Althea Technologies inks DNA bird flu vaccine deal
manufacture clinical supplies of its flu vaccine that can
significantly speed up production.
PowderMed believes the vaccine's novel plasmid DNA production method will offer new solutions to the serious challenges of current vaccine production methods.
The traditional method for developing flu vaccines involves using chicken eggs or mammalian cells as a growth medium, however, this manufacturing method requires a long development time of up to six months to produce a viable vaccine, as well as posing the potential risk of allergic reactions.
On the other hand, plasmid DNA can be produced very quickly, in as little as a few weeks, and may more accurately represent the viral antigens allowing for better protection, according to PowderMed.
There is a surging demand for a widely available flu drug that is cheap to manufacture as worldwide governments prepare for a potential bird flu pandemic.
The US government recently stepped up efforts to replace outdated egg-based manufacturing methods with newer cell-based methods and awarded five-year contracts totaling $1bn (€780m) to five drug companies in order to do so.
However, according to its proponents, recombinant DNA (rDNA) vaccine technology could be the answer as it represents a powerful tool for an innovative vaccine design process known as "genetic immunisation."
"DNA vaccines have the potential to significantly limit the burden of disease," said Clive Dix, CEO of PowderMed.
"The advantage of a DNA-based approach is that the vaccines can be manufactured very rapidly and in large quantities, while yielding an efficacious immune response at low doses."
PowderMed's new DNA vaccine is delivered with the company's Particle Medicated Epidermal Delivery (PMED) needle-free injection system, which delivers DNA to the epidermal layer of the skin where it enters the cells of the immune network, creating immunity and facilitating both treatment and prevention of disease, said the firm.
PowerMed demonstrated the immunogenicity of the vaccine for the first time in humans in a recent Phase I trial and on the back of these results, will start Phase II studies using both annual and bird flu strains later this year.
Althea Technologies was chosen to manufacture the vaccine due to its expertise in the clinical development and manufacture of therapeutic and prophylactic DNA-based vaccines for viral diseases and cancer.
