Rockville Maryland, USA, and Hangzhou, China, December 17, 2023 -- RNAimmune, Inc., a partner of Innoforce, announced the U.S. Food and Drug Administration (FDA) granted IND clearance for its RV-1770 Respiratory Syncytial Virus (RSV) mRNA vaccine. Innoforce congratulates RNAimmune on this significant milestone achievement, which is also significantly advancing in the fight against RSV.  As the CDMO partner for RNAimmune, Innoforce provided end-to-end services from plasmid, mRNA IVT, to LNP encapsulation, including process development and optimization, clinical batch GMP manufacturing, and CTD document preparation for the IND submission to the FDA.

RSV is a highly contagious virus causing severe respiratory illness, particularly in infants, the elderly, and individuals with weakened immune systems. Despite being a significant public health concern, the US has only two approved RSV vaccines. RNAimmune's RSV mRNA vaccine aims to address this unmet medical need by leveraging mRNA technology.

With the FDA's IND clearance, RNAimmune can now commence clinical trials to evaluate the safety and effectiveness of its RSV mRNA vaccine in human subjects. This is also a remarkable example of a CDMO to flawlessly support an IND application to the US FDA, demonstrating the advantages of Innoforce's mature mRNA platform and high-quality CDMO services in accelerating 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 excitement about the IND approval, stating, "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, was delighted with the milestone RNAimmune achieved, stating, “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 bring more effective ATMP to patients worldwide.

• About RNAimmune

RNAimmune is a pioneering biotech company dedicated to developing mRNA-based therapeutics and vaccines. With its global headquarters in Germantown, Maryland, USA, and a China headquarters in International BioIsland, Guangzhou, RNAimmune aims to address unmet medical needs by harnessing messenger RNA technology to create innovative solutions for infectious diseases, cancer, and other health challenges. RNAimmune holds a global exclusive right to the proprietary Polypeptide Lipid Nanoparticle (PLNP) technology for mRNA delivery from Sirnaomics. Additionally, RNAimmune possesses various independent proprietary R&D platforms, including artificial intelligence and directed neoantigen prediction, ALEPVA algorithm for nucleic acid sequence design, next-gen lipid nanoparticle (LNP) carrier systems, circular RNA, and self-amplify mRNA platforms. RNAimmune's diverse pipeline includes vaccines for infectious diseases (RSV, COVID-19, influenza, HSV, etc.), cancer vaccines (RAS, NY-ESO-1), and mRNA-encoded antibodies. RNAimmune has achieved significant potential and is a leader in mRNA vaccines and therapeutics. For more information about RNAimmune and its RSV mRNA vaccine development, please visit www.rnaimmune.com.

• About Innoforce

Innoforce enables the innovation and global supply of plasmid DNA, RNA, and cell and gene therapeutics powered by a world-class manufacturing and development hub. With extensive expertise in process development and manufacturing of ATMPs, Innoforce can be a trusted partner for your innovative ATMP projects from R&D through commercialization.

Learn more about Innoforce at https://www.innoforcepharma.com/index.html