IGF::OT::IGF SBIR TOPIC 255 cGMP Manufacture of

IGF::OT::IGF SBIR TOPIC 255 cGMP 制造

• 批准号: 8738031
• 负责人: FRANK R JONES
• 金额: $ 147.89万
• 依托单位: ETUBICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2015-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8738031
• 关键词: Apoptosis; Biodistribution; Bioreactors; Breast Adenocarcinoma; Cell Line; Cell Proliferation; Clinical; Clinical Trials; Contracts; Cyclic GMP; Distant Metastasis; ERBB2 gene; Enzyme-Linked Immunosorbent Assay; Epidermal Growth Factor Receptor; Family; Freezing; Gene Targeting; Goals; Human; Immune response; Immunity; Immunotherapeutic agent; Life; Neoplasm Metastasis; Organ; Pathogenesis; Patients; Phase; Procedures; Production; Receptor Protein-Tyrosine Kinases; Relapse; Reporting; Running; Small Business Innovation Research Grant; System; Testing; Time; Tissues; Toxic effect; Western Blotting; angiogenesis; cancer cell; design; immunogenicity; malignant breast neoplasm; member; overexpression; phase 1 study; prevent; quality assurance; tumor progression; vector

The objective of this NCI-SBIR manufacturing contract is to produce an immunotherapeutic to treat HER2/neu+ breast cancer. HER2/neu, a member of the epidermal growth factor receptor (EGFR) family, is a transmembrane tyrosine kinase receptor associated with the pathogenesis of certain breast adenocarcinomas. HER2/neu overexpression has been indentified in about one third of invasive breast cancers and is associated with more aggressive progression, shofter relapse time, poorer overall survival, increased cell proliferation, increased regional and distant metastases, accelerated angiogenesis, and reduced apoptosis of cancer cells. The immunogenicity of HER2/neu has been clinically demonstrated and it is a promising target for immunotherapeutic approaches. HER2/neu is classified as a priority target by the NCl. Etubics will emptoy its E.C7 human manufacturing cell line to produce the AdS [E1-, E2b-]-HER2 product that is designed to overcome pre-existing AdS immunity in patients that challenges other vector approaches. This platform contains the HER2/neu gene and induces robust immune responses against the gene target that inhibits tumor progression and may prevent metastases. Our goal is to complete the Aims of this contract and submit an IND to the FDA to initiate a phase l/lla clinical trial to treat HER2/neu+ breast cancer.

该NCI-SBIR制造合同的目的是生产一种免疫治疗以治疗 HER2/NEU+乳腺癌。 HER2/NEU是表皮生长因子受体（EGFR）家族的成员，是一个 跨膜酪氨酸激酶受体与某些乳房的发病机理有关 腺癌。 HER2/NEU过表达已在侵入性乳房的大约三分之一中被缩进 癌症，与更具侵略性的进展相关，复发时间变化，总生存率较差， 细胞增殖增加，区域和远处转移增加，加速血管生成以及 癌细胞凋亡减少。 HER2/NEU的免疫原性已在临床上证明，它 是免疫治疗方法的有希望的目标。 HER2/NEU被归类为优先目标 NCL。 Etubics将空置其E.C7人类制造细胞系，以生成广告[E1-，E2B-] - HER2 旨在克服挑战其他媒介的患者中现有的广告免疫力的产品 方法。该平台包含HER2/neu基因，并诱导了针对该基因的强大免疫反应 抑制肿瘤进展并可能预防转移的基因靶标。我们的目标是完成 该合同并向FDA提交IND，以启动LLA临床试验以治疗HER2/NEU+乳房 癌症。