SBIR Phase I: Development of a transgenic hypoallergenic peanut

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是生产和商业化一种低过敏花生。这种新的花生品种将以低成本为有风险的个人提供广泛和有效的花生过敏保护，即临床上被宣布对花生过敏的个人以及那些可能还没有意识到自己对花生敏感的人。低过敏性花生有望：1)减少花生过敏的发生率，挽救对花生严重过敏的个人的生命；2)消除花生过敏者及其家人的情绪困扰；3)减少花生过敏引起的诉讼费用；4)挽回花生市场遭受的损失，提高美国在国际舞台上的竞争优势。食物过敏每年给美国造成250亿美元的损失，花生是主要的贡献者。该项目将为这一问题带来重大解决方案，并降低食物过敏的总体成本。这个SBIR第一阶段项目建议开发一种转基因低过敏花生，它能产生同质的低过敏花生种子种群。花生过敏正在增加，影响着超过8%的美国婴儿和儿童。目前，花生过敏还没有治愈方法，肾上腺素是作为紧急治疗使用的。RNA干扰(RNAi)技术被用来下调最重要和最有效的过敏原，并导致花生过敏原效力的显著降低。然而，花生种子种群表现出不同程度的致敏效力。这归因于转基因植物中的嵌合体。易碎胚性愈伤组织(FEC)可降低产生嵌合转基因植物的风险。这一阶段项目的目标是：1)利用根癌农杆菌转化花生FEC；2)对转基因再生植株(T0)进行分子分析，并确定转基因在花生基因组中的完整性和稳定性；3)对产生的T1种子进行分子和免疫学分析，以确定过敏性效力的水平。预计在SBIR第一阶段项目结束时，将至少选择一个转基因花生品系作为商业原型进行进一步分析和大规模繁殖。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to produce and commercialize a hypoallergenic peanut. This new peanut variety will provide broad and efficient protection against peanut allergy at low cost to individuals at risk; i.e., individuals who are clinically declared to be allergic to peanut as well as those who might not be aware yet of their sensitivity to peanut. The hypoallergenic peanut is expected to: 1) Reduce the incidence of peanut allergy and save the lives of individuals who are severely allergic to peanut; 2) Eliminate emotional distress of peanut allergic individuals and their families; 3) Reduce the cost of law suits resulting from peanut allergy; and 4) Gain back the loss endured by the peanut market and improve the U.S. competitive edge in the international arena. Food allergies cost the U.S. $25 billion annually and peanut is a major contributor. This project will bring a significant solution to this problem and reduce the overall cost of food allergy. This SBIR Phase I project proposes to develop a transgenic hypoallergenic peanut that produces a homogeneous population of hypoallergenic peanut seeds. Peanut allergy is on the increase and affects over 8% of U.S. infants and children. Currently, there is no cure for peanut allergy and epinephrine is administered as emergency treatment. RNA interference (RNAi) technology was used to down regulate the most important and potent allergens, and resulted in significant reduction in peanut allergenic potency. However, the peanut seed populations displayed variable levels of allergenic potency. This was attributed to chimerism in the transgenic plants. Friable embryogenic callus (FEC) reduces the risks of generating chimeric transgenic plants. The objectives of this Phase I project are: 1) To transform peanut FEC using Agrobacterium tumefaciens; 2) To perform molecular analyses on transgenic regenerants (T0) and determine integrity and stability of the transgene in the peanut genome; and 3) To perform molecular and immunological analyses on resulting T1 seeds to determine the level of allergenic potency. It is expected that at the end of this SBIR Phase I project, at least one transgenic peanut line with homogeneous populations of hypoallergenic seeds will be selected as commercial prototype for further analysis and mass propagation.