AstraZeneca will showcase new preclinical, clinical and real-world data across its Vaccines & Immune Therapies portfolio at the 12th annual IDWeek conference 11-15 October, reinforcing the important role of long-acting antibodies and vaccines to protect at-risk individuals from the increased burdens of common infectious respiratory diseases. The company will present 15 abstracts at the event, featuring three oral presentations, including one late-breaking oral, and 12 poster presentations.

• Real-world evidence demonstrating the continued and disproportionate burden of COVID-19 on immunocompromised individuals
• Beyfortus (nirsevimab), a long-acting antibody for prevention of disease due to respiratory syncytial virus (RSV)
• Self-administration of the FluMist Quadrivalent intranasal influenza vaccine, a potential new option for expanding access to a seasonal influenza vaccine
• AZD3152, an investigational long-acting antibody against COVID-19

Iskra Reic, Executive Vice President of Vaccines & Immune Therapies, AstraZeneca, said: "Our ambition is to provide long-lasting immunity to millions of people where the burden of disease is greatest. This year at IDWeek, our data provide the strongest evidence to date that the burden of COVID-19 on those who are immunocompromised remains significant and disproportionate. In addition, we'll share updated data on AZD3152 and Beyfortus and the important role these long-acting antibodies can play in preventing COVID-19 and RSV among the most vulnerable patients, ensuring that no one is left behind."

Continued evidence on the importance of passive immunisation as an approach to protect immunocompromised individuals
AstraZeneca will present updated in vitro neutralisation data for the investigational long-acting antibody AZD3152 against historical and emerging COVID-19 variants.[1] Additionally, updated data on Beyfortus, a long-acting antibody recently approved by the US Food and Drug Administration (FDA) for the prevention of RSV lower respiratory tract disease (LRTD) in infants, will be presented, reinforcing Beyfortus as an important and differentiated intervention to provide protection for the most at-risk babies.[2-6] Passive immunisation provides infection-fighting antibodies directly to immunocompromised patients who are unlikely to elicit an adequate immune response to traditional vaccinations.[7]

Real-world data highlight continued unmet need and disproportionate impact of COVID-19 for the immunocompromised
Three presentations, including two orals, from the groundbreaking INFORM real-world evidence study in England reveal the increased burden of severe COVID-19 outcomes facing all individuals with immunocompromised conditions compared to the general population, even when fully vaccinated against the virus, and highlight the need for additional protection to target this population.[8,9] The data also examine the increased risk for people with specific immunocompromising conditions, such as solid and haematologic malignancies, solid organ transplant and end-stage renal disease.[10]

Pioneering new ways to protect against influenza 
AstraZeneca will present a summary of the evidence supporting the potential of self-administration of FluMist, its intranasal, injection-free, live attenuated influenza vaccine (LAIV). The study evaluates the potential for self- and caregiver-administered LAIV to enable more equitable access to the influenza vaccine for communities which lack easy access, thereby helping to meet vaccination targets.[11]

Key AstraZeneca presentations during IDWeek 2023

Abstract title Presentation details
 
AZD3152
The SARS-CoV-2 monoclonal antibody AZD3152 Poster session
potently neutralises historical and emerging Date: Fri 13 Oct
variants and is being developed for the Time: 12:15 - 1:30 PM ET
prevention and treatment of COVID-19 in high  
-risk individuals
 
COVID-19 Real-world evidence
Increased risk of severe COVID-19 outcomes Poster session
across all groups of individuals with Date:Thu 12 Oct
hematological malignancies, solid tumours, Time: 12:15 - 1:30 PM ET
and solid organ transplants compared with the  
general population: initial results from
INFORM, a retrospective health database
observational study in England
 
Increased risk of COVID-19 hospitalisation Oral presentation
and death in vaccinated patients with end Date: Fri 13 Oct
-stage renal disease and dialysis: initial Time: 10:45 - 11:00  AM ET
results from INFORM, a retrospective health  
database observational study in England
 
Fully vaccinated individuals with Oral presentation
immunocompromised conditions are still at Date: Fri 13 Oct
increased risk of severe COVID-19 outcomes Time: 11:00 - 11:15 AM ET
from the Omicron variant: initial results  
from INFORM, a retrospective health database
observational study in England
 
FluMist
Self-administration of intranasal live Poster session
attenuated influenza vaccine: a review of Date: Sat 14 Oct
current evidence and potential for meeting Time: 12:15 - 1:30 PM ET
vaccination targets  
 
Beyfortus (nirsevimab)
Nirsevimab is associated with higher and more Late breaking oral presentation
sustained RSV neutralizing antibody responses Date: Fri 13 Oct
compared with standard of care palivizumab: Time: 1:45 PM - 1:57 PM
observations from a 2:1 randomised, phase 2/3  
trial in medically vulnerable children
(MEDLEY)
 
Nirsevimab binding-site conservation in RSV F Poster session
protein between 2015 and 2022: The US Date: Sat 14 Oct
OUTSMART-RSV surveillance study Time: 12:15 - 1:30 PM ET
   
AZD7442 / Evusheld (tixagevimab/cilgavimab)
Clinical effectiveness of the monoclonal Poster session
antibody combination tixagevimab-cilgavimab Date: Thu 12 Oct
as pre-exposure prophylaxis of COVID-19 among Time: 12:15 - 1:30 PM ET
patients with moderate to severe  
immunocompromised conditions across a large
US healthcare system: a propensity score
-matched retrospective cohort study
 
Measuring effectiveness against a shifting Poster session
variant landscape: COVID-19 example in the Date: Sat 14 Oct
Department of Veterans Affairs Time: 12:15 - 1:30 PM ET
   
Early Science
Understanding Clostridioides difficile toxin Poster session
B gene conservation through surveillance of Date: Thu 12 Oct
public data Time: 12:15 - 1:30 PM ET
   

Notes

AZD3152
AZD3152 is an investigational next-generation long-acting antibody (LAAB). AZD3152 has been shown in in vitro studies to have broad and potent neutralising activity across a range of historical and contemporary SARS-CoV-2 variants.[1] AZD3152 binds to a highly conserved area on the SARS-CoV-2 spike protein.[12]

AZD3152 was derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. AZD3152 was optimised with the same half-life extension and reduced Fc effector function and complement C1q binding platform as Evusheld. The extended half-life is expected to confer protection from COVID-19 for six months.[12] The reduced Fc effector function 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.[13]

AstraZeneca licensed AZD3152 from RQ Biotechnology in May 2022. Under the licensing agreement, RQ Bio is eligible to receive single digit royalties on sales in addition to potential milestone payments.

AZD3152 is being investigated in the ongoing SUPERNOVA Phase III COVID-19 prevention trial and is anticipated to be available as early as H2 2023, subject to regulatory reviews and trial readouts.

FluMist Quadrivalent
FluMist Quadrivalent is a quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza. FluMist Quadrivalent is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommended flu vaccine option. FluMist Quadrivalent was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world. 

Beyfortus
Beyfortus (nirsevimab) is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi using AstraZeneca's YTE technology. It is designed to protect infants born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus, provided directly to newborns and infants as a single dose, offers rapid protection via an antibody to help prevent LRTD caused by RSV, without requiring activation of the immune system. Beyfortus administration can be timed to the start of the RSV season.[7]

Beyfortus is currently approved for use in the US, EU, Great Britain and Canada and has been granted regulatory designations to facilitate expedited development by several major regulatory agencies around the world. These include Breakthrough Therapy Designation and Priority Review Designation by the China Center for Drug Evaluation under the National Medical Products Administration and being named "a medicine for prioritized development" under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED), further leveraging Breakthrough Therapy (https://www.astrazeneca.com/media-centre/press-releases/2019/us-fda-grants-breakthrough-therapy-designation-for-potential-next-generation-rsv-medicine-medi8897.html) Designation (https://www.astrazeneca.com/media-centre/press-releases/2019/us-fda-grants-breakthrough-therapy-designation-for-potential-next-generation-rsv-medicine-medi8897.html) in the US and access granted to the European Medicines Agency (EMA PRIority MEdicines (https://www.astrazeneca.com/media-centre/press-releases/2019/ema-grants-prime-eligibility-for-potential-next-generation-rsv-medicine-medi8897-05022019.html) (PRIME) scheme.

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 social media @AstraZeneca (https://www.linkedin.com/company/astrazeneca/).

Contacts
For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

References

1.   Francica J et al. The SARS-CoV-2 Monoclonal Antibody AZD3152 Potently Neutralizes Historical and Emerging Variants and is Being Developed for the Prevention and Treatment of COVID-19 in High-Risk Individuals. Poster 1355. 12th Annual IDWeek Conference (2023)

2.   Wilkins D, et al. Nirsevimab is Associated with Higher and More Sustained RSV Neutralizing Antibody Responses Compared with Standard of Care Palivizumab: Observations from a 2:1 Randomized, Phase 2/3 Trial in Medically Vulnerable Children (MEDLEY). Oral presentation 1934 at 12th Annual IDWeek Conference (2023)

3.   Hammitt LL et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. New England Journal of Medicine. 2022;386(9):837-846

4.   A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. Study Results. ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/results/NCT02878330 [Last accessed: October 2023]

5.   Griffin MP et al. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. New England Journal of Medicine. 2020;383(5):415-425

6.   Simões EAF et al. Efficacy of Nirsevimab against Respiratory Syncytial Virus Lower Respiratory Tract Infections in Preterm and Term Infants, and Pharmacokinetic Extrapolation to Infants with Congenital Heart Disease and Chronic Lung Disease: A Pooled Analysis of Randomised Controlled Trials. Lancet Child Adolesc Health. 2023;7(3):180-189

7.   Centers for Disease Control and Prevention. Immunity Types. Published online 2021. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm [Last accessed: October 2023]

8.   Dube S et al. Increased Risk of COVID-19 Hospitalization and Death in Vaccinated Patients with End-Stage Renal Disease and Dialysis: Initial Results from INFORM, a Retrospective Health Database Observational Study in England. Oral presentation 1095 at 12th Annual IDWeek Conference (2023)

9.   Dube S et al. Fully Vaccinated Individuals with Immunocompromised Conditions Are Still at Increased Risk of Severe COVID-19 Outcomes from the Omicron Variant: Initial Results from INFORM, a Retrospective Health Database Observational Study in England. Oral presentation 1096 at 12th Annual IDWeek Conference (2023)

10. McNulty R et al. Increased Risk of Severe COVID-19 Outcomes Across All Groups of Individuals with Hematological Malignancies, Solid Tumors, and Solid Organ Transplants Compared with the General Population: Initial Results from INFORM, a Retrospective Health Database Observational Study in England. Poster 398. 12th Annual IDWeek Conference (2023)

11. Jhaveri R et al. Home Administration of Intranasal Live Attenuated Influenza Vaccine: A Review of Current Evidence and Potential for Meeting Vaccination Targets. Poster 2610. 12th Annual IDWeek Conference (2023) 

12. AstraZeneca Data on File REF-173312

13. Van Erp EA et al. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus    Infection and Disease. Front Immunol. 2019;10(MAR)