Sotrovimab (Xevudy) Antibody Description
Sotrovimab (Xevudy®) (VIR-7831, GSK4182136) is a fully human anti-SARS-CoV-2 monoclonal antibody 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 important sites of infection).
This antibody therapy binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (SARS). In preclinical 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 Biotechnology and GSK are advancing Sotrovimab (VIR-7831) due to their collaboration to research and develop solutions. Sotrovimab, sold under the brand name Xevudy. The Companies published 'A Detailed Guide for the Use of Sotrovimab' in July 2021.
The U.S. FDA's EUA issued on May 26, 2021, allows for Sotrovimab to be distributed and administered as a 500-milligram single dose intravenously by health care providers.
The data that support the EUA for sotrovimab came from the Phase 3 COMET-ICE trial, which included outpatients with mild to moderate COVID-19 who were at high risk for progression to severe disease and/or hospitalization. A total of 583 participants were randomized to receive sotrovimab 500 mg IV (n = 291) or placebo (n = 292). The primary endpoint was the proportion of hospitalized participants ( ≥24 hours) or who died from any cause by Day 29. Endpoint events occurred in 3 of 291 participants (1%) in the sotrovimab arm and 21 of 292 participants (7%) in the placebo arm (P = 0.002), resulting in a 6% absolute reduction and an 85% relative reduction in hospitalizations or death among the sotrovimab recipients compared to the placebo recipients.
On September 1, 2021, the Fact Sheet for Healthcare Providers was updated. And on September 24, 2021, the U.S. NIH updated COVID-19 Treatment Guidelines on the Emergency Use Authorizations of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19.
On October 8, 2021, the updated FDA EUA provides a broad list of medical conditions or other factors as criteria for use of anti-SARS-CoV-2 mAbs as treatment or PEP
CAS Number: 2423014-07-5; Drugbank: DB16355; UNII: 1MTK0BPN8V; KEGG: D12014
Sotrovimab (Xevudy) Antibody Authorizations
Australia became the first OECD country to issue formal regulatory approval for sotrovimab (XEVUDY) on August 20, 2021. The European Medicines Agency advised using sotrovimab (VIR-7831) to treat COVID-19 on May 21, 2021. On October 4, 2021, Australia confirmed it increased its order of sotrovimab from 7,700 to 31,000 doses.
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization on May 26, 2021, for the investigational monoclonal antibody therapy Sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kilograms 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. The EUA does not authorize the use of anti-SARS-CoV-2 monoclonal antibodies for hospitalized COVID-19 patients.
On May 29, 2021, the United Arab Emirates Ministry of Health and Prevention approved the emergency use of Sotrovimab, becoming the first country in the world to both license and enable immediate patient use. On July 30, 2021, Health Canada authorized sotrovimab for specific populations. The Companies filed for authorization in Japan on September 6, 2021, and Brazil on September 9, 2021.
The EMA's human medicines committee started a 'rolling review' of data on sotrovimab (VIR-7831 and GSK4182136) on July 5, 2021.
Japan's health ministry announced it approved a monoclonal antibody-based treatment developed by GlaxoSmithKline PLC and U.S. firm Vir Biotechnology Inc. on September 27, 2021.
On September 29, 2021, Vir Biotechnology confirmed binding agreements have been received for the sale of more than 420,000 doses of sotrovimab worldwide, including a portion of those procured by the U.S. government. In addition, more than 220,000 doses have been reserved through other agreements.
Updated COVID-19 Treatment Guidelines Panel’s Statement on October 7, 2021, for the Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment or Prevention of SARS-CoV-2 Infection When There Are Logistical or Supply Constraints. Find facilities in the USA administering monoclonal antibodies by using the National Infusion Center Locator or the HHS Therapeutics Distribution locator to find a potential therapy location.
Sotrovimab (Xevudy) Antibody History
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 Severe Acute Respiratory Syndrome.
In April 2020, Vir and GSK announced a collaboration to research and develop coronavirus solutions, including SARS-CoV-2, which causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new antiviral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks.
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, M.D., Ph.D., chief scientific officer of Vir, in a press release.
On December 17, 2020, the U.S. 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. 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. George Scangos stated in a related press release, "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."
George Scangos, Ph.D., CEO of Vir, commented on August 23, 2021, "The provisional approval of sotrovimab in Australia marks an important milestone for Vir, as it is the first marketing authorization of our first commercial product. It also represents an important step forward in the Australian Government's efforts to combat the pandemic and prevent the most severe effects of COVID-19, particularly in the face of new and emerging variants. We eagerly anticipate additional regulatory decisions around the world in the coming months and look forward to working with our partner, GSK, to expand patient access to a much-needed treatment option that continues to demonstrate, in vitro, its ability to retain activity against the tested, currently circulating variants of concern and interest, including Delta and Delta Plus."
VIR Bio is a California-based clinical-stage immunology company that combines immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. 'We engineer the fully human antibodies that we discover to enhance their therapeutic potential,' says the Company's website.
The VIR - GSK study received funding support through Operation Warp Speed, the U.S. government's multi-agency effort to develop, manufacture, and distribute medical countermeasures for COVID-19.
The U.S. NIH issued a SPECIAL BULLETIN COVID-19 #173: Sotrovimab for Intravenous Infusion HCPCS Code Q0247: Billing Guidelines on July 21, 2021. The FDA updated its Fact Sheet for Healthcare Providers EUA 000100 on September 1, 2021.
All treatment sites may also find information on the availability and ordering of sotrovimab by visiting GSK's website.
Sotrovimab (Xevudy) Antibody Indication
When using 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 U.S. 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.
The COVID-19 Treatment Guidelines Panel recommends Sotrovimab 500 mg intravenous (IV) infusion.
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 individuals who are at high risk for progression to severe COVID-19.
Sotrovimab (Xevudy) Antibody and SARS-CoV-2 Virus Variants
On August 6, 2021, data from in vitro studies published in bioRxiv shows that sotrovimab as a single monoclonal antibody maintains activity against currently circulating variants of concern and interest, including Delta and Lambda strains. The clinical implications of the in vitro data on these variants are unknown, and data collection and analysis are ongoing.
On August 27, 2021, the Assistant Secretary for Preparedness and Response and the FDA announced based on in vitro assay data currently available, sotrovimab is likely to retain activity against the P.1, B.1.351, AY.1 and AY.2, B.1.621, and B.1.617.2/Delta variants. As such, the use and distribution of sotrovimab are not impacted by the circulating variants based on information available at this time.
The U.S. CDC publishes updated virus variant information in this Tracker App.
Sotrovimab (Xevudy) Antibody Side Effects
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 administration of 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.
On September 9, 2021, the EMA published COVID-19 treatment: Under Evaluation that is not Authorised specifically for patients with COVID-19.
Sotrovimab (Xevudy) Antibody News
October 9, 2021 - The U.K. government bought 100,000 doses of Sotrovimab, the Telegraph reported. However, Sotrovimab has not been approved by U.K. regulators and the deal is subject to approval.
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 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 23, 2021 - Florida Governor Ron DeSantis announced that 3,000 doses of sotrovimab had been ordered.
September 14, 2021 - Local media reported UAE patients successfully treated with Sotrovimab. 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 U.S. 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 is 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 U.S. 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. The national authorities can now consider the CHMP opinion under Article 5(3) in E.U. 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 E.U. 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 U.S. 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 U.S. 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 E.U. 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 be investigated as 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 key 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 U.S. 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 U.S. 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. 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 therapies 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 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 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 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. 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 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 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 Company announced on May 7, 2021, it plans to initiate two additional Phase 3 trials in the COMET clinical development program for VIR-7831. These Phase 3 programs include 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; and 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.
A Phase 3 randomized, multi-center, open-label study ClinicalTrials.gov Identifier: NCT04913675 to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients was last updated on September 24, 2021.