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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

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