加强CAR-T细胞抗肿瘤效能！优卡迪创新性敲减PD-1赋能多发性骨髓瘤治疗
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2024年5月22日</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">医麦客<span style="color: black;">资讯</span> eMedClub News</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">近期</span>，上海优卡迪生物医药科技<span style="color: black;">机构</span>（简<span style="color: black;">叫作</span>“优卡迪”）<span style="color: black;">科研</span>团队与瑞金医院血液内科糜坚青<span style="color: black;">专家</span>团队在《Journal for ImmunoTherapy of Cancer》杂志<span style="color: black;">发布</span>了题名为“PD-1敲减可<span style="color: black;">保存</span>CAR-T细胞的记忆亚型、减少细胞耗竭，从而<span style="color: black;">加强</span>CAR-T细胞抗肿瘤效能（PD-1 downregulation enhances CAR-T cell antitumor efficiency by preserving a cell memory phenotype and reducing exhaustion<span style="color: black;">）”<span style="color: black;">的创新性<span style="color: black;">科研</span>成果。</span></span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q6.itc.cn/q_70/images03/20240522/6cc6c7aa764840e5a38afb600dfd27fb.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">CAR-T疗法面临的挑战：PD-1降低CAR-T效能，<span style="color: black;">增多</span><span style="color: black;">病人</span>复发<span style="color: black;">危害</span></strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">CAR-T</span>疗法在血液恶性肿瘤的治疗方面<span style="color: black;">已然</span><span style="color: black;">作为</span>一种颇具前景的免疫疗法。靶向<span style="color: black;">BCMA</span>的<span style="color: black;">CAR-T</span>细胞治疗复发难治多发性骨髓瘤<span style="color: black;">病人</span>疗效<span style="color: black;">明显</span>，但仍有相当比例的<span style="color: black;">病人</span>会<span style="color: black;">显现</span>复发。部分<span style="color: black;">原由</span>是<span style="color: black;">CAR-T</span>细胞功能<span style="color: black;">阻碍</span>，表现功能受抑、细胞衰竭或在体内持久性有限。在肿瘤免疫微环境中，<span style="color: black;">CAR-T</span>细胞的<span style="color: black;">PD-1</span>受体与肿瘤细胞的配体<span style="color: black;">PD-L1</span>结合会<span style="color: black;">控制</span><span style="color: black;">CAR-T</span>细胞的<span style="color: black;">初期</span>活化以及后期<span style="color: black;">CAR-T</span>细胞的效应功能。<span style="color: black;">因此呢</span>，<span style="color: black;">能够</span><span style="color: black;">经过</span><strong style="color: blue;">阻断<span style="color: black;">PD-1/PD-L1</span></strong>信号通路来解除免疫<span style="color: black;">控制</span>状态，<strong style="color: blue;">使耗尽的<span style="color: black;">T</span>细胞重新活化，从而逆转<span style="color: black;">CAR-T</span>细胞的抗肿瘤<span style="color: black;">功效</span>。</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">优卡迪创新技术：敲减PD-1基因，<span style="color: black;">提高</span>CAR-T细胞疗法效果</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">在与瑞金医院合作的项目<span style="color: black;">科研</span>中，优卡迪创新性地<span style="color: black;">经过</span><span style="color: black;">shRNA</span>将抗<span style="color: black;">PD-1</span>的沉默片段整合至含有<span style="color: black;">OX-40</span>共刺激域的<span style="color: black;">BCMA-CAR</span>载体中，一方面发挥<span style="color: black;">OX40</span>共刺激分子抗凋亡、<span style="color: black;">保存</span><span style="color: black;">T</span>细胞记忆表型的<span style="color: black;">优良</span>，<strong style="color: blue;">另一方面<span style="color: black;">经过</span><span style="color: black;">shRNA</span>实现<span style="color: black;">PD-1</span>稳定持久的敲减，又<span style="color: black;">保准</span>其临床应用的安全性。</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">体外<span style="color: black;">科研</span>结果<span style="color: black;">显示</span>，<strong style="color: blue;"><span style="color: black;">PD-1</span>沉默能够<span style="color: black;">加强</span><span style="color: black;">BCMA CAR-T</span>细胞的抗肿瘤和增殖能力。</strong>在<span style="color: black;">CAR-T</span>细胞激活的<span style="color: black;">初期</span><span style="color: black;">周期</span>，<span style="color: black;">PD-1</span>的沉默有助于<span style="color: black;">BCMA CAR-T</span>细胞的细胞增殖和细胞因子分泌；在<span style="color: black;">CAR-T</span>细胞接受重复抗原刺激后，其中央记忆<span style="color: black;">T</span>细胞比例<span style="color: black;">增多</span>，细胞耗竭减少。 </span></p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">Ⅰ期临床<span style="color: black;">实验</span>数据喜人</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">鉴于其临床前<span style="color: black;">科研</span>表现出较好的抗肿瘤效应，优卡迪联合瑞金医院在复发难治的多发性骨髓瘤<span style="color: black;">病人</span>中首次进行了这款新型<span style="color: black;">BCMA</span>靶向的<span style="color: black;">CAR-T</span>细胞<span style="color: black;">Ⅰ</span>期临床<span style="color: black;">实验</span>，初步的临床<span style="color: black;">科研</span>结果展示了其在体安全性及临床有效性。<span style="color: black;">截止</span><span style="color: black;">日前</span>，共有<span style="color: black;">7</span>例<span style="color: black;">R/R MM</span>受试者接受了<span style="color: black;">PD-1</span>沉默<span style="color: black;">BCMA CAR-T</span>细胞回输治疗，其中<span style="color: black;">4</span>例受试者<span style="color: black;">最少</span>有一个髓外病灶（<span style="color: black;">4/7</span>，<span style="color: black;">57.1%</span>），<span style="color: black;">4</span>例受试者伴有高危细胞遗传学特征（<span style="color: black;">4/7</span>，<span style="color: black;">57.1%</span>）。经<span style="color: black;">PD-1</span>沉默<span style="color: black;">BCMA CAR-T</span>治疗后，<span style="color: black;">ORR</span>为<strong style="color: blue;"><span style="color: black;">85.7%</span></strong>（<span style="color: black;">6/7</span>），<span style="color: black;">sCR</span>为<span style="color: black;">57.1%</span>（<span style="color: black;">4/7</span>），<span style="color: black;">CR</span>为<span style="color: black;">14.3%</span>（<span style="color: black;">1/7</span>）。在安全性方面，仅<span style="color: black;">1</span>例（<span style="color: black;">14.3%</span>）<span style="color: black;">显现</span><span style="color: black;">3</span>级<span style="color: black;">CRS</span>，<strong style="color: blue;">未观察到神经毒性。</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">优卡迪创新性工程化改造CAR-T，打造更强大、更全面的CAR-T疗法</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">尽管CAR-T疗法<span style="color: black;">做为</span>一种革命性治疗手段，已<span style="color: black;">明显</span><span style="color: black;">提高</span>了复发或难治性多发性骨髓瘤<span style="color: black;">病人</span>的生存率，然而，部分<span style="color: black;">病人</span>仍因肿瘤免疫逃逸<span style="color: black;">引起</span>的CAR-T细胞功能<span style="color: black;">控制</span>而面临复发<span style="color: black;">危害</span>。在当前CAR-T疗法扎堆血液瘤赛道的背景下，<span style="color: black;">怎样</span><span style="color: black;">研发</span>出真正<strong style="color: blue;"><span style="color: black;">拥有</span>差异化<span style="color: black;">优良</span>的创新型<span style="color: black;">药品</span></strong>尤为<span style="color: black;">要紧</span>。优卡迪<span style="color: black;">机构</span>深谙临床CAR-T疗法的挑战，<span style="color: black;">安身</span>于临床CAR-T疗法痛点，致力于优化该疗法，以更切实地<span style="color: black;">处理</span><span style="color: black;">病人</span>问题。<span style="color: black;">与其他<span style="color: black;">经过</span>使CAR-T细胞自分泌抗PD-1抗体的优化<span style="color: black;">办法</span>不同</span>，优卡迪<span style="color: black;">创新性地采用了</span><strong style="color: blue;">RNAi 技术敲减 PD-1 在 CAR-T 细胞内的表达</strong>，从而直接<strong style="color: blue;">降低</strong>CAR-T与肿瘤细胞的 PD-L1“握手”的机会。临床前和临床数据均提示，<span style="color: black;">这种敲减PD-1的策略能<span style="color: black;">明显</span><span style="color: black;">提高</span>CAR-T细胞的抗肿瘤能力。<span style="color: black;">另外</span>，</span>这一创新性的CAR-T工程化改造在靶向CD19和CLL-1的CAR-T细胞中<span style="color: black;">亦</span>得到了验证，为其他肿瘤中的应用推广奠定了<span style="color: black;">基本</span>。<strong style="color: blue;"><span style="color: black;"><span style="color: black;">将来</span>，<span style="color: black;">咱们</span>有望见证一种更加强大和全面的CAR-T疗法。</span></strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;"><strong style="color: blue;">关于优卡迪</strong></span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">上海优卡迪生物医药科技有限<span style="color: black;">机构</span>（以下简<span style="color: black;">叫作</span>“优卡迪”）于2015年2月在上海张江生物高科技孵化中心成立，是一家致力于<span style="color: black;">全世界</span>细胞治疗技术创新和转化的生物制药<span style="color: black;">公司</span>，已有多款First-in-class的<span style="color: black;">制品</span><span style="color: black;">处在</span>临床<span style="color: black;">实验</span><span style="color: black;">周期</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">优卡迪<span style="color: black;">持有</span>多个独创性的核心技术平台，<span style="color: black;">包含</span>SMART小核苷酸基因调控赋能技术平台、MADDS抗体创新成药性技术平台、6H生产质量<span style="color: black;">掌控</span>平台等。并且，<span style="color: black;">机构</span>在宝山落地了CAR-T密闭化生产体系，建筑面积约1万方，用于建设国际先进百亿级的基因和细胞治疗<span style="color: black;">研究</span>、产业化和商务化中心，打造国际一流的免疫治疗肿瘤创新技术转化中心和先进、高端基因工程化免疫细胞产业链中心，<span style="color: black;">重点</span><span style="color: black;">包含</span>CAR-T<span style="color: black;">制品</span>的产业化生产以及质粒、病毒、CAR-T细胞的CDMO服务。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">优卡迪<span style="color: black;">制品</span>管线布局广泛，<span style="color: black;">包含</span>用于治疗血液肿瘤、实体瘤和<span style="color: black;">自己</span>免疫性<span style="color: black;">疾患</span>等<span style="color: black;">制品</span>。2020年9月，<span style="color: black;">机构</span>ssCART-19注射液<span style="color: black;">得到</span>国内临床<span style="color: black;">实验</span>许可，突破性地用于CAR-T禁忌症中枢神经系统白血病（俗<span style="color: black;">叫作</span>“脑白”）的治疗，<span style="color: black;">日前</span>正在开展II期临床<span style="color: black;">实验</span>，预计于2024年底完成，并进入上市申请<span style="color: black;">周期</span>。优卡迪与瑞金医院、仁济医院等多家国内三甲医院血液科合作，已成功救治了1000多例晚期癌症<span style="color: black;">病人</span>，受试晚期肿瘤<span style="color: black;">病人</span>最长<span style="color: black;">存活</span>期已超过8年。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">声明：</strong><span style="color: black;">本文旨在于传递行业发展信息、探究生物医药前沿<span style="color: black;">发展</span>。<span style="color: black;">文案</span>内容仅<span style="color: black;">表率</span>作者观点，并不<span style="color: black;">表率</span>医麦客立场，<span style="color: black;">也</span>不<span style="color: black;">形成</span>任何价值判断、投资<span style="color: black;">意见</span>或医疗<span style="color: black;">指点</span>，如有需求请咨询专业人士投资或前往正规医院就诊。</span></p>
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