US-based biotech Replicate Bioscience has announced positive preliminary data where its self-replicating RNA (srRNA) rabies vaccine, RBI-4000 achieved a strong immune response against the rabies virus. 

RBI-4000, an intramuscular vaccine, leverages self-replicating RNA (srRNA), which can replicate itself after administration and could be effective at very low doses. In a cohort of 84 healthy volunteers in the Phase I trial (NCT06048770), participants received either one or two doses of either 0.1mcg, 1mcg or 10mcg of the vaccine.  

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The vaccine induced neutralising antibody titres at levels that exceeded the World Health Organization’s (WHO’s) defined surrogate level of protection for rabies virus of 0.5 IU/mL. RB1-4000 was well tolerated at all tested doses, with no severe adverse events among the participants in the trial. 

Rabies is a viral disease that affects the nervous system, transmitted through the saliva of infected animals following a scratch or bite. The disease is fatal if not treated promptly. Travelers are often vaccinated against rabies as a preventative measure before going to regions where rabies is prevalent, such as in some parts of Africa and Asia.  

According to a report on GlobalData’s Pharma Intelligence Center, rabies vaccines are associated with the highest costs compared to other travel vaccines like hepatitis A and diptheria due to the long dosing regimen that comes with the vaccine.  

In the announcement accompanying the data, CEO of Replicate Nathaniel Wang said: “Achieving a broad therapeutic window is an important step-up from other existing mRNA and srRNA approaches, which allows us to expand applications of our self-replicating RNA to complex infectious diseases, off-the-shelf cancer vaccines, and as a platform for protein production.” 

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In 2022, the San-Diego headquartered company entered into a strategic collaboration with contract research, development, and manufacturing organisation (CDMO) Curia to develop the platform for Replicate’s srRNA therapeutics. 

In 2021, Replicate raised $40m in Series A funding round led by the venture capital firm ATP to advance its srRNA vaccine programmes into development. 

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