Authored by Zachary Stieber via The Epoch Times (emphasis ours),The Food and Drug Administration is mulling over conducting its own evaluation of the levels of DNA in COVID-19 vaccines, an FDA official has disclosed.The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times“I'll say that that is something that’s being discussed,” Dr. Tracy Hoeg, a senior adviser to the FDA’s commissioner, told members of the Centers for Disease Control and Prevention’s vaccine ...

PresentationCourtney BreenSanford C. Bernstein & Co., LLC., Research Division Fantastic. Hi, everyone. It's great to have you here today. Thank you so much for joining us. I am privileged to be sharing the stage with Rose Loughlin here from Moderna. For those of you who do not know me, my name is Courtney Breen. I cover the U.S. large cap names here at Bernstein. And we're hoping to have a bit of a conversation, particularly into the oncology portfolio at Moderna today. We're going to start first, though, ...

**公司及行业** * 公司为Moderna 专注于利用mRNA平台开发肿瘤治疗产品[1][5][27] * 行业涉及肿瘤免疫治疗 包括个体化新抗原疗法、现成癌症抗原疗法、T细胞衔接器、细胞疗法增强剂和体内细胞疗法[5][11][17][21] **核心观点与论据** * **个体化新抗原疗法(INT/mRNA-4157)临床效益显著** 在辅助黑色素瘤III期研究中与Keytruda联用可将患者癌症复发或死亡风险降低49% 远处转移风险降低62%[6][7] * **安全性表现突出** 所有肿瘤抗原疗法均显示良好耐受性 与Keytruda联用未出现额外安全性问题[7][14] * **现成癌症抗原疗法采用"即用型"设计** mRNA-4359靶向PD-L1和IDO蛋白 适用于多种癌症类型 预计2024年10月ESMO公布与Keytruda联用的ARM1B数据[11][12][13] * **T细胞衔接器平台具有多重靶向优势** 可同时靶向三个表面抗原(mRNA-2808) 并通过mRNA平台提供共刺激信号 增强T细胞活性和特异性[18][19] * **细胞疗法增强剂可改善实体瘤疗效** mRNA-4203设计用于增强Immatics的体外TCRT疗法(IMA203) 通过编码相同抗原来提升工程化T细胞反应[21][23][24] **其他重要内容** * **关键研发里程碑明确** 2026年将公布INT五年随访数据和III期辅助黑色素瘤研究结果 2024年10月ESMO公布mRNA-4359的ARM1B数据[6][9][13][39] * **开发策略系统化** 从高肿瘤突变负荷(黑色素瘤)到低突变负荷癌症 从早期辅助设置到晚期转移设置进行方法学探索[43][44] * **合作伙伴关系策略多样** 与默克(Merck)就INT项目达成50/50成本与利润共享合作 与Immatics合作开发T细胞衔接器靶向细胞内抗原[60] * **平台技术优势明显** mRNA平台可实现多重靶向(最多三个抗原) 并能够编码共刺激蛋白 相比重组蛋白方法具有差异化优势[18][19] * **竞争格局存在差异** BioNTech的iNEST使用20个新抗原和静脉输注脂质复合物 IO Biotech的肽疫苗虽错过统计学显著性但验证了PD-L1/IDO靶点的生物学假设[51][52][53]

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业绩总结 - mRNA-4157/V940与KEYTRUDA联合使用的复发无生存率为74.8%，而KEYTRUDA单独使用为55.6%[12] - 在34.9个月的中位随访中，mRNA-4157/V940与KEYTRUDA联合使用降低复发或死亡风险49%[14] - 在约3年的随访中，mRNA-4157/V940与KEYTRUDA联合使用在远处转移无生存率方面显示出62%的风险降低[17] 用户数据 - mRNA-4157/V940与KEYTRUDA联合使用的治疗相关不良事件发生率为100%，而KEYTRUDA单独使用为82%[18] - mRNA-4157/V940在与KEYTRUDA联合使用时，34.6%的患者出现3级及以上不良事件，而KEYTRUDA单独使用为36%[18] 未来展望 - mRNA-4157/V940的临床试验在2026年将提供5年随访数据[11] - mRNA-4157/V940的III期试验已完全招募，参与者约为1,089人[21] - mRNA-4359正在进行的I/II期研究中，计划招募更多适应症[27] - mRNA-4203的I期研究设计为剂量递增，已对15名患者进行给药[51]

The Moderna Innovation and Technology Centre in Harwell, Oxfordshire is now fully operational and Moderna is licensed to supply British-made COVID-19 vaccines to the UK population The facility marks a cornerstone of Moderna's ten-year strategic partnership with the UK Government, designed to strengthen health resilience and drive economic growth CAMBRIDGE, MA / ACCESS Newswire / September 24, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Moderna Innovation and Technology Centre (MITC) at the H ...

My Sell call on Moderna ( MRNA ) in April 2025 had looked a little bold at the time, given the extent of correction and perception of lack of room to correct further. So I will takeI am a stock analyst with over 20 years of experience in quantitative research, financial modeling, and risk management. My focus is on equity valuation, market trends, and portfolio optimization to uncover high-growth investment opportunities. As a former Vice President at Barclays, I led teams in model validation, stress testin ...

Moderna said on Tuesday its updated COVID-19 vaccine formulation elicited a strong immune response in all adults aged 65 and older, as well as in individuals aged 12 to 64 with at least one underlying... ...

Preliminary analysis showed the 2025-2026 formula of mNEXSPIKE generated greater than a 16-fold increase in LP.8.1-neutralizing antibodies across age groups Both of Moderna's COVID-19 vaccines for the 2025-2026 season have demonstrated strong immune responses against today's top circulating COVID-19 strains CAMBRIDGE, MA / ACCESS Newswire / September 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of mNEXSPIKE® (COVID- 19 Vaccine, mRN ...

公司业务与战略 - 公司专注于mRNA疗法和疫苗 其旗舰产品为COVID-19疫苗[2] - 产品管线正扩展至流感、呼吸道合胞病毒、巨细胞病毒、寨卡病毒以及针对多种呼吸道病原体的联合疫苗[2] - 同时开发用于肿瘤学、罕见病和心血管疾病的mRNA疗法[2] - 创新是公司战略核心 正将mRNA应用扩展到COVID-19之外[5] - 在美国和欧洲设有生产基地 并通过战略联盟和技术转让扩大运营规模[2] 技术研发 - 人工智能和机器学习日益整合到研发管线中 用于加速mRNA设计、优化疫苗配方和预测免疫反应[5] 市场表现与近期挑战 - 2025年9月公司股价下跌近7% 因有报告将COVID-19疫苗与约25例儿童死亡相关联[3] - 政策变化如佛罗里达州取消疫苗授权令 进一步影响近期需求预测[3] 公司回应与数据支撑 - 公司强调透明度和科学严谨性 并引用全球超10亿剂接种的真实世界数据来支撑其安全性[4]