张菁与张文宏教授主持新冠病毒中和抗体临床试验，今日完成首例受试者给药

admin · 发表于 2020-10-14 12:07:06

                  <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-tools="gulangu" data-id="97917"><section><section><section data-bgless="spin" data-bgopacity="30%"><br  /></section><p><p><img src="image/20201014/5456bc04f5881d39f55a0e6a7ed9479f_2.jpg" /></p></p><p><span>中和抗体疗法有望率先成为抗击新冠病毒的治疗选择。</span></p><p><span><br  /></span></p><section><br  /></section><section data-mpa-template="t" mpa-from-tpl="t"><section mpa-from-tpl="t"><p><span>上海君实生物医药科技股份有限公司、中国科学院微生物研究所等单位共同开发的重组全人源抗新冠病毒单克隆抗体注射液（以下简称“JS016”）本周末获国家药监局批准，进入Ⅰ期临床试验。</span></p><p><span><br  /></span></p><p><br  /></p><p><span>今天上午，复旦大学附属华山医院完成了首例受试者给药。这是全球首个在健康受试者中开展的新冠病毒中和抗体临床试验，候选新药具有我国自主知识产权，旨在为探索JS016在人体中抗新冠病毒的治疗与预防效果提供依据。</span></p></section></section><section><br  /></section><p><span>这项临床试验采用随机、双盲、安慰剂对照研究方法，由华山医院张菁教授</span><span>与张文宏教授联合主持，目的是评价JS016静脉输注给药在中国健康志愿者中的耐受性、安全性、药代动力学特征及免疫原性。</span></p><p><span><br  /></span></p><p><p><img src="image/20201014/8d55b2733f5a681ea9bffea1782b0850_3.jpg" /></p></p><p><span>华山医院本次临床试验项目的部分研究团队成员</span></p><p><span><br  /></span></p><p><span>君实生物首席运营官冯辉博士介绍，中和抗体由人体B淋巴细胞产生，当病毒入侵细胞时，这种抗体能抢先与病毒表面的抗原结合，把它们“中和”掉。作为基因工程重组表达的“外援”，中和抗体药物注射进人体后，能抢先与新冠病毒的刺突蛋白（S蛋白）结合，使病毒无法感染人体细胞，从而被免疫系统清除。以往临床试验表明，单克隆中和抗体能降低埃博拉病人的病毒水平，起到有效中和病毒毒力、实质性改善临床症状、降低感染者死亡率等作用。</span></p><p><span><br  /></span></p><p><span>张文宏教授表示，中和抗体可针对新冠病毒精准进攻，具有独特的靶向性，能阻止病毒在人体内复制，快速产生作用。“我们希望在Ⅰ期临床试验中证明JS016良好的安全性和耐受性，为后续临床计划提供数据支持。中和抗体疗法有望率先成为抗击新冠病毒的治疗选择。”</span></p><p><span><br  /></span></p><section><span>除了潜在的治疗效果，中和抗体药物还有望预防病毒感染。与疫苗不同，这种药物更适用于应急状态下重症监护病房的医护人员、高龄老人等重点人群的预防。中科院微生物研究所严景华研究员说：“临床前研究表明，JS016有很强的中和活性和阻断能力，以及针对新冠病毒的预防和治疗双重作用。我们非常期待它能在临床中得到进一步验证。”</span></section><section><br  /></section><section><span>据介绍，这个候选新药源自新冠肺炎康复期患者体内。中科院微生物研究所科研人员利用单细胞测序技术，从患者外周血单个核细胞中分离出新冠病毒中和性单克隆抗体；再利用流式细胞技术，进行阻断试验分析，筛选出中和活性很强的抗体并在体外重组表达。在科技部、上海市科委等部门支持下，君实生物对中科院微生物所筛选的抗体进行多路并行开发，完成了蛋白表达、免疫球蛋白Fc段（可结晶段）工程化改造、细胞株构建等抗体工艺开发和规模化生产的关键步骤。</span></section><section><span><br  /></span></section><section><span>在国务院联防联控机制统筹推进下，抗体研发工作得到了科技部、国家卫健委、国家药监局、中科院、上海市、北京市的大力支持，上下联动、协同攻关，体现出新型举国体制在重大药物研发方面的巨大优势。</span></section><section><span><br  /></span></section><section><span>临床前研究显示，JS016对新冠病毒S蛋白的受体结合区域（RBD）表现出极高的特异性亲和力，达到纳摩尔水平，能够抢先与病毒结合，从源头上阻断病毒入侵宿主细胞。</span></section><section><span><br  /></span></section><section><span>在有效性方面，恒河猴动物感染实验表现出JS016的治疗和预防效果，相关数据已在线发表于国际顶级科技杂志《自然》。</span></section><section><span><br  /></span></section><section><span> </span><p><img src="image/20201014/d7f0c18c3c4763ed9a6852b70751f2b8_4.png" /></p></section><section><span>恒河猴感染后对照组、治疗组、预防组的咽拭子病毒滴度变化</span></section><section><span><br  /></span></section><p><span>在安全性方面，JS016抗体基因来源于康复病人单个B细胞，是全人源天然抗体，预计有较好的安全性。此外，为了减少抗体介导的急性肺损伤风险，确保临床应用中的安全性，科研团队对JS016进行Fc段改造，有效降低了可能存在的抗体依赖增强效应（ADE）、抗体介导的细胞毒作用以及细胞吞噬效应。临床前食蟹猴毒理学研究中，最大耐受剂量、未观察到明显毒性反应剂量是人体临床试验推荐起始剂量的数十倍，意味着存在较大的安全窗。</span></p><p><span><br  /></span></p><p><span>专家表示，从进入人体临床试验阶段，到抗体药物最终使用，还有很长的路要走。成果的取得来之不易，未来依然任重道远。</span></p><p><br  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