Research Triangle Park, NC Aug 14, 2024 – Immorna Biotherapeutics Inc. (Immorna) today announces that it has received a grant to support the clinical development of JCXH-108 from the Bill & Melinda Gates Foundation (the foundation). JCXH-108 is a Respiratory Syncytial Virus (RSV) vaccine based on Immorna’s proprietary mRNA and ‘Ready-to-Use’ lipid nanoparticle (RTU-LNP) technologies. Currently available data suggest that the mRNA-RTU-LNP vaccine can achieve approximately 18 months of shelf-life at 2-8 °C, over 2 months of stability at room temperature, and at least 8 hours of in-use stability in the clinical setting. The enhanced stability is expected to significantly reduce the logistics complexity associated with mRNA vaccine storage, transportation, and distribution, hence enhancing the mRNA vaccine accessibility in low- and middle-income countries (LMICs). Before JCXH-108, Immorna’s mRNA and RTU-LNP platform technology has gone through early-stage human trials through other infectious disease vaccine trials with great safety/tolerability profiles and immunogenicity data, which partially de-risk the clinical development of JCXH-108.

The grant from the foundation will provide staged financial support to expediate JCXH-108’s clinical trials in the US, the process and clinical development of multi-dose vial vaccine (MDV), the marketing application in the US, and the World Health Organization (WHO) Pre-Qualification (PQ). If approved for marketing, Immorna commits to supply the RSV vaccine to LMICs at the pre-negotiated price with the foundation.

“Globally, over 3.2 million of hospitalization and 118,000 deaths in children under five years of age each year are associated with severe lower respiratory tract infection (LRTI) caused by RSV. Among them, over 97% of the deaths occur in LMICs. Introduction of a safe and effective RSV vaccines in these countries and regions will greatly contribute to reduction of RSV related hospitalization and deaths”, says Dr. Zihao Wang, Co-Founder and CEO of Immorna, “we appreciate the trust and support from the foundation. We look forward to working closely with the foundation to expediate the clinical development and marketing of JCXH-108. As a biotech company developing mRNA-based vaccines and therapeutic drugs, Immorna closely follows the global needs for prevention of infectious diseases and strive to help provide more treatment options to patients in needs and contribute the creation of a disease-free, better future. I believe that, if successfully approved for marketing, JCXH-108 may help protect millions of susceptible individuals and their families from the deadly diseases associated with RSV infection, which is particularly meaningful in the LMICs where RSV infection is prevalent. We are on track to enroll the first subject for our clinical trial by the end of Aug 2024.

About JCXH-108

JCXH-108 is a monovalent RSV vaccine being developed by Immorna using its proprietary mRNA and RTU-LNP technologies. Both technologies have gained successful clinical proof-of-concept through clinical trials of other infectious disease vaccines at Immorna. JCXH-108 features a mild storage and transportation condition with shelf life of approximately 18 months at 2-8 °C, which greatly improve the mRNA vaccine’s accessibility. JCXH-108 mRNA encodes an engineered RSV Fusion protein with stabilized pre-fusion configuration (pre-F). The antigen design went through extensive screening and optimization and is proprietary for Immorna. In preclinical studies, the pre-F antigen demonstrated high in vitro and in vivo expression from the mRNA. Very low doses of JCXH-108 elicited high titers of neutralizing antibodies against both RSV A and RSV B strains. Immunization of cotton rats with low dose of JCXh-1108 achieved complete protection against RSV virus challenge.

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 clinical and R&D pipeline spanning cancer immunotherapy, infectious diseases, rare genetic diseases, and medical cosmetology.