RNAimmune, Partner of Innoforce, Receives FDA IND Clearance for Groundbreaking RSV mRNA Vaccine
RNAimmune, Inc., a strategic partner of Innoforce Pharmaceuticals, has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting Investigational New Drug (IND) clearance for its RV-1770 Respiratory Syncytial Virus (RSV) mRNA vaccine.
Innoforce extends its congratulations to RNAimmune for this significant achievement that propels the fight against RSV forward. Serving as the Contract Development and Manufacturing Organization (CDMO) partner for RNAimmune, Innoforce played a crucial role in providing end-to-end services for the vaccine’s development and FDA submission.
Key Points:
1. FDA Clearance: RNAimmune’s RSV mRNA vaccine, designated RV-1770, has received IND clearance from the FDA, allowing the initiation of clinical trials to evaluate safety and effectiveness in human subjects.
2. Collaborative Success: Innoforce, as RNAimmune’s CDMO partner, offered comprehensive services, including plasmid, mRNA IVT, and LNP encapsulation, along with process development, clinical batch GMP manufacturing, and CTD document preparation for the IND submission.
3. Unmet Medical Need: RSV is a highly contagious virus causing severe respiratory illness, particularly in vulnerable populations. With only two approved RSV vaccines in the U.S., RNAimmune’s mRNA vaccine aims to address this unmet medical need using innovative mRNA technology.
4. Global Impact: The FDA clearance underscores the global impact of collaborative efforts, showcasing how a Chinese CDMO, Innoforce, contributes to an IND application for the U.S. FDA. The achievement highlights Innoforce’s mature mRNA platform and high-quality CDMO services.
5. Clinical Trial Advancement: IND clearance enables RNAimmune to advance into clinical trials, marking a significant step forward in developing a safe and effective solution to combat RSV, especially in high-risk populations.
Quotes from Leadership:
• Dr. Dong Shen, President and CEO of RNAimmune: “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, CEO of Innoforce: “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.”
RNAimmune is a pioneering biotech company focused on developing mRNA-based therapeutics and vaccines. With a global presence, including headquarters in Germantown, Maryland, USA, and China headquarters in International BioIsland, Guangzhou, RNAimmune aims to address unmet medical needs using messenger RNA technology for infectious diseases, cancer, and other health challenges. RNAimmune has a diverse pipeline that includes vaccines for infectious diseases and cancer, showcasing its leadership in mRNA vaccines and therapeutics.
