Award
NIH Reporter #5R44DK143865-02
In-vivo study of KSP/QRH heptapeptide dimer for detection of biliary intra-epithelial neoplasia
Recipient
IN VIVO MICROSYSTEMS TECHNOLOGIES, LLC
Award Amount
$1,023,757.00
Ceiling
$1,023,757.00
Awarded
July 28, 2026
Identifier
5R44DK143865-02
A Phase 2 multi-center study to develop and clinically test a novel fluorescent peptide heterodimer imaging agent for early detection of malignant biliary strictures, enhancing specificity and sensitivity over current imaging methods.
Description
This Direct to Phase 2 SBIR project aims to perform a Phase 2 multi-center study to advance the clinical utility of a targeted image contrast agent. The study involves a near-infrared fluorescently-labeled peptide heterodimer specific for EGFR and ErbB2, administered in the biliary tract to distinguish benign versus malignant biliary strictures. The project includes synthesizing the peptide heterodimer under GMP, distributing to clinical sites, monitoring stability, conducting in vivo imaging with a multi-modal fiber cholangioscope, and using a deep learning algorithm to evaluate images for malignancy detection.