US. Eastern Time, July 27 2023, Immorna Biotherapeutics, Inc  ("Immorna") announces that its mRNA-based quadrivalent seasonal influenza vaccine JCXH-107 has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct clinical trial. JCXH-107 represents Immorna’s third RNA (mRNA or self-replicating RNA) vaccine against infectious disease to enter clinical stages.

JCXH-107 is based on conventional (non-replicating) mRNA using modified nucleosides. Through formulation development and optimization, Immorna has been able to address the issue of relatively lower immunogenicity associated with B strain viral subtypes, which are commonly seen in other seasonal influenza vaccines. During a preclinical head-to-head comparison study against FLUAD® (an adjuvanted egg-based influenza vaccine intended for 65 years or old population and arguably one of the strongest commercial influenza vaccines), JCXH-107 demonstrated superiority or non-inferiority for all four strains.

For mRNA delivery vehicle, JCXH-107 uses Immorna’s proprietary RTU lipid particle technology, which features high transfection efficiency and low reactogenicity as evidenced by numerous preclinical studies and two other ongoing clinical studies. RTU-mRNA vaccine is stable at 2-8 °C with long self-life, which eliminates the ultra-low to low storage temperature requirement and the short shelf-life issue associated with other commercial mRNA vaccines.

Immorna is confident in and looks forward to JCXH-107’s success in clinical trials.

About Immorna

Immorna is a rapidly expanding biotechnology company, focusing on the development of RNA-based therapeutics and vaccines. Immorna is utilizing multiple RNA platforms, including conventional, self-replicating and circular RNA.

Since its founding in 2019, Immorna has built a robust CMC platform for RNA synthesis, purification, and analytical testing that is well suited for clinical and commercial development. In addition, with its state-of-the-art screening tools, Immorna has developed an arsenal of RNA delivery vehicles, including polymers and lipid nanoparticles featuring multiple proprietary ionizable cationic lipids suitable for intramuscular, intravenous and tissue-targeting delivery.

Immorna has a growing intellectual property portfolio and a diverse RNA development pipeline spanning cancer immunotherapy, infectious diseases, rare genetic diseases, and medical cosmetology, and quickly advancing its oncology drug and infectious disease vaccine candidates into clinical stages.