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

• 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
• 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

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)。预靶向程序已在临床前和临床上被证明比用于 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）中进行必要的 PK/急性毒性研究，按照考虑要点进行免疫组织学研究，显示 TF10 bsMAb 与组织的反应性，最后使用 GMP 衍生产品进行一些基本动物研究，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。