{"id":1335,"date":"2021-12-19T12:06:58","date_gmt":"2021-12-19T05:06:58","guid":{"rendered":"https:\/\/news.eloqasia.com\/?p=1335"},"modified":"2022-01-10T12:10:39","modified_gmt":"2022-01-10T05:10:39","slug":"evusheld-long-acting-antibody-combination-retains-neutralising-activity-against-omicron-variant-in-independent-fda-study","status":"publish","type":"post","link":"https:\/\/news.eloqasia.com\/?p=1335","title":{"rendered":"Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study"},"content":{"rendered":"

Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19 <\/em><\/p>\n

In this pre-clinical study,\u00a0Evusheld\u2019s<\/em>\u00a0Inhibitory Concentration 50 (IC50), a measure of neutralising potency of an antibody, was 171 ng\/ml and 277 ng\/ml in two confirmatory tests, which is within the range of neutralising titres found in someone who has been previously infected with COVID-19. Evusheld\u2019s<\/em> IC50 for the original strain of SARS-CoV-2, previously referred to as the Wuhan strain, was approximately 1.3 ng\/ml and 1.5 ng\/ml, respectively.<\/p>\n

The early data, generated by pseudovirus testing of the full Omicron variant spike against the combination of tixagevimab with cilgavimab, the antibodies that comprise Evusheld,<\/em> add to the growing body of preclinical evidence demonstrating that Evusheld<\/em> retains activity against all tested variants of concern to date.1<\/sup><\/p>\n

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research. The work was supported by US government research funds.<\/p>\n

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: \u201cThis study shows Evusheld<\/em> retains neutralisation activity against the Omicron variant. By combining two potent antibodies with different and complementary activities against the virus, Evusheld<\/em> was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants. Evusheld<\/em> is the first long-acting antibody to receive emergency use authorisation in the US for pre-exposure prophylaxis of COVID-19, in addition to authorisations in other countries, and we are working with regulators on applications for the use of Evusheld<\/em> in treating COVID-19.\u201d<\/p>\n

The Omicron variant was not in circulation during the Evusheld <\/em>clinical trials. The Company is continuing to collect further data to better understand the implications of this observation in clinical practice. Additional analyses to evaluate Evusheld<\/em> against the Omicron variant are being conducted by AstraZeneca and third-party laboratories, with data anticipated very soon.<\/p>\n

Evusheld<\/em> received Emergency Use Authorization (EUA) in the US in December 2021 for pre-exposure prophylaxis (prevention) of COVID-19 in people with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. The first doses are expected to become available within days.<\/p>\n

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.3,4<\/sup> Emerging evidence indicates that protecting vulnerable populations from getting COVID-19 could help prevent viral evolution that is an important factor in the emergence of variants.5<\/sup><\/p>\n

Additionally, the TACKLE Phase III outpatient treatment trial of Evusheld <\/em>showed it reduced\u00a0<\/em>the\u00a0risk of developing severe COVID-19 or death (from any cause) by 50%\u00a0compared to placebo\u00a0in non-hospitalised patients\u00a0with mild to moderate COVID-19\u00a0who had been symptomatic for seven days or less.6<\/sup><\/p>\n

Notes<\/u><\/strong><\/p>\n

Evusheld <\/em><\/strong><\/p>\n

Evusheld<\/em>, formerly known as AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and\u00a0licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein7<\/sup> and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration;8-10<\/sup> data from the Phase III PROVENT trial show protection lasting at least six months.11<\/sup> The reduced Fc receptor binding aims to minimise the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and\/or disease.12<\/sup><\/p>\n

In December 2021, the U.S. Food and Drug Administration issued an Emergency Use Authorisation (EUA) for the use of Evusheld<\/em> (tixagevimab co-packaged with cilgavimab) for the pre-exposure prophylaxis (prevention) of COVID-19. It is the only antibody authorised in the US to prevent COVID-19 symptoms before virus exposure. Evusheld<\/em> is also authorised for emergency use for prevention of COVID-19 in several other countries.<\/p>\n

In August 2021, AstraZeneca announced that Evusheld<\/em> demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 in the PROVENT trial; efficacy was 83% compared to placebo in a six-month analysis announced on 18 November 2021. In October 2021, AstraZeneca announced positive high-level results from the Evusheld <\/em>TACKLE Phase III outpatient treatment trial.<\/p>\n

Evusheld <\/em>is also being studied as a potential treatment for hospitalised COVID-19 patients as part of the National Institute of Health\u2019s ACTIV-3 trial and in an additional collaborator hospitalisation treatment trial.<\/p>\n

Evusheld<\/em> is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.<\/p>\n

Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.<\/p>\n

AstraZeneca<\/strong><\/p>\n

AstraZeneca (LSE\/STO\/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.<\/p>\n

References <\/strong><\/p>\n

    \n
  1. National Center for Advancing Translational Sciences OpenData Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: https:\/\/opendata.ncats.nih.gov\/variant\/activity [Last accessed: December 2021].<\/li>\n
  2. Neerukonda, S.N. et al. Establishment of a well-characterized SARS-CoV-2 lentiviral pseudovirus neutralization assay using 293T cells with stable expression of ACE2 and TMPRSS2. PLOS ONE March 10, 2021. Available at https:\/\/journals.plos.org\/plosone\/article?id=10.1371\/journal.pone.0248348 [Last accessed December 2021].<\/li>\n
  3. Oliver, S. Data and clinical considerations for additional doses in immunocompromised people. ACIP Meeting July 22, 2021. Available at:\u00a0https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/slides-2021-07\/07-COVID-Oliver-508.pdf. [Last accessed: December 2021].<\/li>\n
  4. AstraZeneca data on file.<\/li>\n
  5. Corey L, et al. SARS-CoV-2 Variants in Patients with Immunosuppression. N\u00a0Engl\u00a0J Med.<\/em> 2021; 385:562-566. DOI: 10.1056\/NEJMsb2104756.<\/li>\n
  6. AstraZeneca news release.\u00a0Evusheld\u00a0reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial. Available at:\u00a0https:\/\/www.astrazeneca.com\/content\/astraz\/media-centre\/press-releases\/2021\/Evusheld-phiii-trial-positive-in-covid-outpatients.html. [Last accessed:\u00a0December\u00a02021].<\/li>\n
  7. Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail.\u00a0bioRxiv. 2021; doi: 10.1101\/2021.01.27.428529.<\/li>\n
  8. Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults.\u00a0Antimicrob Agents Chemother<\/em>. 2013; 57 (12): 6147-53.<\/li>\n
  9. Griffin MP, et al. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults.\u00a0Antimicrob Agents Chemother<\/em>. 2017; 61(3): e01714-16.<\/li>\n
  10. Domachowske JB, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants.\u00a0Pediatr Infect Dis J<\/em>. 2018; 37(9): 886-892.<\/li>\n
  11. AstraZeneca news release. New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention.\u00a0 Available at:\u00a0https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2021\/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html. [Last accessed: December 2021].<\/li>\n
  12. van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease.\u00a0Front Immunol<\/em>. 2019; 10: 548.<\/li>\n<\/ol>\n
    \n

     <\/p>\n

    Press release distributed by\u00a0EloQ Communications<\/a><\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19 In this pre-clinical study,\u00a0Evusheld\u2019s\u00a0Inhibitory Concentration 50 (IC50), a measure of neutralising potency of an antibody, was 171 ng\/ml and 277 ng\/ml in two confirmatory tests, which is within the Read More …<\/a><\/p>\n","protected":false},"author":76,"featured_media":1147,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[649,653,277,267,721,417,671,720,652,650],"yoast_head":"\nEvusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study - EloQ's Newsroom<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/news.eloqasia.com\/?p=1335\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study - 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