Emergex Vaccines Holding Limited ('Emergex'), a biotechnology company pioneering a new approach to synthetic vaccine development in the field of infectious diseases, today announces the successful completion of preclinical toxicology testing on the gold nanoparticle carrier system that forms the fundamental basis for Emergex's entire infectious disease vaccine platform.
Toxicology studies complying with good laboratory practice (GLP) were successfully completed in standard industry models using Emergex's gold nanoparticle at a range of doses. No toxicological effects, as measured by key markers, were detected at any level of dosing, confirming the safety of the gold nanoparticle in these models.
The gold nanoparticle forms the central core (or "scaffold") for immunogenic peptides that together form the final construct for development. The particles can be made to measure less than 5 nanometers in diameter. They act as the carrier system for immunogenic vaccine constructs that comprise synthetic peptides derived from highly conserved components of the disease-causing virus, microbe or pathogen. These peptides have been reverse-engineered using post-infectious blood to identify and select peptides that elicit the strongest cell-mediated immune response. The excellent safety profile demonstrated in these successful preclinical studies now enables Emergex to progress further toxicology testing on viral vaccine constructs in Emergex's development pipeline and, provided they are successful, first-in-man Phase I safety studies.
Emergex's first vaccine candidate is scheduled to enter Phase I clinical testing in 2019. It contains immunogenic peptides that are derived from viruses such as Dengue and Zika within the Flavivirus family. The Flavivirus vaccine is designed to universally target this viral genus.
Due to their small size, Emergex's vaccines can directly enter immune processing cells and trigger cell-mediated immune responses within infected host cells. The small size also enables administration via microneedle patch technology which is less invasive than conventional needle vaccination. Using this administration method the vaccine enters the dermal level of the skin, which then directly stimulates the immune system. Emergex's vaccine technology can also be applied for the development of vaccines for other pathogenic microbes such as antibiotic-resistant bacteria.
Laurens Rademacher, Emergex's Chief Technology Officer commented: "These results are a significant milestone as we advance towards clinical development of our Flavivirus vaccine. The excellent safety profile that we have seen on our base gold nanoparticle in these preclinical studies provides us with renewed confidence in a significant part of the contributing technology. We therefore expect the regulatory process for the upcoming clinical phases to be attainable within our anticipated timelines, ensuring that we remain on course to achieve our vision of providing vaccines that are effective, affordable and safe."
Emergex's business model is to create International Vaccine Repositories of post Phase I vaccines that act as a first-line of defense against existing, emerging and emergency infectious outbreaks and that will be subscribed to by governments, non-governmental organizations and/or charities. Access to these are repository is expected to provide Emergex with initial revenues.