approval announced July 2, 2020.
Cabotegravir HPTN 083
HIV
Phase 3
Phase 3
Phase 3 trial stopped early due to sufficient efficacy.
Niraparib - PRIMA
Ovarian cancer
Approved
Approved
FDA Approval announced April 29, 2020.
M72/AS01E
Pulmonary tuberculosis
Phase 2b
Phase 2b
Phase 2b data significantly reduced incidence of pulmonary tuberculosis disease - October 29, 2019.
Niraparib - (QUADRA trial)
Ovarian cancer
Approved
Approved
FDA Approval announced October 23, 2019.
Mepolizumab
Severe eosinophilic asthma - pediatric
Approved
Approved
FDA Approval announced June 6, 2019.
Mepolizumab
Severe eosinophilic asthma (6-11 yrs)
Approved
Approved
FDA approval announced September 12, 2019.
Rolapitant - intravenous (IV)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved
CRL January 11 2017. FDA Approval announced October 25, 2017 following resubmission.
Danirixin
Chronic obstructive pulmonary disease (COPD)
Phase 2b
Phase 2b
Development discontinued due to lack of efficacy.
Dolutegravir + lamivudine
HIV
Approved
Approved
FDA approval announced April 8, 2019.
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved
Approved September 2, 2015.
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
Approved
Approved
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
Mepolizumab
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
CRL
CRL
Advisory Committee July 25, 2018 voted 3-16 against recommending approval. CRL issued September 7, 2018.
Tafenoquine
Malaria
Approved
Approved
FDA Approval announced July 23, 2018.
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
Approval announced April 24, 2018 for expanded label.
Closed Triple
COPD
Approved
Approved
Approval announced September 19, 2017.
Shingrix
Shingles
Approved
Approved
Approval announced October 20, 2017.
Dolutegravir + rilpivirine
HIV
Approved
Approved
Approval announced November 21, 2017.
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
Approval announced September 18, 2017.
Benlysta (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
Approved
Approved
Approval announced July 21, 2017.
Fluarix Quadrivalent (Influenza Vaccine)
Influenza A - children 6-35 months of age.
Approved
Approved
Approval announced January 11, 2018.
Mepolizumab
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Approved
Approved
Approval announced December 12, 2017.

Latest News

  1. – 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:
    Cara Miller
    VP, Corporate Communications
    
    + 1 415 941 6746
    
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    Media:
    
    Simon Steel
    +44 (0) 20 8047 5502
    (London)
    
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    (Philadelphia)
    
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    +1 202 603 5003
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  2. WARREN, N.J., Feb. 16, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of TUMS Naturals, a new naturally-powered antacid joining the TUMS portfolio. As America's #1 heartburn relief medicine, TUMS is building its already expansive portfolio to meet growing consumer preferences for natural products by adding antacids that are free-from artificial flavors and dyes to its wide-range of heartburn relief offerings. Like all the brands' products, new TUMS Naturals deliver fast and powerful multi-symptom relief from the discomforts of burning in the chest, acid indigestion, sour and upset stomach, so heartburn sufferers can enjoy "worth the burn" or #TUMSworthy moments.

    WARREN, N.J., Feb. 16, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of TUMS Naturals, a new naturally-powered antacid joining the TUMS portfolio. As America's #1 heartburn relief medicine, TUMS is building its already expansive portfolio to meet growing consumer preferences for natural products by adding antacids that are free-from artificial flavors and dyes to its wide-range of heartburn relief offerings. Like all the brands' products, new TUMS Naturals deliver fast and powerful multi-symptom relief from the discomforts of burning in the chest, acid indigestion, sour and upset stomach, so heartburn sufferers can enjoy "worth the burn" or #TUMSworthy moments.

    Research has continued to demonstrate that a growing number of consumers prefer products with natural ingredients but struggle to find options from brands they love and trust. This insight sparked TUMS to adapt their long-trusted products to satisfy this consumer desire, without having to sacrifice the fast heartburn relief consumers depend on from TUMS.

    "As consumers are increasingly aware of the ingredients they consume, we saw an opportunity to offer them the efficacy they rely on and expect from TUMS, while delivering on their desire for more natural-leaning solutions to their medicinal needs," says Amy Sharon, Director at TUMS. "Millions of people suffer from heartburn, caused by things like stress and the foods they consume, and our mission is to continue ensuring they have access to relief that fits their personal preferences, so heartburn isn't something they have to worry about."  

    TUMS Naturals goes to work in seconds by travelling directly to the source of heartburn, dissolving swiftly to neutralize stomach acid on contact. It is available in two fruity flavor combinations – Black Cherry & Watermelon and Coconut Pineapple – both of which feature the natural active ingredient Calcium Carbonate and do not contain artificial flavors, dyes, GMOs or gluten. Additionally, the packaging is 100% recyclable.

    TUMS Naturals are available now at drugstores nationwide in a variety of sizes joining a large portfolio of products that provide fast heartburn relief. From TUMS Chewy Bites which feature a chewy outer shell to the deliciously smooth and tasty TUMS Smoothies – there's a TUMS flavor and form to ensure everyone can get back to enjoying #TUMSworthy moments. For more information on TUMS and the new products, visit www.TUMS.com.

    About TUMS

    TUMS Antacid Tablets go to work in seconds for delicious, chewable heartburn relief. Featuring the active ingredient calcium carbonate, these chewable antacid tablets provide heartburn, sour stomach and acid indigestion relief, as well as upset stomach relief associated with these symptoms. TUMS antacid tablets are the #1 recommended adult antacid brand by doctors, pharmacists and OBGYNs. As America's #1 antacid and trusted as a heartburn medicine for 90 years, TUMS is fully supported with a satisfaction guarantee.

    About GSK Consumer Healthcare

    We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer. We develop and market a portfolio of consumer-preferred and expert-recommended brands including TUMS, Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu. For further information please visit www.gsk.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/tums-expands-portfolio-to-meet-consumer-demands-for-naturally-sourced-products-301227635.html

    SOURCE GSK Consumer Healthcare

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    • Companies aim to develop a multi-valent candidate vaccine to address emerging variants for pandemic and endemic use
    • Development to begin immediately targeting vaccine availability in 2022, subject to regulatory approval
    • GSK will also support manufacture of up to 100 million doses of CureVac's first generation COVID-19 vaccine CVnCoV in 2021

    LONDON, UK / TUBINGEN, GERMANY / BOSTON, MA / ACCESSWIRE / February 3, 2021 / GlaxoSmithKline plc (NYSE:GSK) and CureVac N.V. (NASDAQ:CVAC) today announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.

    GSK will also support the…

    • Companies aim to develop a multi-valent candidate vaccine to address emerging variants for pandemic and endemic use
    • Development to begin immediately targeting vaccine availability in 2022, subject to regulatory approval
    • GSK will also support manufacture of up to 100 million doses of CureVac's first generation COVID-19 vaccine CVnCoV in 2021

    LONDON, UK / TUBINGEN, GERMANY / BOSTON, MA / ACCESSWIRE / February 3, 2021 / GlaxoSmithKline plc (NYSE:GSK) and CureVac N.V. (NASDAQ:CVAC) today announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.

    GSK will also support the manufacture of up to 100 million doses of CureVac's first generation COVID-19 vaccine candidate CVnCoV in 2021

    Through this new exclusive co-development agreement, GSK and CureVac will contribute resources and expertise to research, develop, and manufacture a number of novel mRNA vaccine candidates, including multi-valent and monovalent approaches. The aim of this work is to offer broader protection against a variety of different SARS-CoV2 variants, and to enable a quick response to new variants potentially emerging in the future. The development programme will begin immediately, with the target of introducing the vaccine in 2022, subject to regulatory approval.

    The increase in emerging variants with the potential to reduce the efficacy of first generation COVID-19 vaccines requires acceleration of efforts to develop vaccines against new variants to keep one step ahead of the pandemic. These next generation COVID-19 vaccines may either be used to protect people who have not been vaccinated before, or to serve as boosters in the event that COVID-19 immunity gained from an initial vaccination reduces over time. In addition, the collaboration will assess the development of novel mRNA vaccines to protect against multiple respiratory viruses, including COVID-19.

    This collaboration will build on CureVac's first generation COVID-19 vaccine candidate CVnCoV, which is currently in Phase 2b/3 clinical trial and on CureVac's ability to optimise mRNA for a strong immune response, manufacturability, and stability at standard 2-8 C cold chain conditions for vaccines. CureVac's platform is uniquely adapted to designing multi-valent vaccines with a balanced immune response and a low dose of mRNA.

    Emma Walmsley, Chief Executive Officer, GSK, said: "We believe that next generation vaccines will be crucial in the continued fight against COVID-19. This new collaboration builds on our existing relationship with CureVac and means that together, we will combine our scientific expertise in mRNA and vaccine development to advance and accelerate the development of new COVID-19 vaccine candidates. At the same time, we will also support the production of CureVac's first generation vaccines with the manufacture of 100 million doses in 2021."

    Franz-Werner Haas, Chief Executive Officer of CureVac, said: "We are very pleased to build on our existing relationship with GSK with a new agreement to jointly develop next generation mRNA-based vaccines, in addition to our current candidate CVnCoV. With the help of GSK's proven vaccine expertise, we are equipping ourselves to tackle future health challenges with novel vaccines."

    As part of the new collaboration, GSK will also support manufacture of CureVac's first-generation COVID-19 vaccine candidate CVnCoV which is currently in Phase 2b/3 trials. Using its established manufacturing network in Belgium, GSK aims to support manufacturing of up to 100 million doses of the vaccine in 2021.

    Under the terms of the new collaboration agreement, GSK will be the marketing authorisation holder for the next generation vaccine, except in Switzerland, and will have exclusive rights to develop, manufacture, and commercialise the next generation COVID-19 vaccine in all countries with the exception of Germany, Austria and Switzerland. GSK will make an upfront payment of €75m and a further milestone payment of €75m, conditional on the achievement of specific milestones.

    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 CureVac
    CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. In January 2021 the company entered into a collaboration and services agreement with Bayer. CureVac is headquartered in Tübingen, Germany, and employs more than 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.

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    Jeff McLaughlin+1 215 751 7002(Philadelphia)
    Frannie DeFranco+1 215 751 4855(Philadelphia)

    CureVac enquiries:

    Media enquiries:
    Thorsten Schüller, Corporate Communications
    CureVac AG, Tübingen, Germany
    T: +49 7071 9883-1577

    Investor enquiries:
    Dr. Sarah Fakih, Vice President Investor Relations
    CureVac AG, Tübingen, Germany
    T: +49 7071 9883-1298

    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 any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road
    Brentford, Middlesex
    TW8 9GS

    CureVac Forward-Looking Statements
    This press release contains statements that constitute "forward looking statements" as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potency efficacy of the company's vaccine candidate and the company's strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as "anticipate," "intend," "believe," "estimate," "plan," "seek," "project," or "expect," "may," "will," "would," "could," "potential," "intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

    For further information, please reference the company's reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

    SOURCE: CureVac AG



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  3. WARREN, N.J., Feb. 1, 2021 /PRNewswire/ -- GlaxoSmithKline (LSE: GSK) (NYSE:GSK) – This year, the #TUMSBingoSweepstakes is the BIG GAME within the BIG GAME and takes place on a day known for indulging in heartburn-inducing food and fans experiencing TUMSworthy moments. TUMS®, America's #1 heartburn medicine that provides fast-acting relief from the pain of heartburn, today is launching the first-ever #TUMSBingoSweepstakes - an interactive digital game of bingo featuring dozens of heartburn-inducing moments that could happen on or off the field. The #TUMSBingoSweepstakes gives both hardcore and casual fans an opportunity to participate in all of the action and earn a chance to win a piece of $55,000 in prizes, and the grand prize winner will…

    WARREN, N.J., Feb. 1, 2021 /PRNewswire/ -- GlaxoSmithKline (LSE: GSK) (NYSE:GSK) – This year, the #TUMSBingoSweepstakes is the BIG GAME within the BIG GAME and takes place on a day known for indulging in heartburn-inducing food and fans experiencing TUMSworthy moments. TUMS®, America's #1 heartburn medicine that provides fast-acting relief from the pain of heartburn, today is launching the first-ever #TUMSBingoSweepstakes - an interactive digital game of bingo featuring dozens of heartburn-inducing moments that could happen on or off the field. The #TUMSBingoSweepstakes gives both hardcore and casual fans an opportunity to participate in all of the action and earn a chance to win a piece of $55,000 in prizes, and the grand prize winner will take home $35,000.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8845951-tums-bingo-sweepstakes/

    Fans can get their official digital game board at TumsworthyBingo.com beginning today and follow along during the BIG GAME on February 7 to experience the event and surrounding spectacle in a new and exciting way, no matter how many spicy wings or footballs may be dropped.

    "This year, TUMS® is not only easing symptoms of heartburn, but rewarding people with a fun way to experience all the excitement and action surrounding the BIG GAME," says Amy Sharon, Director at TUMS®. "Through the #TUMSBingoSweepstakes, we can celebrate how TUMSworthy moments offer an extra layer of stress, and at the same time, excitement for everyone watching the BIG GAME - satisfying an appetite for relief from savory food options and competition no matter what kind of fan is watching."

    It will be easy for anyone to play along as TUMS® will identify TUMSworthy moments that occur live during the BIG GAME and participants' digital game boards will update automatically following each #TUMSworthy moment announced via @TUMSOfficial. TUMSworthy moments will include everything from action on the field, during halftime, and, of course, the after-effects of gameday food and excitement. For many, the BIG GAME is still worth the burn.

    Players who complete a line on their B-I-N-G-O board by the end of the game, and tweet #TUMSBingoSweepstakes, are entered to win the grand prize of $35,000. To earn additional chances to win, players are encouraged to tweet after the completion of each square on their board using #TUMSBingoSweepstakes in their posts and can also choose to share TUMSworthy moments not reflected on their game board. For many, enjoying those inevitable heartburn-inducing options during the BIG GAME is still worth the burn.

    TUMS® is partnering with Sports Analyst Kenny White aka the "Wizard of Odds," to leverage his odds making expertise and develop the game board.

    "After an unprecedented and uncertain year in sports, TUMS® is giving everyone an even better reason to look forward to game day," says White. "While there are various odds associated with the TUMSworthy moments that will potentially occur, it's certain that the #TUMSBingoSweepstakes will get everyone excited about being part of the BIG GAME, no matter the outcome."

    For more information on how to participate or view the official rules, please visit TumsworthyBingo.com.

    The #TUMSBingoSweepstakes follows the brand's successful TUMS® Game Day sweepstakes promotion in 2020. For more information on TUMS®, please visit TUMS.com.

    About TUMS®

    TUMS Antacid Tablets go to work in seconds for delicious, chewable heartburn relief. Featuring the active ingredient calcium carbonate, these chewable antacid tablets provide heartburn, sour stomach and acid indigestion relief, as well as upset stomach relief associated with these symptoms. TUMS antacid tablets are the #1 recommended adult antacid brand by doctors, pharmacists and OBGYNs. As America's #1 antacid and trusted as a heartburn medicine for 90 years, TUMS is fully supported with a satisfaction guarantee.

    About GSK Consumer Healthcare

    GSK Consumer Healthcare combines science and consumer insights to create innovative world-class health care brands that consumers trust and experts recommend for oral health, pain relief, respiratory and wellness.

    Fans can download their official digital game board from @TUMSOfficial beginning today and follow along during the BIG GAME on February 7.

     

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    Cision View original content:http://www.prnewswire.com/news-releases/tums-kicks-off-55-000-tumsbingosweepstakes-for-the-big-game-301219096.html

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  4. 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
    
    +1-415-506-5256
    
    Media, Vir
    Cara Miller
    VP, Corporate Communications
    
    +1-415-941-6746
    
    Investors, Lilly
    Kevin Hern
    
    +1-317-277-1838
    
    Media, Lilly
    Molly McCully
    
    +1-317-478-5423
    
    Media, Lilly
    Dani Barnhizer
    
    +1-317-607-6119
    
    Investors, GSK
    Jeff McLaughlin
    
    +1-215-751-7002
    
    Media, GSK
    Lyndsay Meyer
    
    +1-202-302-4595

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