TAS::75 0849::TAS TOPIC 255 CGMP MANUFACTURE OF A NOVEL HER2/NEU EXPRESSING ADEN

该I期SBIR合同旨在开发一种针对表达HER 2/neu的乳腺癌的新疫苗。该疫苗诱导细胞介导和体液免疫，该公司正计划进行首次人体I/II期临床试验。预计这种新的生物素产品将补充和增加现有治疗HER 2/新表达乳腺癌的疗法。在本SBIR I期研究中，该项目将（1）根据cGLP生产Ad 5 [E1-，E2 b]-HER 2/新治疗产品，（2）对治疗产品进行毒性评价，（3）采集并冷冻器官/组织用于生物分布研究。 Etubics正在开发一种针对HER 2/neu表达乳腺癌的新疫苗。疫苗诱导 细胞介导和体液免疫，我们正计划进行第一次人体1111期临床试验。是 预计这一新的biopsy产品将补充和增加现有的医疗设备， 治疗表达HER 2/neu的乳腺癌的疗法。该产品由我们的新型腺病毒 血清型-5载体平台（Ad 5 [E1-，E2 b-]-HER 2/neu），其在未治疗的小鼠中诱导HER 2/neu特异性免疫 和Ad 5免疫临床前动物模型。用该产品治疗可减少肿瘤体积， 建立HER 2/neu阳性肿瘤，并防止肿瘤植入和进展。产品 在公司的必要和充分的E.C？人体细胞主细胞库已 在cGMP条件下生产。在SBIR I期研究中，我们将（1）生产Ad 5 [E1-，E2 b] HER 2/ cGLP下的neu治疗产品，（2）进行治疗产品的毒性评价，以及 (3)收集和冷冻器官/组织用于生物分布研究。在完成这些研究后， 公司将准备与FDA批准的Ad 5 [E1-，E2 b-]-CEA IND交叉备案，并启动 生产用于乳腺癌患者1111期临床试验的临床级材料。 提供关键

This Phase I, SBIR contract is for the development of a new vaccine targeting HER2/neu expressing breast cancers. The vaccine induces both cell-mediated and humoral immunity and the company is planning a first-in-man Phase I/Phase II clinical trial. It is anticipated that this new biotherapeutic product will complement and add to the armamentarium of existing therapies that treat HER2/new expressing breast cancers. In this SBIR Phase I study, the project will (1) manufacture the Ad5 [E1-, E2b]-HER2/new therapeutic product under cGLP, (2) perform toxicity evaluations of the therapeutic product, (3) collect and freeze organs/tissues for biodistribution studies. Etubics is developing a new vaccine targeting HER2/neu expressing breast cancers. The vaccine induces both cell-mediated and humoral immunity and we are planning a first-in-man Phase 1111 clinical trial. It is anticipated that this new biotherapeutic product will complement and add to the armamentarium of existing therapies that treat HER2/neu expressing breast cancers. The product consists of our novel Adenovirus serotype-5 vector platform (Ad5 [E1-, E2b-]-HER2/neu) that induces HER2/neu specific immunity in naIve and Ad5 immune pre-clinical animal models. Treatment with the product reduces tumor volume in established HER2/neu positive tumors and prevents tumor implantation and progression. The product is manufactured in the Company's necessary and sufficient E.C? human cells. A Master Cell Bank has been produced under cGMP conditions. In SBIR Phase I studies, we will (1) manufacture the Ad5 [E1-, E2b]HER2/ neu therapeutic product under cGLP, (2) perform toxicity evaluations of the therapeutic product, and (3) collect and freeze organs/tissues for biodistribution studies. Upon completion of these studies, the Company will be prepared to cross-file with our FDA approved Ad5 [E1-, E2b-]-CEA IND and initiate manufacture of clinical grade material for a Phase 1111 clinical trial in breast cancer patients. Provide key