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

TAS::75 0849::TAS 主题 255 新型 HER2/NEU 表达亚丁的 CGMP 制造

基本信息

批准号：
8351873
负责人：
JOSEPH BALINT
金额：
$ 20万
依托单位：
ETUBICS CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-30 至 2012-06-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8351873
关键词：
Aden Adenoviruses Animal Model Animals Biodistribution Biological Response Modifier Therapy Cancer Patient Cell Line Cells Clinical Clinical Research Clinical Trials Complement Contracts Cyclic GMP Development Dose ERBB2 gene Ensure Evaluation FDA approved Freezing Future Human Humoral Immunities Immune Immunity Mediating Mouse Strains Organ Phase Phase II Clinical Trials Preparation Procedures Process Production Research Design Running Safety Serotyping Small Business Innovation Research Grant Therapeutic Tissue and Organ Harvesting Tissues Toxic effect Toxicology Tumor Volume Vaccines Vertebral column base cell bank experience flasks implantation in vivo malignant breast neoplasm man manufacturing process novel novel therapeutics novel vaccines phase 1 study pre-clinical preclinical study prevent therapeutic evaluation therapeutic vaccine tumor vector vector vaccine

项目摘要

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

SBIR合同的这一阶段是用于开发针对HER2/NEU表达乳腺癌的新疫苗。该疫苗诱导细胞介导的和体液的免疫力，该公司正在计划进行第一阶段I/II期临床试验。可以预料，这种新的生物治疗产品将补充并增加治疗HER2/新表达乳腺癌的现有疗法的武术。在这项SBIR I期研究中，该项目将（1）在CGLP下生产AD5 [E1-，E2B] -HER2/新的治疗产品，（2）对治疗产物进行毒性评估，（3）收集和冻结器官/冻结器官/组织进行生物分布研究。 Etubics正在开发一种靶向HER2/NEU表达乳腺癌的新疫苗。疫苗会引起细胞介导的和体液免疫，我们正在计划进行第一阶段1111临床试验。这是预计这种新的生物治疗产品将补充并增加现有的武术治疗HER2/NEU表达乳腺癌的疗法。该产品由我们的小说腺病毒组成血清型-5矢量平台（AD5 [E1-，E2B-] - HER2/neu）诱导HER2/NEU特异性免疫力和AD5免疫前动物模型。用产品处理减少肿瘤体积建立了HER2/NEU阳性肿瘤，并防止肿瘤植入和进展。产品是在公司必要和足够的E.C中制造？人类细胞。大型细胞库已经在CGMP条件下生产。在SBIR I期研究中，我们将（1）生产AD5 [E1-，E2B] HER2/ CGLP下的NEU治疗产物，（2）对治疗产品进行毒性评估，并且（3）收集和冻结器官/组织进行生物分布研究。完成这些研究后，公司将准备与我们的FDA批准的AD5 [E1-，E2B-] - CEA Ind和Intipation杂交在乳腺癌患者中生产1111期临床试验的临床级材料。提供钥匙