来自INFORM研究的真实数据表明，严重COVID-19的风险增加
outcomes among all individuals with immunocompromising conditions
and highlight need for additional protection
FluMist四价数据支持自我注射流感疫苗扩大的潜力
access to an important tool for prevention
澳门在线赌城娱乐将展示其疫苗的临床前、临床和实际数据 & 10月11日至15日第12届年度IDWeek会议上的免疫疗法组合, 加强长效抗体和疫苗的重要作用，保护高危人群免受常见呼吸道传染病负担的增加. The company will present 15 abstracts at the event, featuring three oral presentations, including one late-breaking oral, and 12 poster presentations.
Data will be presented featuring:
- 现实证据表明，COVID-19对免疫功能低下者造成了持续和不成比例的负担
- Beyfortus (nirsevimab), 预防呼吸道合胞病毒(RSV)疾病的长效抗体
- Self-administration of the FluMist Quadrivalent intranasal influenza vaccine, 扩大获得季节性流感疫苗的潜在新选择
- AZD3152, an investigational long-acting antibody against COVID-19
Iskra Reic, Executive Vice President of Vaccines & Immune Therapies, AstraZeneca, 他说:“澳门第一赌城在线娱乐的目标是为疾病负担最重的数百万人提供持久的免疫力. This year at IDWeek, 澳门第一赌城在线娱乐的数据提供了迄今为止最有力的证据，表明COVID-19对免疫功能低下者的负担仍然严重且不成比例. In addition, we’ll share updated data on AZD3152 and Beyfortus 以及这些长效抗体在最脆弱的患者中预防COVID-19和RSV的重要作用, ensuring that no one is left behind.”
继续有证据表明被动免疫作为一种保护免疫功能低下个体的方法的重要性
澳门在线赌城娱乐将公布针对历史和新出现的COVID-19变体的研究性长效抗体AZD3152的最新体外中和数据.1 Additionally, updated data on Beyfortus, 一种长效抗体，最近被美国食品和药物管理局(FDA)批准用于预防婴儿RSV下呼吸道疾病(LRTD), will be presented, reinforcing Beyfortus 作为一项重要的、有区别的干预措施，为最危险的婴儿提供保护.2-6 被动免疫直接向免疫功能低下的患者提供抗感染抗体，这些患者不太可能对传统疫苗产生足够的免疫反应.7
现实世界的数据凸显了COVID-19对免疫功能低下人群的持续未满足需求和不成比例的影响
Three presentations, including two orals, 英国开创性的INFORM现实世界证据研究显示，与普通人群相比，所有免疫功能低下的个体面临的COVID-19严重后果负担增加, even when fully vaccinated against the virus, 并强调需要针对这一人群提供额外保护.8,9 这些数据还检查了患有特定免疫功能低下疾病的人的风险增加, such as solid and haematologic malignancies, solid organ transplant and end-stage renal disease.10
Pioneering new ways to protect against influenza
澳门在线赌城娱乐将提交一份支持自我给药潜力的证据摘要 FluMist，其鼻内无注射减毒流感活疫苗(LAIV). 该研究评估了自我和护理人员管理的LAIV的潜力，使难以获得流感疫苗的社区能够更公平地获得流感疫苗, thereby helping to meet vaccination targets.11
Key AstraZeneca presentations during IDWeek 2023
Abstract title |
Presentation details |
|---|---|
AZD3152 |
|
SARS-CoV-2单克隆抗体AZD3152可有效中和历史和新出现的变体，目前正在开发中，用于预防和治疗高危人群的COVID-19
|
Poster session Date: Fri 13 Oct Time: 12:15 – 1:30 PM ET
|
COVID-19 Real-world evidence |
|
所有血液系统恶性肿瘤患者发生COVID-19严重后果的风险增加, solid tumours, 实体器官移植与普通人群的比较:INFORM的初步结果, a retrospective health database observational study in England |
Poster session Date: Thu 12 Oct Time: 12:15 – 1:30 PM ET
|
接种疫苗的终末期肾病和透析患者COVID-19住院和死亡风险增加:INFORM的初步结果, a retrospective health database observational study in England
|
Oral presentation Date: Fri 13 Oct Time: 10:45 – 11:00 AM ET
|
免疫功能低下的完全接种疫苗的个体仍然面临欧米克隆变异导致的COVID-19严重后果的风险增加:INFORM的初步结果, a retrospective health database observational study in England |
Oral presentation Date: Fri 13 Oct Time: 11:00 – 11:15 AM ET
|
FluMist |
|
鼻内自行注射流感减毒活疫苗:对现有证据和满足疫苗接种目标的潜力的回顾
|
Poster session Date: Sat 14 Oct Time: 12:15 – 1:30 PM ET
|
Beyfortus (nirsevimab) |
|
与标准护理帕利珠单抗相比，Nirsevimab与更高和更持久的RSV中和抗体反应相关:来自2:1随机化的观察结果, phase 2/3 trial in medically vulnerable children (MEDLEY) |
Late breaking oral presentation Date: Fri 13 Oct Time: 1:45 PM – 1:57 PM
|
2015 - 2022年RSV F蛋白Nirsevimab结合位点保护:美国OUTSMART-RSV监测研究 |
Poster session Date: Sat 14 Oct Time: 12:15 – 1:30 PM ET
|
AZD7442 / Evusheld (tixagevimab/cilgavimab) |
|
美国大型医疗系统中重度免疫功能低下患者暴露前预防COVID-19单克隆抗体联合用药的临床效果:倾向评分匹配回顾性队列研究
|
Poster session Date: Thu 12 Oct Time: 12:15 – 1:30 PM ET
|
根据变化的不同环境衡量有效性:退伍军人事务部的COVID-19例子 |
Poster session Date: Sat 14 Oct Time: 12:15 – 1:30 PM ET
|
Early Science |
|
Understanding Clostridioides difficile toxin B gene conservation through surveillance of public data |
Poster session Date: Thu 12 Oct Time: 12:15 – 1:30 PM ET |
Notes
AZD3152
AZD3152 is an investigational next-generation long-acting antibody (LAAB). AZD3152在体外研究中显示，在一系列历史和当代SARS-CoV-2变体中具有广泛而有效的中和活性.1 AZD3152 binds to a highly conserved area on the SARS-CoV-2 spike protein.12
AZD3152来源于SARS-CoV-2感染后恢复期患者捐献的b细胞. 优化后的AZD3152具有相同的半衰期延长，降低了Fc效应函数和补体C1q结合平台 Evusheld. 延长的半衰期预计将为COVID-19提供6个月的保护.12 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.13
AstraZeneca licensed AZD3152 from RQ Biotechnology in May 2022. Under the licensing agreement, 除了潜在的里程碑付款外，RQ Bio有资格获得个位数的销售版税.
AZD3152正在进行的SUPERNOVA III期COVID-19预防试验中进行研究，预计最早将于2023年下半年上市, 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 免疫实践咨询委员会(ACIP)和美国儿科学会(AAP)是否推荐流感疫苗. FluMist Quadrivalent 最初于2003年在美国获得批准，从那时起，世界各地已分发了近2亿剂疫苗.
Beyfortus
Beyfortus (nirsevimab) is a single dose long-acting antibody, 由澳门在线赌城娱乐和赛诺菲合作开发和商业化，使用澳门在线赌城娱乐的YTE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, 通过抗体提供快速保护，帮助预防由RSV引起的LRTD, without requiring activation of the immune system. Beyfortus administration can be timed to the start of the RSV season.7
Beyfortus 目前已被批准在美国、欧盟、英国和加拿大使用 是否已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. 其中包括被国家药品监督管理局中国药品评价中心认定为“突破性疗法”和“优先审评”，并被日本医学研究开发机构(AMED)评为“促进儿科新药开发的药物选择项目”中的“优先开发药物”。, further leveraging Breakthrough Therapy Designation in the US and access granted to the European Medicines Agency (EMA PRIority MEdicines (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, 澳门在线赌城娱乐在100多个国家开展业务，其创新药物被全球数百万患者使用. Please visit chippyirvine.com and follow the Company on social media @AstraZeneca.
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References
1. Francica J et al. SARS-CoV-2单克隆抗体AZD3152有效中和历史和新出现的变体，并正在开发用于预防和治疗高危人群的COVID-19. Poster 1355. 12th Annual IDWeek Conference (2023)
2. Wilkins D, et al. 与标准护理帕利珠单抗相比，nirseimab与更高和更持久的RSV中和抗体反应相关:来自2:1随机化的观察, 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. 评价MEDI8897预防医疗护理下健康早产儿RSV下呼吸道感染的安全性和有效性的研究. Study Results. ClinicalTrials.Gov. http://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. 尼西米单抗早产儿和足月儿呼吸道合胞病毒下呼吸道感染的疗效, 先天性心脏病和慢性肺病婴儿的药代动力学外推:随机对照试验的汇总分析. Lancet Child Adolesc Health. 2023;7(3):180-189
7. Centers for Disease Control and Prevention. Immunity Types. Published online 2021. http://www.cdc.gov/vaccines/vac-gen/immunity-types.htm [Last accessed: October 2023]
8. Dube S et al. 接种疫苗的终末期肾病和透析患者COVID-19住院和死亡风险增加:INFORM的初步结果, a Retrospective Health Database Observational Study in England. Oral presentation 1095 at 12th Annual IDWeek Conference (2023)
9. Dube S et al. 免疫功能低下的完全接种疫苗的个体仍然面临由组粒变异导致的COVID-19严重后果的风险增加:INFORM的初步结果, a Retrospective Health Database Observational Study in England. Oral presentation 1096 at 12th Annual IDWeek Conference (2023)
10. McNulty R et al. 所有血液系统恶性肿瘤患者的COVID-19严重结局风险增加, Solid Tumors, 和实体器官移植与普通人群的比较:INFORM的初步结果, a Retrospective Health Database Observational Study in England. Poster 398. 12th Annual IDWeek Conference (2023)
11. Jhaveri R et al. 家庭注射鼻内减毒流感活疫苗:当前证据的回顾和满足疫苗接种目标的潜力. Poster 2610. 12th Annual IDWeek Conference (2023)
12. AstraZeneca Data on File REF-173312
13. Van Erp EA et al. fc介导的抗体效应在呼吸道合胞病毒感染和疾病中的作用. Front Immunol. 2019;10(MAR)