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Novel Antithrombotic Diadenosine Tetraphosphate Analogs

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA171744-01A1
Agency Tracking Number: R43CA171744
Amount: $213,982.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA12-088
Timeline
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
300 The American Road
Morris Plains, NJ 07950-
United States
DUNS: 115350605
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 WILLIAM WEGENER
 (973) 605-8200
 bwegener@immunomedics.com
Business Contact
 CHENG CHAU
Phone: (973) 605-8200
Email: ccheng@immunomedics.com
Research Institution
 Stub
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, Immunomedicswill 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. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: This project seeks to develop a bispecific antibody (bsMAb) pretargeting procedure based on the humanized PAM4 antibody that is highly specific for pancreatic cancer. Since preclinical studies have shown pretargetingcan be more sensitive and specific than 18F-FDG-PET for cancer detection, we believe the specificity of the bsMAb for pancreatic carcinoma can allow this pretargeting procedure to become a highly reliable method for detecting pancreatic cancer, potentiallyin its early stage of development.

* Information listed above is at the time of submission. *

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