AstraZeneca has entered into an agreement with the Swiss Government to supply 5’000 doses of tixagevimab and cilgavimab, a long-acting antibody (LAAB) combination for the prevention of COVID-19. Delivery of the first doses is anticipated in May 2022.This follows the regulatory submission of tixagevimab and cilgavimab for the prevention of COVID-19 in adults and adolescents (from 12 years of age with a body weight of at least 40 kg). to Swissmedic on February 9, 2022.
The prophylactic use of tixagevimab and cilgavimab was studied in certain high-risk groups with weakened immune systems (e.g. triggered by cancers or chronic diseases like multiple sclerosis, when using certain medicines or after a transplant or dialysis). These individuals often cannot be sufficiently protected against COVID-19 by vaccination and are also at increased risk of a severe course of COVID-19 due to their pre-existing disease. Affected individuals therefore require an alternative protection against COVID-19.
Tixagevimab and cilgavimab antibody combination (AZD7442)
The antibody therapy (AZD7442) is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) – originally derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. The human monoclonal antibodies were discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020. They bind to distinct sites on the SARS-CoV-2 spike protein1 and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. Due to the longer half-life, the duration of effect is prolonged compared to conventional antibodies.2-4 Data from the still ongoing Phase III PROVENT trial showed a protective effect of at least six months.5 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.6 AZD7442 is delivered as an IM dose of 150mg tixagevimab and 150mg cilgavimab administered in two separate, consecutive injections.
In December 2021, the FDA issued an EUA for the use of AZD7442 for the pre-exposure prophylaxis (prevention) of COVID-19. To date, it is the only antibody authorised in the US to prevent COVID-19 symptoms before virus exposure. AZD7442 is also authorised for emergency use for prevention of COVID-19 in several other countries.
According to the PROVENT trial; AZD7442 showed a statistically significant reduction in the risk of developing symptomatic COVID-19; efficacy was 83% compared to placebo in a six-month analysis. The AZD7442 TACKLE Phase III outpatient treatment trial also showed positive results. AZD7442 is also being studied as a potential treatment for hospitalised COVID-19 patients as part of the National Institute of Health’s ACTIV-3 trial and in an additional collaborator hospitalisation treatment trial.
The antibody combination AZD7442 is not yet authorized by Swissmedic.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries.
AstraZeneca in Switzerland
AstraZeneca has 120 employees who are responsible for coordinating business operations in Switzerland. The site in Baar is also the headquarters of the Europe & Canada Commercial Regional Team and the Europe & International Oncology Team, which employ a further 60 staff in Switzerland. Our primary therapeutic areas are Oncology, Cardiovascular, Renal and Metabolism, and Respiratory & Immunology. To meet our climate goals ahead of schedule, we are working tirelessly to further reduce CO2 emissions and waste. As part of our Ambition Zero Carbon strategy, we are transitioning to a carbon-free business operation by taking steps to reduce and ultimately eliminate greenhouse gas emissions. In 2021, AstraZeneca Switzerland was recognized by its employees for the fourth time as an outstanding employer, and was awarded the external “Great place to work®” certification.
Find out more: astrazeneca.ch
AstraZeneca Switzerland Media Department
Tel. +41 (0) 41 725 75 75; media.switzerland@astrazeneca.com
Dr. Angelika März, Corporate Affairs Lead
References
1. Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail. bioRxiv. 2021; doi: 10.1101/2021.01.27.428529.
2. Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013; 57 (12): 6147-53.
3. 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): e01714-16.
4. 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.
5. AstraZeneca news release. New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention. Available at: https://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].
6. van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol. 2019; 10: 548.
CH-5741, 03/2022