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Sotrovimab (Xevudy) Antibody

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January 18, 2022
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Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Description

GSK and Vir Biotechnology's Sotrovimab (Xevudy®) (VIR-7831, GSK4182136) is a pan-sarbecovirus anti-SARS-CoV-2, human neutralizing monoclonal antibody (mAbs) selected based on its potential to neutralize the betacoronavirus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the essential sites of infection). 

The Sotrovimab antibody therapy binds to an epitope on the SARS-CoV-2 coronavirus. In preclinical trials, the antibody has shown the ability to neutralize the coronavirus, indicating that the epitope is highly conserved, making it more difficult for escape mutants to develop. Sotrovimab was derived from a parent antibody (S309), first isolated in 2003 from memory B cells taken from an individual who had recovered from the SARS-1.

In April 2020, Vir Biotechnology, Inc. and GSK announced a collaboration to research and developed Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new antiviral antibodies. On May 26, 2021, GlaxoSmithKline LLC received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody (mAb) sotrovimab. The U.S. NIH issued a SPECIAL BULLETIN COVID-19 #173: Sotrovimab for Intravenous Infusion HCPCS Code Q0247: Billing Guidelines on July 21, 2021. In December 2021, the FDA updated the EUA, allowing healthcare providers to administer sotrovimab to treat 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.

The companies announced preclinical data found sotrovimab retains in vitro activity against the SARS-CoV-2 virus variant Omicron spike protein on December 7, 2021. In addition, the U.S. government stated on December 17, 2021, 'early in vitro data suggests sotrovimab retains activity against the Omicron variant.' In addition, the US NIH published updated COVID-19 Treatment Guidelines on the Emergency Use Authorizations of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19 on December 30, 2021.

The European Medicines Agency (EMA) and the European Commission authorized Xevudy (Sotrovimab) on December 17, 2021. The UK's MHRA approved Xevudy (sotrovimab) on December 2, 2021. And the WHO issued an update on January 14, 2022.

The University of Oxford, located in England, is also studying Sotrovimab among patients hospitalized with COVID-19 in the United Kingdom as part of the Randomized Evaluation of COVID-19 Therapy (RECOVERY) Phase 2/3 Trial. Early VIR - GSK clinical studies received funding support through the U.S. Operation Warp Speed.

Updated Fact Sheet for Healthcare Providers, the FDA Letter of Authorisation, and the full Fact Sheet for Patients, Parents, and Caregivers. CAS Number: 2423014-07-5; Drugbank: DB16355; UNII: 1MTK0BPN8V; KEGG: D12014.

Vir Biotechnology, Inc. (Nasdaq: VIR) is a California-based clinical-stage immunology company that combines immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

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

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody and Coronavirus Variants (Omicron)

Vir Bio and partner GSK announced preclinical live virus data support pseudovirus testing demonstrating that the investigational monoclonal antibody retains activity against all tested SARS-CoV-2 variants of concern, including, but not limited to, Delta and Omicron. As of January 18, 2022, the U.S. NIH OpenData Portal reported Sotrovimab's effectiveness against the Omicron virus variant. And the U.S. CDC and Scripps publish updated virus variant information in this Tracker App. Additionally, on December 23, 2021, the U.S. HHS Assistant Secretary for Preparedness and Response (ASPR) confirmed sotrovimab appears to retain activity against the Omicron variant. 

To date, sotrovimab has demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization. The EMA announced on December 16, 2021, based on laboratory studies, Xevudy is expected to be active against SARS-CoV-2 virus variants, including Omicron. In addition, non-peer-reviewed research was published by bioRxiv on December 15, 2021, with preclinical data demonstrating that sotrovimab retains activity against key mutations of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab.

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Availability

On January 17, 2022, the U.S. HHS Assistant Secretary for Preparedness and Response (ASPR) confirmed 52,064​ sotrovimab doses were distributed in the U.S. The state, territory, and agency allocations are listed on this ASPR webpage. Since October 2021, about 437,00 doses have been shipped in the U.S. 

On January 11, 2022, the companies announced that the US Government would purchase an additional 600,000 doses of sotrovimab to be delivered throughout the first quarter of 2022. This agreement is an amendment to earlier commitments announced with the US Government ($1 billion) in November 2021. Sotrovimab is not available for retail purchase as of January 2022. Find facilities in the USA administering monoclonal antibodies using the National Infusion Center Locator or the HHS  Therapeutics Distribution locator to find a potential therapy location  Treatment sites may also find information on the availability and ordering of sotrovimab by visiting GSK's website

As of January 18, 2022, Sotrovimab (Xevudy) had been granted authorization in Australia, Ireland, Saudi Arabia, EuropeJapanAustralia, Bahrain, Brazil, Canada, Egypt, Italy, Kuwait, Oman, Qatar, Singapore, Switzerland, Thailand, the United Kingdom, the United Arab Emirates, and by the WHO. In addition, GSK confirmed the total number of doses secured to date through binding agreements to approximately 1.7 million globally. Sotrovimab has been invited for WHO Prequalification, which assesses the quality, efficacy, and safety of priority health products to increase access in lower-income countries. 

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody History

A phase 2/3 clinical study was launched on September 10, 2020, in which subjects with COVID-19 will receive VIR-7831 or placebo and be assessed for safety, tolerability, efficacy, and pharmacokinetics. 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. A manuscript developed by Vir in collaboration with the MRC-University of Glasgow Centre for Virus Research, published on November 5, 2020, "shows that the receptor-binding motif of SARS-CoV-2, a major target of neutralizing antibodies, is evolving at a higher rate than the rest of the receptor-binding domain and spike, and is resilient to change," said Herbert "Skip" Virgin, MD, Ph.D., chief scientific officer of Vir, in a press release. 

On December 17, 2020, the US NIH stated, 'One sub-study evaluates VIR-7831  Antibodies are infection-fighting proteins naturally made by the immune system  Antibodies can prevent viruses from infecting cells, sometimes binding to the viruses' surface  Synthetic versions of these antibodies, prepared in a laboratory, are known as monoclonal antibodies.'

On March 3, 2021, 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 were available data raised concerns about the magnitude of potential benefit. As a result, the independent Data and Safety Monitoring Board has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. And the NEJM published an ORIGINAL ARTICLE on November 8, 2021: Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab - Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression.

The NEJM published an ORIGINAL ARTICLE on November 18, 2021: Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. The phase 2/3 study conclusion stated, 'Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression, and no safety signals were identified.' The Phase 3, randomized, open-label, non-inferiority COMET-TAIL clinical trial, which achieved its primary endpoint, demonstrated that 500 mg IM administration of sotrovimab (n=376) was non-inferior and offered similar efficacy to 500 mg IV administration (n=378) for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents. In addition, low rates of serious adverse events (≤1% in both arms) were observed in the headline data.

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Indication

Recommendations issued on January 14, 2022, form the eighth update of WHO's living guidelines on therapeutics and COVID-19. The U.S. NIH published COVID-19 Treatment Guidelines Panel's Statement on Therapies for High-Risk, Non-hospitalized Patients With Mild to Moderate COVID-19 on December 30, 2021.

A study published by The Lancet of December 23, 2021, concluded a potential opportunity for mAds therapies to be targeted to patients hospitalized with early-stage COVID-19 who have not developed endogenous antibodies. On December 16, 2021, the U.S. published: Federal Response to COVID-19: mAbs Clinical Implementation Guide. And Sotrovimab is included in NIH COVID-19 Treatment Guidelines. The COVID-19 Treatment Guidelines Panel recommends using anti-SARS-CoV-2 monoclonal antibodies to treat mild to moderate COVID-19 and for post-exposure prophylaxis of SARS-CoV-2 infection in high-risk individuals progression to severe COVID-19.  

When using Anti-SARS-CoV-2 monoclonal antibodies, treatment should be started as soon as possible after the patient receives a positive result on a SARS-CoV-2 antigen or nucleic acid amplification test (NAAT) and within ten days of symptom onset  Authorized by the US FDA, the benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19  In addition, 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.

And the U.S. FDA says 'Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above.'

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Overview

The SARS-CoV-2 genome encodes four major structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N), as well as nonstructural and accessory proteins. The spike protein is further divided into S1 and S2, which mediate host cell attachment and invasion. Through its receptor-binding domain (RBD), S1 attaches to angiotensin-converting enzyme 2 (ACE2) on the host cell; this initiates a conformational change in S2 that results in virus-host cell membrane fusion and viral entry.

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Side Effects

The safety profile of Xevudy was favorable, with a small number of hypersensitivity (allergic) reactions and infusion-related reactions, and the EMA's CHMP concluded that the medicine's benefits are greater than its risks for the approved use.

Adverse reactions: Diarrhea, hypersensitivity reactions (includes rash, dermatitis contact, skin reaction, hypersensitivity, multiple allergies, infusion-related reaction, and bronchospasm)  One case of anaphylaxis was reported following infusion of sotrovimab in a study in hospitalized patients; the patient received epinephrine, and the event resolved.

Clinical worsening of COVID‑19 after SARS-CoV-2 monoclonal antibody treatment has been reported. It may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. However, it is unknown if these events were related to SARS-CoV-2 monoclonal antibody use or were due to the progression of COVID‑19.

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

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

SARS-CoV-2 mAbs Payment in the U.S.

During the COVID-19 public health emergency, Medicare pays for mAbs infusions (when furnished consistent with their respective EUAs) the same way it covers and pays for COVID-19 vaccines  CMS identified specific code(s) for each COVID-19 monoclonal antibody product and a particular administration code (Q0247) for Medicare payment.

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Financial News

January 14, 2022 - Zacks Equity Research published a review.

Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody News

January 17, 2022 - The U.S. government confirmed state, territory, and agency-based allocations of Sotrovimab for this week.

January 14, 2022 - The World Health Organization panel of experts conditionally recommended the use of sotrovimab for treating mild or moderate COVID-19 in patients who are at high risk of hospitalization. This includes patients who are older, immunocompromised, have underlying conditions like diabetes, hypertension, and obesity, and those unvaccinated.

January 13, 2022 - GSK and Vir Biotechnology, Inc. announced the submission of an application to the U.S. FDA requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab include intramuscular administration (500 mg). The EUA for sotrovimab was granted by the FDA in May 2021 as an investigational single-dose intravenous (500 mg) infusion SARS-CoV-2 monoclonal antibody for the early treatment of COVID-19.

January 11, 2022 - GSK and Vir Biotechnology, Inc. announced that the US Government will purchase an additional 600,000 doses of sotrovimab.

January 6, 2022 - GSK Canada announced it has signed agreements with the Government of Canada to supply 20,000 doses of Sotrovimab for injection. This order follows an initial purchase agreement to supply 10,000 doses of Sotrovimab, announced on October 4, 2021. 

January 5, 2022 - Ireland's Health Minister Stephen Donnelly brought a memo to Cabinet proposing the Government expand ordering new COVID-19 treatments. Ireland is already part of an EU agreement for the purchase of the GSK monoclonal antibody product Xevudy (Sotrovimab).

January 2, 2022 - Sotrovimab was approved for use by Health Canada in July 2021. To date, Canada has received 10,000 doses of sotrovimab from Italy, Public Services and Procurement Canada told Global News.

December 31, 2021 - Vir Biotechnology, Inc. announced new non-peer-reviewed preclinical research describing the structural basis and magnitude of the new SARS-CoV-2 Omicron variant (B.1.1.529) evades antibody-mediated immunity, as well as its enhanced ability to bind to the human ACE-2 receptor. 

December 27, 2021 - The State of Texas announced its regional infusion centers had exhausted their supply of sotrovimab, the monoclonal antibody effective against the COVID-19 Omicron variant, due to the national shortage from the federal government. Other monoclonal antibodies have not been effective against the Omicron variant, which accounts for more than half of all new COVID-19 cases. The infusion centers will continue to offer those antibodies as prescribed by health care providers for people diagnosed with a non-Omicron case of COVID-19. 

December 23, 2021 - The Texas Department of State Health Services confirmed the Amarillo Area Infusion Center would begin providing Sotrovimab on Dec. 24, 2021. Sotrovimab will replace Bamlanivimab and Regeneron as a treatment for COVID-19 patients eligible for treatment at the infusion center, located at 808 S. Johnson St. 

December 20, 2021 - The UK announced the Sotrovimab monoclonal antibody would be given as a transfusion to transplant recipients, cancer patients, and other high-risk groups. Initial tests suggest it should still work against the Omicron variant. "These new drugs have an important role to play," said Prof Steven Powis, the national medical director of NHS England.

December 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the European Commission had granted marketing authorization to Xevudy (sotrovimab) for the early treatment of COVID-19. 

December 16, 2021 - The EMA's vaccine committee has recommended authorizing the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19 for certain people. In reaching its conclusion, the CHMP evaluated data from a study involving 1,057 patients with COVID-19 showing that treatment with Xevudy significantly reduces hospitalization and deaths in patients with at least one underlying condition putting them at risk of severe COVID-19  Following treatment with Xevudy, 1% of patients (6 out 528) were hospitalized for longer than 24 hours within 29 days of treatment compared with 6% of patients on placebo (30 out of 529), 2 of whom died.

December 7, 2021 - GSK and Vir Biotechnology announced an update to preclinical data demonstrating that sotrovimab retains in vitro activity against the full known Omicron (B.1.1.529)  spike protein. Additionally, they announced that Management would host a conference call at 8:30 am ET, December 7, 2021, to discuss the new data.

December 2, 2021 - Xevudy (sotrovimab) was approved by the UK's Medicines and Healthcare products Regulatory Agency after it was found to be safe and effective at reducing the risk of hospitalization and death in people with mild to moderate COVID-19 infection who are at increased risk of developing severe disease.

December 2, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced an update with preclinical data demonstrating that sotrovimab retains activity against key mutations of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab. The companies are now completing in vitro pseudovirus testing to confirm the neutralizing activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.

November 18, 2021 - The EMA confirmed it will assess the benefits and risks of Xevudy under a reduced timeline and could issue an opinion within two months, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation. Such a short timeframe is only possible because EMA's CHMP has already reviewed some data on the medicine during a Rolling Review. 

November 17, 2021 - GSK and Vir Biotechnology announced US government contracts totaling approximately $1 billion to purchase sotrovimab  GSK would supply these doses to the US government by December 17, 2021, enabling further expanded nationwide access to sotrovimab for patients.

November 12, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced headline data from the COMET-TAIL Phase III trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high-risk patients up to seven days after symptom onset  In the IM administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalization for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm (also 500mg)  The upper bound of the 95% CI is within the predetermined 3.5% non-inferiority margin set for the trial's primary endpoint in consultation with the US FDA.

October 27, 2021 - The NEJM published an ORIGINAL ARTICLE - Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. CONCLUSIONS: Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified in this phase 2/3 clinical trial.

October 27, 2021 - GSK announced Xevudy sales reached £114 million  And received binding agreements to sell more than 420,000 doses worldwide, including a portion of those procured by the US Government. In addition, more than 220,000 doses have been reserved through other agreements, Granted conditional or provisional marketing authorization in Australia, Japan, and Saudi Arabia, and been granted emergency or temporary authorization in Brazil, Canada, Italy, Singapore, Switzerland, the United States, and several other countries.

October 4, 2021 - GSK today announced it had signed an agreement with the Government of Canada to supply 10,000 doses of Sotrovimab for injection, a COVID-19 monoclonal antibody therapy developed by GSK and Vir Biotechnology  Health Canada granted authorization for Sotrovimab for injection on July 30, 2021.

October 3, 2021 - Local media reported fifteen thousand doses of sotrovimab have landed in Australia in recent days. Health Minister Greg Hunt said sotrovimab would reduce the impact of COVID-19 for many people who catch it.

September 29, 2021 - Vir Biotechnology confirmed binding agreements had been received to sell more than 420,000 doses of sotrovimab worldwide, including a portion of those procured by the US government. In addition, more than 220,000 doses have been reserved through other agreements.

September 27, 2021 - The Fred Hutch news service published: Ongoing trials test COVID-19 drugs for earlier, more accessible treatment. Injected monoclonal antibodies or oral antivirals could help more patients recover faster.

September 27, 2021 - Local media in Japan reported 'Dr. Joe Chiba, professor emeritus at the Tokyo University of Science, said that the drug will expand treatment choices at a time when some high-risk patients, such as those with rheumatoid arthritis or cancer, are not seeing any rise in neutralizing antibodies for the coronavirus despite the completion of a two-shot COVID-19 vaccine regimen, due to the use of immunosuppressive drugs.'

September 23, 2021 - Australia's Hon Greg Hunt MP, Minister for Health and Aged Care, announce 'that we are lifting our purchase of sotrovimab from 7,700 units to 30,000 units.'

September 14, 2021 - Local media reported UAE patients successfully treated with Sotrovimab. In addition, the Abu Dhabi Health Services Company (Seha) said its facilities have "effectively supported patients" with the treatment.

September 9, 2021 - Local media reported Brazil issued a EUA for Sotrovmab.

September 6, 2021 - GlaxoSmithKline announced that it had applied for approval to the Japanese Ministry of Health, Labour, and Welfare for sotrovimab, a single-dose, monoclonal antibody, for the treatment of COVID-19  GSK  Japan seeks to obtain Special Approval for Emergency for this application.

August 27, 2021 - The Assistant Secretary for Preparedness and Response and the US Food and Drug Administration announced their commitment to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

August 23, 2021 - Vir Biotechnology, Inc. announced the first marketing authorization granted in Australia for sotrovimab, developed with GlaxoSmithKline  Sotrovimab, the first monoclonal antibody approved in Australia. As part of its overarching effort to address COVID-19, the Australian Government also recently announced an agreement to purchase sotrovimab, the first supply of which arrived in the country last week.

August 20, 2021 - The Australian Therapeutic Goods Administration, part of the Department of Health, granted provisional approval to GlaxoSmithKline Australia Pty Ltd for its COVID-19 treatment sotrovimab (XEVUDY). Australia is the first OECD country to issue formal regulatory approval for sotrovimab (XEVUDY).

August 4, 2021 - The US NIH added sotrovimab as a recommended treatment for non-hospitalized patients with mild to moderate COVID-19 at high risk for clinical progression.

July 28, 2021 - GSK reported its financial results and disclosed Vir and GSK announced full results from the Phase III COMET-ICE trial demonstrating a 79% reduction in hospitalization for more than 24 hours or death due to any cause with early treatment with sotrovimab in adult patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease. • Received Emergency Use Authorisation from the FDA to treat mild-to-moderate COVID-19 in high-risk adults and pediatric patients. • Received a positive scientific opinion from the EMA's Committee for Human Medicinal Products (CHMP) for the early treatment of COVID-19. As a result, the national authorities can now consider the CHMP opinion under Article 5(3) in EU member states.

July 28, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they had signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab. The Joint Procurement Agreement enables participating European Union 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.

July 24, 2021 - Local UAE health authorities in Abu Dhabi recently announced that the medicine was 100% successful in preventing deaths and led to a recovery rate of 97% among patients  And patients at the Covid-19 Prime Assessment Center, run by Abu Dhabi Health Services Company, said they felt relieved after the treatment.

July 13, 2021 - Italy approves GSK-Vir antibody to treat COVID-19.

July 8, 2021 - The US National Institutes of Health 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.

June 21, 2021 - The companies issued a press statement stating: '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. Further research was 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.'

May 29, 2021 - The United Arab Emirates Ministry of Health and Prevention (MoHAP) announced the emergency use Approval of the GSK, "Sotrovimab (Vir-7831)" treatment that offers the prospect of reducing hospitalization for more than 24 hours and fatalities by as much as 85% when administered to patients as an early treatment for COVID-19.

May 26, 2021 - The US FDA issued a EUA for the investigational monoclonal antibody therapy sotrovimab to treat mild-to-moderate COVID-19 in adults and pediatric patients  George Scangos, Ph.D., CEO 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  Thus, I believe that sotrovimab is a critical new treatment option to fight against the current pandemic and potentially future coronavirus outbreaks  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."

May 21, 2021 - A positive scientific opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use, under Article 5(3) of Regulation 726/2004, which can be considered by the national authorities in the EU Member States when making evidence-based decisions on the early use of the medicine before marketing authorization. 

May 7, 2021 - The European Medicine Agency (EMA) human medicines committee confirmed it had started a 'rolling review' of data on sotrovimab (VIR-7831 and GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, Inc. for the treatment of COVID-19  The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to prevent hospitalization or death in non-hospitalized patients with COVID-19. However, EMA has not yet received the entire dataset, and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

May 7, 2021 - Vir Bio confirmed Sotrovimab, along with VIR-7832, is evaluated in 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 investigate a potential COVID-19 treatment.

April 15, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. (Nasdaq: VIR) announced that the European Medicines Agency had 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.

April 14, 2021 - Australia's Therapeutic Goods Administration (TGA) has granted a provisional determination to GlaxoSmithKline Australia Pty Ltd (GSK) concerning the monoclonal antibody treatment SOTROVIMAB (GSK4182136). The granting of an interim determination means that the TGA has decided that GSK can now apply for provisional registration for the Australian Register of Therapeutic Goods treatment.

April 8, 2021 - Vir Biotechnology, Inc. announced new preclinical research highlighting novel mechanisms by which the SARS-CoV-2 virus enters host cells and identifying how auxiliary receptors may impact the clinical efficacy of monoclonal antibodies (mAbs). The research highlights the distinct mechanism of action of a non-receptor-binding motif (RBM)-targeting antibodies, such as VIR-7831 and VIR-7832, the Company's investigational SARS-CoV-2 mAbs that target a conserved non-RBM site within the receptor-binding domain.

April 5, 2021 - Vir Biotechnology, Inc. today announced new preclinical research demonstrating the ability of VIR-7831, the Company's investigational SARS-CoV-2 virus monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor-binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California variant (B.1.427/B.1.429)  Study results also demonstrate that the L452R mutation reduced the neutralization potency of plasma from vaccinated and convalescent donors and the neutralization activity of 14 RBD-specific and 10 N-terminal domain (NTD)-specific monoclonal antibodies, including three clinical-stage mAbs.

April 1, 2021 - A non-peer-reviewed study, 'SARS-CoV-2 immune evasion by variant B.1.427/B.1.429', was published. In this new study, Vir and the University of Washington researchers report the rapid and exponentially increasing spread of the California variant throughout all 50 states and 29 additional countries worldwide and characterize the impact of its three mutations: S13I and W152C in the NTD and L452R in the RBD.

March 29, 2021 - Vir Biotechnology, Inc., Eli Lilly and Company, and GSK plc 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 seven compared to placebo, meeting the primary endpoint. Also, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the critical virologic secondary endpoints of mean change from baseline to days 3, 5, and 7 SARS-CoV-2 viral loads.

March 26, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced the submission of an application to the US Food and Drug Administration requesting Emergency Use Authorization 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  GSK and Vir will continue discussions with the European Medicines Agency and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. 

March 10, 2021 - Vir Biotechnology, Inc. and GlaxoSmithKline plc (LSE/NYSE: GSK) announced that an Independent Data Monitoring Committee 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, demonstrating an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy placebo, the primary endpoint of the trial  Based on these results, Vir and GSK plan to submit an Emergency Use Authorization application to the US Food and Drug Administration (FDA) and authorizations in other countries  In addition, data from this registrational trial will also form the basis for a Biologics License Application submission to the FDA.

March 3, 2021 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health's 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  As a result, 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 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  The companies stated they '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.'

February 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they had 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 builds on the agreement signed in 2020 to research and develop treatments for coronaviruses.

February 1, 2021 - Vir Biotechnology, Inc. announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 spike protein – specifically the N-terminal domain  Together with data on immune evasion by mutations elsewhere in the spike protein published by scientists in Cell, the study findings begin to paint a comprehensive picture of the mechanisms that SARS-CoV-2 may utilize to evade immunity  Furthermore, these data collectively indicate the importance of carefully targeting conserved regions of the spike for vaccines and clinical monoclonal antibodies.

January 27, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc 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 assess 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 monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

January 12, 2021 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in Phase 1b/2a clinical trial  VIR-7832 is a different neutralizing COVID-19 antibody that preclinical data suggests has two distinctive properties: an enhanced ability to clear infected cells and the potential to strengthen virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection  This is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

December 17, 2020 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that the first patient had been dosed in a new sub-trial of the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines 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.

November 10, 2020 - George Scangos, Ph.D., chief executive officer of Vir Bio, said in a press release: "We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient populations alongside the initiation of Phase 1b/2a trial for our second investigational SARS-CoV-2 neutralizing antibody, VIR-7832."

November 6, 2020 - California based Vir Biotechnology, Inc. announced the publication of new research demonstrating that the immunodominant SARS-CoV-2 receptor binding motif (RBM) is the least conserved region in the SARS-CoV-2 spike protein, allowing for the occurrence of mutations without disrupting human ACE2 (hACE2) binding, which mediates viral entry  Researchers also characterize the virulence and fitness of N439K, a prevalent variant in the RBM that demonstrated resistance to human neutralizing monoclonal antibodies (mAbs), including one that is currently being evaluated in clinical trials.

October 8, 2020 - Study published by Nature: Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection.

October 6, 2020 - Vir Biotechnology and GSK announce the global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 to treat COVID-19  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 essential 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 expand globally to additional North American sites in South America and Europe.

September 24, 2020 - RESEARCH ARTICLE: Ultrapotent human antibodies protect against the SARS-CoV-2 challenge via multiple mechanisms.

September 16, 2020 - Study published by Cell: Mapping Neutralizing and Immunodominant Sites on the SARS-CoV-2 Spike Receptor-Binding Domain by Structure-Guided High-Resolution Serology.

August 31, 2020 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that the first patient was dosed last week in a phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.

May 18, 2020 - Study published in Nature: Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody.

April 21, 2020 - Study: Developing therapeutic monoclonal antibodies at a pandemic pace.

Sotrovimab (Xevudy) Antibody Clinical Trials

Sotrovimab is currently conducting various clinical trials.

The COMET-ICE: a Phase 3, multi-center, double-blind, placebo-controlled trial investigated IV infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalized and not requiring oxygen. The final COMET-ICE trial results in the full trial 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. Interim data were published in The New England Journal of Medicine on October 27, 2021, and final data were pre-published on November 8, 2021, on medRxiv.