Immorna today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to conduct a Phase 1/2 multi-center study of JCXH-221.
| MORRISVILLE, N.C., Nov. 21, 2022 /PRNewswire/ -- Immorna, a rapidly expanding biotechnology company, focusing on the development of multi-platform RNA-based therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to conduct a Phase 1/2 multi-center study of JCXH-221, a lipid nanoparticle (LNP) complexed broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases. The goal of this multi-center study is to assess the safety and immunogenicity of JCXH-221 in healthy adult subjects. “We are excited to receive our second US IND clearance this year for our innovative RNA-based pipeline asset, and further strengthen our portfolio,” said NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna. “Vaccination remains a key component of the complex approach required to reduce the impact of SARS-CoV-2 infection and diseases. The continued emergence of new variants, the waning of the immune response after vaccination, and the limited availability of currently approved vaccines in lower-income countries, necessitate the development of new COVID-19 vaccine candidates with broadly protective potential and ready availability for rapid pandemic response. We strongly believe that JCXH-221 is an excellent vaccine candidate to address this unmet medical need.” JCXH-221 is a mono-valent yet broadly protective mRNA-LNP vaccine. Once administered, the single chain mRNA will translate and be spontaneously assembled into multimers that contain immune epitopes from several SARS-CoV-2 strains. The multimer configuration is believed to further enhance their immunogenicity. In preclinical testing, JCXH-221 elicited robust neutralizing antibodies against an assay of viral strains, including the ancestral, Beta, Delta, Omicron BA.1, BA.2.12.1, and BA.4/5. JCXH-221 is formulated with a thermal stable nanoparticle delivery system that is stable at 2-8°C for at least 18 months. Zihao Wang, Ph.D., Co-Founder and Chief Executive Officer of Immorna added, “The COVID-19 virus will likely remain a challenge for the foreseeable future and continue to evolve. New variants may be able to evade the protective immunity that individuals have established from prior infection or immunization. A resurgence of the past, more lethal, variants could also have a devastating effect on those whose immunity has waned. Therefore, we believe developing a broadly protective (ideally universal) COVID-19 vaccine is critically important to keep this virus under control. Additionally, lessening the ultra-low temperature storage and transportation requirements could enable a more affordable and accessible vaccine option worldwide. We believe the combined features of JCXH-221 could address these needs and make it well positioned to become a next generation vaccine against this evolving pandemic.” The Phase 1 part of this study will be a randomized, double-blinded, placebo-controlled, dose-escalation study to assess the safety, immunogenicity, and determine the Recommended Phase 2 Dose (RP2D) for JCXH-221. The Phase 2 part will be a randomized, double-blinded, active-controlled study to further characterize the safety and immunogenicity of JCXH-221 at the RP2D. More information can be found at www.immorna.com. About Immorna 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. Website: www.immorna.com
SOURCE Immorna |
View original content:
