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

Etubics公司正在FDA IND 14325下的I/II期临床试验中临床测试一种靶向表达癌胚抗原（CEA）的癌症的新疫苗。许多癌症表达CEA，包括结肠癌、乳腺癌和胰腺癌。预计这种新的生物素产物将补充现有治疗CEA表达癌症的方法。该产品由该公司的新型腺病毒血清型-5平台组成，表达CEA（Ad 5 [E1-，E2 b-]-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。本品在必要且足够的人E.C7细胞系中生产。已在cGMP条件下生产主细胞库。在该II期SBIR项目中，我们将（1）评价生产工艺的耐用性，（2）进行额外的GMP生产运行以支持下一阶段临床试验，（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试验，以及（5）进行产品的有效期研究。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，这些试验是批准这种新的生物素用于表达CEA的癌症的主动免疫治疗所必需的。

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.