来自INFORM研究的真实数据表明，严重COVID-19的风险增加
所有免疫功能低下患者的结局
并强调需要额外的保护
FluMist四价数据支持自我注射流感疫苗扩大的潜力
获得一项重要的预防工具
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, reinforcing the important role of long-acting antibodies and vaccines to protect at-risk individuals from the increased burdens of common infectious respiratory diseases. 该公司将在此次活动上展示15篇摘要, 有三个口头报告, 包括一个迟到的口头语, 还有12个海报展示.
数据将呈现以下特点:
- 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
- 自我管理 FluMist Quadrivalent 鼻内流感疫苗, 扩大获得季节性流感疫苗的潜在新选择
- AZD3152，一种正在研究的抗COVID-19的长效抗体
Iskra Reic，疫苗部执行副总裁 & 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, our data provide the strongest evidence to date that the burden of COVID-19 on those who are immunocompromised remains significant and disproportionate. 此外，澳门第一赌城在线娱乐将分享AZD3152和AZD3152的最新数据 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, 确保不让任何人掉队.”
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
AstraZeneca will present updated in vitro neutralisation data for the investigational long-acting antibody AZD3152 against historical and emerging COVID-19 variants.1 此外，更新的数据 Beyfortus, a long-acting antibody recently approved by the US Food and Drug Administration (FDA) for the prevention of RSV lower respiratory tract disease (LRTD) in infants, 将呈现，强化 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 Passive immunisation provides infection-fighting antibodies directly to immunocompromised patients who are unlikely to elicit an adequate immune response to traditional vaccinations.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, from the groundbreaking INFORM real-world evidence study in England reveal the increased burden of severe COVID-19 outcomes facing all individuals with immunocompromised conditions compared to the general population, 即使完全接种了病毒疫苗, 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, 如实体和血液恶性肿瘤, 实体器官移植和终末期肾脏疾病.10
开创预防流感的新方法
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). The study evaluates the potential for self- and caregiver-administered LAIV to enable more equitable access to the influenza vaccine for communities which lack easy access, 从而有助于实现疫苗接种目标.11
澳门在线赌城娱乐在IDWeek 2023期间的主要报告
Abstract title |
展示细节 |
|---|---|
AZD3152 |
|
The SARS-CoV-2 monoclonal antibody AZD3152 potently neutralises historical and emerging variants and is being developed for the prevention and treatment of COVID-19 in high-risk individuals
|
Poster session Date: Fri 13 Oct 时间:美国东部时间下午12:15 - 1:30
|
COVID-19真实证据 |
|
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, 英国的一项回顾性健康数据库观察性研究 |
Poster session Date: Thu 12 Oct 时间:美国东部时间下午12:15 - 1:30
|
Increased risk of COVID-19 hospitalisation and death in vaccinated patients with end-stage renal disease and dialysis: initial results from INFORM, 英国的一项回顾性健康数据库观察性研究
|
Oral presentation Date: Fri 13 Oct 时间:美国东部时间上午10:45 - 11:00
|
Fully vaccinated individuals with immunocompromised conditions are still at increased risk of severe COVID-19 outcomes from the Omicron variant: initial results from INFORM, 英国的一项回顾性健康数据库观察性研究 |
Oral presentation Date: Fri 13 Oct 时间:美国东部时间上午11:00 - 11:15
|
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 时间:美国东部时间下午12:15 - 1:30
|
Beyfortus (nirsevimab) |
|
Nirsevimab is associated with higher and more sustained RSV neutralizing antibody responses compared with standard of care palivizumab: observations from a 2:1 randomised, 医学弱势儿童2/3期临床试验(MEDLEY) |
迟交口头陈述 Date: Fri 13 Oct 时间:下午1:45 - 1:57
|
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 时间:美国东部时间下午12:15 - 1:30
|
AZD7442 / Evusheld (tixagevimab / cilgavimab) |
|
Clinical effectiveness of the monoclonal antibody combination tixagevimab-cilgavimab as pre-exposure prophylaxis of COVID-19 among patients with moderate to severe immunocompromised conditions across a large US healthcare system: a propensity score-matched retrospective cohort study
|
Poster session Date: Thu 12 Oct 时间:美国东部时间下午12:15 - 1:30
|
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 时间:美国东部时间下午12:15 - 1:30
|
Early Science |
|
Understanding Clostridioides固执的 毒素B基因保护通过监测公共数据 |
Poster session Date: Thu 12 Oct 时间:美国东部时间下午12:15 - 1:30 |
Notes
AZD3152
AZD3152是正在研究的下一代长效抗体(LAAB). AZD3152 has been shown in in vitro studies to have broad and potent neutralising activity across a range of historical and contemporary SARS-CoV-2 variants.1 AZD3152与SARS-CoV-2刺突蛋白上的一个高度保守区域结合.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 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, 感染和/或疾病.13
澳门在线赌城娱乐于2022年5月从RQ Biotechnology获得AZD3152许可. 根据许可协议, 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 is being investigated in the ongoing SUPERNOVA Phase III COVID-19 prevention trial and is anticipated to be available as early as H2 2023, 根据监管审查和试验读数.
FluMist Quadrivalent
FluMist Quadrivalent 是一种四价流感减毒活疫苗(LAIV), 预防流感的鼻喷雾剂是什么. 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. 喷雾疫苗四价的 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)是单剂量长效抗体, 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. 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, 以单剂形式直接提供给新生儿和婴儿, 通过抗体提供快速保护，帮助预防由RSV引起的LRTD, 不需要激活免疫系统. Beyfortus 可以在RSV季节开始的时候给药.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. These include 突破性的治疗 Designation and Priority Review Designation by the China Center for Drug Evaluation under the National Medical Products Administration and being named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED), further leveraging 突破性的治疗 Designation 在美国和欧洲药品管理局(EMA)获得许可 PRIority MEdicines (PRIME) scheme.
AstraZeneca
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, development, 以及肿瘤学处方药的商业化, Rare Diseases, 和澳门第一赌城在线娱乐, 包括心血管, Renal & 新陈代谢和呼吸 & 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. 请访问澳门在线赌城娱乐.并在社交媒体上关注公司 @AstraZeneca.
References
1. Francica J et al. 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. Poster 1355. 第十二届IDWeek年会(2023)
2. Wilkins D, et al. Nirsevimab is Associated with Higher and More Sustained RSV Neutralizing Antibody Responses Compared with Standard of Care Palivizumab: Observations from a 2:1 Randomized, 医学弱势儿童2/3期临床试验(MEDLEY). 1934年在第12届IDWeek年度会议上的口头报告(2023)
3. Hammitt LL et al. 尼瑟维单抗预防健康晚早产儿和足月婴儿呼吸道合胞病毒. 新英格兰医学杂志. 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 [最后访问日期:2023年10月]
5. Griffin MP et al. 单剂量尼瑟维单抗预防早产儿呼吸道合胞病毒. 新英格兰医学杂志. 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, and Pharmacokinetic Extrapolation to Infants with Congenital Heart Disease and Chronic Lung Disease: A Pooled Analysis of Randomised Controlled Trials. 《澳门第一赌城在线娱乐》. 2023;7(3):180-189
7. 疾病控制和预防中心. Immunity Types. 2021年在线出版. http://www.cdc.gov/vaccines/vac-gen/immunity-types.htm [最后访问日期:2023年10月]
8. Dube S et al. Increased Risk of COVID-19 Hospitalization and Death in Vaccinated Patients with End-Stage Renal Disease and Dialysis: Initial Results from INFORM, 英国一项回顾性健康数据库观察性研究. 第12届IDWeek年会口头报告1095 (2023)
9. Dube S et al. Fully Vaccinated Individuals with Immunocompromised Conditions Are Still at Increased Risk of Severe COVID-19 Outcomes from the Omicron Variant: Initial Results from INFORM, 英国一项回顾性健康数据库观察性研究. 第12届IDWeek年会口头报告1096 (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, 英国一项回顾性健康数据库观察性研究. Poster 398. 第十二届IDWeek年会(2023)
11. Jhaveri R et al. Home Administration of Intranasal Live Attenuated Influenza Vaccine: A Review of Current Evidence and Potential for Meeting Vaccination Targets. Poster 2610. 第十二届IDWeek年会(2023)
12. 澳门在线赌城娱乐数据文件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)