Title |
Localization of Pancreatic Cancer by a Pretargeted 18F-Hapten-Peptide
|
Institution |
IMMUNOMEDICS, INC., MORRIS PLAINS, NJ
|
Principal Investigator |
Wegener, William
|
NCI Program Director |
Ming Zhao
|
Cancer Activity |
Small Business - Cancer Detection/ Diagnosis/ Prog
|
Division |
SBIRDC
|
Funded Amount |
$213,982
|
Project Dates |
08/01/2013 - 07/31/2014
|
Fiscal Year |
2013
|
Project Type |
Grant
|
Research Topics w/ Percent Relevance |
Cancer Types w/ Percent Relevance |
Cancer (100.0%)
Digestive Diseases (100.0%)
|
Pancreas (100.0%)
|
Research Type |
Technology Development and/or Marker Discovery
|
Abstract |
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. |