Coming in from the cold

LONDON—Likening their collaboration to the spokes and hub of a wheel, Lipoxen (a spoke) has announced that it has entered into a research agreement with Cambridge Biostability Limited (CBL) (the hub), the University of Cambridge and the Health Protection Agency (HPA) to develop vaccines that are more stable, have a long shelf-life, require fewer doses to be effective and eliminate the need for 'cold-chain' storage and distribution.

Summarizing the immense benefits foreseen, M. Scott Maguire, Lipoxen CEO, says, "There is little doubt that significant improvements in public health and life expectancy could be achieved if modern vaccines could be delivered to a much greater proportion of the developing world's population."

According to Dr. Kiran Gulati, director of business development at CBL, the collaboration is partly funded by each participant and the partners have agreed to "joint exploitation of whatever comes out of the collaboration."

Lipoxen's "spoke" involves its liposomal co-delivery technology which entraps vaccine antigen in liposomes in both DNA and protein forms, explains Dr. Peter Laing, the company's COO. The process has resulted in "a staggering increase in immune response," Laing says, to the influenza vaccine now under development—which may allow lower doses to be administered—but the vaccine still requires a cold chain, meaning it must be maintained at low temperatures throughout the distribution process.

For obvious reasons, this requirement has limited the availability of many vaccines in the parts of the world that need them most. Infectious diseases are said to kill 15 million people every year, according to the World Heath Organization (WHO).

"We are at the early stages," Laing notes, "but [it is] looking good." Laing is very optimistic based on the preliminary results. If successful, he expects the technology to be applied to a wide range of vaccines. Market potential could exceed a billion dollars per vaccine because of changes in logistics.

CBL's contribution as the lead collaborator in the partnership is to tackle the cold-chain issue. The company is directing research to develop novel vaccine formulations that are stable at room temperature and, in fact, down to below freezing (currently vaccines must be refrigerated but can't be frozen). The vitRIS technology employed by CBL involves spray drying. The company is also developing a manufacturing process for slow-release vaccines based on antigens supplied by the HPA.

The final spoke is the University of Cambridge Center for Biological Imaging, which supplies structural verification via advanced imaging technologies such confocal microscopy and x-ray microanalysis.

"I believe that this consortium is well-positioned to develop the next generation of vaccines which will be of immense benefit for the developing world vaccination programs," Lipoxen CEO Maguire concludes. DDN