Immorna Gets Gates Foundation Grant for mRNA RSV Vaccine Clinical Development

RESEARCH TRIANGLE PARK, N.C., Aug. 26, 2024 -- Immorna Biotherapeutics Inc. has announced that it has been awarded a grant from the Bill & Melinda Gates Foundation. This financial support will advance the clinical development of JCXH-108, an innovative RSV vaccine utilizing Immorna's proprietary mRNA and Ready-to-Use lipid nanoparticle (RTU-LNP) technologies. The grant is expected to significantly expedite the vaccine's journey through clinical trials, regulatory processes, and eventual distribution.

JCXH-108 is designed to combat Respiratory Syncytial Virus (RSV) and has shown promising stability and shelf life. Current data indicate that the vaccine can be stored for around 18 months at temperatures between 2-8 °C, maintain stability for over two months at room temperature, and remain usable for at least eight hours in clinical settings. This stability could simplify the logistic challenges of mRNA vaccine storage and transport, making it more accessible to low- and middle-income countries (LMICs).

Prior to JCXH-108, Immorna's mRNA and RTU-LNP technologies have been tested in early-stage human trials for other infectious diseases, showing favorable safety and immunogenicity profiles. These positive results help mitigate the risks associated with JCXH-108's clinical development.

The grant from the foundation is structured to provide phased financial support. This will accelerate JCXH-108's clinical trials in the United States, aid in the development of a multi-dose vial vaccine, and support the marketing application process in the U.S., as well as obtaining World Health Organization Pre-Qualification. Upon receiving marketing approval, Immorna is committed to supplying the vaccine to LMICs at a pre-negotiated price with the foundation.

Dr. Zihao Wang, Co-Founder and CEO of Immorna, highlighted the global impact of severe lower respiratory tract infections caused by RSV, which lead to over 3.2 million hospitalizations and 118,000 deaths annually in children under five. A staggering 97% of these deaths occur in LMICs. He emphasized that introducing an effective RSV vaccine in these regions could significantly reduce hospitalization and mortality rates. Dr. Wang expressed gratitude for the foundation's support and stated that Immorna aims to enroll the first subject for the clinical trial by the end of August 2024. 

Immorna is a burgeoning biotech company founded in 2019, specializing in RNA-based therapeutics and vaccines. The company leverages various RNA platforms, including conventional, self-replicating, and circular RNA. Immorna has established a robust platform for RNA synthesis, purification, and analytical testing, suitable for both clinical and commercial development. Additionally, it has developed a range of RNA delivery vehicles featuring proprietary ionizable cationic lipids for different types of delivery, such as intramuscular and intravenous. Immorna's diverse pipeline spans cancer immunotherapy, infectious diseases, rare genetic disorders, and medical cosmetology.

JCXH-108 is a monovalent RSV vaccine developed using Immorna's proprietary mRNA and RTU-LNP technologies. The vaccine is designed for mild storage conditions with an approximate shelf life of 18 months at 2-8 °C, enhancing its accessibility. The mRNA encodes a specially engineered RSV Fusion protein in a pre-fusion configuration, which has been optimized for high expression. Preclinical studies show that even low doses of JCXH-108 produce high levels of neutralizing antibodies against both RSV A and B strains. In cotton rats, low doses provided complete protection against RSV challenges.

Immorna is rapidly positioning itself as a leader in RNA-based therapeutics, with a comprehensive intellectual property portfolio and an expanding clinical and research pipeline. The collaboration with the Bill & Melinda Gates Foundation marks a significant step in addressing global health challenges, particularly in underserved regions.

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