Localization of Pancreatic Cancer by a Pretargeted 18F-Hapten-Peptide

描述（由申请人提供）：本SBIR申请的总体目标是启动一项使用双特异性抗体（bsMAb）预靶向程序检测胰腺癌的临床试验。 癌症，基于高度特异性抗体（PAM 4）识别胰腺粘蛋白中发现的表位。在临床前和临床上，预靶向程序已经显示出比用于PET成像的18F-FDG更高的灵敏度和更高的特异性，并且最近我们已经开发了一种新的“AlF”程序，用于氟化肽用于具有预靶向的免疫PET。Immunomedics已经完成了将用于本临床研究的bsMAb（TF 10）和半抗原肽（IMP 485）的GMP生产。然而，在开始临床研究之前，Immunomedics需要在相关动物种属（猴）中进行所需的PK/急性毒性研究，按照考虑要点进行免疫组织学研究，显示TF 10 bsMAb与组织的反应性，最后使用GMP衍生产品进行一些基础动物研究，以说明靶向条件。我们打算完成这些工作，作为第一阶段SBIR申请的一部分，然后申请第二阶段资金，以支付临床试验的部分费用。

DESCRIPTION (provided by applicant): The overall goal of this SBIR application is to initiate a clinical trial with a bispecific antibody (bsMAb) pretargeting procedure for detecting pancreatic carcinoma, based on a highly specific antibody (PAM4) recognizing an epitope found in pancreatic mucin. The pretargeting procedure has been shown pre-clinically and clinically to be highly sensitive and more specific than 18F-FDG for PET imaging, and recently we have developed a novel "AlF"-procedure for fluorinating peptides for immunoPET with pretargeting. Immunomedics has already completed the GMP-manufacturing of the bsMAb (TF10) and the hapten-peptide (IMP485) that will be used for this clinical study. However, prior to initiating clinical studies, Immunomedics will need to have a required PK/acute toxicity study performed in a relevant animal species (monkeys), an immunohistology study following the Points to Consider, showing the reactivity of the TF10 bsMAb with tissues, and finally some basic animal studies with the GMP-derived products to illustrate targeting conditions. We intend to complete these tasks as part of the Phase I SBIR application, and then later apply for Phase II funding to cover part of the expenses of the clinical trial.