HDT Bio Corp., a clinical stage private company developing advanced RNA vaccine products to treat and prevent infectious diseases and cancer, today announced the publication of preclinical data demonstrating that the company's AMPLIFY vaccine platform, comprised of self-replicating RNA (repRNA) and LION™ formulation technology, holds a more favorable safety profile and increased durability and localization compared to repRNA vaccines delivered by lipid nanoparticles (LNPs), similar to those used to deliver currently-available RNA vaccines for COVID-19. The data were published in the journal Molecular Therapy, in an article entitled, "A localizing nanocarrier formulation enables multi-target immune responses to multivalent replicating RNA with limited systemic inflammation."
"While RNA vaccines have greatly curtailed the COVID-19 pandemic, legitimate safety concerns have arisen that must be taken into consideration," said Steve Reed, Ph.D., Chief Executive Officer of HDT Bio. "The findings of this study demonstrate that our LION delivery system offers unique properties that greatly improve upon the safety, immunogenicity and efficacy of the type of lipid nanoparticles that are currently in use. This is a clear demonstration that AMPLIFY is a next-generation platform with the potential to transform immunizations worldwide."
The key findings of the publication, conducted in a mouse model, are summarized below.
– Intramuscular administration of repRNA with LION technology (repRNA/LION) restricted RNA expression to the muscle, whereas repRNA with LNPs (repRNA/LNP) was observed broadly throughout the body;
– repRNA/LNP triggered both local and systemic innate immune/inflammatory responses, whereas repRNA/LION restricted innate immune activity to the local injection site, but did not trigger a systemic inflammatory response;
– repRNA/LION induced a comparable antibody and T cell response to repRNA/LNP, despite the absence of a systemic response;
– In a multivalent vaccine design repRNA/LION induced potent neutralizing antibody responses to each antigen.
The publication can be found on the Molecular Therapy website and on the Publications page of the HDT Bio website.
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