6257rv7 发表于 2024-5-20 23:35:00

卵巢癌DNA疫苗获准进入2期，龙头折戟后DNA疫苗或将走出低谷


    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/bK2EFoTdFIukgHwibkKSEIicakAKf9gSNyplbOP1I0j0EuIuiaAnxQnFzwAhdfPk4qA7B6yOwLcH7ZaZ3hhknN3eQ/640?wx_fmt=jpeg&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" 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;">2023年9月15日/医麦客<span style="color: black;">资讯</span> eMedClub News/--</span></span><span style="color: black;"><span style="color: black;">近期</span>，生物技术<span style="color: black;">机构</span>Aston Sci宣布，其创新DNA癌症疫苗AST-201已<span style="color: black;">得到</span>FDA<span style="color: black;">准许</span>开展2期临床。该<span style="color: black;">科研</span>是一项随机对照<span style="color: black;">实验</span>，旨在<span style="color: black;">评定</span>基于质粒的DNA疫苗AST-201与标准辅助化疗（紫杉醇/卡铂）联合疗法，用于治疗手术<span style="color: black;">干涉</span>后复发的III期晚期卵巢癌<span style="color: black;">病人</span>的临床疗效和安全性，对照组采用安慰剂，临床疗效以<span style="color: black;">没</span><span style="color: black;">发展</span><span style="color: black;">存活</span>率（PFS）来衡量。</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/bK2EFoTdFIsu0YN0VjhplyGZibG4193ibnwiaU6G9mUpzW4cgTv3J2nia9YQMGicLNiaOSsDicee5YKj3kluNDx2dSesg/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" 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;">卵巢癌是卵巢肿瘤的一种恶性肿瘤，<span style="color: black;">因为</span>其<span style="color: black;">初期</span>缺少症状，即使有症状<span style="color: black;">亦</span>不特异，筛查的<span style="color: black;">功效</span>又有限，<span style="color: black;">因此呢</span><span style="color: black;">初期</span>诊断比较困难，就诊时60%～70%已为晚期，而晚期病例又疗效<span style="color: black;">不良</span>，<span style="color: black;">日前</span>临床上仍然存在着<span style="color: black;">海量</span>未被满足的治疗需求。</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/bK2EFoTdFIsu0YN0VjhplyGZibG4193ibnGkUYcTYcjY5ROgDUKhkTESGlGW1ZA5icM3eAsLBD9zl3ofSuy2ZNuxQ/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" 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;">相较于传统治疗手段而言，DNA疫苗<span style="color: black;">经过</span>激活<span style="color: black;">病人</span><span style="color: black;">自己</span>的免疫系统来对抗癌症，并且能够诱导持久性免疫效应。DNA疫苗中的DNA片段<span style="color: black;">能够</span>编码癌症特异抗原，这些抗原<span style="color: black;">能够</span>刺激免疫系统产生特异性抗体和细胞免疫反应，从而攻击和杀死癌细胞。并且，一旦<span style="color: black;">病人</span>的免疫系统被激活并对抗癌症，DNA疫苗将保持对癌细胞的警觉性，并在<span style="color: black;">必须</span>时重新<span style="color: black;">起步</span>攻击。这种持久性的免疫效应<span style="color: black;">能够</span>减少癌症复发的<span style="color: black;">危害</span>。再加上DNA疫苗能够<span style="color: black;">经过</span>注射或皮肤贴片等方式给予<span style="color: black;">病人</span>，<span style="color: black;">没</span>需<span style="color: black;">繁杂</span>的手术或治疗设备，这使得DNA疫苗<span style="color: black;">作为</span>一种新的、<span style="color: black;">方便</span>的治疗<span style="color: black;">选取</span>。</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_gif/bK2EFoTdFItmGCeC9ANvIiaykFResMA8Uh3cib6fPKlVKVXFZTHibM49S7BHDdqPoMOCnH2XhouzRpzyxgnHjruqg/640?wx_fmt=gif&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1" 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;">AstonScience<span style="color: black;">机构</span>则是一家专门从事治疗性癌症疫苗临床<span style="color: black;">研发</span>的临床<span style="color: black;">周期</span>生物制药<span style="color: black;">机构</span>，其<span style="color: black;">重点</span><span style="color: black;">制品</span>AST-301(HER2-hICD疫苗)的2期临床<span style="color: black;">实验</span>已于2022年9月<span style="color: black;">得到</span>FDA的新药临床<span style="color: black;">实验</span><span style="color: black;">准许</span>，治疗乳腺癌。AST-301的人体安全性、免疫原性和存活率<span style="color: black;">已然</span>得到了初步的验证，在2021年ASCO大会<span style="color: black;">颁布</span>的1期临床结果，这种治疗性癌症疫苗有望在预防手术后癌症复发和治疗晚期癌症方面发挥<span style="color: black;">要紧</span><span style="color: black;">功效</span>，与现有的抗癌治疗相比，<span style="color: black;">导致</span>的不良反应更少，并能保持<span style="color: black;">长时间</span>免疫记忆。</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;">大<span style="color: black;">精细</span>免疫疗法时代题</strong></span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">&nbsp;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;">实质</span>上，虽然<span style="color: black;">基本</span><span style="color: black;">科研</span>做的比较多，但DNA疫苗近几年的发展并不快，早先，<span style="color: black;">相关</span>DNA疫苗<span style="color: black;">科研</span>的论文<span style="color: black;">发布</span>、专利申请数量，在20世纪90年代末至21世纪初达到高峰。但</span><span style="color: black;">在新冠疫苗军备竞赛中，</span><span style="color: black;">DNA疫苗<span style="color: black;">显著</span>落后了。</span><span style="color: black;">时<span style="color: black;">迄今</span>日，仅有印度药厂Zydus Cadila的DNA疫苗<span style="color: black;">获准</span>上市，</span><strong style="color: blue;"><span style="color: black;"><span style="color: black;">全世界</span>领头羊Inovio<span style="color: black;">亦</span>在2022年10月宣布，<span style="color: black;">再也不</span>继续<span style="color: black;">研发</span>新冠DNA疫苗INO-4800。</span></strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">虽然DNA疫苗仍面临<span style="color: black;">许多</span>挑战，仍<span style="color: black;">必须</span>进一步的<span style="color: black;">科研</span>和临床<span style="color: black;">实验</span>来验证其疗效和安全性。但<span style="color: black;">能够</span>确定的是，核酸<span style="color: black;">药品</span><span style="color: black;">关联</span><span style="color: black;">行业</span>的交叉合作及原创突破，将给<span style="color: black;">病人</span>重大<span style="color: black;">疾患</span>临床诊治带来新的突破性<span style="color: black;">处理</span><span style="color: black;">方法</span>。随着<span style="color: black;">科研</span>人员在DNA疫苗<span style="color: black;">行业</span>的<span style="color: black;">持续</span>探索，除了Aston Sci外，近段时期来还涌现了许多优异的<span style="color: black;">开发</span>成果。</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2023年1月,据CDE官网公示，<strong style="color: blue;">固安鼎泰的NMM肿瘤治疗性DNA疫苗裸质粒注射液<span style="color: black;">得到</span>临床<span style="color: black;">实验</span>默示许可，适应症为晚期实体瘤和复发、难治性淋巴瘤。</strong>NMM肿瘤治疗性DNA疫苗是一种可<span style="color: black;">经过</span>局部注射就能产生<span style="color: black;">有效</span>的系统抗肿瘤免疫反应的新型免疫治疗<span style="color: black;">药品</span>，安全性和耐受性良好，<span style="color: black;">拥有</span>发展为有效的抗肿瘤复发<span style="color: black;">药品</span>的<span style="color: black;">潜能</span>，是国内首款三靶点DNA肿瘤疫苗。</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/bK2EFoTdFIsu0YN0VjhplyGZibG4193ibnib01UicP4ab8aM5tw6lcgPgEmaoxtVXOlksuTaGiaYd4siaoTs7nCUc0xQ/640?wx_fmt=png&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" 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;">照片</span><span style="color: black;">源自</span>：CDE</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2023年4月召开的AACR年会，<span style="color: black;">颁布</span>了一项DNA疫苗诱导的免疫<span style="color: black;">检测</span>点阻断和放射治疗相结合可诱导抗肿瘤免疫<span style="color: black;">关联</span><span style="color: black;">科研</span>的最新<span style="color: black;">发展</span>结果。<span style="color: black;">科研</span>分别构建了针对CTLA-4和PD-1的ICBDNA疫苗、CTLA-4疫苗和PD-1疫苗。结果<span style="color: black;">表示</span>，单独或联合接种CTLA-4疫苗和PD-1疫苗(DualVax)均<span style="color: black;">不可</span><span style="color: black;">控制</span>小鼠B16黑色素瘤模型；然而，CTLA-4疫苗和放疗的联合<span style="color: black;">功效</span><span style="color: black;">引起</span>TME与效应T细胞的浸润<span style="color: black;">加强</span>，双疫苗联合放疗可使2个B16黑色素瘤荷瘤小鼠产生全身性抗肿瘤免疫。</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">5月19日，<strong style="color: blue;">诺未科技的NWRD06裸质粒DNA注射液<span style="color: black;">得到</span>临床<span style="color: black;">实验</span>默示许可，拟用于GPC3阳性原发性肝细胞癌根治术后<span style="color: black;">病人</span>。</strong>NWRD06以GPC3为靶点，核心序列采用连接趋化因子的靶向<span style="color: black;">加强</span>策略，利用独特趋化因子<span style="color: black;">经过</span>linker连接<span style="color: black;">目的</span>抗原GPC3，形成重组融合质粒DNA<span style="color: black;">药品</span>。该<span style="color: black;">制品</span>进入肌肉细胞后表达的融合蛋白，可靶向APC，促进<span style="color: black;">目的</span>抗原GPC3的加工提呈，促进GPC3特异性T细胞的增殖分化，<span style="color: black;">从而</span>杀伤清除GPC3阳性的肝癌细胞。</span></p><img src="https://mmbiz.qpic.cn/mmbiz_png/jn7Grkxp8c8UjRpdU2lU08K4jhBnd7w4Np7DBP16TPdZibA4d2Zzgu8m6ibyGKXk44uhfE1JCnyGFvxHNxGd661w/640?wx_fmt=png&amp;wxfrom=5&amp;tp=webp&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">▲ <span style="color: black;">照片</span><span style="color: black;">源自</span>：CDE</span>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">9月，生物技术<span style="color: black;">机构</span>INOVIO的HPV疫苗INO-3107，<strong style="color: blue;">获美国FDA授予突破性疗法认定，<span style="color: black;">做为</span>复发性<span style="color: black;">呼气</span>道乳头状瘤病（RRP）<span style="color: black;">病人</span>的潜在治疗<span style="color: black;">药品</span>。</strong>INO-3107是一款潜在FICDNA疫苗，利用DNA质粒表达与HPV-6和HPV-11<span style="color: black;">关联</span>的抗原，激发T细胞寻找并杀死受到HPV-6和HPV-11感染的细胞，潜在阻止或延缓新乳头状瘤的生长。该<span style="color: black;">制品</span>的1/2期<span style="color: black;">实验</span>数据<span style="color: black;">表示</span>，与给药前一年相比，<span style="color: black;">实验</span>中81.3%（26/32）的<span style="color: black;">病人</span>在INO-3107给药后一年内手术<span style="color: black;">干涉</span>减少，28.1%（9/32）的<span style="color: black;">病人</span>在给药窗口<span style="color: black;">时期</span>或之后<span style="color: black;">没</span>需手术<span style="color: black;">干涉</span>。</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">总结</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">&nbsp;eMedClub</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">总体而言，DNA疫苗发展<span style="color: black;">快速</span>，尽管当下DNA疫苗仍然面临着低免疫原性、递送、稳定性、<span style="color: black;">长时间</span>安全性等多方面的挑战。但<span style="color: black;">专家</span>正在<span style="color: black;">奋斗</span><span style="color: black;">解决</span><span style="color: black;">以上</span>难关，当下</span><span style="color: black;">正</span><span style="color: black;">在进行的许多<span style="color: black;">科研</span><span style="color: black;">已然</span>展现出了良好的成果，相信随着对<span style="color: black;">关联</span>机制<span style="color: black;">科研</span>的<span style="color: black;">持续</span>深入和临床的<span style="color: black;">持续</span>推进，DNA疫苗在临床应用中的<span style="color: black;">潜能</span>有望被充分释放。</span></p><span style="color: black;">参考资料：</span><span style="color: black;">1.https://www.biospace.com/article/releases/us-fda-approves-aston-sci-s-phase-2-ind-for-ovarian-cancer-vaccine-ast-201/?keywords=CELL</span><span style="color: black;">2.https://mp.weixin.qq.com/s/IsO58oKoqb1RFYnLV1UMMA</span>
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    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">1</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">9月19日（周二） 19:00-20:20</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">加速放行，CGT<span style="color: black;">药品</span>分析与质控要点系列解析</strong></p><img src="https://mmbiz.qpic.cn/mmbiz_jpg/bK2EFoTdFIukgHwibkKSEIicakAKf9gSNy7ibnmNvanJaQmF2NHicpX49DZoKQJc4JdiclkkW3ziafuNhCTmy5uzgDPg/640?wx_fmt=jpeg&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;">
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    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">2</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">9月26日（周 二） 19:00-21:00</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">ADC<span style="color: black;">药品</span>的工艺<span style="color: black;">研发</span>与<span style="color: black;">重要</span>质控分析</strong></p><img src="https://mmbiz.qpic.cn/mmbiz_jpg/bK2EFoTdFIukgHwibkKSEIicakAKf9gSNyJyFic7PYdjdBXmGj5kKMMWANDnxf1iccwTTNKMZIiccN5JI7kL4TKPo6A/640?wx_fmt=jpeg&amp;tp=webp&amp;wxfrom=5&amp;wx_lazy=1&amp;wx_co=1" style="width: 50%; margin-bottom: 20px;">
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    <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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星☆雨 发表于 2024-8-28 12:19:44

我完全同意你的观点，说得太对了。

j8typz 发表于 2024-11-10 13:42:56

谷歌外贸网站优化技术。
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