MUCOSAL PLANTIBODIES: Anti-HIV

描述(由申请人提供)：本项目的目标是 开发针对人类免疫缺陷病毒(HIV)的抗体，可以 用于阴道杀微生物剂，以防止艾滋病毒的性传播。这些 HIV抗体可以与针对其他性行为的抗体相结合 已经在玉米(植物体内)中产生的传播性疾病病原体 Epicyte用于广谱阴道保护。人源单抗2F5 (抗gp41)和2g12(抗gp20)被广泛认为是最常见的两种 到目前为止，已经开发出了有效的和广泛中和的艾滋病毒抗体，并已经 在给药时可防止SIV在猕猴体内的阴道传播 从系统上讲。2F5和2G12将作为分泌型免疫球蛋白(SIGA)产生， 同型在粘膜表面最占优势。抗体基因将是 导入玉米植株并在种子中表达为Low的“植物抗体” 生产成本高、产能大。抗体将从种子中提纯， 结合在单一配方中，并评估其在预防 SIV在猕猴的阴道传播，当局部应用于阴道时。 第一阶段资助的结果将提供基本信息和GMP 支持该SBIR提案第二阶段临床试验的材料。 建议的商业应用： 植物体内提供了一个独特的机会来提供大量的保护 抗体的成本使防止粘膜传播的技术成为可能 一种广泛的传染病。

DESCRIPTION (provided by applicant): The objective of this project is to develop antibodies specific for human immunodeficiency virus (HIV) that can be used in a vaginal microbicide for preventing sexual transmission of HIV. These HIV antibodies can be combined with antibodies against other sexually transmitted disease pathogens already being produced in corn (plantibodies) by Epicyte for broad-spectrum vaginal protection. Human monoclonal antibodies 2F5 (anti-gp4l) and 2G12 (anti-gpl20) are widely recognized as two of the most potent and broadly neutralizing HIV antibodies developed to date, and have been shown to prevent vaginal transmission of SHIV in macaques when administered systemically. 2F5 and 2G12 will be produced as secretory IgAs (SIgA), the isotype most predominant on mucosal surfaces. The antibody genes will be introduced into corn plants and expressed in seeds as "plantibodies" for low cost and large capacity production. Antibodies will be purified from seeds, combined in a single formulation, and evaluated for effectiveness in preventing vaginal transmission of SHIV in macaques when applied topically to the vagina. The results from phase I funding will provide essential information and GMP material to support clinical trials in the second phase of this SBIR proposal. PROPOSED COMMERCIAL APPLICATION: Plantibodies offer a unique opportunity to provide large quantities of protective antibodies at a cost that enables technology that prevents mucosal transmission of a wide range of infectious diseases.