Sirnaomics Ltd (HKG: 2257) has announced that it has received clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a Phase I clinical trial of RV-1730, a SARS-CoV-2 vaccine booster candidate.
Design of the Phase I Study for RV-1730
The Phase I study is designed to evaluate the safety and efficacy of RV-1730 when administered as a single booster dose to healthy adults aged 18–55 who have previously been vaccinated with either the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine. Participants will be treated with one of three doses of RV-1730: 15 µg, 30 µg, or 100 µg. The trial plans to enroll a total of 45 subjects, divided into three cohorts of 15 subjects each, in the U.S. All subjects will be monitored for 12 months post-vaccination to assess the safety and immunogenicity of RV-1730.
RNAimmune: Focus on mRNA Vaccine and Therapeutics Development
RNAimmune, an international biopharmaceutical company specializing in mRNA vaccine and therapeutics development, has its global headquarters in Germantown, Maryland, USA, and its China headquarters located in International BioIsland, Guangzhou. RNAimmune has obtained the global exclusive rights to the proprietary Polypeptide Lipid Nanoparticle (PLNP) technology for mRNA delivery from Sirnaomics. The company has an extensive pipeline that includes vaccines for infectious diseases such as COVID-19, influenza, VZV, and RSV, as well as cancer vaccines targeting RAS and NY-ESO-1, and protein replacement medication.-Fineline Info & Tech
