Immorna Biotherapeutics, Inc., a leader in RNA-based therapeutics and vaccines, highlights its state-of-the-art mRNA vaccine platform in the open-access report Development of an Influenza/COVID-19 Combination mRNA Vaccine Containing a Novel Multivalent Antigen Design That Enhances Immunogenicity of Influenza Virus B Hemagglutinins published in MDPI Vaccines

RNA 疗法和疫苗领域的领导者 Immorna Biotherapeutics, Inc. 在《MDPI 疫苗》杂志发表的开放获取报告《开发一种含有增强流感病毒 B 血凝素免疫原性的新型多价抗原设计的流感/COVID-19 组合 mRNA 疫苗》中重点介绍了其最先进的 mRNA 疫苗平台：

The development of the mRNA-based seasonal influenza vaccines remains challenging, in part because of the relatively low immunogenicity of influenza B hemagglutinin (HA) antigens. The described systematic vaccine development strategy combined optimized vector and antigen designs. Novel untranslated region (UTR) sequences and a hybrid poly(A) tail were used to increase plasmid stability and mRNA expression. HA antigens were engineered to enhance the immune responses against influenza B lineage strains and to permit the expression of multiple HA ectodomains from a single mRNA strand. The vaccine performance was verified in a traditional encapsulated lipid nanoparticle (LNP) formulation that requires long-term storage at temperatures below -15 °C as well as in a proprietary thermo-stable ready-to-use RTU LNP formulation developed for the long-term storage of the mRNA vaccines at 2–8 °C. The RTU LNP technology has already been validated in Immorna’s clinical stage programs including JCXH-221, mRNA COVID-19 vaccine, JCXH-105, srRNA Shingles vaccine, and JCXH-108, an mRNA RSV candidate vaccine supported by a grant from the Gates Foundation.

基于mRNA的季节性流感疫苗的研发依然充满挑战，部分原因在于乙型流感血凝素(HA)抗原的免疫原性相对较低。所述系统性疫苗研发策略结合了优化的载体和抗原设计。新的非翻译区(UTR)序列和杂合poly(A)尾被用于提高质粒稳定性和mRNA表达。HA抗原被设计用于增强针对乙型流感谱系毒株的免疫应答，并允许单个mRNA链表达多个HA胞外域。疫苗性能已在传统的封装脂质纳米颗粒(LNP)制剂中得到验证，该制剂需要在-15°C以下的温度下长期储存，以及在专有的热稳定即用型RTU LNP制剂中得到验证，该制剂专为在2-8°C下长期储存mRNA疫苗而开发。 RTU LNP 技术已在 Immorna 的临床阶段项目中得到验证，包括 JCXH-221（mRNA COVID-19 疫苗）、JCXH-105（srRNA 带状疱疹疫苗）和 JCXH-108（由盖茨基金会资助的 mRNA RSV 候选疫苗）。

In preclinical studies, the next-generation seasonal influenza vaccine tested alone or as a combination influenza/COVID-19 mRNA vaccine elicited hemagglutination inhibition (HAI) titers significantly higher than Fluzone HD®, a commercial inactivated influenza vaccine comparator, across all 2024/2025 seasonal influenza strains, including the B/Victoria lineage strain. At the same time, the combination mRNA vaccine demonstrated superior neutralizing antibody titers to 2023/2024 Spikevax, a commercial COVID-19 mRNA vaccine. The published data demonstrate that the multimerization of antigens expressed as complex fusion proteins is a powerful antigen design approach that may be broadly applied toward mRNA vaccine development.

在临床前研究中，单独或作为流感/COVID-19 mRNA 疫苗联合测试的下一代季节性流感疫苗，在所有2024/2025年季节性流感毒株（包括B/Victoria谱系毒株）中产生的血凝抑制(HAI)滴度显著高于市售灭活流感疫苗对照品Fluzone HD® 。同时，该联合mRNA疫苗的中和抗体滴度优于2023/2024年上市的COVID-19 mRNA疫苗Spikevax。已发表的数据表明，以复杂融合蛋白形式表达的抗原多聚化是一种强大的抗原设计方法，可广泛应用于mRNA疫苗的开发。

"This publication validates our novel approach to combination influenza/COVID-19 mRNA vaccine development, demonstrating excellent immunogenicity and stability," said Dr. Marcin Bungo, VP Head of RNA Development. "Our findings highlight the potential of multivalent antigen design strategies to simplify vaccine manufacturing and improve efficacy of next-generation mRNA vaccines. We extend our gratitude to Immorna R&D teams and collaborators, whose contributions were instrumental in achieving this milestone."

RNA开发副总裁Marcin Bungo博士表示：“这篇论文验证了我们开发流感/COVID-19 mRNA联合疫苗的创新方法，展现出卓越的免疫原性和稳定性。我们的研究结果凸显了多价抗原设计策略在简化疫苗生产和提高下一代mRNA疫苗效力方面的潜力。我们向Immorna研发团队及合作伙伴表示感谢，他们的贡献对实现这一里程碑至关重要。”

The MDPI Vaccines report underscores Immorna’s commitment to RNA vaccine innovations that address key challenges in infectious disease prevention.

MDPI疫苗报告强调了 Immorna 对RNA 疫苗创新的承诺，以解决传染病预防方面的关键挑战。