Immorna (Hangzhou) Biotechnology Co., Ltd has announced that the US FDA has cleared its investigational new drug (IND) application to conduct a Phase I/II multi-center study assessing the safety and immunogenicity of JCXH-221, a lipid nanoparticle (LNP) complex broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases, in healthy adult subjects. JCXH-221 will be evaluated in non-inferiority terms against the current mainstream bivalent mRNA vaccines in the US market.
JCXH-221 Profile
JCXH-221 is a mono-valent yet broadly protective mRNA-LNP vaccine. Once administered, the single-chain mRNA translates and spontaneously assembles into multimers containing immune epitopes from several SARS-CoV-2 strains. This multimer configuration is believed to enhance immunogenicity. In preclinical testing, JCXH-221 elicited robust neutralizing antibodies against various viral strains, including the ancestral, Beta, Delta, Omicron BA.1, BA.2.12.1, and BA.4/5. The vaccine is formulated with a thermally stable nanoparticle delivery system that remains stable at 2-8°C for at least 18 months.
Company Profile
Immorna is a rapidly expanding biotechnology company focusing on the development of RNA-based therapeutics and vaccines. Since its founding in 2019, Immorna has built a robust CMC platform for RNA synthesis, purification, and analytical testing, well-suited for clinical and commercial development. Utilizing multiple RNA platforms, including conventional, self-replicating, and circular RNA, 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.-Fineline Info & Tech
