Immorna Biotherapeutics announced in August 2024 that it has received a grant, worth $3,800,000, from the Bill & Melinda Gates Foundation in support of the clinical development of JCXH-108. JCXH-108 is a Respiratory Syncytial Virus (RSV) vaccine based on Immorna’s proprietary mRNA and ‘ready-to-use’ lipid nanoparticle (RTU-LNP) technologies. The grant will provide staged financial support to expedite clinical trials in the US, the process and clinical development of multi-dose vial vaccine (MDV), a marketing application in the US, and WHO Pre-Qualification (PQ). If the vaccine is approved for marketing, Immorna has committed to supplying it to LMICs at a pre-negotiated price.
JCXH-108
JCXH-108 is a monovalent RSV vaccine that uses Immorna’s mRNA and RTU-LNP technologies, which have “gained successful clinical proof-of-concept” in other infectious disease vaccines. This vaccine encodes an engineered RSV Fusion protein with stabilised pre-fusion configuration (pre-F). The pre-F antigen demonstrated “high” in vitro and in vivo expression from the mRNA in preclinical studies, and low doses of JCXH-108 elicited high titres of neutralising antibodies against both RSV A and RSV B strains.
The vaccine “features a mild storage and transportation condition” with a shelf life of around 18 months at between 2°C and 8°C. Enhanced stability should “significantly reduce the logistics complexity” associated with mRNA vaccine storage, transportation, and distribution.
Reducing the burden of RSV
Dr Zihao Wang, Co-Founder and CEO of Immorna, appreciates the “trust and support” shown by the foundation as the company strives to introduce a “safe and effective” RSV vaccine to reduce RSV related hospitalisations and deaths.
“We look forward to working closely with the foundation to expedite 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 strives to help provide more treatment options to patients.”
Dr Wang emphasises the focus on contributing to 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.”
Immorna is “on track” to enrol the first subject in a clinical trial by the end of August 2024.
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