9 October 2020 21:30 BST
Two trials of AZD7442 will enrol over 6,000 adults for the prevention of COVID-19 with additional trials enrolling ~4,000 adults for the treatment of SARS-CoV-2 infections
US Government to invest ~$486m for development and supply of up to 100,000 doses and can acquire another one million doses
AstraZeneca’s long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,将于未来几周在美国境内外的网站上招募1000名参与者. laab采用了澳门在线赌城娱乐专利的半衰期延长技术，可在单次给药后增加6至12个月的治疗耐久性. 两种抗体的组合还旨在降低SARS-CoV-2病毒产生耐药性的风险.
根据与生物医学高级研究与发展管理局(BARDA)的协议，该公司已获得美国政府约4.86亿美元的支持，用于AZD7442的开发和供应。, 隶属于美国卫生与公众服务部负责准备和应对的助理部长办公室, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
其中一项试验将评估AZD7442预防感染长达12个月的安全性和有效性, in approximately 5,000 participants. 第二项试验将评估暴露后预防和预防性治疗,100 participants.
AstraZeneca is planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19.
AstraZeneca plans to supply up to 100,根据一项单独的协议，美国政府可以在2021年额外购买多达100万剂疫苗.
Pascal Soriot, Chief Executive Officer, 他说:“与美国政府达成的这项协议将有助于加速澳门第一赌城在线娱乐长效抗体组合的开发，这种组合有可能在预防和治疗COVID-19感染方面提供即时和持久的效果. 澳门第一赌城在线娱乐将评估不同情况下LAAB组合与预防, to outpatient treatment to hospitalisation, with a focus on helping the most vulnerable people.”
LAABs模拟天然抗体，有可能治疗和预防已经感染病毒的患者的疾病进展, 也可作为接触病毒前的预防性干预措施. A LAAB combination could be complementary to vaccines as a prophylactic agent, e.g. 对于可能不适合接种疫苗的人或为高危人群提供额外保护. It could also be used to treat people who have been infected.
今天的协议建立在美国政府机构BARDA和国防高级研究计划局(Defense Advanced Research Projects Agency)此前为发现和评估单克隆抗体提供的2500多万美元资金的基础上, as well as the Phase I clinical trial started in August 20201 评估AZD7442在健康个体中的安全性、耐受性和药代动力学.
Financial considerations
该协议预计不会影响公司2020年的财务指导，因为美国政府的资金正在被AZD7442的临床试验进展以及制造工艺和升级成本的费用所抵消. III期试验是否会成功，AZD7442是否会成为一种获批的药物, 公司预计在当前冠状病毒大流行期间和之后以商业条款提供该药物.
AZD7442
AZD7442是来自SARS-CoV-2感染后恢复期患者的两种laab的组合. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020澳门在线赌城娱乐对laab进行了优化，延长了半衰期，减少了Fc受体的结合. 延长的实验室抗体的半衰期应提供6至12个月的COVID-19防护.2-5 减少Fc受体结合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.6
In a recent Nature publication, 临床前实验显示，这些LAABs可阻断SARS-CoV-2病毒与宿主细胞的结合，并在细胞和动物疾病模型中防止感染.7
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 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 sh-fyz.com and follow the Company on Twitter @AstraZeneca.
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References
1. ClinicalTrials.gov. NCT04507256. http://clinicaltrials.gov/ct2/show/NCT04507256?term=NCT04507256&draw=2&rank=1.
2. Robbie, G.J., et al., A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother, 2013. 57(12): p. 6147-53.
3. Griffin, M.P., et al., Safety, Tolerability, and Pharmacokinetics of MEDI8897, 延长半衰期的呼吸道合胞病毒预融合f靶向单克隆抗体, in Healthy Adults. Antimicrob Agents Chemother, 2017. 61(3).
4. Yu, X.Q., et al., Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother, 2017. 61(1).
5. Domachowske, J.B., et al., Safety, Tolerability and Pharmacokinetics of MEDI8897, 延长半衰期单剂量呼吸道合胞病毒预融合f-靶向单克隆抗体单剂量给予健康早产儿. Pediatr Infect Dis J, 2018. 37(9): p. 886-892.
6. Van Erp EA, Luytjes W, Ferwerda G and van Kasteren PB. 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. http://doi.org/10.3389/fimmu.2019.00548.
7. Zost SJ et al. 有效中和阻断SARS-CoV-2受体结合并保护动物的人类抗体. Nature. 2020. DOI: 10.1038/s41586-020-2548-6.
Adrian Kemp
Company Secretary
AstraZeneca PLC