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 制造合同的目标是生产一种免疫治疗药物来治疗 HER2/neu+ 乳腺癌。 HER2/neu 是表皮生长因子受体 (EGFR) 家族的成员， 跨膜酪氨酸激酶受体与某些乳腺发病的相关性 腺癌。大约三分之一的浸润性乳腺中已发现 HER2/neu 过度表达 癌症，并与更积极的进展、更短的复发时间、更差的总体生存率相关， 细胞增殖增加，区域和远处转移增加，血管生成加速， 减少癌细胞的凋亡。 HER2/neu的免疫原性已得到临床证明， 是免疫治疗方法的一个有前途的靶点。 HER2/neu 被列为优先目标 NCl。 Etubics 将利用其 E.C7 人类制造细胞系生产 AdS [E1-, E2b-]-HER2 该产品旨在克服患者体内已有的 AdS 免疫力，从而挑战其他媒介 接近。该平台包含 HER2/neu 基因，可诱导针对 HER2/neu 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点。我们的目标是完成以下目标 签署本合同并向 FDA 提交 IND，启动治疗 HER2/neu+ 乳腺癌的 l/lla 期临床试验 癌症。