TAS::75 0849 - TOPIC 255 PHASE II, CGMP MANUFACTURE OF A NOVEL CEA EXPRESSING A

TAS::75 0849 - 主题 255 第二阶段，表达 A 的新型 CEA 的 CGMP 制造

• 批准号: 8346726
• 负责人: Frank R. Jones
• 金额: $ 149.9万
• 依托单位: ETUBICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8346726
• 关键词: Active Immunotherapy; Adenoviruses; Animals; Antibodies; Biodistribution; Biological Assay; Biological Response Modifier Therapy; Carcinoembryonic Antigen; Cell Line; Clinical Trials; Colon Carcinoma; Complement; Cyclic GMP; Enzyme-Linked Immunosorbent Assay; Human; Life; Malignant Neoplasms; Malignant neoplasm of pancreas; Phase; Phase III Clinical Trials; Process; Production; Running; Serotyping; Small Business Innovation Research Grant; Techniques; Testing; Therapeutic Studies; Therapeutic Uses; Tissues; Transgenes; Western Blotting; cell bank; cell mediated immune response; malignant breast neoplasm; manufacturing process; novel; novel vaccines; programs; tumor

Etubics Corporation is clinically testing a new vaccine targeting carcinoembryonic antigen (CEA) expressing cancers in a Phase I/II clinical trials under FDA IND14325. Many cancers express CEA, including colon, breast and pancreatic cancers. It is anticipated that this new biotherapeutic product will complement the armamentarium of existing therapies for the treatment of CEA expressing cancers. The product consists of the Company¿s novel Adenovirus serotype-5 platform expressing CEA (Ad5 [E1-, E2b-]-CEA) that induces antibodies and cell mediated immune responses that result in anti-tumor activity. The product is manufactured in the necessary and sufficient human E.C7 cell line. A Master Cell Bank has been produced under cGMP conditions. In this Phase II SBIR program, we will (1) evaluate the robustness of the manufacturing process, (2) perform an additional GMP manufacturing run to support the next phase clinical trials, (3) perform a product biodistribution study in animals, (4) develop functional assays using the therapeutic product, and (5) perform shelf-life studies of the product. It is expected that completion of these processes and studies will allow us to produce sufficient product to support large-scale clinical trials required to move toward approval of this new biotherapeutic for active immunotherapy of CEA expressing cancers.

Etubics公司正在FDA IND14325的I/II期临床试验中测试一种针对癌胚抗原(CEA)表达癌症的新疫苗。许多癌症都表达CEA，包括结肠癌、乳腺癌和胰腺癌。预计这种新的生物治疗产品将补充现有治疗CEA表达癌症的治疗手段。该产品由S公司新型腺病毒血清-5型平台组成，表达CEA(Ad5[E1-，E2b-]-CEA)，可诱导抗体和细胞介导的免疫反应，从而产生抗肿瘤活性。该产品是在必要和充足的人类E.C7细胞系中生产的。在cGMP条件下已经产生了一个主细胞库。在此第二阶段SBIR计划中，我们将(1)评估制造过程的稳健性，(2)执行额外的GMP生产运行以支持下一阶段的临床试验，(3)在动物中进行产品生物分布研究，(4)使用治疗产品开发功能分析，以及(5)对产品进行货架期研究。预计这些过程和研究的完成将使我们能够生产足够的产品来支持大规模临床试验，以推动这种用于CEA表达癌症的主动免疫疗法的新生物疗法的批准。