Comirnaty-COVID-19 mRNA vaccine

VANCOUVER, British Columbia--(BUSINESS WIRE)--Acuitas Therapeutics, a global leader in lipid nanoparticle (LNP) delivery systems for the acceleration of partners’ clinical development, recently presented its Next-Generation LNP advancements, a suite of novel and enhanced technologies that expand the range of diseases treatable with mRNA-LNP medicines, at the 13th International mRNA Health Conference in Berlin. Also at the conference, the company highlighted additional preclinical data on its LNP formulations’ applicability in cancer vaccines, potency, and safety. "Commercial validation of our technology has provided both an important milestone of success and the impetus for continued advancement,” said Dr. Thomas Madden, CEO of Acuitas Therapeutics. “Commercial validation of our technology has provided both an important milestone of success and the impetus for continued advancement,” said Dr. Thomas Madden, CEO of Acuitas Therapeutics. “Our research, presented at the mRNA Health Conference, is focused on two key goals: expanding the application of our technology into new therapeutic areas and enhancing the potency and safety of the platform itself, with novel LNP formulations and various improvement strategies. Underpinning both is our commitment to improving the translatability of preclinical data, which is essential for accelerating the journey of mRNA and personalized therapies from the laboratory bench to the clinic.” Next-Generation LNP for mRNA-based Therapeutics At the conference, Acuitas’ Chief Scientific Officer, Dr. Ying Tam, showcased the company’s Next-Generation LNP advancements, a comprehensive approach that uses multiple technologies and strategies to improve all aspects of LNP utility and applicability – from potency, safety, extrahepatic targeting, to manufacturing. The advancements were featured in an oral presentation titled “Next-Generation Lipid Nanoparticles for Clinical Development of mRNA-based Therapeutics.” The presentation detailed Acuitas’ efforts in advancing mRNA-LNP beyond current clinical standards and broadening the range of diseases these therapies can treat. Key highlights of the presentation include: Novel LNP candidates engineered for significantly improved potency, as high as a four-fold increase for some cases, in gene editing and vaccine applications. Optimized lipid structures reduced liver exposure, leading to increased tolerability, lowered liver enzymes, while preserving therapeutic activity in mice. DARPin-conjugated LNP candidates that achieved highly targeted delivery to immune cells (T-lymphocytes), with a long-circulating format further enhancing uptake efficiency and expression levels. Mucous penetrant mRNA-LNP candidates capable of extrahepatic delivery to airway epithelial cells in cystic fibrosis lung models, enabling effective gene editing compared to control LNP. An alternative LNP manufacturing approach, called pre-formed vesicles (PFV), with equivalent potency to standard benchmark manufacturing methods, offered significant improvements in cost, storage, distribution, and flexibility of LNP manufacturing, especially for personalized mRNA-LNP therapies. Additional Posters Presented In addition to its lead presentation, Acuitas also showcased three posters that elucidated the mechanics of LNP delivery and assessed its existing slate of lipids, as well as explored novel options for future formulations. Applying Clinically Approved ALC-315™ in Cancer Vaccines Acuitas’ ALC-315™ ionizable lipid — used in the Pfizer-BioNTech COVID-19 vaccine (COMIRNATY®) — was assessed for its cancer vaccine development potential. The research directly compared Acuitas’ LNP to lipoplexes and evaluated modified mRNA against the unmodified mRNA predominantly used in current cancer vaccine trials. Key highlights of this data include: Using LNP comprised of ALC-315™, unmodified RNA induced a stronger antigen-specific CD8 T-cell response compared to a nucleoside-modified mRNA incorporating N1methylpseudouridine-encoding OVA payload as a model tumour antigen, while maintaining strong immunogenicity at one-tenth of the initially tested dose. Using LNP comprised of ALC-315™, mRNA delivered intramuscularly induced equal or superior cellular and humoral immunity compared to intravenously (IV) administered mRNA lipoplexes – an alternative mRNA cancer vaccine format in clinical development – despite mRNA lipoplexes being administered at four-fold higher doses and with more boosts. Several potent novel proprietary lipids were identified that achieved equivalent cellular responses to ALC-315™. Further assessment will be conducted to compare potency and activity using syngeneic neoantigen models. Novel Lipids with Improved Activity for Prophylactic Vaccine Development Acuitas identified and validated six novel lipids that induce higher virus-specific immunogenicity compared to ALC-315™. Key findings related to these novel lipids include: The six novel lipid candidates induced equivalent neutralizing antibody titres at a five-fold lower dose than ALC-315™. The lipid candidates demonstrated favorable reactogenicity profiles comparable to ALC-315™, while eliciting stronger cellular- and B-cell responses. Innate immune responses induced by LNP correlated with their reactogenicity, but not with adaptive and innate immune responses. Several lipid candidates achieved higher in vivo expression in secondary lymphoid organs and reduced liver expression compared to ALC-315™. Impact of Body Weight and Medications on mRNA-LNP Safety in Monkeys As the industry continues using larger nonhuman primates in translational work, Acuitas sought to understand how body weight, premedications (steroid, H1 and H2 blockers), and concomitant medications (meloxicam) impact LNP activity and tolerability. The study was conducted in monkeys using an IV-administered mRNA-LNP encoding human IgG. Key highlights of this data include: LNP tolerability is reduced in larger monkeys (>6 kg). Premedications helped reduce the elevation of liver transaminases. Premedications improved tolerability but reduced the level of IgG mRNA expression. Platelet count decreases were greatest in large monkeys and monkeys given meloxicam. More information on posters presented at the mRNA Health Conference and Vaccine R&D Conference can be found here. About Acuitas Therapeutics Acuitas Therapeutics, Inc. is a Vancouver-based company focused on developing and optimizing lipid nanoparticle (LNP) delivery systems for nucleic acid-based therapeutics. They collaborate with pharmaceutical and biotech companies, academic researchers, and global health organizations to advance a broad range of medicines for a variety of diseases. Acuitas’ clinically validated LNP technology has had a profound global impact — most notably enabling the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY®, which has protected billions of people in more than 180 countries. Our technology also enables ONPATTRO® by Alnylam Pharmaceuticals, the first FDA-approved RNAi therapeutic for treating the rare and fatal disease transthyretin amyloidosis. More recently, Acuitas’ LNP technology has delivered other groundbreaking firsts: the first in-human proof of concept for genome base editing and the first personalized CRISPR therapy. Today, they are advancing next-generation LNP to support a variety of therapeutic modalities. This includes targeted LNP for extrahepatic and in vivo CAR T-cell therapies, epigenetic medicines to modulate gene expression without altering DNA, multivalent vaccines for infectious diseases — such as malaria, HIV/AIDS, and tuberculosis — as well as oncology vaccines, including personalized cancer vaccines. For more information, visit www.acuitastx.com.

据彭博社近日报道，辉瑞正在考虑出售其合作伙伴BioNTech的股份。 彭博社援引熟悉内情的匿名消息人士称，辉瑞正寻求出售约455万股美国存托凭证，每股价值在108至111.7美元之间。按照这一价格区间的最高点计算，出售该股份的价值约为5亿美元。 对此，BioNTech在一份声明中对路透社表示，与辉瑞的关系依然牢固。该发言人称：“我们继续保持紧密且强有力的合作关系”，但拒绝就辉瑞的商业行为发表评论。 2020年，辉瑞与BioNTech合作开发了mRNA新冠疫苗Comirnaty，当时辉瑞向BioNTech支付了1.85亿美元的前期款项，加上其他条款，总计7.48亿美元。该疫苗在疫情期间的销售达到了顶峰，成为2021年全球最畅销的药物，当年的收入接近600亿美元，轻松超越了艾伯维的抗炎药物Humira。 然而，新冠业务此后出现了急剧下滑。对于辉瑞而言，这意味着连续几个季度的销售额下降，这迫使其启动了一系列成本削减措施： 2023年10月，辉瑞启动了一项“多年度、全公司范围的成本重组计划”，目标是到2024年节省35亿美元。 2023年12月，辉瑞加大了这一力度，将节省目标增加了5亿美元。 2024年5月，辉瑞又进行了一轮新的费用削减，目标是到2027年底再节省15亿美元。 在最近一个季度，Comirnaty的销售额同比下降了20%，全球收入约为11亿美元。随着疫情的逐渐消退，辉瑞目前正在转向下一个大市场——肥胖症。近期辉瑞在经历了一些波折之后，终于完成了对减肥生物技术公司Metsera的100亿美元收购。 与此同时，BioNTech在新冠之后的计划主要集中在癌症领域。其备受关注的资产之一是实验性PD-1/VEGF阻断剂pumitamig。今年6月，百时美施贵宝支付了15亿美元用于共同开发该候选药物，并承诺支付20亿美元的非或有价值付款以及76亿美元的里程碑付款。总的来说，如果pumitamig能够成功上市，BioNTech将从百时美施贵宝获得超过110亿美元的资金，以及销售分成。 辉瑞的撤资符合其更广泛的战略，即解决即将到来的关键药物专利悬崖并为大规模收购提供资金。通过减持54.7%的BioNTech股份并仅保留166万股美国存托股票（ADS），该公司正在重新分配资本以加强其产品线——包括以430亿美元收购Seagen和以100亿美元收购Metsera的管线。这些举措凸显了辉瑞打算在大流行时期的收入之外实现多元化，并进入高增长的治疗领域。 辉瑞的撤资还凸显了一个更广泛的行业趋势：从合作伙伴关系转向垂直整合。赛诺菲和阿斯利康等公司正在通过收购扩大其研发管道，而百时美施贵宝等其他公司则正在与BioNTech等生物技术公司结成高价值联盟。这种调整反映了药物开发日益复杂的情况以及对细胞治疗和人工智能驱动的药物发现等领域专业知识的需求。 分析师对于辉瑞的举动是否预示着抛售或战略再平衡存在分歧。一方面，此次撤资可能被解释为对BioNTech的独立增长潜力缺乏信心，特别是当后者转向肿瘤学时。另一方面，它符合辉瑞的长期战略，即减少对波动市场的风险敞口并专注于可持续的收入流。 投资者情绪仍然谨慎乐观。尽管mRNA行业面临监管和财务障碍，但其在下一代疗法（例如个性化癌症疫苗）中的基础作用确保了其相关性。对于投资者来说，关键问题是这次撤资是代表短期调整还是长期调整。鉴于辉瑞在专利悬崖上的记录及其积极的并购活动，后者似乎更有可能。 参考资料： [1]Pfizer Reportedly Planning To Divest BioNTech Stake.Tristan Manalac.November 14, 2025. [2]Pfizer's Strategic Divestment from BioNTech and Its Implications for Post-Pandemic Pharma Rebalancing.Generated by AI AgentPhilip Carter,Reviewed byAInvest News Editorial Team.Thursday, Nov 13, 2025 10:33 pm ET. 识别微信二维码，可添加药时空小编 请注明：姓名+研究方向！