AstraZeneca today finalised an agreement with Thailand’s Department of Disease Control to supply 257,500 doses of the long-acting antibody (LAAB) combination (tixagevimab and cilgavimab)* AZD7442, aimed at protecting immunocompromised individuals from developing symptomatic COVID-19, with the first delivery scheduled for within the third quarter this year.
Certain people are “immunocompromised” as they are unable to mount an adequate response from a vaccine, due to an underlying health condition or medication they take that compromises or suppresses their immune system. These individuals are at a high risk of severe COVID-19 if they were to become infected.
AZD7442 was granted conditional marketing authorisation last week by the Food and Drug Administration in Thailand for the prevention of COVID-19, in a broad population of adults and adolescents aged 12 years and older weighing at least 40kg, no matter their COVID-19 vaccination status.
James Teague, Country President, AstraZeneca (Thailand) Ltd., said: “As we transition from pandemic to endemic, AstraZeneca remains committed to ensuring that no one in need of ongoing COVID-19 protection is left behind. The long-acting antibody combination provides people at high-risk of COVID-19 infection with another important prevention option alongside vaccination. While vaccines remain a critically important tool to reduce severe COVID-19 outcomes, some vulnerable populations are unable to develop adequate protection from vaccination alone.”
According to data from the University of Oxford,1 the antibody combination retains its neutralising activity against Omicron subvariants, BA.4 and BA.5 (both dominant in Thailand), and all other variants of concern. Additionally, results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial published in the New England Journal of Medicine showed that AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 77% in the primary analysis, and by 83% in the six-month follow-up analysis.2
AZD7442 has marketing authorisation in the European Union and conditional marketing authorisation in Great Britain for the prevention of COVID-19. It is also authorised for emergency prevention use in the US and is being supplied in several other countries around the world.
*150mg each of tixagevimab and cilgavimab
AZD7442
AZD7442 is derived from B-cells donated by individuals previously infected with the SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein3 and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding.4 The half-life extension more than triples the durability of its action compared to conventional antibodies;5-7 data from the Phase III PROVENT trial show protection lasting six months.6 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.8
AstraZeneca
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.
References
1. AstraZeneca news release. Evusheld long-acting antibody combination retains neutralising activity against Omicron variants BA.4 and BA.5, according to new study from University of Oxford. Available at: https://www.astrazeneca.com/media-centre/medical-releases/evusheld-long-acting-antibody-combination-retains-neutralising-activity-omicron-variants-ba4-ba5-according-new-study-university-oxford.html. [Last accessed: June 2022].
2. AstraZeneca news release. Evusheld significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/evusheld-significantly-protected-against-symptomatic-covid-19-for-at-least-six-months-in-provent-phase-iii-trial-in-high-risk-populations1.html. [Last accessed: June 2022].
3. Dong J, et al. Genetic and Structural Basis for SARS-CoV-2 Variant Neutralization by a Two-Antibody Cocktail. Nat Microbiol. 2021;6(10):1233-1244. doi:10.1038/s41564-021-00972-2.
4. Loo YM, et al. AZD7442 Demonstrates Prophylactic and Therapeutic Efficacy in Non-Human Primates and Extended Half-Life in Humans. Sci Transl Med. 2022;14(635):eabl8124.
5. Robbie GJ, et al. A Novel Investigational Fc-Modified Humanized Monoclonal Antibody, Motavizumab-YTE, Has an Extended Half-Life in Healthy Adults. Antimicrobial Agents and Chemotherapy. 2013;57(12):6147. doi:10.1128/AAC.01285-13.
6. 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. Antimicrob Agents Chemother. 2017;61(3).
7. 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. Pediatr Infect Dis J. 2018;37(9):886-892.
8. van Erp EA, et al. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus Infection and Disease. Front Immunol. 2019;10 (MAR).