首个mRNA癌症疫苗有望明年上市，AI助力治疗多种实体瘤
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2024年4月29日</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">医麦客<span style="color: black;">资讯</span> eMedClub News</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">1980年，人类就<span style="color: black;">经过</span>疫苗灭绝了天花病毒。自此，疫苗<span style="color: black;">行业</span>繁荣发展，乙肝、HPV、狂犬、百白破、乙脑等。然而，<span style="color: black;">治疗性</span>癌症疫苗却<span style="color: black;">发展</span>缓慢，40年来<span style="color: black;">始终</span>很难有所突破……</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">随着<span style="color: black;">由</span><span style="color: black;"><span style="color: black;">Moderna</span><span style="color: black;"><span style="color: black;">和</span>默沙东（MSD）<span style="color: black;">主导的</span></span></span>新型</span><span style="color: black;">癌症疫苗<span style="color: black;"><span style="color: black;">mRNA-4157</span>接近关键临床<span style="color: black;">实验</span>读数</span></span><span style="color: black;">，FDA<span style="color: black;">生物制品<span style="color: black;">评定</span>和<span style="color: black;">科研</span>中心（CBER）<span style="color: black;">专家</span></span>——“疫苗沙</span><span style="color: black;">皇<span style="color: black;">”</span>Peter Marks博士表</span><span style="color: black;">示，“尽管人工智能（AI）存在<span style="color: black;">关联</span>的未知数，FDA 已准备好审评这些疫苗。”</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">在2024年世界疫苗大会（WVC）上，Marks博士谈到癌症疫苗时说：“<span style="color: black;">咱们</span>准备好了审查，<span style="color: black;">咱们</span>对这类疗法的<span style="color: black;">商场</span>化持开放态度。</span><span style="color: black;">面对到来的<strong style="color: blue;">治疗性<span style="color: black;">mRNA</span>癌症疫苗</strong>的审评审批，</span><span style="color: black;">我认为<span style="color: black;">咱们</span>会像<span style="color: black;">审评</span><span style="color: black;">CAR-T细胞或其他治疗<span style="color: black;">制品</span><span style="color: black;">同样</span></span>对它们进行<span style="color: black;">审评</span>。</span><span style="color: black;">”</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">FDA之前<span style="color: black;">已然</span><span style="color: black;">准许</span>了一种癌症疫苗，即Dendreon的前列腺癌疫苗Provenge（普列威）。尽管下一波治疗性癌症疫苗的<span style="color: black;">目的</span>是<span style="color: black;">经过</span><span style="color: black;">平常</span>的临床终点（如肿瘤<span style="color: black;">发展</span>）来证明疗效，但其技术的新颖性<span style="color: black;">诱发</span>了新的监管问题，<span style="color: black;">亦</span>将带来新的审批政策。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">癌症疫苗<span style="color: black;">明显</span>降低癌症转移或死亡<span style="color: black;">危害</span>达</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">eMedClub</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2022年12月13日</span><span style="color: black;">，由默沙东与Moderna联合<span style="color: black;">研发</span>的个体化癌症疫苗mRNA-4157/V940与PD-1<span style="color: black;">控制</span>剂<span style="color: black;">K药（帕博利</span><span style="color: black;">珠单抗）</span>的组合疗法，在临床2b期<span style="color: black;">实验</span><span style="color: black;">其中</span><span style="color: black;">表示</span>，<span style="color: black;">该<span style="color: black;">科研</span>达到五年<span style="color: black;">没</span>复发<span style="color: black;">存活</span>率（RFS）<span style="color: black;">重点</span>终点，</span>与Keytruda单药治疗相比，组合疗法<span style="color: black;">能够</span><strong style="color: blue;"><span style="color: black;">明显</span>降低III、IV期黑色素瘤<span style="color: black;">病人</span>在肿瘤完全切除后</strong><strong style="color: blue;">的复发或死亡<span style="color: black;">危害</span>达44%</strong>！</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q5.itc.cn/q_70/images03/20240429/2d1cc685b2214034b233e9f6cc4d1584.png" 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;"><span style="color: black;">▲</span></span><span style="color: black;">mRNA-4157联合帕博利珠单抗可将复发或死亡<span style="color: black;">危害</span>降低44%</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2023年12月14日，<span style="color: black;">Moderna</span>和默沙东宣布2b期临床<span style="color: black;">实验</span>KEYNOTE-942/mRNA-4157-P201的<strong style="color: blue;">3年随访积极结果</strong>。在三年期内，mRNA-4157联合PD-1疗法K药<span style="color: black;">运用</span>可使皮肤癌黑色素<span style="color: black;">瘤</span><span style="color: black;">病人</span>的复发<span style="color: black;">危害</span>降低49%（HR=0.510，95% CI：0.288-0.906；单侧p=0.0095），并改善<span style="color: black;">远处转移<span style="color: black;">存活</span>期（DMFS）</span>，<strong style="color: blue;">使<span style="color: black;">病人</span>的远处转移或死亡<span style="color: black;">危害</span>降低62%</strong>（HR=0.384，95% CI：0.172-0.858；单侧p=0.0077）。</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;">按照</span>如上这个KEYNOTE-942数据，美国FDA和欧洲<span style="color: black;">药物</span>管理局（EMA）分别授予mRNA-4157与帕博利珠单抗组合突破性疗法认定（BTD）和PRIME资格。在黑色素瘤适应症外，<span style="color: black;">Moderna还针对<span style="color: black;">mRNA-4157用于<span style="color: black;"><span style="color: black;">非小细胞肺癌<span style="color: black;">起步</span>了<span style="color: black;"><span style="color: black;">3期临床<span style="color: black;">科研</span>，用于膀胱癌、肾细胞癌<span style="color: black;"><span style="color: black;">起步</span>了</span><span style="color: black;">2期临床<span style="color: black;">科研</span>。</span></span></span></span></span></span></span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2023年底，Moderna首席执行官Stéphane Bancel接受采访时曾<span style="color: black;">暗示</span>，“Moderna针对黑色素瘤的mRNA癌症疫苗可能在两年内上市，这将是抗击这种最严重形式的皮肤癌的里程碑式一步。”</span><span style="color: black;">Stephane Bancel<span style="color: black;">暗示</span>，“<span style="color: black;">咱们</span>认为，</span><strong style="color: blue;">在<span style="color: black;">有些</span>国家，这款mRNA癌症疫苗<span style="color: black;">能够</span>在2025年前<span style="color: black;">得到</span>加速<span style="color: black;">准许</span>上市</strong><span style="color: black;">。</span><span style="color: black;">”</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;">今年2月，《柳叶刀》文献<span style="color: black;">报告</span>了mRNA-4157在美国和澳大利亚进行的多<span style="color: black;">公司</span>的2b期<span style="color: black;">科研</span>结果</span><span style="color: black;">，与K药（PD-1<span style="color: black;">控制</span>剂，ICIs）单药治疗相比，mRNA-4157治疗联合</span><span style="color: black;">K药</span><span style="color: black;">，<span style="color: black;">明显</span></span><span style="color: black;">延长了术</span><span style="color: black;">后高危黑色素瘤<span style="color: black;">病人</span>的<span style="color: black;">没</span>复发<span style="color: black;">存活</span>期，并<span style="color: black;">表示</span>出可控的安全性。</span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">个体化癌症疫苗是<span style="color: black;">怎样</span>制造出和应用？</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">eMedClub</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">个体化癌症疫苗的目的是<span style="color: black;">经过</span><span style="color: black;">按照</span><span style="color: black;">病人</span>个体化肿瘤突变类别设计的疫苗，可<span style="color: black;">帮忙</span><span style="color: black;">病人</span>产生相对应的抗肿瘤反应，<span style="color: black;">从而</span><span style="color: black;">提高</span>癌症<span style="color: black;">病人</span>的免疫能力。癌症疫苗的制造和应用<span style="color: black;">过程</span>简化如下：<span style="color: black;">①肿瘤样本采集</span></span><span style="color: black;">→</span><span style="color: black;"><span style="color: black;">②基因组测序<span style="color: black;">→</span>③新抗原预测和筛选<span style="color: black;">→</span>④疫苗设计和生产<span style="color: black;">→</span>⑤质量<span style="color: black;">掌控</span><span style="color: black;">→</span>⑥<span style="color: black;">病人</span>接种<span style="color: black;">→</span>⑦监测与<span style="color: black;">评定</span>。</span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q8.itc.cn/q_70/images03/20240429/fddf19d035284702a8ca3fca1bd29a2d.png" 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;"><span style="color: black;"><span style="color: black;"><span style="color: black;">▲</span></span><span style="color: black;"><span style="color: black;">个体化<span style="color: black;">新抗原</span>癌症疫苗的制造和应用流程</span></span></span></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;"><span style="color: black;"><span style="color: black;"><span style="color: black;">Moderna<span style="color: black;">机构</span>的技术</span>平台</span>对<span style="color: black;">病人</span>的肿瘤和健康组织进行测序，<span style="color: black;">并<span style="color: black;">经过</span><span style="color: black;">运用</span>一种专有算法，识别出免疫原性肿瘤特异性新抗原。</span></span></strong><span style="color: black;"><span style="color: black;">其<span style="color: black;">算法<span style="color: black;">能够基于人体外测定数据，高准确度的预测和筛选<span style="color: black;">拥有</span>TIL反应性的新生抗原，mRNA-4157<span style="color: black;">便是</span><span style="color: black;">这里</span>算法下诞生。</span></span></span></span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q3.itc.cn/q_70/images03/20240429/25565907eaa244df8d23dad566b045ba.png" 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;"><span style="color: black;"><span style="color: black;"><span style="color: black;"><span style="color: black;">▲</span></span><span style="color: black;"><span style="color: black;"><span style="color: black;">新生抗原的筛选算法概览</span></span></span></span></span></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;"><span style="color: black;">新生抗原构<span style="color: black;">成为了</span>疫苗构建的<span style="color: black;">基本</span>，而由此产生的蛋白质在个体之间可能存在很大差异。</span></span></span><span style="color: black;">mRNA-4157是一种基于mRNA的新型<span style="color: black;">科研</span>型</span><strong style="color: blue;">个体化新抗原疗法</strong><span style="color: black;">（INT），由编码多达34种新抗原的合成mRNA<span style="color: black;">构成</span>，这种mRNA是<span style="color: black;">按照</span><span style="color: black;">病人</span>肿瘤DNA序列的独特突变特征设计和生产的。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q1.itc.cn/q_70/images03/20240429/1852044db7d54da2ad962623617ec464.png" 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;"><span style="color: black;">▲</span></span><span style="color: black;">Moderna个体化癌症疫苗设计</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;">针对</span></span><span style="color: black;">mRNA-4157<span style="color: black;">来讲</span>，AI决定个体化疫苗应该<span style="color: black;">怎样</span>制定来攻击癌症。</span><span style="color: black;">该疫苗</span><span style="color: black;">在给药到<span style="color: black;">身体</span>后，算法衍生、RNA编码的新抗原序列被内源性翻译并进行天然细胞抗原加工和呈递，这是适应性免疫的<span style="color: black;">重要</span><span style="color: black;">过程</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">Moderna的治疗学和肿瘤学发展负责人Kyle Holen在<span style="color: black;">世界疫苗大会</span>的场外告诉记者，“<span style="color: black;">因为</span>AI是该项目的核心<span style="color: black;">构成</span>部分，Moderna预计<span style="color: black;">做为</span>mRNA-4157审评的一部分，FDA 将<span style="color: black;">必须</span>审查其算法。</span><span style="color: black;">Holen接着说，</span><span style="color: black;"><span style="color: black;">咱们</span><span style="color: black;">必要</span>把<span style="color: black;">咱们</span>的算法放在硬盘上，装在装甲车里，<span style="color: black;">而后</span>运到FDA。</span><span style="color: black;">”</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">众所周知，<span style="color: black;">AI</span>算法在吸收新信息的过程中<span style="color: black;">持续</span>进化。<span style="color: black;">然则</span>为了<span style="color: black;">守护</span>基于<span style="color: black;">AI</span>疫苗的临床<span style="color: black;">实验</span>的完整性，Moderna不得不在<span style="color: black;">科研</span>之前“锁定”算法，以避免任何可能<span style="color: black;">引起</span>结果混乱的变化，Holen<span style="color: black;">弥补</span>说。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">所有这些都提出了一个新的监管问题：在疫苗被认为是一个全新的<span style="color: black;">制品</span>之前，<span style="color: black;">AI</span>算法<span style="color: black;">准许</span>多大的改变？<span style="color: black;">Holen</span>说，“<span style="color: black;"><span style="color: black;">咱们</span></span><span style="color: black;">不<span style="color: black;">晓得</span>，</span>没人<span style="color: black;">晓得</span>。<span style="color: black;">这儿</span>是<span style="color: black;">没</span>人区，<span style="color: black;">由于</span>没人做过这种事。”</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">FDA<span style="color: black;">针对</span>癌症疫苗的新技术打算<span style="color: black;">这般</span>管</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">eMedClub</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;">Moderna</span>与美国FDA就mRNA-4157疫苗项目进行沟通，探讨了<strong style="color: blue;">更换基因组测序的供应商和<span style="color: black;">调节</span>抗原数量范围的影响</strong>，这些变更将被认为是对项目的重大修改。然而，<span style="color: black;">日前</span>尚未<span style="color: black;">知道</span>这些<span style="color: black;">调节</span><span style="color: black;">可否</span><span style="color: black;">必须</span>提交新的<span style="color: black;">弥补</span>申请，或是在首次<span style="color: black;">得到</span><span style="color: black;">准许</span>后，针对任何重大变更提交全新的新药申请。</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;">思虑</span>到癌症疫苗可能<span style="color: black;">必须</span>频繁更新，<span style="color: black;">需求</span>每次更新都经过全面的审评或进行大型随机临床<span style="color: black;">实验</span>似乎不切<span style="color: black;">实质</span>。<span style="color: black;">因此呢</span>，<span style="color: black;">FDA的Peter Marks</span>博士提出，美国FDA正在<span style="color: black;">思虑</span>的平台技术认定（platform technology designation）可能针对该问题<span style="color: black;">供给</span><span style="color: black;">认识</span>决<span style="color: black;">方法</span>，</span><span style="color: black;">目的是为了让</span><span style="color: black;"><span style="color: black;">运用</span>相同平台技术<span style="color: black;">研发</span>的<span style="color: black;">制品</span>享受到更简化的审评流程。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">虽然FDA提出“平台技术认定”的概念已有一段时间，但Marks博士指出，该概念尚未得到充分应用。<strong style="color: blue;">他强调，mRNA技术的应用将迫使FDA积极探索并扩大这一理念的应用范围，以适应新兴技术的发展</strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">结语</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">eMedClub</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;"><span style="color: black;">在近十来年针对癌症的<span style="color: black;">科研</span>中，人们<span style="color: black;">发掘</span>不同病人身上的同种癌症<span style="color: black;">拥有</span>大相径庭的<span style="color: black;">药品</span>应答、细胞毒性以及预后，<span style="color: black;">因此呢</span>为不同的病人裁剪特定的癌症治疗<span style="color: black;">方法</span><span style="color: black;">作为</span>一种极具<span style="color: black;">潜能</span>的手段。继PD-1/PD-L1和CAR-T疗法之后，个体化癌症疫苗<span style="color: black;">逐步</span><span style="color: black;">作为</span>肿瘤免疫治疗新的发展方向。<span style="color: black;">将来</span>，</span><span style="color: black;">除了</span><span style="color: black;">mRNA-4157，mRNA-5671、BioNTech与基因泰克（Genentech）的autogene cevumeran（RG6180）等<span style="color: black;">mR</span><span style="color: black;">NA癌症疫苗在抗击实体瘤上均展现了有力前景。这些</span></span>个体化的<span style="color: black;">癌症疫苗有望<span style="color: black;">获准</span><span style="color: black;">信息</span>让<span style="color: black;">大众</span>感到兴奋。</span></span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">个体化新抗原癌症疫苗兴起之下<span style="color: black;">亦</span>显现了些问题。如前面<span style="color: black;">说到</span>的测序供应商变更，抗原数量范围<span style="color: black;">调节</span><span style="color: black;">这般</span>的疫苗生产制造上的变化<span style="color: black;">可否</span>会影响抗癌效果？<span style="color: black;">另一</span>，如</span><span style="color: black;">mR</span><span style="color: black;">NA癌症疫苗<span style="color: black;">可否</span>专注于对抗组织中的癌细胞而不<span style="color: black;">损伤</span>健康组织？<span style="color: black;">必须</span>靶向的最佳抗原是什么？疫苗<span style="color: black;">制品</span>的最佳佐剂是什么？哪种免疫<span style="color: black;">检测</span>点<span style="color: black;">控制</span>剂（ICIs）能最好地<span style="color: black;">加强</span>癌症疫苗的疗效？</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">为紧抓行业当下面临的机遇，推动行业<span style="color: black;">一起</span>发展。</span><span style="color: black;">医麦客将于2024年6月14-15日在南京举办2024 IBI EXPO生物创新药产业大会，</span><span style="color: black;">并召开“第三届核酸<span style="color: black;">药品</span><span style="color: black;">研发</span>论坛”，</span><span style="color: black;">探讨“人工智能加速mRNA癌症疫苗<span style="color: black;">研发</span>”这一<span style="color: black;">热榜</span><span style="color: black;">专题</span></span><span style="color: black;">。<span style="color: black;">这次</span>会议将邀请该<span style="color: black;">行业</span>的先锋与领袖，聚焦最新<span style="color: black;">科研</span>动态与<span style="color: black;">发展</span>，深度探讨和展望<span style="color: black;"><span style="color: black;">核酸<span style="color: black;">药品</span><span style="color: black;">研发</span></span></span>的<span style="color: black;">将来</span>发展趋势。</span></p>
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<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">2024 IBI EXPO 日程一览</strong></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;">参考资料：</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"></span><span style="color: black;">Were open for business: FDAs Peter Marks says agency ready to review novel cancer vaccines despite unknowns ，from https://www.fiercebiotech.com/biotech/were-open-business-fdas-peter-marks-says-agency-ready-review-novel-cancer-vaccines-despite</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;">声明及版权说明</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">声明：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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