GSK GlaxoSmithKline PLC

37.27
-0.13  -0%
Previous Close 37.4
Open 37.32
52 Week Low 31.43
52 Week High 48.25
Market Cap $93,499,820,983
Shares 2,508,715,347
Float 2,508,715,347
Enterprise Value $124,245,862,676
Volume 5,785,165
Av. Daily Volume 4,986,327
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Upcoming Catalysts

Drug Stage Catalyst Date
Adjuvanted COVID-19 vaccine
COVID-19 vaccine
Phase 1/2
Phase 1/2
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SCB-2019 + adjuvant system (Clover)
COVID-19 vaccine
Phase 1
Phase 1
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Benlysta (belimumab) and rituximab
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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VIR-7831 / GSK418213
COVID-19 antibody
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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Otilimab
COVID-19
Phase 2a
Phase 2a
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Bintrafusp alfa
Biliary tract cancer
Phase 2/3
Phase 2/3
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TSR-022 + TSR-042 AMBER
Solid tumors
Phase 1
Phase 1
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Daprodustat
Anemia
Phase 3
Phase 3
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Dostarlimab Plus Carboplatin-paclitaxel (RUBY)
Endometrial Cancer
Phase 3
Phase 3
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Zejula and dostarlimab - MOONSTONE
Ovarian cancer
Phase 2
Phase 2
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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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Otilimab (MOR103/GSK3196165)
Rheumatoid Arthritis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Dostarlimab
dMMR pan-tumor
Phase 3
Phase 3
Phase 3 positive in-house data.
VIR-7832
COVID-19 vaccine/therapeutic
Phase 2
Phase 2
Phase 2 trial to commence 1Q 2021.
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.
Benlysta (belimumab)
Lupus Nephritis
BLA Filing
BLA Filing
Phase 3 trial met primary endpoint - December 18, 2019. BLA filed 2Q 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.
Dolutegravir + rilpivirine
HIV
CRL
CRL
Complete Response Letter issued December 21, 2019.
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.
Cabotegravir + rilpivirine - ATLAS2M
HIV
Phase 3
Phase 3
Phase 3 primary endpoint met - August 22, 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.
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.
Shingrix
Shingles
Approved
Approved
Approval announced October 20, 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. WARREN, N.J., Dec. 1, 2020 /PRNewswire/ -- GlaxoSmithKline (LSE/NYSE: GSK) today announced a donation of $1 million to Direct Relief on behalf of consumers who have purchased its consumer healthcare products since the onset of the COVID-19 pandemic. According to the COVID Tracking Project, hospitalizations have more than doubled in less than two months. GSK recognizes that with cases rising so rapidly, there is a critical need to continuously support health care workers. The monetary donation will be used to purchase personal protective equipment (PPE) and essential medical items for U.S. health workers on the front line dealing with this unrelenting crisis.

    WARREN, N.J., Dec. 1, 2020 /PRNewswire/ -- GlaxoSmithKline (LSE/NYSE: GSK) today announced a donation of $1 million to Direct Relief on behalf of consumers who have purchased its consumer healthcare products since the onset of the COVID-19 pandemic. According to the COVID Tracking Project, hospitalizations have more than doubled in less than two months. GSK recognizes that with cases rising so rapidly, there is a critical need to continuously support health care workers. The monetary donation will be used to purchase personal protective equipment (PPE) and essential medical items for U.S. health workers on the front line dealing with this unrelenting crisis.

    Since the outbreak, GSK has been providing its scientific expertise to support the global response to COVID-19 and ensuring its global supply chain continues to deliver vital medicines and consumer healthcare products to the people who depend on them. GSK Consumer Healthcare's portfolio includes leading brands such as Sensodyne, Advil, Voltaren, Excedrin, Theraflu, Flonase, Centrum, and Emergen-C.

    "We are so proud to partner with Direct Relief to support the amazing work they are doing to ensure health professionals have the essential items that they need as the COVID-19 pandemic continues," said Lisa Paley General Manager, U.S. and Puerto Rico for GSK Consumer Healthcare. "We know how important maintaining health is, especially as newly diagnosed coronavirus cases and hospitalizations continue to rise. As one of the leading consumer healthcare companies, we have an obligation to pay it forward and give back to frontline workers who have been working tirelessly to keep us safe over the past nine months. Our continued focus remains, ensuring healthcare worker's needs are being met, staying vigilant as the pandemic continues and keeping a steadfast focus on how critical these needs really are."

    Direct Relief is coordinating with public health authorities, nonprofit organizations, and businesses to provide personal protective equipment and essential medical items to health workers responding to COVID-19. Since January, Direct Relief has delivered more than 46 million N95 and surgical masks, more than 8 million gloves, and tens of thousands of protective suits and other items to help safeguard health workers

    "Direct Relief is so deeply grateful for the leadership and commitment reflected by GSK's action today, which is both keenly needed and will be put to immediate use," said Thomas Tighe, CEO and President of Direct Relief. "This is a perfect example of what's needed as we all face this historic threat to the health of people everywhere."

    Since the outbreak, GSK has been providing its scientific expertise to support the global response to COVID-19 and ensuring its global supply chain continues to deliver vital medicines and consumer healthcare products to the people who depend on them.

    GSK Consumer Healthcare has been supporting U.S. communities and its employees nationwide in the wake of the COVID-19 crisis in many ways, including:

    • Participated in a major industry-wide movement to amplify one resonant message: #StayHome. Save lives. GSK Consumer Healthcare brands in the U.S. added a roof icon to their brand logo and shared assets on brand social channels with the hashtags #StayHome and #AloneTogether.
    • Coordinated a donation of ChapStick and Abreva to 12 high-impact areas, including New York, Michigan, California, Washington, Florida, Texas, Illinois, Ohio and Maryland.
    • Sponsored the Global Citizen special, One World: Together at Home.
    • Donated $10,000 to the NJ Community Food Bank, which serves several hard-hit New Jersey areas. In March, the organization supplied enough food for 4.8 million meals to those in need.
    • Shipped 3,000 care packages to every essential GSK Consumer Healthcare manufacturing and distribution center employee across the country.

    GSK Consumer Healthcare is also encouraging customers to #BeWellStayWell by taking care of themselves and their families with health and wellness products, more information can be found at  BeWellandStayWell.com

    Globally, GSK is closely monitoring the COVID-19 pandemic and supporting efforts to tackle the virus. The company is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of its innovative vaccine adjuvant technology. It is also supporting screening and research into potential medicines for COVID-19, as well as providing expertise and financial support to relief organizations. For more information on GSK's global efforts, visit https://www.gsk.com/en-gb/media/resource-centre/our-contribution-to-the-fight-against-2019-ncov/.

    About Direct Relief

    A humanitarian organization committed to improving the health and lives of people affected by poverty or emergencies, Direct Relief delivers lifesaving medical resources throughout the world to communities in need—without regard to politics, religion, or ability to pay. For more information, please visit https://www.DirectRelief.org

    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. 

    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 gsk.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gsk-consumer-healthcare-partners-with-direct-relief-to-donate-1-million-to-support-frontline-healthcare-workers-301182883.html

    SOURCE GSK Consumer Healthcare

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  2. WARREN, N.J., Oct. 28, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of Robitussin® Naturals, the brand's first-ever line of drug-free products that provide relief from occasional cough†*. As the #1 cough relief brand** with more than 70 years of experience treating coughs, Robitussin® knows what it takes to shut a cough down and especially in these trying times, knows that all Americans could use a boost of cheer. To help inspire consumers to take action to shut down their coughs, Robitussin has partnered with Collegiate National Champion Cheer Coach, Monica Aldama.

    Aldama is no stranger to a hoarse throat and cough thanks to her intense workdays spent coaching and shouting encouraging words at elite athletes. The famous coach will impart the tough love that she is known for to prompt consumers to overcome their health setbacks and support the brand in championing victory over coughs. A longtime user of Robitussin and advocate of natural wellness products, Aldama has teamed up with the brand for the launch of Robitussin Naturals, which are formulated with ingredients found in nature to help consumers feel good about what they use to help relieve occasional coughs†*.  

    Robitussin Naturals Cough Relief Syrup and Robitussin Naturals Cough Relief + Immune Health Syrup are the experts' in coughs first-of-their-kind, drug-free dietary supplements formulated with real True Source certified honey and English ivy to help relieve occasional coughs associated with hoarseness, dry throat or irritants†*. Robitussin Naturals Gummies also include naturally sourced ingredients in a convenient chewable form.

    "Anyone who knows me knows I'm equal parts tough and love and I lead my team with both any time they face an obstacle that could interfere with achieving victory," said Cheer Coach Monica Aldama. "After hours of yelling from the sidelines, I often find myself feeling hoarse and experiencing occasional coughing that comes with it, so I'm excited to head into this season with Robitussin Naturals in my personal wellness arsenal to shut those discomforts down before they get in my way." 

    When feeling under the weather, daily tasks like changing out of sick day sweatpants can feel like trying to land a standing back tuck. As a coach of collegiate athletes, Coach Aldama knows the power that positive encouragement can have on helping people overcome setbacks, which is the sentiment she will bring to consumers throughout her partnership with Robitussin.

    "We know consumers are continually looking for products that align with their lifestyle, which our consumer research has shown often includes using natural ingredients," said Jennifer Yomoah, Robitussin Senior Brand Manager. "Through thoughtful innovation, we are excited that the launch of Robitussin Naturals can help provide a solution for these evolving needs and preferences by harnessing natural ingredients like ivy leaf while continuing to offer the trusted efficacy expected of Robitussin."

    Robitussin Naturals Cough Relief Syrups and Gummies are available now at drugstores nationwide in varieties for both adults and children. Robitussin Naturals dietary supplements are the latest addition to an expansive portfolio of products that cater to many needs from daytime and nighttime relief, to multi-symptom relief benefits and products in a variety of forms for everyone in the family. For more information on Robitussin and the new products, visit www.Robitussin.com.

    †Ivy leaf relieves occasional cough associated with hoarseness, dry throat and irritants*

    *These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

    **Based on IRI data as of 8/9/2020

    About Robitussin®

    Robitussin is the #1 cough relief brand with more than 70 years of history providing consumers with powerful cough relief. Boasting a portfolio of more than 20 products, Robitussin® offers medicines and dietary supplements in a number of forms to help provide relief for a variety of symptoms associated with a cough, cold or the flu. For more information on Robitussin® products visit www.Robitussin.com.

    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.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/robitussin-launches-their-first-ever-drug-free-products-for-cough-relief-with-a-cheerful-collaboration-301161619.html

    SOURCE GSK Consumer Healthcare

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  3. Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has appointed M. Michelle Berrey, M.D., M.P.H. and Annamaria T. Kausz, M.D., M.S. as members of the company's Board of Directors.

    "We are delighted to welcome Drs. Berrey and Kausz to our Board of Directors. Each brings a wealth of expertise in medical and regulatory strategy, drug development, commercialization and corporate financing," said William Golden, Founder, Chairman and CEO of Noveome.

    "Both Drs. Berrey and Kausz are joining Noveome at a crucial time as we continue our work to advance ST266 for the treatment of ophthalmology indications including persistent…

    Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has appointed M. Michelle Berrey, M.D., M.P.H. and Annamaria T. Kausz, M.D., M.S. as members of the company's Board of Directors.

    "We are delighted to welcome Drs. Berrey and Kausz to our Board of Directors. Each brings a wealth of expertise in medical and regulatory strategy, drug development, commercialization and corporate financing," said William Golden, Founder, Chairman and CEO of Noveome.

    "Both Drs. Berrey and Kausz are joining Noveome at a crucial time as we continue our work to advance ST266 for the treatment of ophthalmology indications including persistent corneal epithelial defects, and systemic inflammation including the cytokine storm often seen in COVID-19."

    Dr. Berrey has over 25 years of combined industry and clinical experience. She is a seasoned industry executive with a proven track record in first-in-class therapeutics targeting viral diseases. Currently, Dr. Berrey serves on the Scientific Advisory Board for ViiV/GSK, and is on the Executive Committee and Board of the NC Biotechnology Center. Dr. Berrey was most recently president and CEO at Chimerix (NASDAQ:CMRX) and previously served as Chief Medical Officer at Pharmasset (acquired by Gilead Sciences (NASDAQ: GILD) and Vice President of Clinical Development for Antivirals and Metabolic Diseases at GlaxoSmithKline (NYSE:GSK). Throughout her career she has focused on diseases threatening the most immunocompromised patient populations. Dr. Berrey holds an M.P.H. from Emory University and an M.D. from the Medical College of Georgia.

    "It's exciting to join the Board of a company like Noveome, rooted in novel science that is unlocking the vast potential of a multi-targeted secretome such as ST266," said Dr. Berrey. "I look forward to working together with the Noveome management team as we aim to improve clinical outcomes in a range of complex diseases."

    Dr. Kausz brings 14 years of experience in drug development and regulatory strategy across several disease areas and all phases of development, including post-marketing. She led the successful filing of two new drug approvals in the U.S. and E.U for renal and metabolic indications, and supported their commercial launch in the U.S. Dr. Kausz is currently the Chief Medical Officer of Allena Pharmaceuticals (NASDAQ:ALNA), where she was instrumental in securing agreement with the FDA on an accelerated approval strategy for a novel indication using a novel endpoint, led several clinical trials, and supported financing activities. Dr. Kausz also serves on the Board of Directors for the Kidney Health Initiative (KHI). She previously held various clinical development roles at EMD-Serono, Keryx, Reata, and AMAG. Dr. Kausz has an M.D. from the University of Virginia and an M.S. in Epidemiology with a concentration in Biostatistics from the University of Washington.

    "It is an honor to join the Noveome Board and I look forward to working with leadership on regulatory strategy, evaluation of indication expansion and business development opportunities," said Dr. Kausz. "ST266 has exciting potential to address the challenges of severe inflammatory responses that can occur in a wide range of indications, and I am eager to help advance Noveome's programs."

    About ST266

    ST266 is a cell-free biologic made by culturing a novel population of human amnion-derived cells. Through a proprietary culturing method, these cells produce an array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation.

    About Noveome Biotherapeutics, Inc.

    Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection as well as the post-COVID-19 symptoms experienced by many COVID-19 patients. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). ST266 is also being evaluated in a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye. Noveome is currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs and a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

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    • Data demonstrate potential to enhance effector function of monoclonal antibodies and induce a protective T-cell or "vaccinal" response
    • Therapeutic approach previously applied to treatment of oncologic diseases may now have broader implications across a range of infectious diseases

    SAN FRANCISCO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of preclinical research in an influenza animal model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response. Data demonstrate that selective engagement of an activating Fc receptor on dendritic cells by antiviral monoclonal antibodies induced protective CD8+ T cell…

    • Data demonstrate potential to enhance effector function of monoclonal antibodies and induce a protective T-cell or "vaccinal" response

    • Therapeutic approach previously applied to treatment of oncologic diseases may now have broader implications across a range of infectious diseases

    SAN FRANCISCO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of preclinical research in an influenza animal model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response. Data demonstrate that selective engagement of an activating Fc receptor on dendritic cells by antiviral monoclonal antibodies induced protective CD8+ T cell adaptive responses. The paper, entitled "Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection," was published in the October 8, 2020 online edition of Nature.

    "In the past several years, we've gained a better understanding of how integral Fc mediated effector functions of monoclonal antibodies are for their therapeutic efficacy in pre-clinical models of neoplastic, infectious and inflammatory diseases," said Jeffrey V. Ravetch, M.D., Ph.D., study senior author and Theresa and Eugene M. Lang Professor and Head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at The Rockefeller University. "These approaches have been successfully applied to anti-tumor therapeutics and have resulted in improved clinical outcomes in a variety of oncologic diseases. Our present studies have uncovered a significant new mechanism by which antibodies, through their Fc region, can not only engage innate immune responses but activate adaptive T cell responses, thereby stimulating protective anti-viral immunity in these models."

    The research published in Nature focuses on the role of the Fc domain of monoclonal antibodies, regions with the capacity to bind to other immune cells through a family of receptors (the Fc receptors). By engineering antibodies with modified Fc domains to enhance binding to specific Fc receptors on innate immune cells, investigators observed an enhanced protective immune response. Certain modifications (GAALIE variants) were associated with activation of dendritic cells, as well as antiviral effector T-cells, indicating induction of the adaptive arm of the immune system, which is responsible for long-term immunity. Based on this research, monoclonal antibodies programmed with improved effector function represent a potential new approach in the design of therapeutic antibodies for both the prevention and treatment of infectious diseases.

    "By observing and learning from our body's powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases," said Herbert "Skip" Virgin, M.D., Ph.D., study co-author and executive vice president, research, and chief scientific officer of Vir. "These data may have significant implications across a wide range of infectious diseases, and we look forward to exploring the vaccinal potential of the GAALIE-engineered antibodies we are advancing through clinical development – VIR-3434 for chronic hepatitis B and VIR-7832 for SARS-CoV-2."

    The preclinical study was conducted by Dr. Ravetch and Stylianos Bournazos, Ph.D., of the Laboratory of Molecular Genetics and Immunology at The Rockefeller University, in collaboration with Dr. Virgin and Davide Corti, Ph.D., senior vice president of antibody research at Vir's subsidiary Humabs BioMed SA.

    "This type of exceptional collaborative partnership between cutting-edge science and clinical application has the potential to significantly improve our ability to address infectious diseases," stated Dr. Virgin.

    Vir is currently evaluating several monoclonal antibodies that have been Fc engineered to include the XX2 "vaccinal mutation" (or GAALIE variant) for which Vir has licensed exclusive rights for all infectious diseases. 

    About VIR-3434

    VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.

    About VIR-7832 

    VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine. VIR-7832 is being developed by Vir and its partner GlaxoSmithKline plc (NYSE:GSK) as part of their broader collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2. 

    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

    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 "potential," "may," "will," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "candidate," "continuing," "developing" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the ability of enhanced Fc mediated effector functions in enhancing the efficacy of monoclonal antibodies to treat viral infections and inducing a protective response in animal models, using an oncological therapeutic approach and enhanced effector function in the treatment of infectious diseases, the vaccinal potential of specifically engineered antibodies in the treatment of chronic hepatitis B and SARS-CoV-2, and statements around the company's plans to explore the vaccinal potential of engineered antibodies as it advances through clinical development of VIR-3434 for the treatment of chronic hepatitis B and VIR-7832 for SARS-CoV-2. 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 treating chronic hepatitis B and neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

     

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

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    • Independent Data Monitoring Committee recommended on September 30, 2020 that the study continue into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in
    • Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021
    • If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19
    • Patient enrollment underway; website live at https://vircovid19study.com/

    SAN FRANCISCO and LONDON, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal…

    • Independent Data Monitoring Committee recommended on September 30, 2020 that the study continue into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in
    • Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021
    • If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19
    • Patient enrollment underway; website live at https://vircovid19study.com/

    SAN FRANCISCO and LONDON, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the major sites of infection). Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee on September 30, 2020, the COMET-ICE registrational study will now expand globally to additional sites in North America, South America and Europe.

    George Scangos, Ph.D., chief executive officer of Vir, said: "The rapid achievement of this important milestone reflects the urgency with which we're mobilizing our resources in the hope of preventing the worst consequences of this deadly virus. VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalization or death via multiple mechanisms. We look forward to continuing to collaborate with GSK to accelerate its development."

    Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "Given the urgent patient need, I am very pleased that we have progressed VIR-7831 from pre-clinical studies to a Phase 3 trial in only six months since announcing our collaboration with Vir. We believe this neutralizing antibody's high barrier to resistance, notable effector function and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic."

    The Phase 3 portion of the COMET-ICE study will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally (670 patients in the treatment arm and approximately 670 patients in the placebo arm). The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. Interim analyses are planned to evaluate safety, futility and efficacy, the results of which may be available as early as the end of 2020. Results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021.

    The COMET clinical development program for VIR-7831 includes two additional planned trials – one for the treatment of hospitalized patients and another for the prevention of symptomatic infection. The companies also expect to start a Phase 1b/2a trial in the second half of 2020 evaluating VIR-7832, a second investigational SARS-CoV-2 neutralizing antibody that shares the same characteristics as VIR-7831, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.

    About VIR-7831 / GSK4182136

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

    About VIR-7832 

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

    About the Vir and GSK Collaboration

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

    About Vir Biotechnology

    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting 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.

    Vir Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of Vir's collaboration with GSK, the expected timing of clinical study results for VIR-7831, Vir-7831's potential to treat COVID-19 and its expected clinical activity, clinical trials for VIR-7832, the ability of VIR-7832 to function as a therapeutic and/or prophylactic vaccine and its clinical activity, as well as Vir's ability to identify new anti-viral antibodies and its technologies, as well as Vir's ability to address the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, challenges in identifying new anti-viral antibodies, challenges in neutralizing SARS-CoV-2 or in identifying and inhibiting cellular targets, difficulties in obtaining regulatory approval, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

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    GSK Contacts:
    
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