Additional analyses from TACKLE Phase III treatment trial further demonstrate Evusheld's potential to reduce COVID-19 severity and mortality
Analysis of long-acting antibody Beyfortus across respiratory syncytial virus (RSV) season further underscores the potential of the investigational treatment to be the first and only single-dose preventative option for all infants
Data featuring Evusheld (tixagevimab and cilgavimab)1-5 and Vaxzevria (ChAdOx1-S [Recombinant], formerly AZD1222)6 in COVID-19 and Beyfortus (nirsevimab), in respiratory syncytial virus (RSV)7 will be presented. Beyfortus has the potential to transform RSV protection as the first and only single-dose preventative option for the broad infant population, including those born healthy, at term, pre-term or with specific medical conditions. In September, Beyfortus received a positive opinion from
Iskra Reic, Executive Vice-President Vaccines and Immune Therapies,
Evusheld's role in protecting against COVID-19
Data from three abstracts from the Phase III TACKLE trial of Evusheld in adults with mild to moderate COVID-19 will be presented, whichinclude new analyses on the prevention of hospitalisation and death;1 reduction in the severity and progression of COVID-19 symptoms;2 and the susceptibility of treatment-emergent viral variants to Evusheld.Data on the activity of Evusheld against circulating SARS-CoV-2 variants and those identified in the Phase III PROVENT prophylaxis trial will also be presented.4
Pursuing a breakthrough in infant RSV care
New viral susceptibility data on Beyfortus data in infants up to 150 days post-dose will be presented during IDWeek. Beyfortus is the first investigational passive immunisation with the potential to help protect a broad infant population across the entire RSV season with a single dose.
Additional data on Vaxzevria
Key
Abstract title
Presentation details
Hobbs R. et al. Outpatient treatment with the SARS-COV-2-neutralizing antibody combination AZD7442 (tixagevimab/cilgavimab) for preventing COVID-19 hospitalizations in the Phase 3 TACKLE trial
Poster; Sat 22 Oct,
Simón-Campos JA, et al. Impact of the SARS-COV-2-neutralizing antibody combination AZD7442 (tixagevimab/cilgavimab) on the severity and progression of COVID-19 symptoms in the Phase 3 TACKLE trial
Poster, Sat 22 Oct,
Kijak G, et al. Treatment-emergent viral variants in the Phase 3 TACKLE trial investigating efficacy and safety of AZD7442 (tixagevimab/cilgavimab) for the treatment of mild to moderate COVID-19 in adults
Poster, Sat 22 Oct,
Tuffy K, et al. AZD7442 (tixagevimab/cilgavimab) demonstrates potent in vitro activity against SARS-COV-2 spike variants identified in circulation and in prophylaxis clinical studies
Poster, Fri 21 Oct,
Herbert A, et al. Prophylactic and therapeutic activity of AZD7442 (tixagevimab/cilgavimab) in SARS-COV-2 hamster challenge models
Poster, Fri 21 Oct,
Sobieszczyk M, et al. Immune responses, viral shedding, and COVID-19 symptom burden from breakthrough SARS-CoV-2 infection in a 2:1 randomized, double-blind, placebo-controlled Phase 3 study of AZD1222 (ChAdOx1 nCoV-19) vaccination
Poster, Sat 22 Oct
Abram M, et al. Pooled analysis of nirsevimab resistance through 150 days post dose in preterm and term infants
Oral, Thu 20 Oct,
Notes
Evusheld
Evusheld, formerly known as AZD7442, is a combination of two long-acting antibodies - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Discovered by
Results from the TACKLE Phase III trial published inThe Lancet Respiratory Medicine showed that Evusheld significantly reduced the relative risk of progressing to severe COVID-19 or death (from any cause) through day 29 compared to placebo in non-hospitalised patients with mild-to-moderate COVID-19. Evusheld was generally well-tolerated in the trial. 90% of participants were at high risk of progression to severe COVID-19 due to age or co-morbidities, including cancer, diabetes, obesity, chronic lung disease or asthma, cardiovascular disease or immunosuppression.
Evusheld is authorised for use for pre-exposure prophylaxis (prevention) of COVID-19 in the US (emergency use), EU,
Evusheld is being developed with support from the US government, including federal funds from the
Under the terms of the licensing agreement with Vanderbilt,
Vaxzevria (ChAdOx1-S [Recombinant], formerly AZD1222)
AstraZeneca COVID-19 vaccine was invented by the
Vaxzevria is a 'viral vector' vaccine, which means a version of a virus that cannot cause disease is used as part of the vaccine, leaving the body knowing how to fight it if it is exposed to the real virus later. This vaccine technology has been used by scientists over the past 40 years to fight other infectious diseases such as the flu, Ebola, and HIV.16
The vaccine has been granted a conditional marketing authorisation or emergency use in more than 125 countries. It also has Emergency Use Listing from the
Under a sub-license agreement with
Beyfortus (nirsevimab)
Beyfortus (nirsevimab), an investigational long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is being developed jointly by
Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent lower respiratory tract infection caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.17 The recommended dose of Beyfortus is a single intramuscular injection of 50 mg for infants with body weight
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