RNAimmune Receives FDA Clearance of Investigational New Drug Application for Phase 1 Trial of RV-1730 COVID-19 Booster Vaccine

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GERMANTOWN, Md. and GUANGZHOU, China, April 27, 2023 /PRNewswire/ -- RNAimmune, Inc. (the "Company" or "RNAimmune"), a biopharmaceutical company specializing in discovery and development of mRNA-based therapeutics and vaccines, today announced that the Company has received a clearance from the United States Food & Drug Administration (FDA) cleared its Investigational New Drug (IND) application a Phase I clinical trial for RV-1730, a SARS-CoV-2 vaccine booster candidate. The proposed clinical study will involve in an evaluation of RV-1730 for its safety and prophylaxis efficacy against SARS-CoV-2 infection with people previously immunized with other mRNA-based COVID-19 vaccines. RNAimmune is the non-wholly owned subsidiary of Sirnaomics Ltd ("Sirnaomics", Stock Code: 2257.HK).

During the proposed Phase I clinical study, RNAimmune will investigate the safety and efficacy of RV-1730 when administered as a single booster dose to healthy adults aged 18-55, previously vaccinated with either the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine. Participants will be treated with one of the three doses of RV-1730 at 15 µg, 30 µg or 100 µg accordingly. Investigators plan to enroll a total of 45 subjects divided into three different cohorts (15 subjects each) in the U.S. All subjects will be followed through 12 months post-vaccination for assessing RV-1730 safety and immunogenicity.

"The IND clearance from the FDA will allow us to investigate RV-1730 as an effective vaccine booster with the potential to provide continued protection against COVID-19," said Dong Shen, M.D., Ph.D., founder and President of RNAimmune. "This study is expected to provide 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."

"Receiving FDA clearance for RV-1730 Phase I clinical as a novel COVID-19 booster vaccine marks a significant milestone for RNAimmune. As the world continues to search for effective methods of battling COVID-19, RV-1730 will provide another important option related to vaccine boosters." said Patrick Lu, Ph.D., Chairman of the board of directors of RNAimmune. "More importantly, the discovery and development efforts of RV-1730 has helped advancement of the technology platforms and regulatory capability of RNAimmune for novel mRNA-based vaccine and therapeutic product developments."

About RNAimmune

RNAimmune is an international biopharmaceutical company focusing on mRNA vaccine and therapeutics development. Its global headquarter is in Germantown, Maryland, USA, while the China headquarter is located in International BioIsland, Guangzhou. RNAimmune has received a global exclusive right to the proprietary Polypeptide Lipid Nanoparticle (PLNP) technology for mRNA delivery from Sirnaomics. In addition, RNAimmune has various independent proprietary R&D platforms, including artificial-intelligence and directed neoantigen prediction, ALEPVA algorithm for nucleic acid sequence design and lipid nanoparticle (LNP) carrier systems. RNAimmune also deployed various vaccines and therapeutics pipelines, including vaccines for infectious diseases (COVID-19, influenza, VZV and RSV etc.) and cancer vaccines (RAS, NY-ESO-1), and protein replacement medication. RNAimmune has extremely high potential and has become one of the leading companies in the field of mRNA vaccines and therapeutics. Learn more at: www.rnaimmune.com.

SOURCE Sirnaomics