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

这份第一阶段的SBIR合同是为了开发一种针对HER2/neu表达乳腺癌的新疫苗。该疫苗同时诱导细胞免疫和体液免疫，该公司正计划进行第一人第一阶段/第二阶段临床试验。预计这种新的生物治疗产品将补充和增加现有治疗HER2/新表达乳腺癌的疗法。在这项SBIR第一阶段研究中，该项目将(1)在cGLP下制造Ad5[E1-，E2b]-HER2/新治疗产品，(2)对治疗产品进行毒性评估，(3)收集和冷冻器官/组织进行生物分布研究。 Etubics正在开发一种针对表达HER2/neu乳腺癌的新疫苗。疫苗可诱导 包括细胞免疫和体液免疫，我们正在计划一项首例人1111期临床试验。它是 预计这一新的生物治疗产品将补充和增加现有的医疗设备 治疗HER2/neu表达乳腺癌的治疗方法。该产品含有我们的新型腺病毒 诱导HER2/neu特异性免疫的5型载体平台(Ad5[E1-，E2b-]-HER2/neu) 和Ad5免疫临床前动物模型。使用该产品治疗可减少肿瘤体积 建立HER2/neu阳性肿瘤，防止肿瘤种植和进展。该产品是 在公司必要和充足的E.C.中制造的？人类细胞。已经建立了一个主细胞库 在cGMP条件下生产。在SBIR第一阶段研究中，我们将(1)制造Ad5[E1-，E2b]HER2/ CGLP下的Neu治疗产品，(2)对该治疗产品进行毒性评估，以及 (3)收集和冷冻器官/组织以进行生物分布研究。在完成这些研究后， 公司将准备向FDA批准的Ad5[E1-，E2b-]-CEA Ind交叉提交文件并启动 用于1111期乳腺癌患者临床试验的临床分级材料的制造。 提供密钥

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