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news.Genetic Immunity, a multi-national biopharmaceutical company developing nanomedicine vaccines, has developed a stable liquid formulation to deliver a novel nanomedicine.
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Genetic Immunity said that it has implemented ‘Quality-by-Design’ in biologic product development to manufacture a nanomedicine resulting in a new formulation of pDNA surrounded by a chemical polymer capable of maintaining the physical stability and biological activity of DermaVir at 4ºC.
Julianna Lisziewicz, CEO of Genetic Immunity, said: “Biological activity of DermaVir depends upon its nanomedicine formulation that is essential for the potent expression of plasmid-DNA-encoded antigens.
“During Phase I and II clinical trials, DermaVir formulation required on-site admixture of three separate components followed by patient administration within three hours. We report here the development of a stable single liquid nanomedicine formulation, a significant milestone in developing DermaVir as a commercially viable global product to treat HIV/AIDS.
“These discoveries will support DermaVir as it enters into Phase II/III human trials as a topically administered nanomedicine therapeutic vaccine. Our Phase I trial demonstrated the preliminary safety and immunogenicity of DermaVir in HIV-positive people treated with HAART.
“We have now also obtained Phase II data showing safety, immunogenicity and viral load reductions when DermaVir is used for initial treatment of HIV-infected individuals. This is the human proof of concept of our topical nanomedicine vaccine technology. It is our belief that DermaVir will become the first nanomedicine vaccine developed to reconstitute HIV-specific immunity with the potential to maintain the health of people living with HIV infection.”