• LION™-formulated repRNA vaccination exhibited a significant safety profile, along with enhanced efficacy and biodistribution response when compared to lipid nanoparticle (LNP)-formulated repRNA vaccines in mice

  • Study findings, published in the peer-reviewed journal Molecular Therapy, suggest repRNA and LION has potential as a next-generation vaccine platform technology

SEATTLE, July 24, 2023 /PRNewswire/ — 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.

About HDT Bio

HDT Bio is a Seattle-based, clinical-stage biopharmaceutical development company. With core technology and expertise in nucleic acid formulation, the company develops products that seek to harness host-directed immune responses. HDT Bio’s work focuses on infectious disease and oncology vaccines and therapeutics through early-stage collaborations with partners worldwide. The company’s vaccine platforms combine formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses. HDT Bio’s repRNA/LION™ is the first self-amplifying RNA vaccine platform to ever receive a regulatory authorization.