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

NCI-SBIR制造合同的目标是生产一种用于治疗的免疫疗法 HER2/neu+乳腺癌。HER2/neu是表皮生长因子受体(EGFR)家族的成员，是一种 跨膜酪氨酸激酶受体与某些乳腺疾病的发病机制 腺癌。HER2/neu过度表达在大约三分之一的侵袭性乳腺中被发现。 癌症与更具侵袭性的进展、更快的复发时间、更差的总存活率、 促进细胞增殖，增加区域和远处转移，加速血管生成，以及 减少癌细胞的凋亡。HER2/neu的免疫原性已被临床证实，它 是免疫治疗方法的一个很有前途的靶点。HER2/NEU被列为优先目标 NCL。Etubics将清空其E.C7人类制造细胞系以生产ADS[E1-，E2B-]-HER2 一种产品，旨在克服患者原有的ADS免疫力，挑战其他媒介 接近了。该平台包含HER2/neu基因，并诱导针对HER2/neu基因的强大免疫反应 抑制肿瘤进展并可能防止转移的基因靶点。我们的目标是完成 该合同并向美国食品和药物管理局提交了IND，以启动L/11a期临床试验，以治疗HER2/Neu+乳腺 癌症。

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.