FDA Approval of RNAimmune’s Investigational New Drug Application for the RV-1730 COVID-19 Booster Vaccine Phase I Trial
The United States Food & Drug Administration (FDA) has given the go-ahead for the company’s Investigational New Drug (IND) application of a Phase I clinical trial for RV-1730, a SARS-CoV-2 vaccine booster candidate. RNAimmune is a biopharmaceutical company that specialises in the discovery and development of mRNA-based therapeutics and vaccines. It is a non-wholly owned subsidiary of Sirnaomics Ltd. In the proposed clinical investigation, the drug’s safety and prophylactic effectiveness against SARS-CoV-2 infection will be assessed in individuals who have already received immunisation with existing mRNA-based COVID-19 vaccines.
The proposed Phase I clinical study is that RNAimmune will examine the safety and effectiveness of RV-1730 which is given as a single booster dose to healthy persons between the ages of 18 and 55 who have already received either the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine. A total of 45 subjects will be enrolled by the investigators in the U.S., with three separate cohorts and each cohort consisting of 15 subjects. The safety and immunogenicity of RV-1730 will be evaluated by following all subjects for 12 months post-vaccination period.
Dong Shen, M.D., Ph.D., founder and President of RNAimmune said – “This study is expected to make available preliminary data on the safety, tolerability, and immunogenicity of RV-1730’s technology when using a vaccine construct that targets the SARS-CoV-2 variants. With further research, RNAimmune’s vaccine candidate may be the focus of future studies with more contemporary variant constructs or multivalent constructs like Omicron, XBB, and other COVID-19 variants.”
RNAimmune is a biopharmaceutical company with a worldwide focus on developing mRNA vaccines and therapeutics. The company’s global headquarters is based in Germantown, Maryland, USA, and its China headquarters is situated in International BioIsland, Guangzhou.