Pharma Focus Asia

FDA Approves Investigational New Drug Status for RSV mRNA Vaccine Developed by RNAimmune, in Collaboration with Innoforce

Tuesday, December 19, 2023

RNAimmune, Inc., together with its partner Innoforce, has obtained IND clearance from the U.S. Food and Drug Administration (FDA) for its RV-1770 Respiratory Syncytial Virus (RSV) mRNA vaccine. Innoforce extends its congratulations to RNAimmune for reaching this noteworthy milestone, representing a significant step forward in the ongoing fight against RSV. Acting as the CDMO partner for RNAimmune, Innoforce played a pivotal role by delivering comprehensive services, encompassing plasmid and mRNA IVT to LNP encapsulation. This included process development and optimization, clinical batch GMP manufacturing, and the preparation of CTD documents for the IND submission to the FDA.

RSV is a highly contagious virus recognized for causing severe respiratory illness, especially in infants, the elderly, and individuals with weakened immune systems. Despite its substantial impact on public health, the U.S. currently only has two approved RSV vaccines. RNAimmune's RSV mRNA vaccine aims to address this unmet medical need by utilizing mRNA technology.

With the FDA's clearance of the IND, RNAimmune is now poised to initiate clinical trials to assess the safety and efficacy of its RSV mRNA vaccine in human subjects. This development highlights the role that a Chinese CDMO like Innoforce can play in supporting an IND application to the U.S. FDA. It underscores the advantages of Innoforce's mature mRNA platform and high-quality CDMO services in expediting the development and commercialization of mRNA therapeutics and other advanced therapy medicinal products (ATMPs).

Dr. Dong Shen, President and Chief Executive Officer of RNAimmune, expressed his enthusiasm about the IND approval, emphasizing its significance in the prevention of infectious diseases. He stated, "We are thrilled to receive IND approval for our RSV mRNA vaccine, a groundbreaking advancement in infectious disease prevention. This marks a significant step forward in our mission to provide a safe and effective solution to combat RSV and its devastating impact on human health."

Dr. Dewan Zeng, Chief Executive Officer of Innoforce, shared in the excitement, congratulating RNAimmune on the FDA clearance of the IND application. He expressed his honor in being a partner in this innovative journey and highlighted Innoforce's commitment to leveraging cutting-edge technologies in ATMP manufacturing to contribute to bringing more effective ATMPs to patients worldwide.



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