AstraZeneca

AstraZeneca will share new data across its Vaccines & Immune Therapies portfolio at the 13^th annual IDWeek in Los Angeles, California, from 16-19 October 2024. The Company will highlight progress in advancing novel immunisations against infectious diseases of high unmet need and share real-world evidence showing the burden of respiratory viral infections and the continued need for protection.

Iskra Reic, Executive Vice President of Vaccines & Immune Therapies, AstraZeneca, said: "The data being presented at IDWeek demonstrate our commitment to addressing the impact of infectious diseases, notably our progress in developing our vaccine and antibody candidates against viral and bacterial pathogens, including IVX-A12, the first potential combination RSV/hMPV vaccine, and AZD5148 against C. diff infections. The advancement of IVX-A12 builds on our scientific leadership in RSV, with data being presented on Beyfortus demonstrating how, in its first season, it has delivered significant real-world impact in protecting a broad infant population against the disease, with millions more children set to benefit this season."

Data in RSV, combination vaccines, C. diff and influenza

Data will be presented on Beyfortus (nirsevimab), AstraZeneca's long-acting antibody for the prevention of RSV disease, showing that Beyfortus does not interfere with RSV detection by rapid antigen tests enabling accurate diagnosis to support clinical management.¹⁰ Additional data, presented by our partner Sanofi, confirm the significant real-world effectiveness of Beyfortus in reducing RSV disease and hospitalisations in infants. These data build on recent evidence, including from the US Advisory Committee on Immunisation Practices, demonstrating Beyfortus was associated with a 90% reduction in RSV-associated hospitalisations in its first season.

Interim Phase II data on IVX-A12, an investigational combination virus-like particle vaccine, will be presented, demonstrating that IVX-A12 was well-tolerated and immunogenic against both RSV and hMPV in older adults 60 to 85 years of age.^6,7

Pre-clinical data will be shared showing that AZD5148, an anti-toxin B neutralizing monoclonal antibody now in Phase I trials, may provide protection against Clostridioides difficile (C. diff) infection, a condition that can cause life-threatening diarrhea and intestinal inflammation.⁹

Additionally, AstraZeneca is presenting vaccine effectiveness data for FluMist (live attenuated influenza vaccine), recently approved in the US as the only vaccine for self- or caregiver administration for the prevention of influenza.⁸

Real-world evidence shows the need for protection against respiratory viral infections

Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are in the same family of respiratory viruses and can cause serious respiratory infections, especially in children, older adults and those with co-morbid conditions.¹ AstraZeneca will present data highlighting the seasonal patterns of hMPV and RSV, reflecting a return to pre-pandemic seasonality. Overlapping seasonal patterns of hMPV and RSV were seen in most countries, underscoring the importance of continued surveillance during the coming season and the potential benefit of a combination vaccine that offers protection against both viruses.²

Additional findings analysed hMPV outcomes in nursing homes, indicating that in high-risk older adults, hMPV outcomes of hospitalisation and death were comparable with influenza.³ These analyses highlight the risk that hMPV can present to high-risk older adults living in nursing homes and the need for advancements in testing and prevention.³

Updated data from INFORM, a retrospective health database observational study in England,

highlight the continued burden of COVID-19 on immunocompromised patients.^4,5 Findings show the continued increased risk of COVID-19 hospitalisation and death in immunocompromised patients despite receiving ≥4 vaccine doses, as well as consistently showing higher COVID-19 mortality among hospitalised immunocompromised individuals compared to non-immunocompromised individuals.^4,5

Key AstraZeneca presentations during IDWeek 2024

Notes

FluMist (Live Attenuated Influenza Vaccine)

FluMist is a live attenuated influenza vaccine (LAIV) administered as a nasal spray for the prevention of influenza. FluMist is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommended influenza vaccine option. FluMist was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.¹¹ In September 2024, the US FDA approved an expansion to those who can administer FluMist to include self-administration for eligible 18-49 year olds or administration by a caregiver for eligible 2-17 year olds.¹² The self/caregiver administration option will be available as soon as the 2025/26 influenza season.¹³ 

IVX-A12
IVX-A12 is a liquid, refrigerator-stable formulation comprised of IVX-121, Icosavax's RSV prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax's hMPV prefusion F protein VLP vaccine candidate.⁷ IVX-A12 was acquired with AstraZeneca's acquisition of Icosavax.

In the Phase II trial, IVX-A12 showed robust immune responses across RSV and hMPV antibodies, reconfirming previous immunogenicity data seen in the smaller Phase I trial.^6,7 The data are the first to demonstrate hMPV immune response in a Phase II combination vaccine trial.^6,7 IVX-A12 was generally well-tolerated in the trial, with a safety profile similar to that seen in the Phase I trial.^6,7

IVX-A12 has been granted Fast Track Designation from the US Food and Drug Administration, a programme designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need.¹⁴ If approved, IVX-A12 will be the world's first-in-class, differentiated, combination vaccine targeting RSV and hMPV to prevent lower respiratory tract disease.

Beyfortus
Beyfortus (nirsevimab) is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi using AstraZeneca's YTE extended-half-life 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.¹⁵

Beyfortus administration can be timed to the start of the RSV season.¹⁵

Beyfortus was granted regulatory designations to facilitate expedited development by several major regulatory agencies around the world. Beyfortus has been approved for use in the European Union, China and Japan and received approval by the US Food and Drug Administration following a unanimous recommendation by the Antimicrobial Drugs Advisory Committee. Beyfortus is recommended by the Advisory Committee on Immunization Practices for broad infant use and was included in the Vaccines for Children programme in the US.⁶ Early data from the US Centers for Disease Control and Prevention, show that in the 2023/4 RSV season, Beyfortus was associated with a 90% reduction against RSV-associated hospitalisation among infants in their first RSV season.¹⁶

IDWeek 2024™

IDWeek 2024^TM is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). With the theme "Advancing Science, Improving Care," IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2024™ takes place 16-19 October at the Los Angeles Convention Center (1201 S Figueroa St) in Los Angeles, CA. For more information, visit www.idweek.org.

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's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

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References

1. U.S. Centers for Disease Control and Prevention. About Human Metapneumovirus. Accessed 7 October 2024. https://www.cdc.gov/human-metapneumovirus/about/
2. Billard MN, Wildenbeest JG, Braas O, et al. Global surveillance of human Metapneumovirus (hMPV) and respiratory syncytial virus (RSV) epidemiology since 2022. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-2338
3. Bhaskar N, Abul Y, Devone F, et al. Outcomes of human Metapneumovirus in nursing home residents: a matched analysis. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-342
4. Dube S, Carty L, Talarico C. Individuals on Immunosuppressive or Immunomodulatory Therapies Remain at Increased Risk of COVID-19 Hospitalization, Despite Vaccination: Findings from INFORM, a Retrospective Health Database Study in England. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-2006
5. Carty L, Dube S, Talarico C, et al. COVID-19 Mortality Among Immunocompromised Individuals is Consistently High Compared with Non-Immunocompromised Individuals: Results of the INFORM Study 2022, England. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-1989
6. Davis M, Shapiro C, Adams M, et al. Safety and immunogenicity of a Respiratory Syncytial Virus and human Metapneumovirus virus-like particle protein subunit combination vaccine in 60-85-year-old adults: interim results from a Phase 2a clinical trial. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-601
7. Icosavax [press release]. Icosavax Announces Positive Topline Interim Phase 2 Results for Combination VLP Vaccine Candidate IVX-A12 Against RSV and hMPV in Older Adults. 12 December 2023. Accessed 20 September 2024. https://www.globenewswire.com/en/news-release/2023/12/12/2794421/0/en/Icosavax-Announces-Positive-Topline-Interim-Phase-2-Results-for-Combination-VLP-Vaccine-Candidate-IVX-A12-Against-RSV-and-hMPV-in-Older-Adults.html
8. Bandell AR, Barker C, Dibben O. Effectiveness of Live Attenuated and Inactivated Influenza Vaccines in Children: Data from the 2023/24 Influenza Season. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-612
9. Tkaczyk C, Dayao D, Girouard D, et al. Anti-Toxin B Neutralizing Monoclonal Antibody AZD5148 Provides Protection in a Clostridioides difficile Gnotobiotic Piglet Model. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-1055
10. Sincero SR, Streicher K, Kelly EJ, e t al. Nirsevimab in Patient Samples Does Not Interfere with Respiratory Syncytial Virus (RSV) Detection by Commercially Available Rapid Antigen Tests. Presented at: IDWeek 2024; 16-19 October 2024; Los Angeles, California. Abs P-2179
11. FluMist Prescribing Information. March 2024.
12. AstraZeneca [Press Release]. FluMist approved for self-administration in the US. 20 September 2024. Accessed 3 October 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html
13. U.S. Food & Drug Administration. FluMist. 26 December 2024. Accessed 3 October 2024. https://www.fda.gov/vaccines-blood-biologics/vaccines/flumist
14. Icosavax [press release]. Icosavax Granted FDA Fast Track Designation for IVX-A12. 21 February 2023. Accessed 20 September 2024. https://www.globenewswire.com/en/news-release/2023/02/21/2612100/0/en/Icosavax-Granted-FDA-Fast-Track-Designation-for-IVX-A12.html
15. Jones JM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925.
16. Moline HL, et al. Early Estimate of Nirsevimab Effectiveness for Prevention of Respiratory Syncytial Virus-Associated Hospitalization Among Infants Entering Their First Respiratory Syncytial Virus Season - New Vaccine Surveillance Network, October 2023-February 2024. MMWR Morb Mortal Wkly Rep. 2024;73:209-214.