Open Competition 1 - Biotechnology

Novel Plant Produced Virus-Like Particles for the Delivery of Rapid and Effective Vaccines

Sponsor: Large Scale Biology Corporation

• Project Performance Period: 11/1/2002 - 10/31/2005
• Total project (est.): $4,645,934.00
• Requested ATP funds: $1,999,934.00

The activation of the immune system with vaccines in response to pathogens and tumor cells has long been a major focus of medical scientists. Vaccines against most pathogens have generally been successful in controlling their spread and adverse affects. However, many pathogens and almost all tumor cells have developed strategies to avoid the immune system. In addition, aspects of recent vaccine development have caused concerns, such as occupational safety, low yield/high costs of production, and severe adverse side effects. Consequently, research has focused on developing "subunit" vaccines that are composed of pathogen protein(s) or peptides generally targeted by the host immune response for protective immunity and are safer to produce. Unfortunately, subunit vaccine production remains expensive and these vaccines may not be as effective as the standard vaccines currently used in medical practice. The goal of the multi-year ATP-supported program is to develop a platform for generating virus-like particle (VLP) vaccines that are bi-functional, with protein and genetic constituents working in concert to generate strong and lasting immunological responses. LSBC's improved technology would permit the simultaneous production of multiple vaccine constituents on the surface of Tobacco Mosaic Virus (TMV), which the company can propagate rapidly and economically in non-recombinant plants. With the NIST ATP support, this system will be adapted to produce desired amounts and types of disease-associated antigens, cellular targeting signals, and immune-enhancing peptides. The VLPs will be tested in vitro and in two animal models of disease. Production of VLPs with foreign surface proteins is subject to variability and is of high technical risk. Difficulty also resides in developing the appropriate immune response with the VLP. The economic benefit to LSBC will primarily derive from the commercial manufacture of vaccine products aimed at the adult market in cancer and infectious diseases, which is expected to reach $2.3 billion by 2005. The nation benefits through the availability of potentially more effective, low-cost vaccines to control current diseases and those previously resistant to treatment, such as the 5 million living cancer patients of whom 30 to 40 percent will have a recurrence of the disease in which current intervention will be relatively ineffective. Production costs should decrease to 20 percent of current levels and efficiency should increase by 20 times based on the TMV vaccine strategy. Commercialization through collaborative relationships with pharmaceutical companies will follow in vitro validation. ATP funding will accelerate development of the technology by two years.

For project information:

Dr. Alison McCormick, (707) 469-2384
alison.mccormick@lsbc.com

ATP Project Manager

Thomas Wiggins, (301) 975-5416
thomas.wiggins@nist.gov