AstraZeneca advances the science of infectious disease protection at ECCMID 2024

Real-world effectiveness data on Beyfortus reinforce the impact of passive immunisation protecting infants from RSV hospitalisation.
Updated real-world data demonstrate continued risk of severe COVID-19 outcomes among immunocompromised populations.

AstraZeneca will showcase new clinical, real-world and early science data across its Vaccines & Immune Therapies portfolio at the 34^th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Barcelona, Spain from 27-30 April 2024. The company has 19 abstracts at the event, including four oral presentations and four late-breaking presentations, which will highlight the continued need to protect at-risk individuals from the increased burden of common infectious diseases and the important role of long-acting antibodies and vaccines.

Data will be presented featuring:

• Real-world data on effectiveness of Beyfortus (nirsevimab), a long-acting antibody, in the prevention of hospitalisation due to respiratory syncytial virus (RSV)
• Updated real-world evidence demonstrating the continued disproportionate burden of COVID-19 infection on immunocompromised individuals, highlighting the need for additional protection
• Pharmacokinetic and safety data on sipavibart, an investigational long-acting antibody for the prevention of COVID-19 in immunocompromised individuals
• Research on early pipeline assets, including a late-breaking oral presentation on a novel mRNA-VLP vaccine platform and data on a monoclonal antibody to prevent recurrent C. difficile infection

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “We are excited to share data at ECCMID showcasing the progress across our early- and late-stage Vaccines and Immune Therapies portfolio and our ambition to deliver long-lasting immunity to protect against infectious diseases with differentiated antibodies and vaccines. As well as our innovative science, we are proud of the difference our preventative therapeutics are making in reducing the burden of respiratory infections, with new real-world data highlighting the effectiveness of our long-acting antibody Beyfortus in preventing infant hospitalisations due to RSV. In addition, our data provide evidence that immunocompromised individuals continue to face a significant and disproportionate burden from COVID-19, highlighting the need for additional protection.”

Real-world evidence highlighting the impact of Beyfortus in preventing RSV-related hospitalisations
New real-world data from NIRSE-GAL, an investigator-initiated, population-based three-year follow up study in the Galicia community in Spain, looked at the effectiveness of the 2023/2024 Beyfortus immunisation campaign in a broad infant population in reducing RSV-related hospitalisations.¹ The data add to the existing body of evidence that reinforces the high efficacy of Beyfortus from clinical trials resulting in protection against hospitalisation for RSV-associated lower respiratory tract infection (LRTI).

The significant burden of COVID-19 on the immunocompromised
Five presentations, including one oral, will highlight the ongoing risk and healthcare burden of COVID-19 on immunocompromised individuals. Data will include updated analyses from INFORM, a retrospective health database study in England, examining the continued increased risk of severe COVID-19 outcomes in several different immunocompromised populations despite receiving multiple COVID-19 vaccinations.^2-3 Real-world data from the COVIDRIVE study platform (run by the id.DRIVE public-private partnership) highlight the disproportionately high prevalence of immunocompromising conditions in SARS-CoV-2-positive hospitalised patients with severe acute respiratory infection in Europe.^4-6

Key AstraZeneca presentations during ECCMID

Abstract title	Presentation details
Beyfortus (nirsevimab)
Universal prophylaxis with nirsevimab for prevention of infant hospitalizations due to respiratory syncytial virus. A longitudinal study in Galicia Spain	Late-breaking oral sessionDate: 29/04/2024Time: 11:00 - 12:00 CET
Sipavibart (AZD3152)
Pharmacokinetics and safety of the SARS-CoV-2 monoclonal antibody AZD3152 are consistent with those of tixagevimab/cilgavimab	Late-breaking posterDate: 30/04/2024Time: 12:00 - 13:30 CET
Sentinel cohort safety of AZD5156/AZD3152 from the phase 1/3 SUPERNOVA trial for COVID-19 prevention in participants with immune impairment	Poster sessionDate: 27/04/2024Time: 12:00 - 13:30 CET
COVID-19 Real-world evidence
Individuals with multiple sclerosis are at high risk for COVID-19 hospitalization and death despite high rates of vaccination: results from the England INFORM study	Oral sessionDate: 27/04/2024Time: 08:30 - 10:30 CET
Continued increased risk of COVID-19 hospitalisation and death in immunocompromised individuals despite receipt of ≥4 vaccine doses: updated 2023 results from INFORM, a retrospective health database observational study in England	Poster sessionDate: 27/04/2024Time: 12:00 - 13:30 CET
High prevalence of immunocompromising conditions among patients with severe acute respiratory infection, including SARS-CoV-2: results from a multicentre, test-negative case-control study	Poster sessionDate: 27/04/2024Time: 12:00 - 13:30 CET
Immunocompromise, cancer and other comorbidities in patients with severe acute respiratory infection testing positive versus negative for SARS-CoV-2: a post hoc analysis of COVIDRIVE data from May 2021 to May 2023	Poster sessionDate: 27/04/2024Time: 12:00 - 13:30 CET
COVIDRIVE: a European public-private partnership for generating real-world evidence on the effectiveness of COVID-19 vaccines	Poster sessionDate: 27/04/2024Time: 12:00 - 13:30 CET
Early Science
An mRNA vaccine expressing a self-assembling virus-like particle antigen provides a more potent, durable and broader immune response to SARS-CoV-2 in animal models vs native mRNA vaccines	Late-breaking oral sessionDate: 27/04/2024Time: 14:45 - 15:45 CET
Anti-toxin B neutralizing mAb AZD5148 provides protection in a Clostridioides difficile gnotobiotic piglet model	Poster sessionDate: 30/04/2024Time: 12:00 - 13:30 CET

Notes

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.⁷

Beyfortus administration can be timed to the start of the RSV season.⁷

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.⁷ 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.⁸

Sipavibart
Sipavibart (formerly AZD3152) is an investigational long-acting monoclonal antibody (LAAB) against COVID-19. Sipavibart was designed to provide broad and potent coverage across Omicron and ancestral viral variants by neutralising spike protein interaction with the host receptor ACE2.⁹

Sipavibart was derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Sipavibart has been engineered using the same antibody scaffold as Evusheld and was optimised with the same half-life extension and reduced Fc effector function and complement C1q binding platform. 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.¹⁰

Sipavibart was acquired by AstraZeneca in May 2022 from RQ Biotechnology.

The safety and efficacy of sipavibart is being studied in the global SUPERNOVA COVID-19 prevention trial, with data anticipated in the first half of 2024.

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.

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References

1. Mallah N, et al. Universal prophylaxis with nirsevimab for prevention of infant hospitalizations due to respiratory syncytial virus. A longitudinal study in Galicia Spain. Oral Presentation. 34^th ECCMID Global; 29 April 2024; Barcelona, Spain.
2. Dube S, et al. Individuals with multiple sclerosis are at high risk for COVID-19 hospitalization and death despite high rates of vaccination: results from the England INFORM study. Oral Presentation. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
3. Dube S, et al. Continued increased risk of COVID-19 hospitalisation and death in immunocompromised individuals despite receipt of ≥4 vaccine doses: updated 2023 results from INFORM, a retrospective health database observational study in England. Poster P0409. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
4. Bollaerts K, et al. COVIDRIVE: a European public-private partnership for generating real-world evidence on the effectiveness of COVID-19 vaccines. Poster P0380. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
5. Meeraus W, et al. High prevalence of immunocompromising conditions among patients with severe acute respiratory infection, including SARS-CoV-2: results from a multicentre, test-negative case-control study. Poster P0381. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
6. Meeraus W, et al. Immunocompromise, cancer and other comorbidities in patients with severe acute respiratory infection testing positive versus negative for SARS-CoV-2: a post hoc analysis of COVIDRIVE data from May 2021 to May 2023. Poster P0382. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
7. 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. 
8. 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. 
9. Francica JR, et al. 1355. 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. Open Forum Infect Dis. 2023 Nov 27;10(Suppl 2):ofad500.1192. doi: 10.1093/ofid/ofad500.1192.
10. Van Erp EA, et al. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus    Infection and Disease. Front Immunol. 2019;10(March).