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Innorna Receives IND Clearance by FDA Enabling Phase I Initiation for Herpes Zoster mRNA Vaccine

Innorna focuses on developing best-in-class LNP delivery technology and advancing innovative RNA therapies to address unmet medical needs globally.

We believe IN001 has the potential to be a best-in-class HZ vaccine, which is well tolerated with high efficacy and can be efficiently manufactured and expeditiously distributed worldwide”
— Linxian Li, Ph.D., CEO and Founder of Innorna
UNITED STATES, October 3, 2023 /EINPresswire.com/ -- Innorna, a clinical-stage biotech company pioneering its proprietary lipid nanoparticle (LNP) technology to develop novel RNA therapeutics, announces that its Herpes Zoster (HZ) IN001 mRNA Vaccine has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to initiate a Phase I clinical trial. This is the third HZ mRNA vaccine granted with FDA’s IND clearance using mRNA-LNP technology, following Moderna and Pfizer/BioNTech.

Herpes Zoster, also known as shingles, is a disease caused by the varicella-zoster virus (VZV) reactivation, typically occurring in adults or the elderly. With an aging global population, a next-generation HZ vaccine with high efficacy, a well-tolerated safety profile, and efficient manufacturing production can improve vaccine accessibility and help address this critical global healthcare priority.

"We are pleased to have received IND clearance from the FDA to initiate our Phase I clinical trial of IN001, our second IND clearance," said Linxian Li, Ph.D., CEO and Founder of Innorna. "There is a great need for new and improved vaccines against HZ, a painful and debilitating disease. We believe IN001 has the potential to be a best-in-class HZ vaccine that is well tolerated with high efficacy and can be efficiently manufactured and expeditiously distributed to patients worldwide."

About IN001

IN001 is a novel HZ mRNA vaccine developed by Innorna, utilizing a proprietary LNP delivery system specifically designed for vaccines. This vaccine LNP delivery system was designed to induce a strong and durable immune response against HZ with low toxicity. In preclinical studies, IN001 is safe and highly immunogenic for both humoral and cellular immunity, especially TH1-based cellular immunity, in multiple animal models. The cellular immunity induced by IN001 immunization showed superior persistence to that of the marketed HZ vaccine (recombinant antigen/adjuvant system). In addition, IN001 is manufactured using an optimized process with a short production time and low production cost. This allows IN001 to be quickly delivered to a broad population globally to satisfy the growing demand for HZ vaccines among the aging population.

About Innorna

Founded in 2019, Innorna focuses on developing best-in-class LNP delivery technology and advancing innovative RNA therapies to address unmet medical needs globally. Innorna has built a diversity-oriented lipid library (DOLL) of over 5,000 ionizable lipids, which can be applied in various modalities or scenarios, including mRNA vaccines and therapeutics, genome editing therapies, and cell therapies. Innorna has developed an extensive global patent portfolio and filed over 40 patent applications regarding the innovation of LNP and mRNA technology.

Based on its proprietary technology platform, Innorna has built several internal R&D pipelines for infectious and rare diseases. In addition, the company has established partnerships with pharma and biotech to explore the potential of the technology in broader therapeutic areas. Since its establishment more than three years ago, Innorna has been widely recognized by the investment community and industry. It has won many awards, including MIT Technology Review's Global 50 Smartest Companies and Fortune China's Most Socially Influential Startups.

At Innorna, we value INNOVATION, INTEGRITY, EFFICIENCY, and OPENNESS. Innorna is committed to exploring the frontier of mRNA application based on platform technologies and leading the revolutionary step toward expanding the clinical application of mRNA in various therapeutic approaches to fulfill the unmet medical needs of patients worldwide!

Please visit the Innorna website at www.innorna.com for more information.

bd@innorna.com
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