AstraZeneca Presents New Data at IDWeek 2024, Showcasing Progress in Respiratory Disease Prevention and Vaccine Innovation

AstraZeneca Presents New Data at IDWeek 2024, Showcasing Progress in Respiratory Disease Prevention and Vaccine Innovation

(IN BRIEF) AstraZeneca presented significant advancements in the prevention of infectious diseases at IDWeek 2024, showcasing its dedication to addressing respiratory infections caused by RSV, hMPV, and COVID-19. The company revealed promising data across its portfolio, including Beyfortus, an antibody effective against RSV in infants, and IVX-A12, a combination vaccine showing strong results against RSV and hMPV in older adults. Pre-clinical data on a new monoclonal antibody for C. diff infections and real-world evidence on the burden of respiratory viral infections, particularly for high-risk populations, were also highlighted. AstraZeneca reaffirmed its commitment to combating infectious diseases through vaccine development and real-world data analysis.

(PRESS RELEASE) CAMBRIDGE, 16-Oct-2024 — /EuropaWire/ — AstraZeneca is making significant strides in the field of infectious disease prevention, with new data set to be showcased at IDWeek 2024 in Los Angeles from October 16-19. This data highlights the company’s progress in developing advanced immunizations to combat serious respiratory infections, such as those caused by respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and COVID-19. AstraZeneca will present findings that underscore the urgent need for continued protection against these illnesses, supported by real-world evidence.

Iskra Reic, Executive Vice President of Vaccines & Immune Therapies at AstraZeneca, stated: “The data presented at IDWeek reflect our dedication to addressing the global impact of infectious diseases. We have made remarkable progress in developing vaccine and antibody candidates, such as IVX-A12, the first potential combination RSV/hMPV vaccine, and AZD5148 for C. diff infections. Data from Beyfortus shows significant real-world results in reducing RSV hospitalizations in infants, and with millions more children to benefit this season, the impact will be even greater.”

Key presentations include data on Beyfortus (nirsevimab), AstraZeneca’s long-acting antibody for RSV, demonstrating that the treatment does not interfere with RSV detection using rapid antigen tests. Additional real-world data from Sanofi confirms the effectiveness of Beyfortus in reducing RSV hospitalizations by 90% during its first season of use. AstraZeneca will also present interim results from a Phase II trial of IVX-A12, showing that the investigational vaccine is well-tolerated and immunogenic in older adults.

Pre-clinical findings will reveal the potential of AZD5148, a monoclonal antibody targeting Clostridioides difficile (C. diff) infections, which can cause severe intestinal issues. In addition, vaccine effectiveness data on FluMist, the only self-administered flu vaccine approved in the US, will be presented.

Real-world evidence further emphasizes the need for ongoing protection against respiratory viruses. Data on the seasonal overlap of hMPV and RSV, along with the severe outcomes of hMPV in nursing homes, highlight the importance of testing and prevention for high-risk populations. Updated data from the INFORM study also reveals the continued heightened risk of COVID-19 for immunocompromised patients, even after multiple vaccine doses, underscoring the necessity of vigilant protection for this vulnerable group.

With a broad array of research and developments in vaccines and immune therapies, AstraZeneca remains committed to advancing science and improving health outcomes worldwide.

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 2024TM 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.

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.

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SOURCE: AstraZeneca