INNORNA Completes Phase II Enrollment and Vaccination of Bivalent RSV mRNA Vaccine IN006

Innorna today announced the completion of enrollment and vaccination in its Phase II clinical trial for IN006, the world’s first bivalent respiratory syncytial virus (RSV) mRNA vaccine currently in development by the company.

IN006 is also China's first domestically developed RSV vaccine to enter clinical trials, following IND approval in June 2024. The Phase I trial began with the first subject vaccinated in November 2024. Completion of enrollment and dosing in Phase II marks a milestone toward dose optimization and sets the stage for Phase III efficacy studies.

The Phase II study is a randomized, double-blind, placebo-controlled trial 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.

“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.”

About RSV

RSV is a highly contagious virus that poses elevated risks to older adults, young children, immunocompromised individuals, and those with chronic conditions—potentially leading to pneumonia, respiratory failure, or death.

With no approved antiviral treatment and no authorized RSV vaccine in China, the need for effective prevention remains critical.

About IN006

IN006 is a bivalent mRNA vaccine targeting RSV-A and RSV-B, built on Innorna’s proprietary pre-fusion F protein design, mRNA, and LNP platforms.

Preclinical studies showed a favorable safety profile and strong humoral and cellular immune responses. In challenge models, IN006 provided effective protection against both RSV-A and RSV-B.

As China’s first domestically developed RSV vaccine—and its first non-COVID mRNA vaccine in clinical trials—IN006 marks a major step in public health innovation.

About INNORNA

Innorna develops next-generation LNP platforms and RNA medicines to address global health needs. Its proprietary, rationally designed lipid library comprising over 6,000 chemically diverse ionizable lipids enables breakthroughs in mRNA vaccines and therapeutics. Innorna has built a robust pipeline targeting infectious diseases, rare diseases, metabolic disorders, and cancer immunotherapy.

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