GSK GlaxoSmithKline PLC

Las Vegas, USA, Oct. 11, 2021 (GLOBE NEWSWIRE) -- Acne Vulgaris Pipeline: Therapeutic Assessment, Emerging Drugs, Key Pharma Players, Clinical Trials, and Growth Prospects Analysis | DelveInsight

Approximately 22+ key companies are developing therapies for Acne Vulgaris. Some of the major key players developing therapies to treat acne vulgaris are Bausch Health Companies, BioPharmX Corporation, Boston Pharmaceuticals, Eligo Bioscience, Suzhou Kintor Pharmaceuticals, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, and others.

DelveInsight's ‘Acne Vulgaris Pipeline Insight 2021' report offers detailed coverage of available, marketed, and pipeline therapies being clinically developed, key companies working to advance the pipeline space, and future growth potential of the Acne Vulgaris pipeline domain. 

Some of the major pointers from the Acne Vulgaris Pipeline report:

• DelveInsight's Acne Vulgaris Pipeline analysis depicts the space with 22+ active players working to develop 22+ pipeline therapies. 
• Major pharmaceutical companies are developing potential drug candidates to improve the Acne Vulgaris treatment scenario, such as BOS-356, Imsidolimab, Aminolevulinic acid (ALA), IDP-126, BTX 1503, FCD 105, GT 20029,  and others.
• Key pharmaceutical companies involved in the development of therapies to treat acne vulgaris are Bausch Health Companies, Botanix Pharmaceuticals, Boston Pharmaceuticals, Eligo Bioscience, Suzhou Kintor Pharmaceuticals, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, BioPharmX Corporation, AnaptysBio, VYNE Therapeutics, and others.
• In December 2020, Sol-Gel Technologies announced that their New Drug Application (NDA) for Twyneo for the treatment of acne vulgaris, has been accepted for filing by the U.S. Food and Drug Administration (FDA). 
• In January 2021, Eligo Bioscience SA (Eligo) announced that it had entered into a research and option agreement with GlaxoSmithKline (NYSE:GSK) aimed at advancing Eligobiotics® for the treatment or prevention of acne vulgaris with a pioneering CRISPR-based therapeutics for strain-specific microbiome modulation.
• BioPharmX is developing a novel, proprietary topical minocycline gel formulation (BPX-01) for the treatment of acne vulgaris. The product is the first candidate from the company's anhydrous hydrophilic topical delivery system and in our formulation, the minocycline is completely solubilized. The formulation is currently in clinical development for patients with inflammatory lesions of acne vulgaris.
• In April 2021, Kintor Pharmaceutical Limited (HKEX: 9939), a clinical-stage biotechnology company developing small molecule and biological therapeutics, announced that the clinical trial of Pyrilutamide as a treatment for the acne vulgaris has completed the first batch of patients enrolment and successfully dosed in China.
• In April 2021, Bausch Health Companies Inc., and its dermatology business, Ortho Dermatologics, announced statistically significant topline results from a second pivotal Phase 3 clinical trial evaluating its investigational medicine IDP-126, a combination retinoid, anti-bacterial and antibiotic topical, to treat acne vulgaris in patients nine years of age and older.

Know which pharma company is anticipated to take charge of Acne Vulgaris pipeline in the coming years by requesting a sample @ Acne Vulgaris Emerging Therapies and Forecast 

The Acne Vulgaris pipeline report lays down detailed profiles of the pipeline assets,  inactive and dormant assets, comparative analysis of clinical and non-clinical stage Acne Vulgaris products, comprehensive assessment of driving and restraining factors, along with the opportunities and risks in the Acne Vulgaris pipeline landscape.

Acne Vulgaris Overview

Acne Vulgaris is considered as an inflammatory disorder of the pilosebaceous unit, which runs a chronic course and it is self-limiting. It is classified into different forms which vary in severity, lesion type, and localization. It is a very common skin disorder that can present with inflammatory and non-inflammatory lesions chiefly on the face but can also occur on the upper arms, trunk, and back. 

Acne vulgaris symptoms can be mild, moderate, or severe and are diagnosed clinically and Acne Vulgaris treatment is based on severity and can involve a variety of topical and systemic agents directed at reducing sebum production, comedone formation, inflammation, and bacterial counts and at normalizing keratinization.

Discover more about the therapeutic scenario in Acne Vulgaris @ Acne Vulgaris Emerging Therapies 

Acne Vulgaris Pipeline Drugs

Explore the scope of Acne Vulgaris pipeline therapies @ Acne Vulgaris Pipeline Analysis

Acne Vulgaris Therapeutics Assessment

The Acne Vulgaris Pipeline report proffers an integral view of the Acne Vulgaris emerging novel therapies segregated by Stage, Product Type, Route of Administration, Molecule Type, and Mechanism of Action.

By Product Type

• Mono
• Combination
• Mono/Combination

By Stage

• Discovery 
• Pre-clinical
• Phase I
• Phase II
• Phase III
• Pre-registration

By Route of Administration

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

By Molecule Type 

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

By Mechanism of Action

• Keratinocyte inhibitors
• Protein 50S ribosomal subunit inhibitors
• Glial cell inhibitors; Interleukin 1 alpha inhibitors
• Interleukin 36 receptor antagonists
• Diacylglycerol O acyltransferase inhibitors
• Androgen receptor degradation enhancers

Scope of the Acne Vulgaris Pipeline Report 

• Coverage: Global 
• Major Players: Bausch Health Companies, Boston Pharmaceuticals, Eligo Bioscience, Suzhou Kintor Pharmaceuticals, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, VYNE Therapeutics, Botanix Pharmaceuticals, BioPharmX Corporation, and others.
• Key Acne Vulgaris Pipeline Therapies: IDP-126, FCD 105, BTX 1503, Imsidolimab, Aminolevulinic acid, GT 20029, BOS-356, BPX-01, and others.

Learn more about the report offerings @ Acne Vulgaris Pipeline Emerging Novel Therapies 

Table of Contents 

Get Acne Vulgaris customized report @ Acne Vulgaris Emerging Therapies 

Track candidate's clinical development journey here @ Profiling and Comparative Therapeutic Assessment

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About DelveInsight

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For more insights, visit Pharma, Healthcare, and Biotech News 

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WARREN, N.J., Sept. 28, 2021 /PRNewswire/ -- GSK Consumer Healthcare (NYSE:GSK) is raising a cup – or two – of coffee to celebrate enjoying life's simple pleasures without the interruption of tooth sensitivity. Joy – something we haven't had much of throughout the pandemic – is all about feeling good in small and seemingly simple moments, but for those who suffer from sensitive teeth, something as little as enjoying a cup of coffee might not be so joyful.

Wednesday, September 29 is National Coffee Day and Sensodyne, the #1-dentist recommended toothpaste brand for sensitive teeth, has launched Repair and Protect with Deep Repair, a toothpaste for those with dentin hypersensitivity so they can enjoy a cup of coffee from their favorite café.

Americans agree that their morning cup of coffee is the most important thing needed to start the day, and hot coffee remains superior to iced coffee. According to research conducted by OnePoll on behalf of Sensodyne®*, the 2,000-person study also found that:

• HOT, HOT, HOT: 43% of people surveyed prefer hot coffee to the 34% of people who prefer iced coffee.
• COFFEE TIME = ME TIME: 55% of people surveyed prefer to enjoy their coffee alone, followed by grabbing a cup with friends or family, and then at a café.
• CAFFEINE CRAZED: 42% admitted that over the past year their daily coffee intake has increased.

Sensodyne Repair and Protect with Deep Repair is scientifically proven to go deep within the dentin tubules^1** and provides clinically significant sensitivity relief with twice daily brushing². Your caffeine addiction likely isn't going anywhere, but your tooth sensitivity doesn't have to stay.

For people with sensitive teeth, hot or cold beverages can unexpectedly trigger a jolt of nerve pain.

"Tooth sensitivity is something many people struggle with but by switching to Sensodyne, you can manage unwanted tooth sensitivities and get the protection you need," said GSK Oral Care expert, Monica Biga. "It also provides a variety of benefits such as cavity protection, breath freshening, and whitening. Sensodyne helps people maintain a healthy smile and get back to enjoying coffee without the pain of sensitivity!" 

YouTube creators such as The Try Guys, Slice N Rice, The Icing Artist, Adam Ragusea and more will encourage others who suffer from tooth sensitivity to also take control of their oral care by switching to Sensodyne®, reminding individuals that tooth sensitivity shouldn't stop them from enjoying the little moments, and let them get back to enjoying the drinks they love.

Sensodyne® Repair and Protect with Deep Repair contains stannous fluoride, which creates a reparative†*** layer over exposed dentin for lasting dentin hypersensitivity protection²***, it provides effective lasting relief from the twinge of sensitivity*** and offers everyday cavity protection.

As part of the Sensodyne® portfolio, Repair and Protect with Deep Repair is available online and at major retail stores nationwide. To learn more about how to get relief for your sensitive teeth, visit sensodyne.com and follow Sensodyne® on Twitter and Facebook.

About Sensodyne®

Sensodyne is the #1 dentist-recommended toothpaste brand for sensitive teeth. Sensodyne has created unique formulations to help people overcome tooth sensitivity pain*** and maintain healthy teeth, while still providing varied benefits such as cavity protection, whitening and breath freshening.

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

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.

*Methodological Notes

This online survey of 2,000 U.S. Americans was commissioned by Sensodyne and conducted by market research company OnePoll, in accordance with the Market Research Society's code of conduct. Data was collected between June 15, 2021 and June 18, 2021. All participants are paid an amount depending on the length and complexity of the survey. This survey was overseen and edited by OnePoll, who are members of the MRS and have corporate membership to ESOMAR and AAPOR.

Sources

1 In vitro report number G7322/014; GSK data on file; 2020.

2 Parkinson et al; Am J Dent; 2015; 28 (4): 190-196. 

3 OnePoll Uninterrupted Joy and Summer Moments Online Survey; GSK data on file; 2021.

**As shown in an in vitro study.

***With twice daily brushing.

†Sensodyne Repair & Protect is intended for relief of occasional dentin hypersensitivity that occurs when sensitive teeth are exposed to hot or cold substances. It contains stannous fluoride, a well-established, effective tooth desensitizer with remineralization properties. There is general scientific consensus that occluding exposed dentin effectively relieves the occasional pain of dentin hypersensitivity. 

Contact:

Jessica Moschella

jessica.moschella@edelman.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/sensodyne-repair-and-protect-with-deep-repair-is-proud-to-deliver-a-minty--whitening-toothpaste-just-in-time-for-national-coffee-day-301385989.html

SOURCE GlaxoSmithKline Consumer Healthcare

• First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation
• Fourth indication for mepolizumab in the US for eosinophil-driven diseases

GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

CRSwNP accounts for 2-4% of the US population, affecting more than 5 million people. CRSwNP is one of a variety of diseases arising from inflammation in different tissues associated with elevated levels of a type of white blood cell called eosinophils. It is often characterised by raised eosinophil levels, in which soft tissue growth, known as nasal polyps, develop in the sinuses and nasal cavity. CRSwNP can cause chronic symptoms such as nasal obstruction, loss of smell, facial pressure and nasal discharge.

Mepolizumab is the first anti-IL-5 biologic to be approved for adult patients with CRSwNP in the US.

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: "More than 5 million people in the US suffer with chronic rhinosinusitis with nasal polyps and today's approval provides these patients with the first anti-IL-5 treatment option and an alternative to surgery to help reduce symptoms of this disease. GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients."

Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: "Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. As there have been limited treatment options, particularly for those patients with severe disease, they may rely on oral steroids and recurrent surgery to manage their condition. We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery."

The approval of mepolizumab as a treatment for CRSwNP is based on data from the pivotal SYNAPSE study which explored the effect of mepolizumab vs. placebo in over 400 patients with CRSwNP. Mepolizumab achieved significant improvement in reducing the size of nasal polyps and nasal obstruction. All patients in the study received standard care, had a history of previous surgery (approximately one in three had ≥3 surgeries) and were in need of further surgery due to severe symptoms and increased size of their polyps. SYNAPSE showed that there was a 57% reduction in the proportion of patients who had surgery in the group treated with mepolizumab vs. placebo, HR=0.43 (95% CI 0.25, 0.76). In addition, the proportion of patients requiring systemic corticosteroid use during the 52-week treatment period was lower in patients who received mepolizumab.

Mepolizumab is also approved for use in three other eosinophilic driven diseases, the first indication being for patients with severe eosinophilic asthma aged six years and older. Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES).

With 41 clinical trials, mepolizumab has been studied in over 4,000 patients. GSK is committed to improving the lives of those living with disease associated with uncontrolled eosinophilic inflammation, continuously innovating in order to address the unmet needs in this broad patient group.

Nucala is indicated in the US:

• As an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. Nucala is not indicated for the relief of acute bronchospasm or status asthmaticus.
• For the treatment of adult patients with EGPA.
• For the treatment of adult and paediatric patients aged 12 years and older with HES for ≥6 months without an identifiable non-hematologic secondary cause.
• As an add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

About chronic rhinosinusitis with nasal polyps (CRSwNP)

CRSwNP is a chronic inflammatory disease of the nasal passage linings or sinuses which can lead to soft tissue growths known as nasal polyps and is often characterised by elevated levels of eosinophils. The resultant swellings can grow in both nostrils (bilateral) greatly impacting a patient due to various symptoms including nasal obstruction, loss of smell, facial pressure and nasal discharge. Surgery may be indicated for severe cases. However, polyps have a strong tendency to reoccur often leading to repeat surgery.

About mepolizumab

First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels. A normal level of blood eosinophils being less than 500 eosinophils/microliter. The mechanism of action for mepolizumab has not been definitively established.

Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 4,000 patients in 41 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets. In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with EGPA. Mepolizumab was approved for use in HES in the US in September 2020, followed by Brazil in February 2021 and Argentina in May 2021. Mepolizumab is currently being investigated in COPD. It is not currently approved for use in COPD anywhere in the world.

Important safety information

The following information is based on the US Prescribing Information for Nucala in licensed indications only. Please consult the full Prescribing Information for all the labelled safety information for Nucala.

CONTRAINDICATIONS

Nucala should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS

• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of Nucala. Discontinue Nucala in the event of a hypersensitivity reaction.
• Do not use to treat acute bronchospasm or status asthmaticus.
• Herpes zoster infections have occurred in patients receiving Nucala. Consider vaccination if medically appropriate.
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Nucala. Decrease corticosteroids gradually, if appropriate.
• Treat patients with pre-existing helminth infections before therapy with Nucala. If patients become infected while receiving treatment with Nucala and do not respond to anti-helminth treatment, discontinue Nucala until parasitic infection resolves.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5%) in severe asthma clinical trials included headache, injection site reaction, back pain, and fatigue. Injection site reactions (e.g. pain, erythema, swelling, itching, burning sensation) occurred in 8% of subjects treated with 100 mg of Nucala versus 3% treated with placebo.

In a clinical trial in patients with EGPA receiving 300 mg of Nucala, no additional adverse reactions were identified to those reported in severe asthma clinical trials. Injection site reactions (e.g. pain, erythema, swelling) occurred in 15% of subjects treated with 300 mg of Nucala versus 13% treated with placebo.

In a clinical trial in patients with hypereosinophilic syndrome, no additional adverse reactions were identified to those reported in the severe asthma trials. Injection site reactions (e.g. burning, itching) occurred in 7% of subjects treated with 300 mg of Nucala versus 4% treated with placebo.

In a clinical trial with CRSwNP, the most common adverse reactions (incidence >/= 5%) in patients receiving NUCALA 100 mg was oropharyngeal pain and arthralgia. Injection site reactions (e.g., erythema, pruritus) occurred in 2% of patients receiving Nucala versus <1% treated with placebo.

GSK's commitment to respiratory disease

For over 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world's first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today's industry-leading respiratory portfolio, we continue to innovate so we can reach the right patients, with the right treatment. Working together with the healthcare community, we apply world-class science to discover and understand the molecules that become the medicines of tomorrow. We won't stand still until the simple act of breathing is made easier for everyone.

About GSK

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

Cautionary statement regarding forward-looking statements

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

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

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

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

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

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

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

About the COMET-ICE Study

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

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

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

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

About the Sotrovimab Clinical Development Program

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

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

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

About Sotrovimab

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

Important Information about Sotrovimab in Europe

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

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

Reporting of suspected adverse reactions

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

Sotrovimab in the United States

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

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

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

Authorized Use 

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

Limitations of Authorized Use 

Sotrovimab is not authorized for use in patients: 

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

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

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

About the Vir and GSK Collaboration

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

GSK Commitment to Tackling COVID-19

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

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

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

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

Vir's Commitment to COVID-19

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

About GSK

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

About Vir Biotechnology

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

GSK Cautionary Statement Regarding Forward-Looking Statements

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

Vir Forward-Looking Statements

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

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Vir Biotechnology Contacts:

Heather Rowe Armstrong
VP, Investor Relations
harmstrong@vir.bio
+1 415 915 4228

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

GSK Contacts:
 
Media:

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Lyndsay Meyer
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LONDON and PHILADELPHIA, July 26, 2021 /PRNewswire/ -- GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.

Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix is not indicated for prevention of primary varicella infection (chickenpox). The approval for this new population expands the number of people who can be protected against shingles by Shingrix.

"We're proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease," said Thomas Breuer, Chief Medical Officer, GSK Vaccines. "Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition."

The GSK Clinical Development Program evaluated the benefit-risk profile of Shingrix in heterogeneous immunocompromised patient populations.

This approval for a new population was based on clinical studies examining the safety and efficacy of Shingrix in adults (≥18 years of age) who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for hematological malignancies (post-hoc analysis). Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.^1,2,3,4,5,6 

"In addition to this new patient population, there are more than 100 million adults 50 years and older in the US already recommended to receive Shingrix," said Breuer. "We know many of these individuals missed recommended vaccines during the pandemic and we hope this can be a reminder to them to catch up on all their immunizations, including Shingrix."

According to recently published report from Avalere Health and supported by GSK, more than 17 million doses of recommended vaccines, including Shingrix, were missed by adults during the pandemic.

Shingrix is the first shingles vaccine indicated for use in those who are at increased risk of the disease due to being immunodeficient or immunosuppressed due to disease or therapy. It combines a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant system to generate a Varicella Zoster Virus (VZV)-specific immune response. For immunocompetent adults, Shingrix is intended to be administered in two doses, 2 to 6 months apart.

However, for adults who are or will be immunodeficient or immunosuppressed due to known disease or therapy and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose.

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has begun discussions to consider recommendations for use of Shingrix in immunocompromised adults.

Shingrix was previously approved by the European Commission (EC) for prevention of shingles and post-herpetic neuralgia (PHN) in adults 18 years of age or older at increased risk of shingles and granted marketing authorization on August 25, 2020.

About Shingles

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox.⁷ Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.⁸ As people age, the cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation.^7,9 

Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks.^9,10 The pain associated with shingles is often described as burning, shooting or stabbing. Even once the rash is gone, a person can experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years.⁷ PHN is the most common complication of shingles, occurring in 10 to 18 percent of all shingles cases.^7,11

There are an estimated 1 million cases of shingles in the US each year.⁷  More than 99 percent of those over 50 years old are infected with VZV, and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older. 

About Shingrix

Shingrix is a non-live, recombinant subunit vaccine approved in the US, Canada, EU, UK, China, Japan, Hong Kong, Australia, New Zealand, and Singapore to help prevent shingles (herpes zoster) in people aged 50 years or older. It combines an antigen, glycoprotein E, and an adjuvant system, AS01_B, intended to generate a Varicella Zoster Virus (VZV)-specific immune response immune response that can help overcome the decline in immunity as people age.

Shingrix was previously approved by the European Commission (EC) and in the UK for prevention of shingles and post-herpetic neuralgia (PHN) in adults 18 years of age or older at increased risk of shingles and granted marketing authorization on August 25, 2020.

The updated US Prescribing Information will be available soon at www.gskpro.com.

Important Safety Information for Shingrix

The following is based on the US Prescribing Information for Shingrix. Please consult the full Prescribing information for all the labeled safety information.

• Shingrix is contraindicated in anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix.
• Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Shingrix.
• In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with Shingrix.
• Syncope (fainting) can be associated with the administration of vaccines, including Shingrix. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
• In individuals aged 50 years and older: Solicited local adverse reactions were pain, redness, and swelling. Solicited general adverse reactions were myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms.
• In autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and >50 years of age): Solicited local adverse reactions were pain, redness, and swelling. Solicited general adverse reactions were fatigue, myalgia, headache, gastrointestinal symptoms, shivering, and fever.
• The data are insufficient to establish if there is vaccine-associated risk with Shingrix in pregnant women.
• It is not known whether Shingrix is excreted in human milk. Data are not available to assess the effects of Shingrix on the breastfed infant or on milk production/excretion.
• Vaccination with Shingrix may not result in protection of all vaccine recipients.

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.

Cautionary statement regarding forward-looking statements

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

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

¹ Bastidas A, et al. JAMA 2019;132:123–133.

² Berkowitz EM, et al. J Infect Dis 2015;211:1279–1287.

³ Vink P, et al. Cancer 2019;125:1301–1312.

⁴ Dagnew AF, et al. Lancet Infect Dis 2019;19:988–1000.

⁵ Vink P, et al. Clin Infect Dis 2019. doi: 10.1093/cid/ciz177.

⁶ Stadtmauer E, et al. Blood. 2014;124(19):2921-2929.

⁷ Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30.

⁸ Gnann et al. Clinical practice. Herpes zoster. N Eng J Med. 2002;347(5):340-6.

⁹ Johnson RW et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic Advances in Vaccines. 2015;3(4):109-120.

¹⁰ Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96.

¹¹ Yawn et al. Health care utilization and cost burden of herpes zoster in a community population. Mayo Clin Proc. 2009;84(9):787-94.

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SOURCE GlaxoSmithKline plc

Midatech Pharma PLC ('Midatech' or the 'Company') Midatech Strengthens Management Team with Appointment of Dr. Dmitry Zamoryakhin as Chief Scientific Officer

ABINGDON, OXFORDSHIRE / ACCESSWIRE / July 12, 2021 / Midatech Pharma PLC ((AIM:MTPH, NASDAQ:MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, announces the appointment of Dr. Dmitry Zamoryakhin as Chief Scientific Officer, a non-board role, with immediate effect.

Dr. Zamoryakhin has broad experience across all phases of development of drugs and medical devices, working with regulatory authorities including the EMA, FDA, PMDA, and NMPA. Most recently, he was Chief Medical Officer of Oxford Biomedica plc (LON: OXB), having previously held positions of increasing responsibility at Grunenthal GmbH, Daiichi Sankyo Company Limited (TYO:4568), Ono Pharmaceutical Co., Limited (TYO:4528), and GlaxoSmithKline plc ((LON:GSK, NYSE:GSK). He qualified as a doctor of medicine at Perm State Medical Academy, Russia, before earning a diploma in Pharmaceutical Medicine at PHARMED, Universite Libre de Bruxelles, and an MBA at Warwick Business School.

Dr. Zamoryakhin will take over from Steve Damment, EVP R&D who, after six years with the Company, has decided to retire from full-time employment at the end of September 2021.

Commenting, Stephen Stamp, CEO, and CFO of Midatech said: 'I am delighted to welcome Dmitry to the Midatech team. He is a medic, was big pharma trained, and has been biotech battle hardened. His breadth of experience will be invaluable as we move our Q-Sphera programmes and MTX110 through proof of concept to partnering.

'On behalf of everybody at Midatech, I should also like to express our thanks to Steve Damment for his service to the Company and, in particular, the key role he has played in championing MTX110.'

For more information, please contact:

About Midatech Pharma PLC

Midatech Pharma PLC ((dual listed on LSE AIM: MTPH, NASDAQ:MTP) is a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines. The Company combines approved and development medications with its proprietary and innovative drug delivery technologies to provide compelling products that have the potential to powerfully impact the lives of patients.

The Company has developed three in-house technology platforms, each with its own unique mechanism to improve delivery of medications to sites of disease. All of the Company's technologies have successfully entered human use in the clinic, providing important validation of the potential for each platform:

· Q-Sphera™ platform: a disruptive micro-technology used for sustained release to prolong and control the release of therapeutics over an extended period of time (from weeks to months).

· MidaSolve™ platform: an innovative nanotechnology used to dissolve insoluble drugs so that they can be administered in liquid form directly and locally into tumours.

· MidaCore™ platform: a leading-edge nanotechnology used for targeting medications to sites of disease.

The platform nature of the technologies offers the potential to develop multiple drug assets rather than being reliant on a limited number of programmes. Midatech's technologies are supported by 36 patent families including 120 granted patents and an additional 70 patent applications. Midatech's headquarters and R&D facility is in Cardiff, UK. For more information please visit www.midatechpharma.com

Forward-Looking Statements

Certain statements in this press release may constitute 'forward-looking statements' within the meaning of legislation in the United Kingdom and/or United States Private Securities Litigation Reform Act. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

Reference should be made to those documents that Midatech shall file from time to time or announcements that may be made by Midatech in accordance with the London Stock Exchange AIM Rules for Companies ('AIM Rules'), the Disclosure and Transparency Rules ('DTRs') and the rules and regulations promulgated by the US Securities and Exchange Commission, which contains and identifies other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Midatech are expressly qualified in their entirety by the cautionary statements above. Except as may be required under the AIM Rules or the DTRs or by relevant law in the United Kingdom or the United States, Midatech does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or otherwise arising.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

SOURCE: Midatech Pharma PLC

• Alector and GSK to co-develop progranulin-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases, including frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson's disease and Alzheimer's disease
• Companies will co-commercialize and share profits in the US; GSK will retain exclusive commercialization rights outside the US
• Alector will receive $700 million in upfront payments, up to $1.5 billion in potential milestone payments, profit sharing and royalties
• Alector management to host conference call today at 8:30 a.m. ET

SOUTH SAN FRANCISCO, Calif. and LONDON, July 02, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC) and GlaxoSmithKline plc (NYSE:GSK), today announced a strategic global collaboration for the development and commercialization of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments.

The collaboration brings together Alector's leading immuno-neurology expertise with GSK's R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. Enrollment is currently underway for a pivotal Phase 3 trial for AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis and has no approved treatments. AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson's disease and Alzheimer's disease.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. Working with Alector's world class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson's and Alzheimer's."

Arnon Rosenthal, Ph.D., Chief Executive Officer, Alector, said: "This transformative collaboration brings together Alector's leading immuno-neurology expertise with GSK's commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of our progranulin franchise into large indications, while bolstering the build out of our own late-stage development and commercial capabilities. Importantly, this collaboration is designed to fully support AL001 and AL101's development and to enable Alector to continue building a fully integrated company as we strive to address the high unmet medical need in patients suffering from neurodegenerative diseases. We are confident that GSK's extensive experience launching ground-breaking medicines at the intersection of immunology and human genetics, will ensure that AL001 and AL101 are developed to their full potential."

As part of the recent Investor Update day on 23 June 2021, GSK committed to an R&D approach focused on maximizing opportunities by leveraging an increased understanding of the science of the immune system and human genetics. The collaboration with Alector on AL001 and AL101, two antibodies designed to elevate PGRN levels and potentially slow the progression of FTD and other neurological disorders, provides GSK access to a promising clinical program in immuno-neurology.

Terms of the Collaboration

Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. In addition, Alector will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.

Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. Thereafter, Alector and GSK will share development responsibilities for all late-stage clinical studies for AL001 and AL101 and all costs for global development will be divided between the two companies.

The companies will be jointly responsible for commercialization in the U.S. and will share profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications and GSK will lead the commercialization of AL101 in Alzheimer's and Parkinson's disease. Outside the U.S., GSK will be responsible for commercialization of AL001 and AL101 and Alector will be eligible for tiered royalties.

The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

About the Progranulin-Elevating Monoclonal Antibodies - AL001 and AL101

Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. AL001 and AL101 are novel human monoclonal antibodies that elevate levels of progranulin by blocking the sortilin receptor responsible for progranulin degradation. AL001 is currently in a pivotal Phase 3 clinical study in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a C9orf72 mutation, with another Phase 2 study in patients with ALS planned to begin in the second half of 2021. AL101, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers. AL101 is intended to be developed for treatment of Parkinson's disease and Alzheimer's disease.

About Frontotemporal Dementia (FTD)

Frontotemporal dementia is a rapidly progressing and severe form of dementia. It affects 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America. There are currently no FDA-approved treatment options for FTD.

There are multiple heritable forms of FTD. In one form, FTD-GRN, people have a mutation in the progranulin gene. This population represents 5% to 10% of all people with FTD. Mutations in a single copy of a progranulin gene leads to a 50% or greater decrease in the level of progranulin protein and invariably leads to development of FTD. In another form, people with mutations in the chromosome 9 open reading frame 72 (C9orf72) gene can develop FTD. FTD-C9orf72 is associated with abnormal accumulation of the protein TDP-43, which is also a hallmark in FTD-GRN. To date researchers have identified more than 120 inherited loss of function mutations in the progranulin gene that lead to FTD.

Alector Conference Call Information

Alector management will host a conference call to discuss the collaboration today at 8:30 a.m. ET. Analysts and investors are invited to participate in the conference call by dialling (888) 705-0365 from the U.S. and Canada or (415) 817-9241 internationally and using the conference ID 9476664. The live webcast can be accessed on the investor page of Alector's website at investors.alector.com. A replay of the webcast will be available on Alector's website approximately two hours after the completion of the event and will be archived for up to 30 days.

About GSK

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

About Alector

Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain's immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company's immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer's disease. This scientific approach is also the basis for the Company's immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

GSK Cautionary Statement Regarding Forward-Looking Statements

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

Alector Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the current expectations and beliefs of Alector. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to the outcome, benefits and synergies of the proposed collaboration with GSK, the anticipated completion of the proposed transaction and risks and uncertainties related to market conditions, Alector and its business as set forth in Alector's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2021, as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector's forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Alector Contacts:

Michelle Corral

VP, Communications and Investor Relations

650-808-7016

michelle.corral@alector.com

1AB (media)

Dan Budwick

973-271-6085

dan@1abmedia.com

Argot Partners (investors)

Joseph Rayne

Argot Partners

212.600.1902

joseph@argotpartners.com

Registered in England & Wales:

No. 3888792

Registered Office:

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TW8 9GS

WARREN, N.J., June 29, 2021 /PRNewswire/ -- GlaxoSmithKline (LSE: GSK) (NYSE:GSK) – Get ready for a red hot American summer! In time for July 4, as restrictions lift, temperatures rise and Americans hit the road, TUMS®, America's #1 heartburn brand, is unveiling the best spicy dishes in each state and giving consumers a chance to win a taste. In partnership with spicy food connoisseur and media personality, Sean Evans (@seanseaevans), TUMS® will introduce the Autoburn Road Trip, a route highlighting some of the best and spiciest fare at local restaurants across the country.

Through the Autoburn Road Trip Sweepstakes, TUMS® will help reunite fans with the people and foods they love, awarding one lucky winner and their three best buds the chance to put their taste buds to the test and join Sean at the New York City stop for a meal to remember.

"After a remarkably bland year, TUMS® is giving everyone an extra reason to spice things up this summer," says Sean Evans. "Nothing brings people together quite like our favorite foods, and in partnership with TUMS®, I look forward to helping Americans turn up the fun – and the heat – when a little excitement is desperately needed."

As friends and family come back together again to enjoy the food and fun that they have missed, TUMS® found in its survey of 5,000 Americans that 63% say they look forward to eating meals this summer they haven't been able to enjoy during the past year's pandemic. The brand also found that Americans are certainly united in their love of spicy foods. Tacos take the crown for Americans' favorite spicy food, with 46% of respondents naming it as such, followed by salsa (41%), Buffalo hot wings (37%) and chili (37%). However, pizza is the food for which Americans are most willing to endure heartburn.

The favorite spicy foods by state, according to the residents who live there, include:

Some other spicy stats include:

• Americans say Louisiana (42%), Texas (31%) and New Mexico (25%) are the states with the spiciest cuisine, followed by California and Arizona. Conversely, Vermont, North Dakota and Montana are the states least considered to bring the heat.
• 44% of Americans believe their tolerance for spicy food is higher than average
• 37% of Americans consider themselves a spicy food aficionado

To help deliver the spice Americans crave, beginning today through July 23, TUMS® will also draw 25 winners weekly to receive Autoburn Road Trip Kits, filled with essentials to fuel their red hot road trip adventures. At the end of the sweepstakes, five additional winners will be selected to receive a travel cooler (perfect for when your summer should get too hot!) along with a grand prize winner who will receive an all-expenses paid trip for four to meet Sean in New York City.

For a shot at the hot, fans can head to TUMSAutoburn.com and fill out the entry form, where they will be prompted to submit a photo showing how they are spicing up their summer – and their plates – with friends and family. For a chance at extra entries, fans can simply follow the additional prompts to share details of the sweepstakes on their social channels – for every referral entry submitted, they will receive a bonus entry.

"We have all been counting down the days until we could reunite with the people we cherish over the food we crave," says Amy Sharon, Director at TUMS®. "Our survey found that 36% of Americans avoid spicy food because it gives them heartburn, but after the past year, we aren't about to allow something like heartburn stand in the way of anyone's good time. That's why we are encouraging Americans to dial up the heat this summer and make it one to remember – and TUMS® will be there with the quick relief needed to keep the good times rolling, wherever the road takes them."

For more information on how to participate and for the official rules, please visit TUMSAutoburn.com.

For more information on TUMS®, please visit TUMS.com.

About TUMS®

TUMS® Antacid Tablets and Chews 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.

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SOURCE GSK Consumer Healthcare

Longwood Fund-founded company has raised over $70 million since its Q4 2020 launch

Proprietary platform licensed from Dr. Stephen Elledge's laboratory used to develop novel therapeutics across multiple therapeutic areas, including autoimmune, oncology, severe allergy and infectious disease

ImmuneID, Inc., a precision immunology company employing a proprietary platform to identify and therapeutically target antibody interactions that drive immune diseases, today announced that it has raised $50 million in Series A financing. This Series A financing brings the total amount raised by ImmuneID since its December 2020 launch to over $70 million. Proceeds from the financing will be used to advance the development of therapeutic candidates to treat autoimmune diseases, severe allergies, cancer and infectious diseases.

"ImmuneID's advanced platform leverages technologies such as next-generation sequencing, robotic automation and artificial intelligence to provide insights that can be used to develop precision immunology therapeutics," said Stephen Elledge, Ph.D., ImmuneID co-founder and SAB chair, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine at Harvard Medical School. The platform was first featured in Science and additional applications of the platform in multiple disease areas have been published in leading journals such as Science, Cell, PNAS and Nature Communications.

"ImmuneID's unique and powerful immunological target identification platform unlocks the complexity of human immune responses to guide the development of precision immunology therapeutics in areas where there remains significant unmet patient need," said Longwood Fund's Christoph Westphal, M.D., Ph.D., ImmuneID co-founder and Executive Chair.

This Series A round was led by new investor Alta Partners and included new investors Alexandria Venture Investments, Redwood Capital Investments, Section 32 and Tekla Capital Management. All existing investors participated in the financing, including Arch Venture Partners, Longwood Fund, Pitango HealthTech, In-Q-Tel, Xfund and others. This Series A financing follows a $22 million seed financing round that was led by founding investor Longwood Fund.

"This financing from an exceptional group of investors positions us to execute on our ambitious plans to develop a new generation of precision immunology therapeutics," said ImmuneID CEO David Donabedian, Ph.D., who brings more than 20 years of experience in biotech company formation and business development to ImmuneID. Dr. Donabedian previously has held various leadership roles at biopharmaceutical companies including AbbVie (NASDAQ:ABBV) and GlaxoSmithKline (NYSE:GSK).

Dan Janney, Managing Partner of Alta Partners, said, "We are excited to lead the Series A financing and join the current syndicate to further support ImmuneID and their promising approach to developing highly targeted therapeutics to treat diseases related to the immune system."

As part of the Series A Financing, Mr. Janney and Dr. Steve Kafka, Managing Partner, Section 32, will join ImmuneID's board of directors.

About ImmuneID's Platform and Technology

ImmuneID's technology platform and the underlying technology is designed to provide insights into human immune response throughout the course of disease progression for the identification of high-quality therapeutic targets. The technology was originally developed in the lab of Stephen Elledge, Ph.D., ImmuneID co-founder and Chair of ImmuneID SAB, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine, Harvard Medical School.

About ImmuneID

ImmuneID is a precision immunology company using its proprietary platform to simultaneously identify and therapeutically target millions of antibody interactions that drive immune diseases. Based on technology developed by scientific founders Stephen Elledge (Harvard), Ben Larman (Johns Hopkins), and Tomasz Kula (Harvard), we are employing our massively parallel, multiplexed and unbiased systems to develop therapeutics for autoimmunity, severe allergy, oncology and infectious disease. ImmuneID was founded in 2020 by Longwood Fund and is headquartered in Cambridge, MA.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005241/en/

LONDON and SAN DIEGO, June 22, 2021 /PRNewswire/ -- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement that gives exclusive access to Halozyme's ENHANZE® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV. 

Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.

The PH20 enzyme breaks down a substance called hyaluronan (HA) that is found in the body's subcutaneous space (under the skin) that acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients. The HA is restored under the skin via normal processes within 24-48 hours.

Halozyme's technology provides ViiV Healthcare with more opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) with its long-acting portfolio and pipeline products. Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months. 

"Many people living with HIV and those vulnerable to HIV tell us that for a variety of reasons, taking medicine every day is a challenge, and we have listened to them," said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare.  "We believe long-acting medicines are the future of HIV therapies and will help address these unmet needs. Our collaboration with Halozyme will keep us at the forefront of developing additional, innovative new options for HIV treatment and prevention as we work towards reducing the burden of HIV treatment."

"We are excited to partner with ViiV Healthcare to create new delivery options for innovative medicines for HIV," said Helen Torley, M.B. Ch. B., M.R.C.P., president and chief executive officer, Halozyme. "This collaboration demonstrates the potential value of our technology to facilitate rapid, large volume subcutaneous injections of not only more traditional medicines but also long-acting injectables, including small molecules, which in turn may further extend dosing intervals for people taking medicines for the treatment and prevention of HIV."

The license gives ViiV exclusive use of Halozyme's proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV's pipeline assets. These assets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors (NRTI) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.

Halozyme has licensed its technology to 11 pharmaceutical and biotechnology companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease with products currently approved in oncology and immune deficiency indications. In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases' Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.

About Halozyme

Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies.  Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success.  As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially validated solution has touched more than 500,000 patient lives via five commercialized products across more than 100 global markets.  Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe.  Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients.  Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics and ViiV Healthcare.  Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®.  Halozyme is headquartered in San Diego.  For more information visit www.halozyme.com. 

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.   

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/en-gb/about-us/.

Cautionary statement regarding forward-looking statements

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

Halozyme Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including potential extension of dosing intervals for people taking medicines for the treatment and prevention of HIV.  These forward-looking statements also include statements regarding the product development and regulatory efforts of Halozyme's ENHANZE® partner and Halozyme's potential receipt of payments associated with   achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products.  These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements.  The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue" and other words of similar meaning.  Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions.  These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.  Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

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SOURCE Halozyme Therapeutics, Inc.

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

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

of progression to severe disease –

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

updated to recommend use of sotrovimab –

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

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

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

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

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

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

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

Updated NIH Guidelines Recommend Sotrovimab

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

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

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

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

Continued Progress with the COMET Clinical Development Program

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

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

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

About Sotrovimab (previously VIR-7831)

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

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

Important Information about Sotrovimab

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

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

Authorized Use 

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

Limitations of Authorized Use 

Sotrovimab is not authorized for use in patients: 

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

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

Important Safety Information for Sotrovimab

Warnings

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

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

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

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

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

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

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

Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration

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

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

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

ADVERSE EVENTS

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

USE IN SPECIFIC POPULATIONS

Pregnancy

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

Lactation

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

About the Vir and GSK Collaboration

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

GSK Commitment to Tackling COVID-19

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

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

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

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

Vir's Commitment to COVID-19

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

About GSK

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

About Vir Biotechnology

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

GSK Cautionary Statement Regarding Forward-Looking Statements

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

Vir Forward-Looking Statements

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

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Vir Biotechnology Contact:

Cara Miller
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cmiller@vir.bio 
+1 415 941 6746

GSK Contacts:
   
Media:

Simon Steel
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Tim Foley
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Kristen Neese
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Lyndsay Meyer
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Analysts/Investors:

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• EOS-448 is currently in phase I for advanced solid tumours with a randomised PD-1 combination study planned for 2022
• iTeos to receive a $625 million upfront payment in addition to potential milestones, and royalty payments on ex-US sales
• GSK and iTeos will co-commercialise and share profits in the US
• GSK now has the leading portfolio of antibodies targeting the CD226 axis - a key target for next-generation immuno-oncology therapies

GOSSELIES, Belgium and LONDON, June 14, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics (NASD: ITOS) and GlaxoSmithKline plc (NYSE:GSK) today announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a potential treatment for patients with cancer. TIGIT, part of the CD226 checkpoint axis, has demonstrated potential as a promising target for the next generation of immuno-oncology therapies based on compelling preclinical data and a phase II randomised clinical trial. With this collaboration GSK is uniquely positioned with access to antibodies that synergistically target all three known CD226 checkpoints - TIGIT, CD96 and PVRIG.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Immuno-oncology has transformed cancer care but unfortunately less than 30 percent of patients respond to treatment with the current leading immune checkpoint inhibitors. Based on the underlying science, we believe that combinations of a PD-1, TIGIT, CD96 and PVRIG inhibitor could become transformative medicines for many patients with cancer. We are excited to collaborate with the team at iTeos and together we can play a leading role in the next generation of immuno-oncology therapies."

Since GSK validated the role of CD226 axis targets as important in oncology, it has been strategically building a carefully constructed set of assets to target this network of checkpoint inhibitors. The addition of EOS-448 results in GSK being the only company with antibodies targeting all three known checkpoints – TIGIT (via EOS-448), CD96 (via GSK'608), and PVRIG (via GSK'562). Together with GSK's recently approved anti-PD-1, Jemperli (dostarlimab), this comprehensive portfolio of potential next generation immuno-oncology agents will be explored through various novel combinations, including doublets and triplets, to evaluate their potential to transform treatment options for patients with multiple different cancers.

Michel Detheux, President and CEO, iTeos, said: "Through this transformative collaboration, iTeos now has access to GSK's best-in-class resources which will provide us with a significant advantage in a highly competitive, global market. We have chosen GSK because of their commercial capabilities, experience in immuno-oncology and their commitment to invest in the rapid advancement of our TIGIT programme and create a clear path forward for EOS-448. Inspired by the multifaceted mechanism of action of EOS-448 and promising early results in clinical trials, this collaboration allows us to accelerate and expand the clinical development of EOS-448. We are more confident than ever in our ability to succeed. This collaboration validates our science and provides a catalyst for the future of iTeos. The collaboration with GSK will allow our team to continue to develop next generation immunotherapies starting with inupadenant, our highly differentiated clinical-stage A2A adenosine receptor antagonist, and to drive scientific innovation with our expertise in tumour immunology to build our pipeline."

EOS-448 is currently in an open-label phase I study in patients with advanced solid tumours. GSK and iTeos plan to start combination studies of EOS-448 with dostarlimab in 2022. GSK'608 (anti-CD96 being developed in collaboration with 23andMe) is in phase I as monotherapy and in combination with dostarlimab. GSK expects to submit an Investigational New Drug application for GSK'562 (anti-PVRIG in-licensed as SRF-813 from Surface Oncology) by mid-2022.

Under the terms of the collaboration agreement, iTeos will receive an upfront payment of $625 million. iTeos will be eligible to receive up to an additional $1.45 billion in milestone payments, should the EOS-448 programme achieve certain development and commercial milestones.

Within the collaboration, GSK and iTeos will share responsibility and costs for the global development of EOS-448 and will jointly commercialise and equally split profits in the US. Outside of the US, GSK will receive an exclusive license for commercialisation and iTeos will receive tiered royalty payments.

The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

Conference Call Details

iTeos will host a conference call to discuss the agreement today, Monday, June 14 at 8:30 a.m. ET. Details are as follows:

Participant Dial-In: (833) 607-1661

International Dial-In: (914) 987-7874

Conference ID: 4598012

Webcast: https://edge.media-server.com/mmc/p/xz7hasbz

The live audio webcast will also be accessible from the Events page of the Company's IR website at https://investors.iteostherapeutics.com/news-and-events/events. A replay will be available on the Company's website approximately two hours after completion of the event and for 30 days following the call.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

About GSK

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

About EOS-448

EOS-448 is a monoclonal human IgG1 antibody designed to bind with high affinity TIGIT, a negative co-stimulatory immune checkpoint expressed T cells and NK cells. EOS-448 potently triggers an antitumor response by the immune system via a multi-faceted mechanism. By binding to TIGIT, EOS-448 blocks its interaction with TIGIT ligands including CD155 and CD112, which can then bind to CD226 and activate immune response of T cells and NK cells. In addition, IgG1 binds to FcγR to trigger pro-inflammatory cytokine release, activation of antigen presenting cells and depletion of TIGIT+ Tregs and exhausted T cells. In a phase 1 dose escalation, presented at AACR 2021, EOS-448 showed a favorable tolerability profile and early signs of clinical activity in advanced cancers with one confirmed partial response and 9 stable diseases out of 20 evaluable patients with advanced, difficult to treat cancers. Depletion of TIGIT+ suppressive and exhausted cells were shown at even the lowest tested dose thereby providing evidence of engagement of the FcγR, and the potential of EOS-448 to activate multiple immune mechanisms. This program was funded by a SPW/EER grant.

About iTeos Therapeutics, Inc.

iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients. The Company's innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology. The initial antibody product candidate, EOS-448, is a high affinity, potent, anti-TIGIT antibody with a functional Fc domain, designed to enhance the anti-tumor response through a multifaceted immune modulatory mechanism. An open-label Phase 1 clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a first insurmountable adenosine A2A receptor antagonist in clinical development tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity as well as the identification of a potential predictive biomarker. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

iTeos Therapeutics, Inc. Forward-Looking Statements

This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include but are not limited to statements regarding the closing of the transaction; iTeos' right to receive any upfront payment, milestones and royalty payments from GSK pursuant to the agreement and GSK's obligation to share responsibility and costs for the global development of EOS-448; EOS-448's potential as a promising target for the next generation of immuno-oncology therapies; the potential of combinations of TIGIT, CD96 and PVRIG to become transformative medicines for many patients with cancer; GSK's best-in-class resources providing iTeos with a significant advantage in a highly competitive global market; the potential of the collaboration with GSK to accelerate and expand the clinical development of EOS-448; iTeos' plan to continue to develop next generation immunotherapies starting with inupadenant; and GSK and iTeos' plan to start combination studies of EOS-448 with dostarlimab in 2022.   

These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements.  Many of these risks and uncertainties are beyond iTeos' control. Known risk factors include, among others, market conditions, the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize than expected due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in product research and development and manufacturing limitations; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; the data for EOS-448 may not be sufficient for obtaining regulatory approval; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos' control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates and the impact of the COVID-19 pandemic; and those risks identified under the heading "Risk Factors" in iTeos's most recent Annual Report on Form 10-K for the year ended December 31, 2020 and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. 

Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of iTeos' common stock. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof. 

iTeos enquiries:

Media contact: media@iteostherapeutics.com

Investor contact: Ryan Baker; Ryan.Baker@iteostherapeutics.com

Cautionary statement regarding forward-looking statements

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

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

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

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

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

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

LONDON and SAN FRANCISCO, May 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for sotrovimab (previously VIR-7831), an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

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

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

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

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

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

Evidence of Sotrovimab's Profound Clinical Efficacy

The EUA was granted to sotrovimab based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial in high-risk adult outpatients, which was stopped early by an independent data monitoring committee in March 2021 due to evidence of profound clinical efficacy. As previously announced, interim study results demonstrated an 85% (p=0.002) reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial. The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (2%) and diarrhea (1%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

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

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

GSK and Vir's Commitment to Patient Access to Sotrovimab

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

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

• On May 21, 2021, the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. The opinion relates to the use of sotrovimab for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.
  
  
• The EMA has also started a rolling review of data on sotrovimab that will continue until enough evidence is available to support the filing of a formal marketing authorization application.
• In April, Health Canada initiated a review of sotrovimab under the expedited Interim Order application pathway for COVID-19 drugs.
• GSK and Vir are continuing discussions with other global regulators on the regulatory pathways available so that sotrovimab can be made available to patients with COVID-19 as soon as possible.

About the COMET-ICE Study Design

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

This ongoing trial evaluated the safety and efficacy of a single IV infusion of sotrovimab (500 mg) or placebo in non-hospitalized participants globally. The safety of sotrovimab is primarily based on an interim analysis from 868 patients (430 patients in the treatment arm and 438 in the placebo arm) through day 15. Among those studied, 63% were Hispanic or Latino and 7% were Black or African American. According to the Centers for Disease Control and Prevention, these populations are approximately three times more likely to be hospitalized and approximately two times more likely to die of COVID-19¹. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for greater than 24 hours for acute management of illness or death.

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

About the Sotrovimab Clinical Development Program

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

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

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

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

About Sotrovimab (previously VIR-7831)

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

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

The following is a summary of information for sotrovimab. Healthcare providers should review the Fact Sheets for information on the authorized use of sotrovimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers.

Important Information about Sotrovimab

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

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

Authorized Use 

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

Limitations of Authorized Use 

• Sotrovimab is not authorized for use in patients: 
  • who are hospitalized due to COVID-19, OR 
  • who require oxygen therapy due to COVID-19, OR 
  • who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity). 

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

Important Safety Information for Sotrovimab

Warnings

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

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions 

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

Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (e.g., pre-syncope, syncope), dizziness and diaphoresis.

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

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

Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration

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

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

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

Adverse Events

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

Use in Specific Populations

Pregnancy

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

Lactation

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

About the Vir and GSK Collaboration

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

GSK Commitment to Tackling COVID-19

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

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

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

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

Vir's Commitment to COVID-19

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

About GSK

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

About Vir Biotechnology

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

GSK Cautionary Statement Regarding Forward-Looking Statements

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing and availability of sotrovimab to providers and patients, the timing and availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalized population, the ability of sotrovimab to neutralize the SARS-CoV-2 live virus, the ability of sotrovimab to maintain activity against all known variants of concern, including the variant from India, and other potential pandemics, statements related to the planned full analysis of the COMET-ICE trial, and statements related to regulatory authorizations and approvals, including plans and discussions with the FDA, EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir's competitors, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Registered Office:

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

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

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

GSK Contacts:

Media:

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Kathleen Quinn
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Lyndsay Meyer
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WARREN, N.J., May 18, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced Advil, a leading over-the-counter (OTC) pain reliever worldwide, is teaming up with Emmy-nominated star and producer, Anthony Anderson, for the launch of #AfterMyShot, a new campaign that aims to help people feel prepared to manage post-COVID-19 vaccine side effects as they occur, so they can start to look forward to life after the shot.

After more than a year of restrictions and physical distancing, people across the U.S. are beginning to move forward as the vaccination effort continues. According to the CDC¹, COVID-19 vaccination may cause temporary side effects, which are normal signs that the body is building protection. The CDC recommends² talking to your doctor about taking an over-the-counter medication, such as ibuprofen (Advil), to relieve potential post-vaccination side effects, such as aches and pains and fever. As a trusted source of safe, effective pain relief for over 35 years, Advil will be there as a recovery aid for side effect relief and help to enable life's moments after vaccination.

When Anthony Anderson experienced side effects after his vaccine earlier this spring, he knew he could trust Advil to help manage his symptoms.

"After my shot I consulted with my doctor and I was prepared with Advil, so when I noticed side effects like soreness in my arm, I took it to help relieve symptoms and felt much better," Anthony said. "Before the vaccine I felt at risk, now that I'm fully vaccinated and it's been over two weeks since my last shot, I feel much safer. I'm looking forward to getting back to doing some of the things I love, like playing golf, spending quality time with friends and family and going out to dinner again."

In a new video series, Anthony will share his experience, including how he relied on Advil for his symptoms after the shot, and the #AfterMyShot moments he's looking forward to most. Advil is also teaming up with a variety of content creators to share their #AfterMyShot aspirations and is encouraging others to share the activities they are most excited to do after getting vaccinated.

"This past year has been difficult for everyone – the pandemic has interrupted our lives in so many ways and has caused us to miss out on important life moments," said Scott Yacovino, Advil Brand Director, GSK Consumer Healthcare. "We're thrilled to partner with Anthony Anderson to bring #AfterMyShot to life to help Americans feel confident that they can rely on Advil for post-vaccine side effect relief, so they can start to look forward to celebrating life after the shot."

Anthony's videos and a collection of #AfterMyShot moments from content creators will be housed on AfterMyShot.com as a celebration of stories of life after the vaccine. Visit the site to see the #AfterMyShot moments and to learn how Advil can help you manage post-vaccination side effects. Share your vaccine story on social media using #AfterMyShot and remember to check health authority recommendations for staying safe, even after being vaccinated.

GSK's commitment to pain relief

We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

About Advil

Patients and doctors have trusted Advil to deliver powerful relief from several kinds of pain, including headache, muscle aches, minor arthritis and other joint pain, and backache for more than 35 years. No other OTC pain reliever has been proven stronger on pain than Advil. Advil's line of products includes Advil Liqui-Gels, Advil Migraine, Advil PM, Children's Advil Allergy & Congestion Relief, and the brand's latest innovation, Advil Dual Action.

Important Safety Information

For more than 30 years, extensive consumer use and numerous clinical studies have shown that, ibuprofen, the active ingredient in Advil, when used as directed, is a safe and effective OTC pain reliever and fever reducer.

Please refer to the full product labeling for additional safety information related to Advil.

About Anthony Anderson

Emmy and Golden Globe nominated actor, Anthony Anderson is the star and executive producer of ABC's multi-award nominated sitcom "black-ish" where he portrays Andre "Dre" Johnson.  He also currently hosts the ABC game show "To Tell the Truth." Anderson is also executive producer of both "black-ish" spin offs "grown-ish" and "mixed-ish" as well as "Road Trippin'" which airs on SnapChat.

Anderson has numerous other television and over twenty film credits including TRANSFORMERS, THE DEPARTED and HUSTLE & FLOW.  Anderson has received six Emmy nominations, two Golden Globe nominations and three Critics Choice nominations for his role on "black-ish." He has won seven Image Awards and a total of 16 nominations in his career. He has been nominated for four Screen Actors Guild awards, BET Awards, and Teen Choice awards as well as one People's Choice Awards and one Kids' Choice Awards. Anderson has also hosted the NAACP Image Awards for the past eight years. In 2020 he was awarded a Star on the Hollywood Walk of Fame.

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.  For further information please visit www.gsk.com.

Media Inquiries:

¹ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html

² https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html

View original content to download multimedia:http://www.prnewswire.com/news-releases/advil-teams-up-with-actor-and-comedian-anthony-anderson-to-inspire-people-everywhere-to-reclaim-lifes-possibilities-after-vaccination-301293758.html

SOURCE GSK Consumer Healthcare

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

– Review will support a formal Marketing Authorization Application –

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

available to patients with COVID-19 –

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

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

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

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

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

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

About the COMET-ICE Study Design

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

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

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

About the Sotrovimab Clinical Development Program

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

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

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

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

About Sotrovimab

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

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration

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

GSK Commitment to Tackling COVID-19

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

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

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

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of efficacy, based on an interim analysis of data from the trial. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

Vir's Commitment to COVID-19

Vir was founded with the mission of addressing the world's most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. Sotrovimab has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with our partners.

About GSK

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

About Vir Biotechnology

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

GSK Cautionary Statement Regarding Forward-Looking Statements

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing and availability of sotrovimab to providers and patients, including arrangements with commercial payers, the timing of availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalized population, the ability of sotrovimab to neutralize the SARS-CoV-2 live virus, statements related to the planned full analysis of the COMET-ICE trial, and statements related to marketing authorizations and regulatory authorizations and approvals, including plans and discussions with the EMA, FDA, Health Canada and other global regulators. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir's competitors, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the US Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Vir Biotechnology Contacts:
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cmiller@vir.bio
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WARREN, N.J., May 3, 2021 /PRNewswire/ -- GSK Consumer Healthcare (NYSE:GSK), the makers of Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1%) today revealed new data that uncovers a painful truth: for people with osteoarthritis (OA), mornings can be the most difficult part of the day. The study, conducted by OnePoll on behalf of Voltaren, found that among 1,000 people with OA surveyed, 67% of Americans reported their joint pain makes it difficult for them to get out of bed in the morning based on their activities from the previous day. This May, national Arthritis Awareness Month, Voltaren is empowering those with joint pain and stiffness to feel the joy of movement and help them take on their day.

After a night of inactivity, aches and pains can be at their worst first thing in the morning. In fact, a painful morning can throw off your entire day, the study shows. Nearly three-quarters of respondents reported that feeling OA pain when they wake up ruins their entire morning, and more than three-quarters of those surveyed reported OA negatively affects them three or more days a week. While 35% described themselves as early birds prior to being diagnosed with OA, only one-quarter are still early risers since learning they have OA.

Joint pain can also impact the livelihoods of people with OA. For the millions of Americans who wake up for work with the sun, OA poses real challenges. The study found that 56% of employed Americans living with OA have shown up late to work because of their pain, and more than half have even had to change their jobs because of it.

"Our research has helped us understand the authentic experience of people with OA, and shows just how difficult mornings can be, especially those who are up and moving very early," said Rishi Mulgund, Pain Portfolio Brand Director at GSK Consumer Healthcare, "As a brand, we want to support people with OA in the mornings, with a topical option that is an alternative to pain relief pills."

Voltaren, the #1 doctor-recommended topical pain relief brand, is the first full prescription strength, clinically-proven nonsteroidal anti-inflammatory (NSAID) gel available over the counter. An alternative to pills, Voltaren is applied directly to the site of pain, delivering powerful arthritis pain relief. It is indicated for the treatment of arthritis pain in the hand, wrist, elbow, foot, ankle or knee. To date, millions of patients around the world have relied on Voltaren as a powerful, well-tolerated and convenient therapeutic alternative for treating arthritis pain.

During Arthritis Awareness Month, Voltaren is proud to feature the stories of real people living with osteoarthritis who wake up and power through early mornings. Stay tuned throughout the month of May for Voltaren's three-part content series, which will air on local and national broadcast and online news outlets, featuring people with OA who refuse to let pain hold them back, and pain relief experts who will offer their advice on how people everywhere can experience the joy of less painful mornings.

Additionally, as part of a multi-year partnership with the Arthritis Foundation to support scientific research, advocacy and community connections for people with arthritis, Voltaren is matching donations made to the Arthritis Foundation (up to $100,000) throughout Arthritis Awareness Month and lending its support to the Arthritis Foundation's annual Walk to Cure Arthritis events.

Voltaren Arthritis Pain Gel is available online and at most major retailers nationwide. To learn more about Voltaren, visit www.voltarengel.com.

About Voltaren Arthritis Pain Gel

An alternative to pills, Voltaren Arthritis Pain Gel targets pain directly at the source to deliver clinically-proven nonsteroidal anti-inflammatory medicine for powerful arthritis pain relief with a proven safety profile. For more information, visit https://www.VoltarenGel.com/.

About osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis. OA occurs when the cartilage between joints begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently with age, and the pain can gradually worsen over time. The most common symptoms associated with OA include joint pain, stiffness, and decreased range of motion.

GSK's commitment to pain relief

We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

Important safety information about Voltaren Arthritis Pain

Before using the product, consumers should read the Voltaren Arthritis Pain Gel Drug Facts Label. 

* Methodological Notes

The GSK Voltaren Survey was conducted by OnePoll (www.onepoll.us) throughout the month of April 2021. The survey sampled a random group of 1,000 employed Americans diagnosed with osteoarthritis.

This random double-opt-in survey was conducted by OnePoll – a market research company and corporate member of both the American Association for Public Opinion Research (AAPOR) and the European Society for Opinion and Marketing Research (ESOMAR) – and adheres to the MRS code of conduct. For more information about OnePoll's research in the media, navigate to their portfolio here.

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. For further information please visit www.gsk.com.

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SOURCE GSK Consumer Healthcare

LONDON, April 22, 2021 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company's Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Unfortunately, as many as 60,000 women are diagnosed with endometrial cancer in the US each year and these women currently have limited treatment options if their disease progresses on or after first-line therapy. Today's approval of JEMPERLI by the FDA has the potential to transform the treatment landscape for these women and demonstrates our continued commitment to helping patients with gynecologic cancers."

Around 1 in 4 women with endometrial cancer may experience a recurrence or be diagnosed with advanced disease.^i,ii For women whose disease recurs after platinum-based chemotherapy, there is generally no accepted standard of care.^iii,iv,v Additionally, endometrial cancer has the highest rate of dMMR among tumor types^vi,vii at approximately 25%,^vii and increased rates of recurrence have been reported for women with dMMR endometrial cancer.^viii

Dr Jubilee Brown, Professor and Division Director of Gynecologic Oncology at Levine Cancer Institute, Atrium Health, and investigator on the GARNET study, noted: "The approval of JEMPERLI has the potential to change the way we've been treating dMMR advanced or recurrent endometrial cancer after standard platinum-based chemotherapy, especially given the overall response rate and durability of response that we saw in the GARNET trial."

The approval is based on results from the dMMR endometrial cancer cohort of the ongoing GARNET trial, a large, multicenter, non-randomized, multiple parallel-cohort, open-label study, representing the largest dataset to date evaluating an anti-PD-1 antibody as monotherapy treatment in women with endometrial cancer.^v The approval was granted under the FDA's Real-Time Oncology Review pilot program, and JEMPERLI was initially granted breakthrough therapy designation in May of 2019 for recurrent or advanced dMMR endometrial cancer. 

The primary endpoints in the GARNET trial were overall response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR). Results showed an ORR of 42.3% (95% CI; 30.6-54.6) with a complete response (CR) rate of 12.7% and partial response rate (PR) of 29.6% among the 71 evaluable patients with dMMR advanced or recurrent endometrial cancer who had progressed on or after treatment with a platinum-containing regimen. Of those that responded, 93.3% demonstrated a DOR of 6 months or more. After a median follow-up of 14.1 months, the median duration of response was not reached (2.6-22.4+).

Patients received 500 mg of JEMPERLI as an intravenous infusion once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression or unacceptable toxicity. Among the 104 patients evaluable for safety, the most commonly reported adverse reactions (occurring in 20% or more of patients) were fatigue/asthenia (48%), nausea (30%), diarrhea (26%), anemia (24%) and constipation (20%). The most common Grade 3 or 4 adverse reactions (≥2%) were anemia and transaminases increase. JEMPERLI was permanently discontinued due to adverse reactions in 5 (4.8%) patients. No deaths attributed to JEMPERLI were reported in the study.

Dr Sue Friedman, Executive Director of Facing Our Risk of Cancer Empowered (FORCE), commented: "We applaud GSK and their ongoing efforts to support women with endometrial cancer, the most common gynecologic malignancy in the US and the sixth most common cancer in women worldwide. For many women whose disease is dMMR and has progressed after platinum-based chemotherapy, the approval of JEMPERLI brings a new treatment option to an underserved patient population."

GSK is also studying JEMPERLI for endometrial cancer in earlier treatment lines and in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer as we work to expand our oncology pipeline and reinforce our portfolio of cancer treatments.

Making our products affordable and accessible

GSK is actively involved in creating solutions that allow patients to have access to new scientific breakthroughs. We remain committed to helping patients access GSK medications and have a long history of providing patient assistance programs. Patients and healthcare professionals can access more information about our oncology specific resources on insurance coverage and financial support at: www.TogetherwithGSKOncology.com or call: 1-844-4GSK-ONC (1-844-447-5662).

About Endometrial Cancer

Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium.^ix Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy.^ix Nearly 60,000 new cases of endometrial cancer are expected in the US in 2021, making endometrial cancer the most common gynecologic malignancy in the US.^x,xi Approximately 25% of women with endometrial cancer will be diagnosed with advanced disease or will experience a recurrence.^i,ii  

About GARNET

The ongoing phase I GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. Part 2B of the study includes five expansion cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair proficient/microsatellite stable (MMRp/MSS) endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial or POLE-mut solid tumor basket cohort (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G). GARNET is still enrolling patients.

About JEMPERLI (dostarlimab-gxly)

JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.^xiii In addition to GARNET, JEMPERLI is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens for women with recurrent or primary advanced endometrial cancer stage III or IV non-mucinous epithelial ovarian cancer for patients with advanced solid tumors or metastatic cancer.

JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: JEMPERLI (GSK4057190), a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialization, and manufacture of each of these Products under the Agreement.

Important Safety Information for JEMPERLI

Immune-Mediated Adverse Reactions

• Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue and can occur at any time during or after treatment with a PD-1/PD-L1–blocking antibody, including JEMPERLI.
• Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. For suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
• Based on the severity of the adverse reaction, withhold or permanently discontinue JEMPERLI. In general, if JEMPERLI requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids.

Immune-Mediated Pneumonitis

• JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. The incidence of pneumonitis in patients receiving PD-1/PD-L1 inhibitors, including JEMPERLI, may be increased in patients who have received prior thoracic radiation.
• Immune-mediated pneumonitis occurred in 1.1% (5/444) of patients, including Grade 2 (0.9%) and Grade 3 (0.2%) pneumonitis. Pneumonitis led to discontinuation of JEMPERLI in 0.7% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 80% of the 5 patients. Three patients reinitiated JEMPERLI after symptom improvement; of these, 33% had recurrence of pneumonitis.

Immune-Mediated Colitis

• JEMPERLI can cause immune-mediated colitis. Cytomegalovirus infection/reactivation occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
• Immune-mediated colitis occurred in 1.4% (6/444) of patients, including Grade 3 (0.7%) and Grade 2 (0.7%). Colitis did not lead to discontinuation of JEMPERLI in any patients. Systemic corticosteroids were required in 17% (1/6) of patients with colitis. Colitis resolved in 50% of the 6 patients. Of the 2 patients in whom JEMPERLI was withheld for colitis, both reinitiated JEMPERLI.

Immune-Mediated Hepatitis

• JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Immune-mediated Grade 3 hepatitis occurred in 0.2% (1/444) of patients. Systemic corticosteroids were required, and the event resolved.

Immune-Mediated Endocrinopathies

• Adrenal Insufficiency
• JEMPERLI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold JEMPERLI if not clinically stable. Adrenal insufficiency occurred in 0.9% (4/444) of patients, including Grade 3 (0.5%) and Grade 2 (0.5%). Adrenal insufficiency resulted in discontinuation in 1 (0.2%) patient and resolved in 25% of the 4 patients.
• Hypophysitis
• JEMPERLI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold JEMPERLI if not clinically stable.
• Thyroid Disorders
• JEMPERLI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold JEMPERLI if not clinically stable.
• Thyroiditis occurred in 0.5% (2/444) of patients; both were Grade 2. Neither event of thyroiditis resolved; there were no discontinuations of JEMPERLI due to thyroiditis.
• Hypothyroidism occurred in 5.6% (25/444) of patients, all of which were Grade 2. Hypothyroidism did not lead to discontinuation of JEMPERLI and resolved in 40% of the 25 patients. Systemic corticosteroids were not required for any of the 25 patients with hypothyroidism.
• Hyperthyroidism occurred in 1.8% (8/444) of patients, including Grade 2 (1.6%) and Grade 3 (0.2%). Hyperthyroidism did not lead to discontinuation of JEMPERLI and resolved in 63% of the 8 patients. Systemic corticosteroids were not required for any of the 8 patients with hyperthyroidism.
• Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis
• JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.

Immune-Mediated Nephritis with Renal Dysfunction

• JEMPERLI can cause immune-mediated nephritis, which can be fatal. Nephritis occurred in 0.5% (2/444) of patients; both were Grade 2. Nephritis did not lead to discontinuation of JEMPERLI and resolved in both patients. Systemic corticosteroids were required in 1 of the 2 patients experiencing nephritis.

Immune-Mediated Dermatologic Adverse Reactions

• JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue JEMPERLI depending on severity.

Other Immune-Mediated Adverse Reactions

• The following clinically significant immune-mediated adverse reactions occurred in <1% of the 444 patients treated with JEMPERLI or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
• Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy
• Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
• Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur.
• Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis
• Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
• Endocrine: Hypoparathyroidism
• Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection

Infusion-Related Reactions

• Severe or life-threatening infusion-related reactions have been reported with PD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3) occurred in 0.2% (1/444) of patients receiving JEMPERLI. All patients recovered from the infusion-related reactions.
• Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue JEMPERLI based on severity of reaction.

Complications of Allogeneic HSCT after PD-1/PD-L1–Blocking Antibody:

• Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with a PD-1/PD-L1–blocking antibody. These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity and Lactation:

• Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after their last dose. Because of the potential for serious adverse reactions from JEMPERLI in a breastfed child, advise women not to breastfeed during treatment with JEMPERLI and for 4 months after their last dose.

Common Adverse Reactions

• The most common adverse reactions (Grades 1-4) in ≥10% of 104 dMMR endometrial cancer patients who received JEMPERLI as monotherapy were fatigue (48%), nausea (30%), diarrhea (26%), anemia (24%), constipation (20%), vomiting (18%), pruritus (14%), cough (14%), decreased appetite (14%), urinary tract infection (13%), and myalgia (12%).
• JEMPERLI was permanently discontinued due to adverse reactions in 5 (4.8%) patients, including transaminases increased, sepsis, bronchitis, and pneumonitis. Dosage interruptions due to an adverse reaction occurred in 23% of patients who received JEMPERLI. Adverse reactions that required dosage interruption in ≥1% of patients who received JEMPERLI were anemia, diarrhea, increased lipase, and pyrexia.

Please see full Prescribing Information

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

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/en-gb/about-us/.

Cautionary statement regarding forward-looking statements

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

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SOURCE GlaxoSmithKline plc

WARREN, N.J., April 19, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK), the maker of Advil, today announced its commitment to reducing the plastic in over 80 million Advil bottles¹ by 20%, which will result in a reduction of nearly 500,000 pounds of plastic in the environment. By 2022, Advil will have reduced the plastic in nearly all bottles available in stores and online.²

The initiative is a first-of-its-kind sustainable plastic technology for over-the-counter (OTC) medicines. This new barrier resin technology reduces the amount of resin required to mold and craft the bottles, while maintaining the same barrier protection properties. It allows for a 20% reduction in material usage for high-density polyethylene (HDPE) bottles that will never enter the environmental waste stream, without a reduction to critical performance characteristics of the bottle.

The new sustainability goal set by Advil is part of GSK's ambition for all consumer product packaging to be recyclable or reusable, including eliminating all problematic and unnecessary plastics when permitted, while ensuring the quality, safety and efficacy of our products, by 2025.

"As a world leader in pain relief, we at GSK are proud to transition Advil to a more environmentally friendly packaging, further supporting GSK's commitment to sustainability," said Sarah McDonald, VP of Sustainability, GSK Consumer Healthcare. "With the new technology available to us, we saw this as an opportunity to invest in the future of our brands and sustainability goals.  Advil's switch to 20% less plastic is a first in the OTC category, and kicks off a series of plastic reduction initiatives across the product portfolio at GSK."

The focus on plastics and packaging is informed by the leading requirements set by the Ellen Macarthur Foundation. GSK joined the Ellen MacArthur Network in 2020 and is committed to playing its part in mobilizing a shift towards a circular economy for plastics.

As part of their 2025 sustainability commitment, GSK also joined the Action for Sustainable Derivatives (ASD), which aims to increase the transparency and traceability of palm oil derivatives supply chains. In collaboration with ASD, GSK introduced the Sustainable Palm Index (SPI), an evaluation scorecard for suppliers of palm oil and palm kernel oil derivatives, intended to support procurement decisions.

Further, last year GSK announced ambitious new environmental sustainability goals in both climate and nature, aiming to have a net zero impact on climate and a net positive impact on nature by 2030.

GSK has already begun transitioning Advil's bottles to 20% less plastic, and the Advil portfolio will have transitioned by 2022, online and on retail shelves nationwide. To learn more about Advil and GSK's sustainability initiatives, visit GSK.com.

GSK's commitment to pain relief

We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

About Advil

Patients and doctors have trusted Advil to deliver powerful relief from several kinds of pain, including headache, muscle aches, minor arthritis and other joint pain, and backache for more than 35 years. No other OTC pain reliever has been proven stronger on pain than Advil. Advil's line of products includes Advil Liqui-Gels, Advil Migraine, Advil PM, Children's Advil Allergy & Congestion Relief, and the brand's latest innovation, Advil Dual Action.

Important Safety Information

For more than 30 years, extensive consumer use and numerous clinical studies have shown that, ibuprofen, the active ingredient in Advil, when used as directed, is a safe and effective OTC pain reliever and fever reducer.

Please refer to the full product labeling for additional safety information related to Advil.

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.  For further information please visit www.gsk.com.

1 Annual volume

2 Does not include Advil "easy open" bottles

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SOURCE GSK Consumer Healthcare

LONDON and SAN FRANCISCO, April 15, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

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

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

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

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

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

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

About COMET-ICE

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

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

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

About the VIR-7831 Clinical Development Program

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

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

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

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

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

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration

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

GSK Commitment to Tackling COVID-19

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

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

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

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and authorizations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

About GSK

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

About Vir Biotechnology

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the EMA's review of VIR-7831, the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 to treat and/or prevent COVID-19 (as monotherapy and in combination with bamlanivimab), the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including plans to continue discussions with the FDA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

GSK Cautionary statement regarding forward-looking statements

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

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

Vir Biotechnology Contacts:

Cara Miller

VP, Corporate Communications

cmiller@vir.bio 

+1-415-941-6746

BELLEVUE, Wash., April 15, 2021 /PRNewswire/ -- Viome, a mission-driven systems biology company aiming to help individuals improve their health, today announced the appointment of Dr. Emmanuel Hanon as Global Head of Research and Development (R&D). Dr. Hanon is a healthcare veteran hailing from GlaxoSmithKline plc (NYSE:GSK), where he spent more than 20 years in R&D roles, most recently as senior vice president, head of vaccine research and development and a core member of the pharmaceutical company's Vaccine Executive Team.

As global head of R&D for the vaccine group at GSK, Dr. Hanon oversaw more than 3,500 employees across 50 countries dedicated to delivering discovery, development and management activities for the company's vaccine efforts. Additionally, Dr. Hanon was responsible for the shared science and technology platforms supporting the entire vaccine business, managing technical development, clinical immunology, and preclinical stages of vaccine developments. Since joining GSK in 2001, Dr. Emmanuel Hanon has contributed to the development of many vaccines targeting human papilloma virus, malaria, tuberculosis, seasonal and pandemic Influenza, Shingles, Meningitis, and RSV.

"I am very grateful for my time with GlaxoSmithKline, which allowed me to transform my scientific curiosity into preventative interventions that have the potential to help millions of people," said Dr. Emmanuel Hanon. "Since establishing partnerships between GSK and Viome a few years ago, I have been blown away by the company's technology and truly believe that its focus on precision medicine is the future of healthcare."

In his new role at Viome, Hanon will work closely with CEO and founder, Naveen Jain, to lead Viome's therapeutics efforts. Emmanuel Hanon will be leading the science team to identify host/microbial interactions from Viome's unique database of gene expression and to turn this knowledge into vaccines and drugs to prevent and intercept chronic diseases. He officially begins his new role as Global Head of R&D on July 1 but will immediately join the Science Advisory Board of Viome.

"The healthcare industry is at an inflection point as humanity struggles with the epidemic of chronic diseases," said Naveen Jain, CEO and Founder of Viome. "We need to move away from managing the symptoms of the chronic diseases and focus on understanding the root causes of chronic diseases, cancers, and aging. The only way to do that is to take advantage of massive datasets that are indicative of progression of diseases and use powerful Artificial Intelligence to identify the mechanisms of action. I am excited for Dr. Hanon to bring his deep expertise in therapeutics development and turn these beliefs into a reality that will positively transform our healthcare system and humanity."

About Viome

Viome was founded in 2016 with a mission to make illness optional by predicting and preventing chronic diseases through a deeper understanding of an individual's biology at a molecular level. Viome is the industry's only direct-to-consumer healthcare company that analyzes microbial and human gene expressions (mRNA), with technology exclusively licensed from Los Alamos National Lab, in order to provide individuals with health insights and the nutrition they need.

Today, Viome has become a global healthcare company, developing precision nutrition, precision drugs, and precision vaccines to help people live a disease free life. Viome has developed a state of the art artificial intelligence platform that analyzes the data from the world's largest and richest gene expression database in order to identify the root causes of chronic diseases and the mechanisms of action to be able to prevent and reverse these diseases.

Contact: viome@factorypr.com

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SOURCE Viome

Westport, CT, April 09, 2021 (GLOBE NEWSWIRE) --

• Global leaders, including Amazon, Bayer, and GE Healthcare, joined the AAIH to date to collaborate on developing novel solutions to improve the quality of care and reduce failure rates
• The Company recently launched a new AI program with the Mayo Foundation for Medical Education

BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it had been invited by, and accepted, an invitation to join the Alliance for Artificial Intelligence in Healthcare (AAIH), following BioSig's major patent awards for its AI-based platform that the Company recently won from the U.S. Patent Office.

The AAIH is the global advocacy organization for the advancement and use of artificial intelligence in healthcare to improve patients' lives and create more efficient, sustainable, and accessible healthcare systems. The AAIH and its member companies and organizations are dedicated to developing novel interventions and product solutions to reduce failure rates and costs while improving quality across the entire healthcare spectrum from biomedical discovery, clinical research, medical diagnostics and devices, and precision medicine. The initiative, which spans out of the Alliance for Regenerative Medicine, was formally launched in 2019 with 22 founders, including Amazon WS (NASDAQ:AMZN), Bayer (XETR: BAYN), GE Healthcare (NYSE:GE), GlaxoSmithKline (NYSE:GSK), and the University of Pittsburg.

 "Artificial intelligence excels at analyzing and uncovering patterns in vast volumes of clinical data – a fundamental building block in improving patient care. BioSig is a company that is committed to providing superior technological solutions based on precise signal information. We believe that a joint effort between various healthcare community representatives is a much-needed step towards solving common challenges and accelerating the adoption of AI-powered solutions. We are excited to join the Alliance and collaborate with its members on our shared goals for improving the standards of patient care,' commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

BioSig recently launched a strategic collaboration with the Mayo Foundation for Medical Education and Research to develop a next-generation AI- and machine learning-powered software for the PURE EP™ System. The Company's platform technology provides signal information during the cardiac ablations for the treatments of arrhythmias or irregular heartbeats, a condition that affects over 33 million people worldwide^[1]. Under the terms of the newly launched  AI initiative, the Company aims to develop novel technological solutions to improve existing therapies by combining the PURE EP™'s electrophysiological signals and other data sources.

 The Company has also announced major strategic collaborations with other subject-matter experts to further the AI and machine learning applications of the PURE EP™ System in their collaboration for AI technical advisory services with Harvard- and MIT-trained computer scientist and physicist, Dr. Wissner-Gross, of Reified. In 2020, the Company co-authored an abstract with Reified, titled ‘Computational Reconstruction of Electrocardiogram Lead Placement,' that presented a new method for analyzing electrocardiograms that may ultimately help to improve the automated classification of patient conditions.

"This is an exciting time for artificial intelligence and machine learning applications in healthcare, and we look forward to contributing to next-generation technological solutions in the space," responded Dr. Wissner-Gross.

The global market for AI in healthcare is expected to grow from $4.9 billion in 2020 to $45.2 billion by 2026 at an estimated compound annual growth rate (CAGR) of 44.9%. According to Accenture, key clinical health AI applications, when combined, can potentially create $150 billion in annual savings for the United States healthcare economy by 2026.

About AAIH

The AAIH is a coalition of technology developers, pharmaceutical companies, and research organizations who have expressed the common goal of realizing the potential for AI and machine learning in healthcare to significantly improve quality of care, but who also recognize the need to address substantial industry challenges. By convening stakeholders to present a unified voice, we are working to establish responsible, ethical, and reasonable standards for the development and implementation of AI in healthcare. As an organization, the AAIH brings together industry, academia, research institutions, government NGOs, key opinion leaders, and other international stakeholders to develop appropriate regulatory principles. By engaging with a wide array of participants across the healthcare spectrum, the AAIH works to actualize the promise of artificial intelligence in medicine thereby improving patients' lives and creating more efficient, sustainable, and accessible healthcare systems. Learn more on www.theaaih.org. 

About BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company's first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements

This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health

Andrew Ballou
BioSig Technologies, Inc. 
Vice President, Investor Relations 
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

WARREN, N.J., April 1, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) announced today that Flonase Allergy Relief (Flonase) is partnering with World Series champion and seasonal allergy-sufferer Cody Bellinger of the Los Angeles Dodgers as the new face of the brand's "Change The Game" campaign. The commitment is part of a larger partnership with Major League Baseball (MLB), recognizing Flonase as the Official Allergy Relief Partner of MLB.

"Baseball is a game that requires extreme focus, but unfortunately the field is full of common allergy triggers like grass pollen that can cause uncomfortable symptoms, like itchy and watery eyes," said Obehi Remi-John, Senior Brand Manager, Flonase. "As the Official Allergy Relief Partner of MLB, we are excited to bring allergy relief to athletes who play the game and fans who support them."

Bellinger is one of the 19.2 million Americans who suffer from seasonal allergies each year^*, making the start of baseball season especially challenging, as it also marks the start of allergy season.  Now a World Series champion, Bellinger knows what it takes to change the game – and isn't going to let spring allergy symptoms get in the way. This season, Bellinger is switching to Flonase to change the game on his allergy symptoms and get ahead of seasonal allergies.

"In this game, you have to be willing to change. Whether it's your stance, grip, or swing, the best players are constantly evolving," said Bellinger. "For years I struggled with allergies on the field, turning to pills that didn't offer complete relief^** of all my worst symptoms and I knew I had to make a change. Flonase gives me 24-hour all-in-one relief^***, so I can stay focused on the game."

With this new partnership, Flonase plans to focus baseball-themed marketing around their line of allergy relief sprays across a variety of digital and broadcast media, including MLB.com, and in-store at major retailers. 

Bellinger is also encouraging allergy sufferers to change their allergy game by trying Flonase with a 100% Money Back Guarantee. To learn more about Flonase and how they are helping Bellinger change the game, visit www.flonase.com/ChangeTheGame.   

^*according to the CDC (https://www.cdc.gov/nchs/fastats/allergies.htm)

^**Vs. single-ingredient antihistamines which do not treat nasal congestion.

^***Flonase relieves nasal congestion, sneezing, runny nose, itchy nose, itchy eyes and watery eyes.

About Flonase Sensimist Allergy Relief

Flonase Sensimist Allergy Relief (fluticasone propionate 50 mcg spray) is an approved over-the-counter (OTC) treatment indicated for hay fever symptoms including nasal congestion, runny nose, sneezing, itchy nose and itchy, watery eyes in adults and children 12 years of age and older.

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. 

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SOURCE GSK Consumer Healthcare

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

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

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

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

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

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

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

Important Information about bamlanivimab

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

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

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

Authorized Use and Important Safety Information

Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Limitations of Authorized Use

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

Important Safety Information

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

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

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

Infusion-related reactions have been observed with administration of bamlanivimab. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:

• fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, and diaphoresis.
  
  

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

Clinical Worsening After Bamlanivimab Administration

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

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

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

Adverse Events

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

Use in Specific Populations

Pregnancy

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

Breastfeeding

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

About BLAZE-4

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

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

About COMET-ICE

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

About bamlanivimab 

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

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

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

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About the Vir and GSK Coronavirus Collaboration

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

About Lilly's COVID-19 Efforts

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

GSK Commitment to Tackling COVID-19

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

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

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

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and authorizations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

About Eli Lilly and Company  

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

About Vir Biotechnology

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

About GSK

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

Lilly Cautionary Statement Regarding Forward-Looking Statements

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 to treat and/or prevent COVID-19 (as monotherapy and in combination with bamlanivimab), the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including plans to continue discussions with the FDA, the EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

GSK Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

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

About COMET-ICE 

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

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

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

About the VIR-7831 Clinical Development Program

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

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

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

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

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration 

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

GSK Commitment to Tackling COVID-19 

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

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

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

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and authorizations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

About GSK

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

About Vir Biotechnology

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including Vir's plans to submit a BLA to the FDA and continue discussions with the EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

GSK Cautionary Statement Regarding Forward-Looking Statements

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

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- The first two programs selected under the agreement are for oncology and CNS disorders -

Boston Pharmaceuticals announced today a pioneering three-year out-license and option agreement with GlaxoSmithKline PLC (NYSE:GSK). Boston Pharmaceuticals will become a preferred GSK partner for select pre-phase 2 programs. This new agreement builds on the relationship established in 2018 with Boston Pharmaceuticals' acquisition of five GSK programs.

"This new agreement validates Boston Pharmaceuticals as a trusted development partner with whom pharmaceutical companies can collaborate," said Robert Armstrong, Ph.D., CEO of Boston Pharmaceuticals. "GSK has been an excellent partner and we look forward to advancing these pre-phase 2 assets into and through the clinic to evaluate their potential to improve patient lives."

Initially, GSK will out-license and option two programs to Boston Pharmaceuticals:

• GSK3903371 - a monoclonal antibody targeting the Interleukin-1 Receptor Accessory Protein (IL1RAP), a tumor-associated antigen driving tumor growth and immunosuppression.
• GSK3502421 - an orally available, small molecule inhibitor for potential neurological disorders that targets Receptor Interacting Serine/Threonine Kinase 1 (RIPK1), a key component of the TNF-driven inflammation and necroptosis pathway.

"We are pleased to further strengthen our relationship with Boston Pharmaceuticals as they continue to help us translate great science into medicines," said John Lepore, SVP, Research of GSK. "This agreement makes strong strategic sense as it helps us assess the potential of multiple early-stage programs and focus on progressing our own internal assets, while maintaining pipeline optionality for the future."

Under the agreement, Boston Pharmaceuticals will be responsible for further development of select programs through proof-of-concept (PoC). Following the completion of PoC studies, GSK will have the option to reacquire each program under pre-agreed terms for subsequent development and worldwide commercialization.

If GSK exercises its repurchase option, Boston Pharmaceuticals will receive a one-time payment, as well as be eligible for approval and sales milestones and royalties. In the event GSK chooses not to reacquire a program, Boston Pharmaceuticals may continue development and potential commercialization of the program. GSK will then be eligible to receive milestones and royalty payments.

About Boston Pharmaceuticals

Boston Pharmaceuticals is a clinical stage biopharmaceutical company that leverages an experienced drug development team to advance a portfolio of high value candidates that address important unmet medical needs. The Company partners with innovative biotechnology and pharmaceutical companies to acquire drug development candidates. We employ unencumbered decision making, follow the data and advance only those programs that meet our stringent development hurdles. Following clinical proof of concept, we establish value creating partnerships with the world's leading biotechnology and pharmaceutical companies or advance programs through commercialization. We are continuously seeking new opportunities to leverage our model to create a path to value for our partners and patients. Boston Pharmaceuticals is a portfolio company of Gurnet Point Capital, a Cambridge, MA based private equity firm focused on healthcare investing. For more information, please visit www.bostonpharmaceuticals.com or follow us on Twitter @BosPharma and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210318005100/en/

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

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

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

SAN FRANCISCO and LONDON, March 10, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy.

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

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

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

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

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

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

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

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

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

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

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

COMET-ICE Clinical Trial Design

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

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

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration

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

GSK Commitment to Tackling COVID-19

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

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

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

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19.

About Vir Biotechnology

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

About GSK

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of clinical data, program updates and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus and statements related to the planned full analysis of the COMET-ICE trial. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

GSK Cautionary Statement Regarding Forward-Looking Statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report published on 9 March 2021 or contained in the Company's Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

Inside Information

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

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TW8 9GS

_______________________________

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

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

Vir Biotechnology Contacts: 
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746

GSK Contacts:
    
Media:

Simon Steel
+44 (0) 20 8047 5502 
(London)

Tim Foley
+44 (0) 20 8047 5502 
(London)

Kristen Neese
+1 804 217 8147 
(Philadelphia)

Kathleen Quinn    
+1 202 603 5003 
(Washington DC)
    
Analysts/Investors:

Sarah Elton-Farr
+44 (0) 20 8047 5194 
(London)

Sonya Ghobrial       
+44 (0) 7392 784784 
(Consumer)

Danielle Smith
+44 (0) 20 8047 0932 
(London)

James Dodwell       
+44 (0) 20 8047 2406 
(London)

Jeff McLaughlin       
+1 215 751 7002 
(Philadelphia)

Frannie DeFranco
+1 215 751 4855 
(Philadelphia)

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

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

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

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

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

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

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

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

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

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

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration

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

GSK commitment to tackling COVID-19

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

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

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

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19.

About Vir Biotechnology

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

About GSK

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of clinical data, program updates and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus and the ability of VIR-7831 to maintain full activity against variant strains of the virus. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

GSK Cautionary Statement Regarding Forward-Looking Statements

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

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

Vir Biotechnology Contacts: 
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746

GSK Contacts:
    
Media:

Simon Steel
+44 (0) 20 8047 5502 
(London)

Tim Foley
+44 (0) 20 8047 5502 
(London)

Kristen Neese
+1 804 217 8147 
(Philadelphia)

Kathleen Quinn    
+1 202 603 5003 
(Washington DC)
    
Analysts/Investors:

Sarah Elton-Farr
+44 (0) 20 8047 5194 
(London)

Sonya Ghobrial       
+44 (0) 7392 784784 
(Consumer)

Danielle Smith
+44 (0) 20 8047 0932 
(London)

James Dodwell       
+44 (0) 20 8047 2406 
(London)

Jeff McLaughlin       
+1 215 751 7002 
(Philadelphia)

Frannie DeFranco
+1 215 751 4855 
(Philadelphia)

PLANEGG/MUNICH, GERMANY / ACCESSWIRE / March 2, 2021 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that its licensing partner GlaxoSmithKline plc (NYSE:GSK) reported preliminary results of the OSCAR (Otilimab in Severe COVID-19 Related Disease) study using otilimab (formerly MOR103/GSK3196165) for the treatment of severe pulmonary COVID-19 related disease. Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and the urgent public health need, GSK has amended the OSCAR study to expand this cohort to confirm these potentially significant findings.

This event of the first patient dosed in the expanded study triggers milestone payments of a total of €16 million to MorphoSys.

Otilimab is an investigational human monoclonal antibody directed against GM-CSF (granulocyte-macrophage colony-stimulating factor) that was generated by MorphoSys and outlicensed to GSK in 2013. GSK is also developing otilimab for the treatment of rheumatoid arthritis in the ongoing Phase 3 ContRAst trials.

"The preliminary study results with otilimab are encouraging news for patients 70 and older with severe COVID-19 related pulmonary disease," said Dr. Malte Peters, Chief Research and Development Officer of MorphoSys AG. "We are pleased that our licensing partner GSK is expanding the study in order to further explore otilimab as a potential treatment option for this group of older adults suffering from severe forms of COVID-19."

About the OSCAR study

This global, randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept phase 2a OSCAR study (NCT04376684) assessed the efficacy and safety of a single intravenous infusion of otilimab 90 mg given over an hour or placebo in addition to standard of care in 806 hospitalised adults (ages 18 to 79 years) with severe COVID-19 related pulmonary disease. Standard of care permitted the use of corticosteroids (including dexamethasone), remdesivir, and convalescent plasma according to local hospital/institutional policies. Study participants were enrolled at 130 sites around the world, including in the United States, Europe, Asia, Russia, South Africa and South America. All participants had a positive SARS-CoV-2 test result; been hospitalised due to a diagnosis of pneumonia; had new onset of oxygenation impairment requiring high-flow oxygen, non-invasive ventilation or mechanical ventilation <48 hours before dosing; and had increased biological markers of systemic inflammation.

Participants were considered ‘alive and free of respiratory failure' if they were off significant oxygen support measured using a GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. A full analysis is ongoing and will be made available in an upcoming pre-print publication when available.

About MorphoSys

MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya^®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi^® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.

Monjuvi^® and HuCAL^® are registered trademarks of MorphoSys AG.

Tremfya^® is a registered trademark of Janssen Biotech, Inc.

MorphoSys Forward-Looking Statements

This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

For more information, please contact:

SOURCE: MorphoSys AG

– 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 Ebanga^TM 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
cmiller@vir.bio
+ 1 415 941 6746

GSK Contacts:

Media:

Simon Steel
+44 (0) 20 8047 5502
(London)

Tim Foley
+44 (0) 20 8047 5502
(London)

Kristen Neese
+1 804 217 8147
(Philadelphia)

Kathleen Quinn
+1 202 603 5003
(Washington DC)

Analysts/Investors:

Sarah Elton-Farr
+44 (0) 20 8047 5194
(London)

Sonya Ghobrial
+44 (0) 7392 784784
(Consumer)

James Dodwell
+44 (0) 20 8047 2406
(London)

Jeff McLaughlin
+1 215 751 7002
(Philadelphia)

Frannie DeFranco
+1 215 751 4855
(Philadelphia)

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.

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SOURCE GSK Consumer Healthcare

• 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.

CureVac enquiries:

Media enquiries:
Thorsten Schüller, Corporate Communications
CureVac AG, Tübingen, Germany
T: +49 7071 9883-1577
thorsten.schueller@curevac.com

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

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

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.

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SOURCE GlaxoSmithKline

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

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

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

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

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

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

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

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

Important Information about bamlanivimab

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

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

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

Authorized Use and Important Safety Information

Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Limitations of Authorized Use

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

Important Safety Information

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

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions have been observed with administration of bamlanivimab. Signs and symptoms of infusion-related reactions may include:

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

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

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

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

Adverse Events

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

Use in Specific Populations

Pregnancy

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

Breastfeeding

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

About BLAZE-4

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

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

About bamlanivimab

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

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

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

About etesevimab

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

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

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is an investigational dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

The COMET clinical development program for VIR-7831 includes a planned Phase 3 trial for the prevention of symptomatic infection. VIR-7831 is also being evaluated in a sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. 

About Lilly's COVID-19 Efforts

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

GSK commitment to tackling COVID-19

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

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

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

About Eli Lilly and Company 

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

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio. 

About GSK

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

Lilly Cautionary Statement Regarding Forward-Looking Statements

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-7831 as a single agent and in combination with bamlanivimab in the treatment of COVID-19, the potential benefits of participating in the BLAZE-4 trial, and the potential benefits of Vir, Lilly, and GSK's collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. 

GSK's cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q3 Results and any impacts of the COVID-19 pandemic. 

Contact:

Investors, Vir
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications
nravindran@vir.bio
+1-415-506-5256

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

Investors, Lilly
Kevin Hern
hern_kevin_r@lilly.com
+1-317-277-1838

Media, Lilly
Molly McCully
mccully_molly@lilly.com
+1-317-478-5423

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

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

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

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

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

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

Phase 1b/2a AGILE Study Design

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

About VIR-7832 / GSK4182137

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

About VIR-7831 / GSK4182136

VIR-7831 is a dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About the Vir and GSK Collaboration

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

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

About GSK

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the potential benefits of VIR-7832 and VIR-7831 in the treatment of COVID-19, the potential benefits of participating in the AGILE study, and statements around the expected timing of the Phase 1b/2a clinical trial. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

GSK Cautionary Statement Regarding Forward-Looking Statements

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

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Seasonal flu vaccine program will cover four seasonal viruses recommended by the World Health Organization (WHO)

HIV vaccine program to accelerate human validation of novel vaccination strategies

Nipah vaccine program established against a virus of public health concern

Moderna now has one commercial medicine and 24 development programs

Multiple therapeutic programs anticipated to see clinical proof of concept data in 2021

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its pipeline of innovative vaccines with three new development programs based on the clinical success of its infectious disease vaccine portfolio to date. This announcement reflects the Company's commitment to accelerating its infectious disease portfolio based on Moderna's experience with its COVID-19 vaccine. The development programs announced today are mRNA vaccine candidates against seasonal flu, HIV and the Nipah virus. Moderna also announced an expansion of its respiratory syncytial virus (RSV) vaccine program into older adults.

"The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna," said Stéphane Bancel, Moderna's chief executive officer. "Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more-ambitious development programs within our prophylactic vaccines modality. Today we are announcing three new vaccine programs addressing seasonal flu, HIV and the Nipah virus, some of which have eluded traditional vaccine efforts, and all of which we believe can be addressed with our mRNA technology. Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas."

Mr. Bancel will present an update on the Company and its pipeline of mRNA development programs on Monday, January 11, 2021 at 4:30 p.m. ET at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will be followed by a question-and-answer session. A live webcast of both the presentation and question and answer session will be available under "Events & Presentations" in the investors section of Moderna's website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for 30 days following the presentation.

Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered the clinic. The Company's updated pipeline can be found at www.modernatx.com/pipeline.

About Moderna's New Infectious Disease Vaccine Development Programs

• Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. The WHO estimates globally about 3,000,000-5,000,000 severe cases of flu each year, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the U.S. population experiences symptoms from flu each year in the US, with 140,000-810,000 hospitalizations and 12,000-61,000 deaths per year. Peak flu activity is seen in temperate climates from fall to winter and is reflected in increases in outpatient visits, urgent care visits, and hospitalizations. In the U.S., the estimated average economic burden of flu is approximately $11 billion per year. The Company plans to explore potential combination vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus (hMPV). The Company's first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the four seasonal viruses recommended by the WHO. The Company expects to begin phase 1 clinical trials for the program in 2021.
  
  
  
  
• HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation (BMGF), is a novel approach to HIV vaccine strategy in humans designed to elicit broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the National Institutes of Health (NIH) and includes multiple native-like trimer antigens. The Company expects to begin phase 1 clinical trials for both mRNA-1644 and mRNA-1574 in 2021.
  
  
  
  
• Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH's Vaccine Research Center (VRC).

Moderna's pipeline is organized into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. The Company's approach is to leverage early programs within a modality to generate clinical data and insights that reduce the technology risk of subsequent programs and accelerate the expansion of the pipeline in that modality. Positive phase 1, 2 and 3 data from Moderna's infectious disease vaccine portfolio and positive phase 1 data from its chikungunya antibody program have de-risked its prophylactic vaccines and systemic therapeutics & cell surface modalities respectively. Beyond these core modalities, the Company has four exploratory modalities in which it is actively pursuing clinical proof of concept.

Summary of Program Updates by Modality:

Core Modalities

Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases and often developed in collaborations with governments and non-profit organizations.

Vaccines requiring complex antigens and against highly prevalent infections

• Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive interim data from the phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 were presented at Moderna's annual R&D Day. Based on the interim analysis of the phase 2 study, the 100 μg dose has been chosen for the phase 3 pivotal study, which is expected to begin this year. Moderna owns worldwide commercial rights for mRNA-1647.

• Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna's CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.
  
  
  
  

Vaccines against respiratory infections

• Moderna COVID-19 Vaccine (mRNA-1273) authorization: On December 18, the U.S. Food and Drug Administration (FDA) authorized the emergency use of mRNA-1273, Moderna's vaccine against COVID-19, in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is also authorized by Canada, Israel, the United Kingdom and the European Union. Additional authorizations are currently under review in additional markets including Singapore, Switzerland and by the WHO. On December 30, interim safety and primary efficacy results from the Phase 3 trial of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the New England Journal of Medicine. The primary endpoint of the Phase 3 COVE study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the Moderna COVID-19 Vaccine group, corresponding to a 94% vaccine efficacy (95% CI 89.3-96.8%; p<0.0001). The most common solicited adverse reactions (ARs) after the two-dose series was injection site pain (86.0%). Solicited systemic adverse events occurred more often in the Moderna COVID-19 vaccine group (54.9% and 79.4%) than in the placebo (42.2% and 36.5%) group after both the first dose and the second dose respectively and were most commonly headache, fatigue and myalgia. While the majority of these ARs were mild (grade 1) or moderate (grade 2), there was a higher occurrence of severe (grade 3) reactions in the Moderna COVID-19 Vaccine group after the first (2.9%) and second (15.8%) injections. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. Safety data continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the NIH. All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety. Additional data to be collected will include longer term safety follow-up, duration of protection against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of mRNA-1273 with federal funding under Contract no. 75A50120C00034. A summary of the Company's work to date on COVID-19 can be found here. Moderna retains worldwide rights to develop and commercialize mRNA-1273.

• Moderna COVID-19 Vaccine (mRNA-1273) additional clinical studies: Moderna is also conducting a phase 2/3 study of the Moderna COVID-19 Vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the Moderna COVID-19 Vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

• Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Sites have resumed dosing seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653) following the COVID-19 related study disruption. Moderna owns worldwide commercial rights to mRNA-1653.

• Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. The first cohort of the phase 1 study of mRNA-1345 is fully enrolled. This phase 1 study includes initial dosing in younger adults, followed by age de-escalation into children. The Company today, announced its plan to amend the protocol to include evaluation of mRNA-1345 in older adults who are also at risk of significant RSV disease. Going forward, the Company intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to mRNA-1345.

Public Health Vaccines

• Zika virus vaccine (mRNA-1893): All dose cohorts (10, 30, 100 and 250 µg) in the phase 1 study of mRNA-1893 have completed enrollment. Moderna is preparing for a phase 2 study of mRNA-1893. mRNA-1893 is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna owns worldwide commercial rights to mRNA-1893.

• Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions regarding funding the Company's pandemic influenza/H7N9 vaccine program through approval are ongoing.

Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

• Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort were presented at Moderna's annual R&D Day and demonstrated dose-dependent increases in levels of antibody against chikungunya. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.

Exploratory Modalities

Cancer Vaccines: These programs focus on stimulating a patient's immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

• Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck's pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. The Phase 1 study is ongoing. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.
  
  
  
  
  • Presentation of Note: Interim data from the phase 1 dose expansion cohort of mRNA-4157 in combination with pembrolizumab was shared at The Society for Immunotherapy of Cancer's Annual Meeting 2020 and supported the expansion of the Head and Neck Squamous Cell Carcinoma (HNSCC) cancer patient cohort.
    
    
    
    
• Mutant KRAS vaccine (mRNA-5671 or V941): The phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.
  
  
  
  

Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

• OX40L (mRNA-2416): The phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The phase 2 dose expansion study of mRNA-2416 in combination with durvalumab in ovarian cancer patients is enrolling and the first patients have been dosed. Moderna owns worldwide commercial rights to mRNA-2416.
  
  
  
  
• OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. mRNA-2752 is an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators. Moderna owns worldwide commercial rights to mRNA-2752.
  
  
  
  
• IL-12 (MEDI1191): The phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

• VEGF-A (AZD8601): The phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.
  
  

Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

• Propionic acidemia (PA) (mRNA-3927): Sites are being initiated, with entry into the clinic expected in 2021. The Company will be looking for biomarkers as early indicators for therapeutic impact. Moderna owns worldwide commercial rights to mRNA-3927.
  
  

Information about each development candidate in Moderna's pipeline, including those discussed in this press release, can be found on the investor relations page of Moderna's website: https://investors.modernatx.com.

Corporate Updates

• Continued growth across organization: Moderna ended 2020 with approximately 1,300 full time employees, an increase from approximately 820 full time employees at the end of 2019. Moderna was named a top employer by Science for the sixth year in a row.
  
  
• Announced additions to the Moderna team:
  
  
  • Corinne Le Goff, Pharm.D., MBA, will join Moderna as Chief Commercial Officer effective Tuesday, January 19, 2021. Dr. Le Goff served as senior vice president and president of the U.S. Business Organization at Amgen (NASDAQ:AMGN). Prior to that, Dr. Le Goff held a number of senior international roles at Roche Group (SWX: RO), including President of Roche France and Global Product Strategy Head of Neuroscience & Rare Diseases, and leadership roles at Sanofi (NASDAQ:SNY) and Pfizer (NYSE:PFE) in the United States.
    
    
  • Ruchira Glaser, M.D., MSCE, joined Moderna as the Senior Vice President, Therapeutic Area Head for the Rare Disease, Autoimmune, and Cardiovascular Therapeutic Areas, where she will oversee development for our broad therapeutics portfolio outside of oncology. Dr. Glaser joins from GlaxoSmithKline (NYSE:GSK), where she was most recently Head of Clinical Sciences for the Respiratory and Specialty areas, including rare diseases, immunology and anemia. Prior to that, Dr. Glaser spent 10 years as an interventional cardiologist and clinical researcher at the University of Pennsylvania.
    
    
• Continued strong cash position: The Company expects cash, cash equivalents, and investments as of December 31, 2020 to be approximately $5.25 billion (unaudited), as compared to $1.26 billion as of December 31, 2019, including customer deposits of $2.81 billion for future supply of product.
  
  
• Moderna has signed Advance Purchase Agreements (APAs) for the delivery of its COVID-19 Vaccine. To date, the product revenue associated with these APAs for FY 2021 is $11.7 billion. These doses of Moderna COVID-19 Vaccine are expected to be delivered in 2021. The company is in active discussions to sign additional APAs for deliveries in 2021 and 2022. Moderna has also made a proposal to COVAX via a UNICEF tender to supply low-and-mid income countries.
  
  
• Commitment to access: The Company published seven principles as part of its Commitment to Vaccines and Therapeutics Access.
  
  
• Shareholder Letter: Moderna CEO Stéphane Bancel published a letter to shareholders on January 4, 2021.

Key 2021 Investor and Analyst Event Dates

• Vaccines Day– April 14
• Science Day – May 27
• R&D Day – September 9

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: development programs for vaccines against influenza, HIV and the Nipah virus and the specifics of those programs, including the timing of potential clinical trials; the timing for receipt of proof of concept clinical data from multiple therapeutics; the potential advantages of infectious disease vaccines; the development of combination vaccines against multiple diseases; the conduct of studies for the Company's vaccines against CMV, Zika virus, anti-cancer vaccines (i.e., OX40L, OX40L/IL-23/IL-36γ and IL-12), VEGF-A and PA; the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the spread of SARS-CoV-2, the safety profile for the Moderna COVID-19 Vaccine; plans for further clinical trials for the Moderna COVID-19 Vaccine; the potential for repeat dosing of certain therapeutics; the Company's plans for research and development and timelines for any individual product or the platform as a whole; cash, cash equivalents and investment balances; and discussions related to further sales of the Moderna COVID-19 Vaccine. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

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PARIS, Jan. 11, 2021 /PRNewswire/ -- Eligo Bioscience SA (Eligo) today announced that it has entered into a research and option agreement with GlaxoSmithKline (NYSE:GSK) aimed at advancing Eligobiotics® for the treatment or prevention of acne vulgaris with a pioneering CRISPR-based therapeutic for strain-specific microbiome modulation.

Under the terms of the agreement, Eligo will receive an upfront payment and R&D funding to advance EB005, its discovery program in acne, until preclinical proof of concept. If GSK exercises its option, GSK and Eligo will enter into a license and collaboration agreement to jointly continue the development of EB005 in acne. Eligo would be eligible to receive up to a total of $224 million in license fees and potential milestone payments, as well as royalties on global sales.

The EB005 program is applying Eligo's Eligobiotics® technology to precisely modify the composition of the skin's microbiome to treat or reduce the risk of developing moderate to severe acne. Acne is a chronic inflammatory disorder, affecting 85 percent of adolescents and young adults around the world and carrying a significant impact on physical and mental health globally. Eligo is leveraging recent insights in acne showing that otherwise beneficial skin bacteria, when expressing pro-inflammatory molecules, trigger the immune system and drive inflammation. EB005 aims to develop Eligobiotics® for topical application to precisely and selectively remove these pro-inflammatory bacterial strains from the microbiome, while sparing the rest of the skin microbiome.

Eligobiotics® is a first-in-class versatile proprietary modality that uses phage-derived particles to deliver an RNA-guided CRISPR-Cas nuclease into bacterial populations of the microbiome. Inside the bacteria, the nuclease will be guided towards specific genomic sequences, and create targeted lethal DNA double strand-breaks only if such sequences are present in the bacterial genome. This strategy enables a precise engineering of the microbiome, by killing only the strains harboring genomic sequences targeted by the nuclease.

If proven safe and effective throughout its development under the partnership with GSK, this unique approach has the potential to change the paradigm of acne treatment by specifically targeting one of its root causes.

"We are excited to work with GSK on advancing our radically new approach to address acne, combining our unique technology platform with GSK's scientific excellence and capabilities to bring innovation from the lab bench, through clinical development, and to patients. This early-stage partnership demonstrates the translational potential of Eligo's technology platform," said Xavier Duportet, PhD, Chief Executive Officer, Eligo Bioscience.

Emmanuel Hanon, Senior Vice-President and Head of R&D for GSK Vaccines, commented: "We are delighted to join forces with Eligo, a biotech company that is pioneering microbiome engineering by leveraging CRISPR technology to address microbiome-associated diseases. This partnership builds on GSK's strong expertise in immunology, bacteriology and product development, and Eligo's robust bacteriophage science, to help improve acne patients' lives."

About acne

Acne is a common chronic inflammatory disorder with significant impact on physical and mental health globally. More than 4 in 5 adolescents are affected by acne, including 10-20% with moderate to severe acne. Some patients have acne that persists into adulthood. In the US alone, acne affects approximately 40 to 50 million people, where it is the most common skin condition and the top reported cause for dermatologist visits, accounting for about one-fourth of U.S. dermatologists' patient volume. Despite the existing available solutions, there is a significant need for new acne interventions that are well-tolerated and with improved effectiveness in treating the disease, and ideally ones that can help reduce the use of antibiotics.

About Eligobiotics®

Eligobiotics® is a versatile modality based on the delivery of a DNA payload, using phage-derived particles, into bacterial populations of the microbiome to modulate its composition or function with unrivaled precision.

Eligobiotics® can be designed, built and optimized for microbiome species of choice with the automated proprietary platform that leverages Eligo's unique expertise in synthetic biology, phage biology, CRISPR-Cas engineering and bioinformatics.

Eligobiotics® can be used to precisely and selectively remove unwanted bacterial strains carrying deleterious genes while leaving beneficial bacterial strains intact through the targeted delivery of a payload encoding an RNA-guided CRISPR-Cas nuclease. Alternatively, Eligobiotics® can deliver to target bacteria the necessary genetic instructions to produce, display or secrete therapeutic proteins of interest in close vicinity to the host's cells.

About Eligo Bioscience

Eligo Bioscience is the world leader in microbiome gene therapy to address microbiome-associated diseases. Eligo was founded by scientists from The Rockefeller University, where CRISPR-based antimicrobials were invented, and by scientists from MIT. Eligo was named a Technology Pioneer by the World Economic Forum in 2017. With venture capital funding from Khosla Ventures and Seventure Partners, and non-dilutive funding from the European Commission, CARB-X, and Bpifrance, Eligo is rapidly advancing its lead program into clinical development, with the first clinical trials on track to begin in 2021.

Through its novel technology platform and robust intellectual property positions, Eligo is poised to be a catalyst for the growth anticipated across the microbiome-associated diseases industry. For more information about Eligo visit https://www.eligo.bio/. Follow us at https://www.twitter.com/EligoBio and https://www.linkedin.com/company/eligo-bioscience/.

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.

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SOURCE Eligo Bioscience

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

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

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

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

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

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

ACTIV-3 Clinical Trial Design

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

About VIR-7831 / GSK4182136

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

About the Vir and GSK Collaboration

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

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

About GSK

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

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-7831 in treating hospitalized patients with COVID-19, the potential benefits of participating in the ACTIV-3 trial, the ability of using a combination of a potent effector function and neutralization capabilities in enhancing the efficacy of monoclonal antibodies to treat hospitalized patients, the efficacy and safety of a single intravenous (IV) infusion of VIR-7831, Vir's plans around the evaluation of interim analyses and the expected timing of clinical study results for VIR-7831, the ability of VIR-7831 to prevent symptomatic infection, the clinical trial design around ACTIV-3 as well as statements around the potential benefits of Vir and GSK's collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. 

GSK Cautionary Statement Regarding Forward-Looking Statements

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

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GSK Contacts:

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Frannie DeFranco  +1 215 751 4855  (Philadelphia)

LONDON, Dec. 17, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations.

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: "Approximately 40% of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease.  BENLYSTA is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease."

The FDA approval for adult patients with active LN follows a Breakthrough Therapy Designation and Priority Review and is based on the positive results of the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study and the unmet need in this patient population. The BLISS-LN study is the largest and longest phase 3 study conducted in active LN, involving 448 adult patients. The study met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) at two years (or 104 weeks) when treated with BENLYSTA plus standard therapy compared to placebo plus standard therapy in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311). Statistical significance compared to placebo across all four major secondary endpoints was achieved, including Complete Renal Response and Time to Renal-Related Event or Death. The safety results are consistent with the known safety profile of BENLYSTA.

Dr. Richard Furie, Chief of the Division of Rheumatology and Professor at the Feinstein Institutes for Medical Research at Northwell Health and Lead Investigator of the BLISS-LN study, commented: "We have long aspired to enhance outcomes for patients with lupus nephritis. In the four decades I have been caring for people with lupus, we have not been able to achieve remission in more than just one-third of patients with lupus nephritis and, despite all of our efforts, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease. The data from the BLISS-LN study show that BENLYSTA added to standard therapy not only increased response rates over two years, but it also prevented worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone. Therefore, it is gratifying to see the rewards of decades of research."

Dr. Brad Rovin, Director of the Division of Nephrology and Medical Director of the Center for Clinical Research Management at the Ohio State University Wexner Medical Center, commented: "The overarching goal in the management of patients with lupus nephritis is to delay the need for kidney replacement therapies, such as dialysis and transplantation. The BLISS-LN study not only demonstrated that the addition of BENLYSTA to standard therapy significantly increased the PERR, but also showed that patients had a 49% decrease in risk for experiencing a renal-related event. I'm encouraged by the progress we're making in lupus nephritis."

About the BLISS-LN study

BLISS-LN is a phase 3, 104-week, randomised, double-blind, placebo-controlled, post-approval commitment study to evaluate the efficacy and safety of intravenous (IV) BENLYSTA 10 mg/kg plus standard therapy (mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard therapy in adult patients with active LN. Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy.

For US Patients: Making our products affordable and accessible

GSK is actively involved in creating solutions that allow patients to have access to new scientific breakthroughs. We remain committed to helping patients access GSK medications and have a long history of providing patient assistance programs. Patients and healthcare professionals who need help with prescription coverage should visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597) for eligibility information.

About lupus nephritis (LN)

Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. In lupus nephritis (LN), SLE causes kidney inflammation (swelling or scarring) of the small blood vessels that filter wastes in your kidney (glomeruli) and sometimes the kidneys, by attacking them like they would attack a disease¹. LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.^2,3 Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of urinary sediment.

About BENLYSTA (belimumab)

BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. By binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. First approved in 2011, it is the first and only approved biologic for both SLE and LN in more than 50 years.

The following information is based on the US Prescribing Information for BENLYSTA in licensed indications only. Please consult the full Prescribing Information for all the labelled safety information for BENLYSTA.

INDICATION

BENLYSTA is indicated for patients aged ≥5 years with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy and patients aged ≥18 with active lupus nephritis who are receiving standard therapy. The subcutaneous (SC) formulation is approved for patients aged ≥18 years. BENLYSTA is not recommended in patients with severe active central nervous system lupus or in combination with other biologics.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The incidence of serious infections was similar in patients receiving BENLYSTA versus placebo, whereas fatal infections occurred more frequently with BENLYSTA.  The most frequent serious infections in adults with SLE treated with BENLYSTA IV included pneumonia, urinary tract infection, cellulitis, and bronchitis. Use caution in patients with severe or chronic infections and consider interrupting therapy in patients with a new infection.

Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.

Hypersensitivity Reactions (Including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis (eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea) and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. With BENLYSTA SC, systemic hypersensitivity reactions were similar to those in IV trials.

Healthcare providers (HCPs) should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction. Premedication may mitigate or mask a hypersensitivity response. Advise patients about hypersensitivity symptoms and instruct them to seek immediate medical care if a reaction occurs.

Infusion Reactions: Serious infusion reactions (eg, bradycardia, myalgia, headache, rash, urticaria, and hypotension) were reported in adults. HCPs should monitor patients and manage reactions if they occur. Premedication may mitigate or mask a reaction. If an infusion reaction develops, slow or interrupt the infusion.

Depression and Suicidality: In adult trials, psychiatric events were reported more frequently with BENLYSTA IV related primarily to depression-related events, insomnia, and anxiety; serious psychiatric events included serious depression and suicidality, including 2 completed suicides. No serious depression-related events or suicides were reported in the BENLYSTA SC trial. Before adding BENLYSTA, assess patients' risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts, or other mood changes.

Malignancy: The impact of BENLYSTA on the development of malignancies is unknown; its mechanism of action could increase the risk for malignancies.

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

Use With Biologic Therapies: BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies.

ADVERSE REACTIONS:

The most common serious adverse reactions in adult SLE clinical trials were serious infections, BENLYSTA IV 6.0% (placebo 5.2%), some of which were fatal infections BENLYSTA IV 0.3% (placebo 0.1%). Adverse reactions occurring in ≥3% of adults and ≥1% more than placebo: nausea 15% (12%); diarrhea 12% (9%); pyrexia 10% (8%); nasopharyngitis 9% (7%); bronchitis 9% (5%);  insomnia 7% (5%); pain in extremity 6% (4%); depression 5% (4%); migraine 5% (4%); pharyngitis 5% (3%); cystitis 4% (3%); leukopenia 4% (2%); viral gastroenteritis 3% (1%).

In adult patients with active lupus nephritis, serious infections occurred in 14% of patients receiving BENLYSTA IV (placebo 17%), some of which were fatal infections, BENLYSTA 0.9% (placebo 0.9%).  Adverse reactions occurring in ≥3% of adults and ≥1% more than placebo were consistent with the known safety profile of BENLYSTA IV in SLE patients. 

Adverse reactions in pediatric patients aged ≥5 years receiving BENLYSTA IV were consistent with those observed in adults.

The safety profile observed for BENLYSTA SC in adults was consistent with the known safety profile of BENLYSTA IV with the exception of local injection site reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.

Pregnancy Registry: HCPs are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.

Lactation: No information is available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. Consider developmental and health benefits of breastfeeding with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness have not been established for BENLYSTA IV in SLE patients <5 years of age, and in active LN patients <18 years of age, and for BENLYSTA SC in SLE and LN patients <18 years of age.

GSK's commitment to immunology

GSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and pediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.

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.

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.

Registered in England & Wales:

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¹ National Kidney Foundation, Lupus and Kidney Disease (Lupus Nephritis).  Available at  https://www.kidney.org/atoz/content/lupus

² Gordon C, Hayne D, Pusey C, et al. European Consensus Statement on the Terminology used in the Management of Lupus Glomerulonephritis. Lupus 2009;18:257-26.

³ Waldman M and Appel GB. Update of the Treatment of Lupus Nephritis. Kidney International 2006;70:1403-1412.

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SOURCE GlaxoSmithKline (GSK)

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.

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

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.

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

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201022005301/en/

• 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
nravindran@vir.bio
+1-415-506-5256

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

• 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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Vir Biotechnology Contacts:

Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications
nravindran@vir.bio 
+1 415 506 5256

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

GSK Contacts:

Media:
Simon Steel  +44 (0) 20 8047 5502  (London)
Tim Foley  +44 (0) 20 8047 5502  (London)
Kristen Neese  +1 804 217 8147  (Philadelphia)
Kathleen Quinn  +1 202 603 5003  (Washington DC)

Analysts/Investors:
Sarah Elton-Farr  +44 (0) 20 8047 5194  (London)
Sonya Ghobrial  +44 (0) 7392 784784  (Consumer)
Danielle Smith  +44 (0) 20 8047 0932  (London)
James Dodwell  +44 (0) 20 8047 2406  (London)
Jeff McLaughlin  +1 215 751 7002  (Philadelphia)
Frannie DeFranco  +1 215 751 4855  (Philadelphia)

RESEARCH TRIANGLE PARK, N.C., Oct. 1, 2020 /PRNewswire/ -- ViiV Healthcare announces its new weekly podcast Being Seen, an in-depth exploration of the role culture plays in resolving how we see ourselves and how we are seen by others. Hosted and narrated by Darnell Moore, award-winning writer and activist, the first season explores current cultural representations of the queer and gay Black male experience and the impact on their lives and society. Being Seen is available October 6^th wherever you get your podcasts and at www.beingseenpodcast.com.

Through conversations with leading artists, writers, activists, entertainers, and community leaders including; writer, director, and producer Lee Daniels and Ben Cory Jones; Samira Nasr, Editor-in-Chief at Harper's Bazaar, and activist, writer, George M. Johnson, ViiV Healthcare hopes Being Seen encourages the creation of more accurate cultural portrayals of the queer and gay Black male experience in order to reduce stigma and change perception - impacting everything from HIV to institutional inequality.

"There is nothing else like Being Seen in the podcast universe for Black gay and queer men – it's a safe space and platform for them to express themselves, share their experiences, and bare their souls and identities freely and uncensored," said Marc Meachem, head of US External Affairs for ViiV Healthcare.  "We think it will reduce stigma and bring hope to Black gay and queer men who may find their story in the stories being shared on the podcast and know they are not alone, they are being seen – and we hope it encourages them to write or tell their own story even if it's just for themselves."  

The project has been enriched and informed by creative consultants and partners Emil Wilbekin founder of Native Son; DaShawn Usher founder of MOBI; Emmy winning producer Darius Brown; Photographers Gioncarlo Valentine and Texas Isaiah – both of whom served as curators for Being Seen photography. As well as the incredible group of illustrators and photographers who either licensed work or created original work to help bring the project to life visually and through sound.  Theme music for the podcast is Colouour by Moses Sumney. 

"Being Seen podcast is another medium through which the lives of Black queer and trans men are uplifted and centered. Our contributions to culture matter. The work that so many of us do on behalf Black people matters" said Darnell Moore. "And we have to share our stories, as different and complex as they may be, to push back against the erasure of our work and voices. I hope that audiences end every episode a bit more committed to co-creating a world where the lives of all Black people matter."

ViiV's evolving commitments to communities in the US most disproportionately impacted by HIV, and the reality of current times have motivated support of this new cultural collaboration.  

"Our sole focus on HIV and the HIV community for more than 10 years has given ViiV clear insights into the importance of listening and hearing the community – and we are committed to amplifying those voices through our work" said Lynn Baxter, Head of North America, ViiV Healthcare. "Being Seen brings awareness to the impact of stigma on every aspect of these individual's lives and spotlights the obligation everyone has to end discrimination against marginalized communities, including people living with HIV." 

Being Seen expands on the insights and findings from landmark ethnographic research conducted by ViiV Healthcare, exploring the lives of Black gay men in Baltimore, Maryland, and Jackson, Mississippi.  This research uncovered that these men wanted the freedom to create their own experiences and live without labels. It also gave life to the ground-breaking experiential theater piece As Much As I Can, created and produced by Harley & Co and presented by ViiV Healthcare.

Being Seen is produced by Harley & Co. and Darnell Moore and created in partnership with ViiV Healthcare.

About Darnell Moore – Being Seen host and producer

Darnell L. Moore is an award-winning writer, activist, organizer, and author of No Ashes in the Fire: Coming of Age Black and Free in America. He is Director of Inclusion Strategy for Content & Marketing at Netflix, editor-at-large at CASSIUS and co-managing editor at The Feminist Wire. A prolific writer, Darnell has been published in various media outlets including MSNBC, The Guardian, Huffington Post, EBONY, The Root, The Advocate, OUT Magazine, VICE and others, as well as numerous academic journals. He received the Humanitarian Award from the American Conference on Diversity for his LGBTQ advocacy and has been named among EBONY Magazine's Power 100, Time Out New York's Eight LGBT Influencers, The Root 100, and Planned Parenthood's Top 99 Dream Keepers.

About Harley & Co – Being Seen Producer

Harley & Co. is a New York based creative studio that produces award-winning multi-platform social justice and culture projects such as activist experiential theater, "As Much As I Can." Their work has won numerous awards including Cannes Lions, AD&D, Shorty for Social Good and most recently, Fast Company's World Changing Ideas. Harley & Co. has been featured in the NYTimes, Teen Vogue, NBC, ABC and Bloomberg, among others, for their unique creative design and approach.  

About ViiV Healthcare

ViiV Healthcare is the only pharmaceutical company solely focused on combating, preventing, and ultimately curing HIV and AIDS.  We exist to make sure no one living with HIV and AIDS is left behind, and we are 100% dedicated to addressing the challenges of the HIV epidemic. Our portfolio ambition is to make HIV a smaller part of people lives.  Beyond developing innovative medicines, ViiV Healthcare works with communities to address enduring disparities in HIV care and outcomes. 

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline and commitment, please visit https://viivhealthcare.com/en-gb/.

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.

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.