Axis Genetics plc, Cambridge,
United Kingdom, has signed its first manufacturing agreement for the production of
hepatitis B Edible Plant Vaccine (EPV) potatoes, with American
Ag-Tec International Ltd.
Under the agreement, Axis Genetics will be supplied with EPV
potatoes both for use in its oral hepatitis B clinical trial scheduled to begin in 1999 in
the US, and for further product development. Axis Genetics is developing a stable, oral
formulation of these novel vaccines using existing food processing technologies.
American Ag-Tec International was selected for its expertise in
pioneering and patenting a technique for the rapid multiplication of disease-free potato
minitubers, not restricted by seasonal or geographic limitations. American Ag-Tec will
utilise their patented Quantum Tubers® the process for multiplication of EPV potatoes,
using certified stocks of potatoes to produce a consistent product to meet Good
Manufacturing Practice standards.
"By investing now we will ensure compliance with production
protocols demanded by the FDA and other regulatory authorities," said Dr Iain Cubitt,
the Chief Executive of Axis Genetics. "We want to ensure that no procedure in the
development chain holds back the commercialisation of these novel vaccines".
The new agreement with Axis Genetics is American Ag-Tec's first
venture into the pharmaceutical sector.
"This is an advancement that will revolutionise vaccination
programmes. It has its roots in agriculture and will raise the importance of the lowly
potato by a quantum leap" said Robert G. Britt, President of American Ag-Tec
International Ltd.
Axis Genetics licensed the EPV technology from the Boyce Thompson
Institute (BTI) of Ithaca, New York, in May 1998. Preliminary animal studies conducted by
the BTI and Roswell Park Cancer Institute of Buffalo, New York, indicated that potatoes
modified to produce hepatitis B antigens have potential as vaccines to prevent hepatitis B
infection. Further animal studies will be conducted using hepatitis B EPV potatoes, under
a collaboration and option agreement between Axis Genetics and Roswell Park Cancer
Institute, as reported in an accompanying announcement.
American Ag-Tec International Ltd., based in Delavan, Wisconsin is
an international agricultural technology development company working in seed and food
production worldwide. The recent development of the Quantum Tubers technology for
pathogen-free seed potato is the only technology of its kind with origins in production
agriculture as well as in space through the NASA research program at the University of
Wisconsin, Madiston (WCSAR).
Axis Genetics is a private company based in Cambridge, UK,
developing vaccines from plants. The company is working with the Boyce Thompson Institute
for Plant Research, Ithaca, New York, to develop Edible Plant Vaccines for the prevention
of hepatitis B, enterotoxigenic E. coli travellers' diarrhoea, and Norwalk virus
infections. Using its proprietary chimaeric virus particle technology EPICOAT, Axis is
developing vaccines for cancer, Pseudomonas aeruginosa and Staphylococcus aureus
infections.