Pharma Focus Asia

RNAimmune Secures FDA Approval for Investigational New Drug Application of mRNA-Based Respiratory Syncytial Virus Vaccine RV-1770

Tuesday, December 19, 2023

Sirnaomics Ltd. (Stock Code: 2257), a prominent biopharmaceutical company specializing in advanced RNAi therapeutics, has recently disclosed a pivotal development through its subsidiary RNAimmune, Inc. The U.S. Food and Drug Administration (FDA) has granted approval for RNAimmune to move forward with its Investigational New Drug (IND) application for Phase I clinical trials of RV-1770, an mRNA vaccine designed to target the human Respiratory Syncytial Virus (RSV).

RNAimmune is set to commence a Phase I clinical study to assess the safety and tolerance of RV-1770, an innovative mRNA-based vaccine incorporating a proprietary lipid nanoparticle formulation. The vaccine aims to prevent RSV infection in adults, with the study enlisting healthy volunteers aged 18–49 and an older adult group aged 60–79. Participants will receive a single intramuscular dose of RV-1770 at one of three dosage levels: 50 μg, 100 μg, or 200 μg. The study is designed to recruit a total of 162 participants, evenly split into two cohorts, and all participants will undergo a 12-month post-vaccination monitoring period to assess RV-1770's safety and immunogenicity.

RV-1770 boasts an innovative mRNA-based vaccine formulation with an AI-enhanced design utilizing the sequence of a recent RSV clinical isolate. Preclinical studies in cotton rats demonstrated immunogenic responses and neutralization against both type A and B strains of RSV. Dr. Dong Shen, President and CEO of RNAimmune, emphasized the significance of FDA clearance, stating that it marks a substantial step forward in providing a safe and effective solution against RSV and its impact on human health.

Dr. Patrick Lu, Chairman of the board of directors of RNAimmune, praised the unique mRNA sequence design and proprietary nanoparticle formulation of RV-1770, highlighting the efficient collaboration between RNAimmune's scientific team, regulatory team, and the FDA in advancing the vaccine program into the clinical stage.

Dr. Dewan Zeng, CEO of Zhejiang Innoforce Pharmaceuticals Co., Ltd., the CDMO partner of the RV-1770 project, expressed congratulations on the FDA clearance and emphasized their commitment to leveraging cutting-edge technologies in ATMP manufacturing to support the global delivery of effective ATMP solutions.

RSV is a significant cause of hospitalizations for pneumonia and bronchiolitis, with notable morbidity and socioeconomic impact worldwide. RV-1770 aims to address this unmet medical need by utilizing messenger RNA technology to combat RSV, with the ultimate goal of providing a preventive solution against associated respiratory diseases.



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