Dartmouth Wins FDA Approval for Aid to Guide Cancer Surgery

The go-ahead is a milestone for Dartmouth and for the future of molecularly guided cancer surgery.

Keith Paulsen, left, the Robert A. Pritzker Professor of Biomedical Engineering and the scientific director of Dartmouth's Center for Surgical Innovation, and Pablo Valdes, GRAD '11, Thayer '11, Geisel '14, discuss tumor fluorescence imaging.

In a major milestone for Dartmouth and for the future of molecularly-guided cancer surgery, Dartmouth has gained FDA approval for a study that may give surgeons a new "guiding light" during cancer surgeries.

The approval gives Dartmouth the go-ahead for the first study involving humans of a fluorescent agent for guiding tumor surgery. The agent, called ABY-029, binds to cancer cell receptors and highlights tumors during surgery. It’s a small, non-biologically produced molecule that is expected to provoke little, if any, immune response.

"Our approach will dramatically accelerate the paradigm shift towards molecularly guided surgical oncology," says Keith Paulsen, the Robert A. Pritzker Professor of Biomedical Engineering and scientific director of Dartmouth's Center for Surgical Innovation. "Dartmouth's platform created a unique path for reducing the up-front costs of producing imaging agents for intraoperative use that allowed us to realize this new molecular probe for guiding surgery. And with FDA approval, we can now test how well it works."

Dartmouth designed a clinical study to test ABY-029 using micro-dose injections, very small quantities that are "well below the doses needed to cause the types of physiological effects often seen with therapeutic drugs, but may still allow surgeons to resect small amounts of residual disease that can be very difficult to detect otherwise," says lead clinical investigator David Roberts of Dartmouth-Hitchcock Medical Center (DHMC).

Thayer School of Engineering — including professors Brian Pogue, Scott Davis, and Jonathan Elliott — and the Geisel School of Medicine coordinated the production of the drug with project partners Affibody AB, LI-COR Biosciences, and the University of Alabama at Birmingham (UAB) Vector Production Facility.

ABY-029 will soon be tested in six to 12 patients with recurrent glioma, a type of tumor that starts in the brain or spine. The study will employ a commercial state-of-the-art surgical microscope adapted to detect fluorescent emissions from ABY-029. DHMC’s Center for Surgical Innovation is a surgical facility that is prioritized for research studies. With its extra-large operating rooms and advanced intraoperative imaging capabilities, MRI, and CT, which can be used to confirm that new procedures and techniques are working correctly, the center is ideally suited to conducting the research.

Although interest in developing ways to augment surgical guidance with molecular-specific information has been growing, economic constraints and scientific challenges have impeded the path to human studies. To address this need, Dartmouth formed an academic-industrial partnership to create a cost-efficient pipeline for low-risk development and clinical translation of molecularly targeted fluorescent imaging agents. The five-year project was funded by the National Cancer Institute in 2013, the second in a continuing series that seeks to improve the success rate of transitioning discoveries and engineering developments into tools to help health care professionals solve problems involving cancerous preconditions, risk, or disease.

Building on the results of this study, Dartmouth expects to continue with its partners to test the safety and efficacy of ABY-029 in additional trials in the future.