Innorna announced the completion of enrollment and vaccination in its Phase II clinical trial for IN006, marking a significant milestone for the world's first bivalent respiratory syncytial virus (RSV) mRNA vaccine. The achievement positions the company closer to Phase III efficacy studies as it advances this groundbreaking vaccine candidate.
Clinical Development Progress
IN006 represents China's first domestically developed RSV vaccine to enter clinical trials, following IND approval in June 2024. The Phase I trial commenced with the first subject vaccinated in November 2024, and the completion of Phase II enrollment and dosing establishes a foundation for dose optimization studies.
The Phase II study follows a randomized, double-blind, placebo-controlled design conducted in China among healthy adults aged 60 and above. Key study objectives include dose optimization, broader population validation, and booster evaluation for annual revaccination strategies.
"This Phase II clinical trial marks a critical step in validating IN006's scientific hypothesis—delivering broad-spectrum, durable protection against RSV," said Dr. Linxian Li, Founder and CEO of Innorna. "We remain committed to advancing the clinical development of this vaccine candidate efficiently. Our goal is to deliver safer, more effective RNA medicines to meet global public health needs."
Addressing Critical Medical Need
RSV poses significant health risks as a highly contagious virus that particularly threatens older adults, young children, immunocompromised individuals, and those with chronic conditions. The infection can potentially lead to pneumonia, respiratory failure, or death in vulnerable populations.
The medical need remains particularly acute in China, where no approved antiviral treatment or authorized RSV vaccine currently exists, highlighting the critical importance of effective prevention strategies.
Innovative Vaccine Design
IN006 is engineered as a bivalent mRNA vaccine targeting both RSV-A and RSV-B strains, built on Innorna's proprietary pre-fusion F protein design, mRNA, and lipid nanoparticle (LNP) platforms. This dual-targeting approach aims to provide comprehensive protection against the primary RSV variants.
Preclinical studies demonstrated a favorable safety profile alongside strong humoral and cellular immune responses. In challenge models, IN006 provided effective protection against both RSV-A and RSV-B strains, supporting its advancement to human clinical trials.
Technological Platform
The vaccine development leverages Innorna's next-generation LNP platforms and RNA medicine capabilities. The company's proprietary, rationally designed lipid library comprises over 6,000 chemically diverse ionizable lipids, enabling breakthroughs in mRNA vaccines and therapeutics.
As China's first non-COVID mRNA vaccine in clinical trials, IN006 represents a major advancement in public health innovation and demonstrates the expanding application of mRNA technology beyond pandemic response.
Company Pipeline
Innorna has established a robust pipeline targeting infectious diseases, rare diseases, metabolic disorders, and cancer immunotherapy, positioning the company at the forefront of RNA medicine development to address diverse global health needs.
