RNAimmune Receives Investigational New Drug Application Clearance from U.S. FDA for mRNA-Based Respiratory Syncytial Virus Vaccine RV-1770 

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Sirnaomics Ltd. (the “Company”, Stock Code: 2257, together with its subsidiaries, the “Group” or “Sirnaomics”), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced that, its subsidiary RNAimmune, Inc. (“RNAimmune”), a leading biotech company specializing in mRNA-based vaccines and therapeutics, has obtained a green light from the U.S. Food and Drug Administration (FDA) to proceed with its Investigational New Drug application for Phase I clinical trials of RV-1770, an mRNA vaccine targeting the human Respiratory Syncytial Virus (RSV).

RNAimmune will begin a Phase I clinical study to assess the safety and tolerance of RV-1770, a combination of an mRNA-based vaccine with a proprietary lipid nanoparticle formulation, aimed at preventing RSV infection in adults. Healthy volunteers between the ages of 18–49 and an older adult group aged 60–79 will receive a single dose of RV-1770 intramuscularly, using one of three dosage levels: 50 μg, 100 μg, or 200 μg. The study plans to recruit a total of 162 participants divided into two cohorts of younger and older adults with 81 each. All participants will undergo a 12-month post-vaccination monitoring for evaluation of RV-1770’s safety and immunogenicity.

RV-1770 is an innovative mRNA-based vaccine formulation with a unique AI-enhanced design using the sequence of the recent RSV clinical isolate. It demonstrated immunogenic responses and neutralization against both type A and B strains of RSV in preclinical cotton rat studies. “The IND clearance from the FDA represents a significant leap forward in our mission to provide a safe and effective solution against RSV infection and its profound impact on human health,” stated Dr. Dong Shen, President and Chief Executive Officer of RNAimmune. “As we embark on clinical trials aimed at assessing the safety and efficacy of RV-1770, this achievement underscores the potential of RNAimmune’s mRNA technology platform in the battle against RSV and the prevention of associated respiratory diseases.

Dr. Patrick Lu, Chairman of the board of directors of RNAimmune, commented: “RV-1770 has a unique mRNA sequence design with a proprietary nanoparticle formulation that has already shown superb preclinical safety and efficacy. These results clearly demonstrate the strength of RNAimmune’s scientific team in quickly executing on its second vaccine program to move into clinical stage, working effectively with the company’s regulatory team and the FDA.”

Dr. Dewan Zeng, Chief Executive Officer of Zhejiang Innoforce Pharmaceuticals Co., Ltd., the CDMO partner of the RV-1770 project, added: “We sincerely congratulate our partner, RNAimmune, on the FDA clearance of this IND application, and we are honored to be a partner in this innovative journey. We aim to leverage our cutting-edge technologies in ATMP manufacturing to help our partners to bring more effective ATMP to patients worldwide.”

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