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

通过预靶向 18F-半抗原肽定位胰腺癌

基本信息

批准号：
8587960
负责人：
William A. Wegener
金额：
$ 21.4万
依托单位：
IMMUNOMEDICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2014-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8587960
关键词：
90Y Acute Address Animals Antibodies Applications Grants Autopsy Binding Biological Markers Bispecific Antibodies Blood CA-19-9 Antigen Cancer Detection Cancerous Clinical Clinical Research Clinical Trials Companions Complement Contracts Detection Development Diagnosis Disease Docking Dose Drug Kinetics Epitopes Funding Glycine Goals Grant Half-Life Haptens Histamine Human Image Immunoglobulin G Institution Investigation Label Legal patent Lesion Longevity Lymphoma Malignant - descriptor Malignant Neoplasms Malignant neoplasm of lung Malignant neoplasm of pancreas Methods Monitor Monkeys Mucins Normal tissue morphology Pancreas Pancreatic Intraepithelial Neoplasia Pancreatic carcinoma Pancreatitis Patients Peptides Phase Positron-Emission Tomography Predictive Value Preparation Procedures Production Radioisotopes Radiolabeled Randomized Recombinants Reporting Running Safety Site Small Business Innovation Research Grant Specificity Staging Technology Therapeutic Therapeutic Uses Time Tissues Toxic effect X-Ray Computed Tomography Xenograft Model Xenograft procedure base cancer type fluorodeoxyglucose fluorodeoxyglucose positron emission tomography imaging modality improved interest molecular imaging novel oncology pre-clinical preclinical study public health relevance radiotracer research clinical testing response tumor uptake

项目摘要

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.

描述（由申请人提供）：该 SBIR 申请的总体目标是启动双特异性抗体 (bsMAb) 预靶向程序的临床试验，用于检测胰腺癌，基于识别胰腺粘蛋白中发现的表位的高度特异性抗体 (PAM4)。预靶向程序在临床前和临床上已被证明比用于 PET 成像的 18F-FDG 具有更高的敏感性和特异性，最近我们开发了一种新型“AlF”程序，用于免疫 PET 预靶向氟化肽。 Immunomedics 已经完成了将用于本临床研究的 bsMAb (TF10) 和半抗原肽 (IMP485) 的 GMP 生产。然而，在开始临床研究之前，Immunomedics 需要在相关动物物种（猴子）中进行所需的 PK/急性毒性研究、遵循考虑要点的免疫组织学研究，显示 TF10 bsMAb 与组织的反应性，以及最后用 GMP 衍生产品进行一些基础动物研究，以说明靶向条件。我们打算将这些任务作为 I 期 SBIR 申请的一部分来完成，然后再申请 II 期资金来支付临床试验的部分费用。