The outbreaks of West Nile Virus (WNV) in North America over the last decade indicate its establishment and continued spread throughout the Western hemisphere. At present, no therapeutic treatment or vaccine is available for human use. The continued expansion of the WNV epidemic demands effective therapeutics and new production technologies that can rapidly transfer them into the clinical setting. In the parent grant, we have generated a promising WNV therapeutic candidate, a plant-derived E16 MAb, which can be rapidly scaled-up for commercial production in a cost-effective manner. The Specific Aim for this supplement is within the scope of Specific Aim 3 of the parent grant. There is no deviation from the original goals and the same methodologies and technologies will be used as in the parent grant to reach these goals. In this supplement proposal, instead of producing hu-E16 in small batches and combining them later, we propose to produce it in large processing scales (in gram quantity per batch vs. milligram level in the parent grant) strictly under FDAs current Good Manufacturing Practices (cGMP) regulations. The advantages of this approach over the one proposed in the parent grant are: 1) it will allow the full compliance of plant-derived hu-E16 production, therefore, the material will be truly cGMP due to the involvement of only large batch processing; 2) it will provide a large quantity (10-50 g) of true cGMP hu-E16 material, which is sufficient for and can be readily used in future toxicology studies and in Phase I human clinical trials; and 3) it will allow us to develop a more relevant in-scale downstream processing procedure which can be directly applied to future commercial production. Therefore, the proposed supplement research will accelerate the tempo for this WNV therapeutic candidate to reach human clinical trial stage, will accelerate the broader application of this promising plant-expression technology platform, and will create jobs for two new postdoctoral researchers with needed expertise.
|Effective start/end date||8/1/07 → 7/31/12|
- HHS: National Institutes of Health (NIH): $1,599,997.00
West Nile virus
Clinical Trials, Phase I
Costs and Cost Analysis