AZ cues up COVID-19 neutralising antibody trials
Drug company is working in partnership with Vanderbilt University in the US
AstraZeneca has said it will start clinical trials of two antibodies targeting SARS-CoV-2, the virus that causes COVID-19, within the next two months.
The two candidates have emerged from a partnership with Vanderbilt University in the US – focusing on up to six coronavirus-targeting neutralising antibodies – which was signed in April. The antibodies have the potential to recognise, bind to and neutralise SARS-CoV-2, decreasing the impact of COVID-19, according to AZ.
The two antibodies selected to go forward into the phase 1 trial as a combination therapy bind to separate parts of the SARS-CoV-2 spike protein, said Mene Pangalos, AZ’s head of biopharmaceuticals R&D.
Using two antibodies in tandem could improve efficacy and reduce the chances of SARS-CoV-2 developing resistance mutations that could undermine treatment, according to AZ.
AZ’s combination will start trials a few weeks behind two other neutralising antibody candidates, backed by Eli Lilly, that are already in human testing.
Earlier this month, Lilly and AbCellera started dosing patients in the US with their candidate LY-CoV555, while this week Lilly said its other partner Junshi Biosciences began a trial of JS016 in China, with US testing also due to start within the next few days.
Meanwhile, Singapore-based biotech Tychan said this morning it is also just about to start initial trials of its antibody TY027 in healthy volunteers next week.
AZ says its selection of six Vanderbilt candidates has come after it screened more than 1,500 monoclonal antibodies for the ability to bind to SARS-CoV-2 and inhibit its capacity to infect healthy cells.
The antibodies came from patients who have recovered from COVID-19, immunised humanised mice and laboratory techniques such as phage display, according to the drugmaker.
AZ’s work on the antibody cocktail will be supported by the US Defense Advanced Research Projects Agency (DARPA) and the Biomedical Advanced Research and Development Authority (BARDA). The US government is providing $23.7m in funding and support for the production of antibodies for the phase 1 trial.
While the greatest hope for defeating the pandemic lies with the development of an effective vaccine – an area where AZ is also at the forefront with its Oxford University-partnered candidate AZD1222 – antibodies could be an invaluable weapon against the coronavirus.
Aside from their use in potentially improving survival and recovery in people who already have COVID-19, they may provide passive immunity to protect at-risk individuals, such as front-line health workers and vulnerable people who are not good candidates for a vaccine.
Cases of coronavirus have now topped an estimated seven million worldwide, claiming more than 400,000 lives.
阿斯利康曾表示，将在未来两个月内开始针对导致 COVID-19 的病毒 SARS—CoV-2 的两种抗体的临床试验。这两位候选人来自与美国范德比尔特大学的合作——专注于多达 6 种冠状病毒靶向中和抗体——于今年 4 月签署协议。据 AZ 说，这些抗体具有识别、结合和中和 SARS-CoV-2 的潜力，降低了 COVID-19 的影响。AZ 生物制药研发部负责人 Mene Pangalos 表示，这两种抗体被选择作为一种组合疗法，与 SARS—CoV-2 刺突蛋白的不同部分结合，进入 1 期试验。根据 AZ 的说法，将两种抗体串联使用可以提高疗效，减少 SARS 病毒 2 型产生耐药突变从而破坏治疗的机会。AZ 的组合将比礼来支持的另外两种中和抗体候选药物晚几周开始试验，这两种药物已经在人体试验中。本月初，礼来和 AbCellera 开始给美国患者服用候选药物 LY-CoV555，而本周礼来表示，其另一个合作伙伴君实生物科技公司 (Junshi Biosciences) 开始在中国进行 JS016 的试验，美国的试验也将在未来几天内开始。与此同时，总部位于新加坡的生物技术公司 Tychan 表示，公司也将于下周在健康志愿者身上开始其抗体 TY027 的初步试验。AZ 表示，在筛选了超过 1500 种单克隆抗体与 SARS-CoV-2 结合并抑制其感染健康细胞的能力后，其选择了 6 种范德比尔特候选抗体。据制药商说，这些抗体来自于已经从 COVID-19 中康复的患者，这些患者接受了人源化小鼠免疫和噬菌体展示等实验室技术。AZ 在抗体鸡尾酒方面的工作将得到美国国防部高级研究计划局 (DARPA) 和生物医学高级研发管理局 (BARDA) 的支持。美国政府正在为 1 期试验的抗体生产提供 2370 万美元的资金和支持。虽然战胜大流行的最大希望在于开发一种有效的疫苗——AZ 也是牛津大学最前沿的领域——与候选药物 AZD1222 合作——抗体可能是对抗冠状病毒的一种无价武器。除了在已经有 COVID-19 的人群中用于潜在改善生存和恢复之外，它们可能提供被动免疫以保护高危个体，例如一线卫生工作者和不适合接种疫苗的脆弱人群。冠状病毒病例目前已超过全球估计 700 万，夺去超过 40 万人的生命
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