Dartmouth, LI-COR and Affibody receive NIH grant for development and
translation of imaging agents for fluorescence-guided surgery
LINCOLN, Neb.--(BUSINESS WIRE)--
Surgery is the cornerstone of oncology treatment, and
molecularly-targeted fluorescent imaging agents have the potential to
guide surgical resection by highlighting the biological margins of the
disease. However, development and testing of such molecular imaging
agents has been lacking. The Thayer School of Engineering and Geisel
School of Medicine at Dartmouth together with LI-COR Biosciences and
Affibody AB announce a new Academic/Industry Partnership to establish an
efficient pipeline for development and translation of
molecularly-targeted agents. The five-year project is funded by the
National Cancer Institute.
This groundbreaking study will use a cost-effective, risk-diluted
approach for rapid development and testing of molecularly-targeted
imaging agents in phase 0 microdosing studies. The microdosing studies
are designed to evaluate imaging of specific targets.
“Targeting an evaluation of imaging in early human surgical trials will
allow us to efficiently assess potential candidates for further
development,” says Dr. Brian Pogue, lead investigator and Professor of
Engineering at Dartmouth. “This approach will dramatically accelerate
the paradigm shift to molecularly-guided surgical oncology. This grant
will allow us to develop and test agents produced with current Good
Manufacturing Practices whose primary use will be in diagnostic guidance
in surgical oncology, and used at microdoses similar to nuclear medicine
The first agent will be an Affibody® molecule targeted to the
epidermal growth factor receptor (EGFR), which is overexpressed in a
broad range of cancers.
“The use of Affibody’s proprietary molecules for optical imaging
represents an exciting extension of our technology,” says Dr. Fredrik
Frejd, CSO at Affibody. “Due to the high target specificity and
favorable tissue distribution properties of Affibody®
molecules, tumors and their boundaries can be rapidly identified and
characterized, which may allow for the development of image-guided
surgery as a potential option for improved brain tumor treatment”.
“Imaging agents will be conjugated with IRDye 800CW (a near-infrared
fluorescent dye developed by LI-COR), and compounds will be produced
under cGMP conditions,” says Dr. Brad Roth, director of business
development at LI-COR. The study will employ commercially available
state-of-the-art surgical microscopes from Leica and Zeiss that are
equipped for intraoperative fluorescence imaging.
Surgical signal detection and binding specificity will be the primary
outcomes from the phase 0 trials. First-in-human studies with recurrent
high-grade brain tumor patients will be pursued at Dartmouth under the
direction of Dr. David Roberts, Section Chief of Neurosurgery, and Dr.
Keith Paulsen, director of the Dartmouth Advanced Imaging Center.
Approval for the microdosing studies will be sought under the
exploratory investigational new drug (eIND) pathway at the FDA. This
unique partnership brings together the intellectual property, expertise,
and infrastructure needed for rapid development and clinical translation
of molecularly-targeted imaging agents for fluorescence-guided surgery.