AstraZeneca advances the science of infectious disease protection at ECCMID 2024

Beyfortus的实际有效性数据强化了被动免疫保护婴儿免受呼吸道合胞病毒住院的影响

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, 这将突出继续需要保护高危个体免受常见传染病负担的增加以及长效抗体和疫苗的重要作用.

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)
• 最新的现实证据表明，COVID-19感染对免疫功能低下个体的负担仍然不成比例, 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, 包括一种新型mRNA-VLP疫苗平台的最新口头报告和一种预防复发的单克隆抗体的数据 C. difficile infection

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, 他说:“澳门葡京赌博游戏很高兴能在ECCMID上分享数据，展示澳门葡京赌博游戏早期和晚期疫苗和免疫疗法产品组合的进展，以及澳门葡京赌博游戏通过分化抗体和疫苗提供持久免疫力以预防传染病的雄心. 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, 澳门葡京赌博游戏的数据提供的证据表明，免疫功能低下的个体继续面临COVID-19带来的严重和不成比例的负担, 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 从临床试验中得出预防rsv相关下呼吸道感染住院(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, 在几个不同的免疫功能低下人群中，尽管接受了多次COVID-19疫苗接种，但发生COVID-19严重后果的风险仍在持续增加.^2-3 Real-world data from the COVIDRIVE study platform (run by the id.驱动(公私伙伴关系)强调，在欧洲，严重急性呼吸道感染的sars - cov -2阳性住院患者中，免疫功能低下的发病率高得不成比例.^4-6

Key AstraZeneca presentations during ECCMID

Notes

Beyfortus
Beyfortus (nirsevimab) is a single dose long-acting antibody, 由澳门葡京网赌游戏和赛诺菲合作开发和商业化，使用澳门葡京网赌游戏的YTE延长半衰期技术. 它旨在保护在第一个RSV季节出生或进入第一个RSV季节的婴儿，以及24个月以下的儿童，他们在第二个RSV季节仍然容易患上严重的RSV疾病.  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 是否被世界各地的几个主要监管机构授予监管指定，以促进加速发展. Beyfortus has been approved for use in the European Union, 并在抗菌药咨询委员会的一致建议下获得了美国食品和药物管理局的批准. Beyfortus 由免疫实践咨询委员会推荐广泛用于婴儿，并被列入美国儿童疫苗计划.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旨在通过中和刺突蛋白与宿主受体ACE2的相互作用，在Omicron和祖先病毒变体中提供广泛而有效的覆盖.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. 减少Fc效应功能的目的是尽量减少抗体依赖性疾病增强的风险——病毒特异性抗体促进疾病增强的一种现象, 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 guidetohairlossproducts.com and follow the Company on social media @AstraZeneca.

Contacts
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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. 尽管疫苗接种率很高，但多发性硬化症患者住院和死亡的风险很高:来自英格兰INFORM研究的结果. Oral Presentation. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
3. Dube S, et al. 尽管接种了4剂以上疫苗，免疫功能低下个体的COVID-19住院和死亡风险仍在持续增加:来自INFORM的2023年最新结果, a retrospective health database observational study in England. Poster P0409. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
4. Bollaerts K, et al. covid - rive:欧洲公私伙伴关系，旨在为COVID-19疫苗的有效性提供真实证据. 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, SARS-CoV-2检测呈阳性与阴性的严重急性呼吸道感染患者的癌症和其他合并症:2021年5月至2023年5月对covid - rive数据的事后分析. Poster P0382. 34th ECCMID Global; 27 April 2024; Barcelona, Spain.
7. Jones JM, et al. 使用尼塞维单抗预防婴幼儿呼吸道合胞病毒疾病:免疫做法咨询委员会的建议-美国, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925.
8. Moline HL, et al. 早期估计尼塞维单抗预防新生儿呼吸道合胞病毒相关住院的有效性-新疫苗监测网络, October 2023–February 2024. MMWR Morb Mortal Wkly Rep. 2024;73:209–214.
9. Francica JR, et al. 1355. SARS-CoV-2单克隆抗体AZD3152有效中和历史和新出现的变异，正在开发用于预防和治疗高危人群的COVID-19. 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).